Search Results
Found 10 results
510(k) Data Aggregation
(347 days)
and accessories regulated under 21 CFR §876.5820, 21 CFR §876.5860, 21 CFR §876.5540, and/or 21 CFR §876.5600
The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. The Theranova Dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for the Theranova Dialyzer and the set should represent less than 10% of the patient's blood volume.
The Theranova 400 and 500 Dialyzers (referred to collectively as Theranova Dialyzers) are hollow fibers dialyzers that are intended for use in the treatment of chronic renal failure by intermittent hemodialysis. The hollow fiber membrane used in this device is a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP). The membrane surface area for the Theranova 400 Dialyzer is 1.7 m2. while that for the Theranova 500 Dialyzer is 2.0 m². Theranova Dialyzers are intended to be used as part of a high permeability hemodialysis system (such as those regulated under 21 CFR §876.5860). Theranova Dialyzers should be used with blood tubing sets with connectors that comply with ISO 8637 and a monitor that controls and monitors the ultrafiltration rate. Theranova Dialyzers are not intended to be used for hemofiltration or hemodiafiltration. Thev are steam-sterilized, single use only devices.
Theranova Dialyzers are intended to treat chronic renal failure by removal of solutes and plasma water from the blood when used with a hemodialysis monitor capable of ultrafiltration control. The blood travels through the hollow fibers and exits via a blood exit port. Plasma water and certain low and middle molecular weight solutes pass through the hollow fiber membrane and into the countercurrent flowing dialysis solution, removing uremic toxins and waste products by means of diffusion and convection. In addition to the typical removal of small solutes and plasma water, Theranova Dialyzers can remove greater amounts of larger solutes (up to 45 kDa) due to the membrane design.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Theranova Dialyzers (Theranova 400, Theranova 500) - Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
The provided document outlines bench performance testing and clinical study endpoints which function as acceptance criteria for the device. Many bench tests are characterized as "N/A; device performance characteristic," meaning an explicit numeric acceptance criterion isn't stated but rather the performance is reported for characterization. For the clinical study, specific non-inferiority and superiority margins serve as acceptance criteria.
Table: Acceptance Criteria and Reported Device Performance
| Test/Endpoint | Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Bench Performance Testing | |||
| Ultrafiltration Coefficient | N/A; device performance characteristic | Theranova 400: 48 mL/h/mmHg, Theranova 500: 59 mL/h/mmHg | Bench |
| Pressure drop -blood compartment (various QB) | N/A; device performance characteristic | See Table 2 (e.g., Theranova 400: ≤90 mmHg @ 200 mL/min, Theranova 500: ≤80 mmHg @ 200 mL/min etc.) | Bench |
| Pressure drop -dialysate compartment (various QD) | N/A; device performance characteristic | See Table 2 (e.g., Theranova 400: ≤20 mmHg @ 300 mL/min, Theranova 500: ≤15 mmHg @ 300 mL/min etc.) | Bench |
| Clearance of Urea | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 191 mL/min @ QB 200, QD 300; Theranova 500: 192 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Phosphate | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 179 mL/min @ QB 200, QD 300; Theranova 500: 182 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Creatinine | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 184 mL/min @ QB 200, QD 300; Theranova 500: 186 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Vitamin B12 | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 148 mL/min @ QB 200, QD 300; Theranova 500: 152 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Inulin | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 119 mL/min @ QB 200, QD 300; Theranova 500: 124 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Cytochrome C (marker molecule) | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 109 mL/min @ QB 200, QD 300; Theranova 500: 114 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Myoglobin | N/A; device performance characteristic | See Table 3 (various QB/QD, e.g., Theranova 400: 93 mL/min @ QB 200, QD 300; Theranova 500: 98 mL/min @ QB 200, QD 300) | Bench |
| Clearance of Chitinase-3-like protein 1 YKL-40 | Mean clearance of YKL-40 is ≥ 22 mL/min (± 20%) | Pass (Mean clearance value for Theranova 400 and 500 at QB/QD 400/700 mL/min = 30 mL/min) | Bench |
| Sieving coefficient of Chitinase-3-like protein 1 YKL-40 | Sieving coefficient of YKL-40 ≥30% (± 20%) | Pass | Bench |
| Protein Loss Test | In-vitro protein loss ≤1.13 g/L | Pass | Bench |
| Endotoxin retention testing | Patient exposure to endotoxin is below 5 EU/kg/hr | Pass | Bench |
| Drug removal testing | N/A; comparative testing of device drug removal to other high-flux dialyzers | Representative drugs were not removed significantly differently by Theranova Dialyzers as compared to other high-flux dialyzers | Bench |
| Mechanical hemolysis testing | NA; comparative testing of mechanical hemolysis testing to other high-flux dialyzers | Results establish that Theranova Dialyzers are comparable to other high-flux dialyzers | Bench |
| Clinical Study Endpoints (Theranova 400 vs. Elisio-17H) | |||
| Primary Safety: Pre-dialysis Serum Albumin (non-inferiority) | Lower bound of two-sided 95% CI > -0.1765 g/dL | Lower bound of two-sided 95% CI was -0.098 g/dL (met non-inferiority) | Clinical Trial |
| Primary Efficacy: Reduction Ratio (RR) of λFLCs (superiority) | Lower bound of two-sided 95% CI around the difference > 0 | Mean Estimated Treatment Difference = 14.828; 95% CI (10.501, 19.156) (demonstrated superiority) | Clinical Trial |
| Secondary Efficacy: λFLC RR (4 weeks) | N/A (evaluated for performance) | Significantly higher in Theranova group | Clinical Trial |
| Secondary Efficacy: CFD RR (4 & 24 weeks) | N/A (evaluated for performance) | Significantly larger reduction ratios in Theranova group | Clinical Trial |
| Secondary Efficacy: κFLC RR (4 & 24 weeks) | N/A (evaluated for performance) | Significantly larger reduction ratios in Theranova group | Clinical Trial |
| Secondary Efficacy: IL-6, TNFα, ß2m RR (4 & 24 weeks) | N/A (evaluated for performance) | Not significantly different between groups | Clinical Trial |
| Secondary Efficacy: Change in pre-dialysis ß2m (24 weeks) | N/A (evaluated for performance) | No significant difference | Clinical Trial |
| Secondary Efficacy: Urea Clearance (Kt/Vurea) (every 4 weeks) | N/A (evaluated for performance) | No significant change in Kt/V (urea) between the two study groups over the course of the study | Clinical Trial |
| Secondary Safety: Pre-dialysis serum albumin (trends) | N/A (evaluated for trends) | Small, but statistically significant reduction at Weeks 4 and 8. Changes from baseline not significantly different between groups at Week 12 and thereafter. | Clinical Trial |
| Secondary Safety: Factor VII, Protein C, Factor II (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: Vitamin A (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: nPNA (trends) | N/A (evaluated for trends) | No significant difference in mean change from baseline | Clinical Trial |
| Secondary Safety: Chemistry, hematology, coagulation lab tests | N/A (evaluated for changes) | Some small, statistically significant changes in electrolytes/hematology, but remained within normal/expected ranges and clinically insignificant. No significant changes for coagulation. | Clinical Trial |
| Secondary Safety: Adverse Events | N/A (evaluated for incidence) | No significant differences in total AEs, SAEs, or device-related AEs. | Clinical Trial |
| Exploratory: hs-CRP | N/A (evaluated for differences) | No significant differences | Clinical Trial |
| Exploratory: KDQOL-36, EQ-5D-5L | N/A (evaluated for differences) | No significant differences | Clinical Trial |
2. Sample size used for the test set and the data provenance
For Bench Testing:
The document does not explicitly state the sample sizes for each specific bench test (e.g., number of dialyzers tested for ultrafiltration coefficient). However, it implies testing was conducted according to various ISO standards and established protocols.
- Data Provenance: In-vitro testing (laboratory setting). No country of origin is specified for these bench tests, but the sponsor is Baxter Healthcare Corporation, based in Illinois, USA.
For Clinical Study (Theranova 400 Randomized Controlled Trial [NCT03257410]):
- Test Set Sample Size:
- Enrolled patients: 172
- Randomized patients: 172 (86 to Theranova 400 group, 86 to Elisio-17H group) - This forms the Full Analysis Set (FAS).
- Completed the trial: 130 patients (65 in each group). This forms the basis for the Per-Protocol Set (PPS).
- Data Provenance: Prospective, multicenter, randomized controlled open-label trial conducted in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not directly applicable in the traditional sense of a diagnostic device where experts label "ground truth" for interpretations (e.g., radiologists for medical images).
- For Bench Testing: The "ground truth" is established by direct physical or chemical measurements according to standardized methods (e.g., ISO 8637, ISO 10993) using laboratory equipment. No human experts are "labeling" the ground truth in this context.
- For Clinical Study: The "ground truth" (i.e., patient outcomes, lab results like serum albumin, λFLC reduction ratios) is established through medical laboratory assays and clinical assessments performed by trained medical personnel and technicians at the participating clinical sites. These are objective measurements rather than subjective expert interpretations requiring adjudication. The study involved a multi-center team of clinicians (treating physicians) and study staff for patient care and data collection.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For Bench Testing: No adjudication method is applicable as these are objective measurements.
- For Clinical Study: The "ground truth" for patient outcomes (laboratory values, adverse events) is based on direct measurements and clinical observation, not subjective interpretation requiring "adjudication" in the sense of multiple readers agreeing on a finding. Adverse events were likely recorded by site investigators and potentially reviewed by a central safety committee, but this is not an "adjudication method" for establishing ground truth like in image analysis.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a hemodialyzer, not an AI software for diagnostic interpretation. Therefore, no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical device (hemodialyzer), not an algorithm. Its performance is tested directly (bench testing) and through its effect on patients (clinical trial), not through an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Bench Testing: Physical and chemical measurements (e.g., concentrations, volumes, pressures) and standardized biological assays (e.g., cytotoxicity, endotoxin levels).
- For Clinical Study:
- Primary Safety Endpoint: Pre-dialysis serum albumin levels (objective laboratory measurement).
- Primary Efficacy Endpoint: Pre- versus post-dialysis Reduction Ratio (RR) of λFLC (objective laboratory measurement).
- Other Endpoints: Other objective laboratory measurements (e.g., B2m, Kt/Vurea, CFD, kFLC, IL-6, TNFα, electrolytes, hematology, coagulation, Vitamin A), and documented adverse events.
- Patient Reported Outcomes (PROs): Standardized questionnaires (KDQOL-36, EQ-5D-5L) provided patient perspectives.
8. The sample size for the training set
- Not applicable. This device is a hemodialyzer. There is no concept of a "training set" in the context of device development as there would be for an AI/ML algorithm. The clinical trial serves as the primary evaluation of the device's performance in a human population.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for this type of device, this question is not relevant.
Ask a specific question about this device
(147 days)
|
| Classification | 21 CFR 876.5600
SmartBag is intended for use inside and out of hospitals for any patient with a diversionary urinary or fecal stoma. It works in conjunction with 11 Health's care management platform known as Alfred. The SmartBag system uses integrated sensors to continuously monitor bag filling and drainage, providing cumulative output data to the patient and clinical team. The system also monitors skin condition, the occurrence of leaks and visual condition of the stoma.
SmartBag's intended use is to help ostomates acclimate to their lifestyle. It works in conjunction with 11 Health's care management platform known as Alfred, designed for patients and medical professionals. The SmartBag system (including the wafer and Hub), offers a continuous ostomy monitoring system, tracks the estimated volumetric filling of the bag and visual condition of the stoma using integrated sensor technology.
The SmartBag Sytem is for adult use only. (22 years and above)
The SmartBag with integrated thermistors and capacitive sensors can be used in place of a traditional ostomy bag. It notifies patients or medical professionals of any potential leaks around the peristomal skin as well as giving an estimate of the output volume within the bag.
Alfred software is a companion software suite for SmartBag. It consists of Alfred mobile app and Alfred hospital app. Alfred mobile app is a companion application for mobile phone. The application provides SmartBag user easy access to bag status, hydration tracking and restroom search functionalities. The SmartBag could operate without Alfred mobile app.
The sensors in the bag and the wafer will be able to transmit data to the hub via NFC protocol communication. The data from the hub will be transmitted to the cloud via LTE-M data transfer via secure MQTT protocol and then this data can be downloaded to web supported devices – such as an iPhone.
The provided text is a 510(k) summary for the SmartBag (SmartPouch) device. While it describes the device's indications for use, comparison to predicate devices, and non-clinical performance data, it does not contain a table of acceptance criteria or a detailed study proving the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity against a defined ground truth on a test set.
The document primarily focuses on demonstrating the functionality and usability of the device's volumetric and leakage detection features through a series of bench experiments and simulations. It concludes that the SmartBag prototype is "proven to be functional for volumetric measurement and leakage detection from our simulated bench tests."
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone performance. The document does not describe a clinical study with these elements.
However, I can extract information about the types of non-clinical tests performed, which could be considered a form of "acceptance criteria demonstration" for basic functionality:
Non-Clinical Performance Data (Functionality Testing):
| Acceptance Criteria (Implied Functionality) | Reported Device Performance (Conclusion) |
|---|---|
| Volumetric Sensor Sheet Functionality: | The volumetric sensor sheet is capable of: |
| Ability to detect dynamic simulated infusions. | - Detecting dynamic simulated infusions |
| Ability to detect static volume of infused materials. | - Detecting static volume of infused materials |
| Ability to recognize different viscosities of simulated infusions. | - Recognizing different viscosities of the simulated infusions |
| Ability to measure volume in different body positions (standing/supine). | - Measure volume of the simulated infusions when user is in standing or supine positions |
| Ability to measure volume in high heat environments (close to infusion temp). | - Measure volume of the simulated infusions when the environment temperature is close to infusion temperature, with the aid of capacitors |
| Wafer Sensor Sheet Functionality: | The wafer sensor sheet is capable to: |
| Ability to detect simulated leakage with correct log interval. | - Detect simulated leakage with the correct log interval |
| Durability and functionality after saturation in water at 37°C for 7 days. | - Remain durable and functional after 7 days of saturation in 37 °C water bath |
| Overall functionality: | Consequently, the SmartBag prototype is proven to be functional for volumetric measurement and leakage detection from our simulated bench tests. (Note: These are functional conclusions, not quantitative performance metrics like accuracy or sensitivity percentages). |
Here's why the other requested information cannot be provided from this document:
- Sample size for the test set and data provenance: The document details "in-house non-clinical bench experiments" and "simulated" tests, some on "human volunteers." It doesn't specify a rigorous, statistically powered "test set" in the context of typical AI/medical device clinical studies (where cases are adjudicated against a ground truth). It refers to test reports like "028_Testing Report 3_SmartBag Prototype Water and Apple Infusion Simulation Test," suggesting a focus on engineering verification rather than clinical validation. The provenance is "in-house."
- Number of experts and qualifications, adjudication method: Not applicable as the testing described is primarily engineering bench testing and simulation, not expert-adjudicated clinical data.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or implied. The device's primary function is continuous monitoring and data collection, not an AI assisting human readers with interpreting medical images or data for diagnostic purposes in a comparative setting.
- Standalone (algorithm only) performance: While the device collects data autonomously, the "performance" described is functional operation in simulated environments rather than a quantifiable diagnostic or predictive accuracy.
- Type of ground truth used: The "ground truth" for these tests appears to be the known conditions of the simulations (e.g., specific volumes of fluid infused, presence/absence of simulated leaks, known temperatures, known viscosities). It's not a clinical ground truth like pathology or patient outcomes.
- Sample size for the training set and how ground truth for training was established: The document does not describe a machine learning model that was "trained" in the typical sense with a separate dataset. The "sensors" and "algorithms" (implicitly) seem to be based on physical principles and engineering design, not data-driven machine learning from a large training dataset.
In summary, this 510(k) summary focuses on demonstrating the engineering functionality and safety of the SmartBag device through non-clinical bench tests and simulations, rather than providing clinical performance data from a statistically designed study involving ground truth established by experts.
Ask a specific question about this device
(64 days)
Classification Name | System, Dialysate Delivery, Sorbent Regenerated |
| Regulation Number | 876.5600
WARRENDALE PA 15086
Re: K123835
Trade/Device Name: 2008 Sorbent System Regulation Number: 21 CFR§ 876.5600
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System consists of two distinct components:
- the 2008 Machine, and .
- . the SORB™ Module.
The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.
During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
The provided text describes a Special 510(k) submission for an updated version of a hemodialysis system, the 2008 Sorbent System. This type of submission focuses on demonstrating substantial equivalence to a predicate device (an already legally marketed device) through verification testing for modifications that do not significantly alter the device's fundamental technology, indications for use, or safety and effectiveness.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense of a performance study with specific outcome measures and thresholds. Instead, it describes a "verification testing summary" aimed at demonstrating that the modified device meets its design requirements and is substantially equivalent to the predicate device.
The "performance" is implicitly defined by the successful completion of these verification activities, indicating that the modified device functions as intended and safely.
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by verification testing) |
|---|---|
| 2008 System Software/Hardware Functionality | Success: Meets performance specifications (Functional SW Verification, Disinfection, Infusate Delivery, Modes of Operation, Alarms testing). |
| HISORB+ Cartridge Performance & Equivalence | Success: Dialysate chemistries are comparable, performance (modified cartridge) is acceptable, and passes shipping test. |
| Substantial Equivalence to Predicate Device (K093362) | Success: Design verification testing demonstrates that the device meets design requirements and supports substantial equivalence. (Implies all functional aspects are comparable). |
| General Safety and Effectiveness (no new questions raised) | Success: Performance and technological characteristics are equivalent, raising no new safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "test sets" in the context of a clinical study. The testing described is non-clinical verification testing (e.g., software testing, hardware testing, cartridge performance), not a study involving human patients. Therefore, the "sample size" would refer to the number of test runs, prototypes, or cartridges used to perform the verification, which is not detailed.
- Data Provenance: The data is likely internal to the manufacturer, Renal Solutions, Inc., and represents retrospective (or in-house) testing focusing on engineering and performance verification of the device itself, rather than prospective clinical data from patients. There is no information regarding the country of origin of data, as it's not a clinical data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for non-clinical verification testing is typically established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel within Renal Solutions, Inc., responsible for design, testing, and regulatory affairs. Their specific numbers and qualifications are not detailed here, as this is not a study requiring expert clinical review for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple human readers assess cases and discrepancies need to be resolved. This submission describes non-clinical verification testing of a device's functionality and performance against engineering requirements and established safety standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a hemodialysis system, not an imaging or diagnostic AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a hemodialysis machine with a sorbent system. It is a physical medical device for treatment, not an algorithm or AI system for standalone performance evaluation. Its operation still requires a healthcare practitioner ("human-in-the-loop") as stated in its Indications for Use.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Engineering Specifications and Design Requirements: The device was tested to ensure it met its own defined performance parameters.
- Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate device (2008 Sorbent System, K093362). The modified device's performance was compared to, and intended to be equivalent to, that of the predicate.
- Regulatory Standards: Implicitly, the verification testing would also adhere to relevant industry standards and regulatory guidance for hemodialysis devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical hemodialysis system, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not a machine learning model).
Ask a specific question about this device
(289 days)
- 772-6925 Classification Name System, Dialysate Delivery, Sorbent Regenerated Regulation Number 876.5600
Re: K093362
Trade/Device Name: 2008 Sorbent System Regulation Number: 21 CFR §876.5600
Regulation Number
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.
The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The 2008 Sorbent System operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). The 2008 Sorbent System consists of two distinct components: the 2008 Machine, and the SORB™ Module. The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system. During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.
The provided text describes the 2008 Sorbent Hemodialysis System, focusing on its substantial equivalence to predicate devices and the verification testing performed. However, it does not include the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered medical device.
The document is a 510(k) summary for a Sorbent Hemodialysis System, which is a medical device for dialysate delivery, not an AI or software-intensive diagnostic device in the sense your questions imply (e.g., test sets, ground truth, expert consensus, MRMC studies). The "software testing" mentioned is to ensure the device's control software meets its design input requirements, not for evaluating an AI algorithm's diagnostic or predictive performance.
Therefore, many of your requested items cannot be extracted from this document as they are not relevant to the type of device being described.
However, I can extract what is available:
1. A table of acceptance criteria and the reported device performance:
The document outlines categories of testing and general objectives, implying acceptance criteria were defined for each. However, it does not explicitly state the quantitative acceptance criteria or the specific numerical performance results. Instead, it refers to "pre-defined acceptance or pass/fail criteria" and states that testing "demonstrates the device meets its performance specifications."
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| 2008 Sorbent System Performance Testing | Functional testing conducted to demonstrate the device performs as designed and expected, meeting its performance specifications. (Specific verification tests, protocols, objectives, test articles, methods, procedures, and pre-defined acceptance criteria were documented in the 510(k) submission, but not detailed here). System-level hazard analysis confirmed the device does not perform in an unexpected and/or unsafe manner. |
| 2008 Sorbent System Safety Testing | Product safety testing conducted demonstrating compliance with FDA Consensus Standards, including: Electrical safety (IEC 60601-1), Electromagnetic compatibility (IEC 60601-2-16), Biocompatibility (AAMI / ANSI / ISO 10993-1) for new patient-fluid contacting materials, and Risk Analysis (ISO 14971). |
| 2008 Sorbent System Software Testing | Software testing conducted demonstrating the device software meets the design input requirements. This included structural charts, development procedures, requirements specifications with traceability to hazard analysis, verification and validation test plans (with pass/fail criteria and traceability), system-level test results, and current software version documentation. |
| Overall Substantial Equivalence to Predicate Devices | Demonstrated the device is as safe, as effective, and performs at least as safely and effectively as the Allient Sorbent Hemodialysis System and Fresenius 2008T Hemodialysis System. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The testing described is non-clinical verification testing of a physical medical device, not a study involving patient data in the context of AI performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The ground truth for this type of device (a hemodialysis system) is established through engineering and performance specifications, adherence to standards, and risk analysis, not expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 are typically used in clinical studies involving multiple readers or interpretations, which is not what is described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done, as this device is a hemodialysis system and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The "software testing" refers to the control software of the device, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, regulatory standards (e.g., IEC, ISO), and performance requirements related to the physical and functional operation of the hemodialysis system. The document lists "pre-defined acceptance or pass/fail criteria" as part of the test protocols.
8. The sample size for the training set
This information is not applicable/provided. This device is a physical medical device, not an AI model trained on a dataset.
9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no AI model or training set in the context of this device.
In summary, the provided document describes a 510(k) submission for a Sorbent Hemodialysis System, focusing on its functional, safety, and software verification to demonstrate substantial equivalence to predicate devices. It does not contain the detailed information typically associated with the evaluation of AI-powered diagnostic or predictive medical devices.
Ask a specific question about this device
(70 days)
15086
Re: K070739
Trade/Device Name: Allient Sorbent® Hemodialysis System Regulation Number: 21 CFR §876.5600
The Allient Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Not Found
This document is a 510(k) clearance letter for the Allient Sorbent Hemodialysis System. It does not contain information on the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance data that led to this determination.
Therefore, I cannot provide the requested table or information based on the content of this document.
Ask a specific question about this device
(99 days)
| |
| 21 CFR
Reference | 876.5600
15086
Re: K060381
Trade/Device Name: Allient® Sorbent Hemodialysis System Regulation Number: 21 CFR §876.5600
The Allient Sorbent Hemodialysis System, including the SORB series and HISORB series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.
The Allient Sorbent Hemodialysis System is intended for the treatment of THE Allent Oorbont Homoutients where hemodialysis is prescribed by the ohysician. The Allient System functions as a traditional re-circulating sorbent hemodialysis system. Either single-needle or dual-needle access to the nemodialysis bystem . The system consists of the Allient hemodialysis machine, SORB™ series of sorbent cartridges, a single-use, sterile, disposable blood tubing set, a single-use disposable dialysate set, and various dialysate and infusate chemicals. The patient's blood is pumped from the access through a dialyzer and is returned to the patient.
This is a 510(k) summary for a medical device (Allient® Sorbent Hemodialysis System) and not a study describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not available in the provided text.
The document primarily focuses on establishing substantial equivalence to a previously cleared predicate device, rather than presenting a performance study with detailed acceptance criteria and results.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not describe specific acceptance criteria (e.g., performance metrics, thresholds) for the device. Instead, it asserts "substantial equivalence" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. There is no mention of a "test set" or any specific clinical data used to evaluate the device's performance against predefined criteria. The assessment is based on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Available. Since no "test set" or performance study is detailed, there's no mention of experts establishing ground truth for such a study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a hemodialysis system, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Available. As no detailed performance study with a test set is described, the concept of "ground truth" in this context is not relevant. The substantial equivalence is based on similar design, operating principles, and intended use as the predicate device.
8. The sample size for the training set
- Not Applicable / Not Available. This device is not an AI/ML algorithm that would typically involve a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Available. As above, this concept doesn't apply to the reported device.
Summary of available information related to the device:
- Device Name: Allient® Sorbent Hemodialysis System
- Intended Use: Treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.
- Predicate Device: Allient Sorbent Hemodialysis System K043572 (or K043574 as cited later, which appears to be the same predicate).
- Basis for Equivalence:
- Same indicated use.
- Same operating principles.
- Same basic system design.
- Incorporates the same accessories and generic materials, manufactured, packaged, and sterilized using the same processes.
- Regulatory Classification: Class II, Product Code FKT, Regulation Number 21 CFR §876.5600 (Sorbent regenerated dialysate delivery system for hemodialysis).
In conclusion, the provided text is a regulatory submission for a 510(k) clearance, which aims to demonstrate substantial equivalence to an already legally marketed device rather than providing a detailed performance study with acceptance criteria and results as typically seen for novel diagnostic or AI devices.
Ask a specific question about this device
(158 days)
15086
Re: K043574
Trade/Device Name: Allient® Sorbent Hemodialysis System Regulation Number: 21 CFR §876.5600
The Allient® Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
The Allient Sorbent Hemodialysis System (Allient System) is intended for the treatment of acute or chronic uremic patients where hemodialysis is prescribed by the physician. The system consists of the Allient hemodialysis machine, SORB™ series of Sorbent cartridges, a single-use, sterile, disposable blood tubing set, a singleuse disposable dialysate set, and various dialysate and infusate chemicals. The system is recommended for use with a variety of dialyzers, access needles or access cannulae, which will be supplied by other manufacturers. The Allient System operates in a similar manner to standard hemodialysis systems currently approved for use. The only significant differences between the Allient System and standard hemodialysis machines are as follows: The Allient System utilizes a Sorbent cartridge to purify dialysate made from potable water. After passing through the dialyzer, the dialysate is recirculated to the dialyzer instead of being disposed of. The Allient System utilizes the Pulsar™ air-activated pump in contrast to the roller-activated pump commonly employed in traditional hemodialysis systems. The Pulsar blood pump is a dual-chamber pneumatically operated pump. All other aspects of Renal Solutions' Allient Sorbent Hemodialysis System process are identical to those employed in the standard "single pass" method of dialysis: there are no significant differences in the technology employed in Sorbent dialysis therapy between the Allient System and traditional methods. The Allient System functions as a traditional recirculating Sorbent hemodialysis system, similar to the REDY 2000 System. Either single-needle or dual-needle access to the patient is permitted. The patient's blood is pumped from the access through a dialyzer and is returned to the patient. Heparin is administered via a flow-controlled heparin pump capable of delivering rates of 0 to 3 milliliter per hour (mL/hr) in 0.5 mL/hr increments as well as an initial bolus of 0 to 10 mL. Blood-flow rates are settable in 10 milliliter per minute (mL/min) increments in the range of 200 to 400 mL/min in the dual-needle mode and 200 to 300 mL/min in the singleneedle mode. The dialysate delivery system consists of a container for dialysate. Sorbent regenerative cartridges, chemical infusion system to replace chemicals removed by the Sorbent cartridges, and an ultrafiltrate control system. The dialysate delivery system operates in a batch recirculating mode and continuously recirculates the dialysate through the cartridge. The cartridge removes dialyzed toxins from the dialysate and buffers the sodium and bicarbonate levels in the dialysate to maintain normal levels in the patient. The Acute mode of operation is intended for use in a hospital, acute or chronic-care facility, or dialysis clinic where the patient is continually monitored. The Acute mode of operation allows the clinician or dialysis technician to enter prescription parameters and machine operating parameters for each patient. The Allient System incorporates a Graphical User Interface (GUI) comprised of a touch-screen display, which controls the System software. The GUI is used to select the mode of operation of the Allient System and enter prescription data and machine control parameters during setup. This information is stored for future reference and verification prior to subsequent treatments. Treatment status and progress, in addition to machine status, is continually collected and displayed on the GUI screen to support treatment. The GUI's touch-screen technology also provides ease of use for Home patients. The Allient System incorporates a control system that contains a number of safety features and audible and visible alert and alarm functions to warn the operator or patient of unsafe conditions.
The provided document describes the "Allient® Sorbent Hemodialysis System" and its substantial equivalence to a predicate device, the REDY 2000. It focuses on the device's specifications and compliance with various domestic and international standards, rather than a clinical study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
However, I can extract the relevant information from the document to construct an answer regarding acceptance criteria based on performance specifications and the study that "proves" (or verifies, in this context) the device meets them.
Acceptance Criteria and Device Performance based on provided specifications:
1. Table of Acceptance Criteria and Reported Device Performance
For a medical device like a hemodialysis system, "acceptance criteria" are more about meeting technical specifications and safety standards rather than diagnostic performance metrics (like sensitivity/specificity). The document details various operating parameters, flow rates, and safety features as the de facto acceptance criteria. The "reported device performance" is implicitly stated by saying the system "meets its specifications" and various standards.
| Feature / Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Dialysate Flow Rate | 0 to 400 +/- 10% mL/min (into 25 psi max back pressure from Sorbent cartridge); Measuring Tolerance: +/- 10% of set point; Increment: 10 mL/min (200-400 mL/min range) | "The Allient System has been tested to verify that it meets its specifications as listed above." (Implicitly, the device performs within these specified tolerances.) |
| Infusate Flow Rate | 0 to 3 mL/hr against +/- psi back pressure; Measuring Tolerance: +/- 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Heparin Flow Rate | 0 to 3 mL/hr; Measuring Tolerance: +/- 0.1mL/hr (1 mL/hr); Increment: 0.25 mL/hr; Accuracy: 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Blood Flow Rates | Single Needle: 150-200 mL/min; Dual Needle: 150-400 mL/min | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Air Detectors | Detection Range: > 1.0 ml bubble or microbubbles > 1.5 ml | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Dialysate Temperature | Control Range: 34°C to 37°C | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Blood Leak Detector | Leak Detection Range: 0.35 ml/min of 0.25% hematocrit Blood in dialyzer output flow | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Saline Flow Rate | Controlled at 200 mL/min; Measuring Tolerance: +/- 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Net Ultrafiltration | Min. 20g/hour to 2000 g/hour (based on acceptable Dialyzer); Measuring Tolerance: +/- 20 g/hr or 5% (whichever is greater) | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Degassing Flow Rate | 750 mL/min (with SORB cartridge bypassed) | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Compliance with Standards | ANSI/AAMI RD17, ANSI/AAMI RD5, EN 556, IEC 60529, IEC 60601 series, ISO 10993 series, ISO 11135, ISO 8638 | "The Allient System has also been tested and meets the following domestic and international standards." |
| Substantial Equivalency | To predicate REDY 2000 system | "All testing performed on the Allient Sorbent Hemodialysis System verifies the substantial equivalency of the Allient System to the predicate REDY 2000 system." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial with patient data. The "testing" referred to is engineering verification and validation against technical specifications and recognized standards. This typically involves testing multiple units of the device and its components in a controlled laboratory environment.
- Test Set Sample Size: Not specified as a number of patients or cases. It would refer to the number of devices or components tested.
- Data Provenance: The testing is internal (by Renal Solutions Inc.) for verification and validation against engineering specifications and international standards (e.g., IEC, ISO, AAMI). This is a technical validation, not clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This concept is not applicable to the type of device and study described. For a hemodialysis machine, the "ground truth" is defined by the physical laws of operation and the engineering specifications that ensure safety and effectiveness. Experts (e.g., engineers, quality control personnel) would be involved in designing, measuring, and verifying these specifications against established benchmarks and regulatory requirements. There is no "ground truth" established by clinical experts reading or interpreting output in the way one would for an AI-driven diagnostic device.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies where there is subjective interpretation (e.g., image reading) and a need to resolve disagreements among multiple experts to establish a definitive ground truth. For the Allient System, performance is measured against objective, quantifiable engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, and the document does not mention any clinical trials comparing human performance with and without AI assistance. This type of study is typically for evaluating diagnostic accuracy or decision support systems, which the Allient System is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Allient System is a physical medical device, not an algorithm or AI system. Its performance is inherent in its electromechanical and chemical operations. Therefore, the concept of "standalone" performance for an algorithm is not applicable here. Its operation is standalone in the sense that it performs its function (dialysis) according to its design.
7. The Type of Ground Truth Used
The "ground truth" for the Allient System is based on:
- Engineering Specifications: Quantifiable parameters and tolerances for flow rates, temperatures, leak detection, etc.
- Compliance with Recognized Standards: Adherence to established domestic and international standards for medical devices (e.g., ANSI/AAMI, IEC, ISO) which define safety, electrical, biological, and sterilization requirements.
- Predicate Device Performance: The predicate device, REDY 2000, serves as a benchmark for "substantial equivalency," implying its established safety and effectiveness forms part of the "ground truth" or acceptable performance standard.
8. The Sample Size for the Training Set
This concept is not applicable. The Allient System is not an AI/ML algorithm that requires a "training set" of data. Its design and operational parameters are determined through engineering principles, bench testing, and adherence to established medical device standards.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no "training set" for this type of medical device. The "ground truth" for its design and verification is established through a combination of engineering design principles, regulatory requirements, and established industry standards for hemodialysis systems.
Ask a specific question about this device
(163 days)
WARRENDALE PA 15086
Re: K031099
Trade/Device Name: SORB+ and HISORB+ Cartridges Regulation Number: 21 CFR §876.5600
The SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
Sorbent (or regenerative) dialysis systems use the chemical action of a sorbent cartridge to remove urea and other waste materials from the dialysate and return the fresh dialysate to the dialysate holding tank. This fresh dialysate then passes through a dialyzer, removes additional waste material, and re-circulates through the sorbent cartridge to continue the process. This contrasts to traditional "single pass" dialysis, which uses purified water passing across the dialysate side of a dializer membrane in a single flow-through system to remove urea and other waste materials from the dialysis patient's bloodstream. Wastewater is routed to a drain and not recirculated. By re-circulating and refreshing the dialysate, the Renal Solutions' REDY System uses 6L of water per dialysis treatment. A traditional single pass dialysis system uses at least 120L of purified water during the typical 4 hour dialysis session.
The SORB+ and HISORB+ Cartridges are intended to be used in a Renal Solutions REDY Sorbent Hemodialysis System as the chemical agents that absorb the urea and other waste material from the dialysate stream.
Here's an analysis of the provided text to extract the acceptance criteria and study information:
Acceptance Criteria and Device Performance Study for SORB+ and HISORB+ Cartridges
This document describes the 510(k) summary for the SORB+ and HISORB+ Cartridges, which are sorbent-regenerated dialysate delivery systems for hemodialysis. The focus is on demonstrating substantial equivalence to predicate devices (K811170 - SORB 3160 and K812869 - HISORB 3260).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" with quantitative targets for each test, but rather states that the device "Pass"ed the tests by conforming to specified standards or predicate device performance. The de facto acceptance criterion for each test was a "Pass" result, indicating conformance.
| Testing Topic | Reference Standards / Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Validation of Maximum Allowable Contamination Levels of Toxic Chemicals in Water Supply for the SORB+ and HISORB+ Cartridges | AAMI/ANSI, RD5-1992 and RD62-2000, RD62, 2001 (Implied acceptance: Conformance to these standards for safe levels of toxic chemicals in water for dialysis) | Pass |
| Limit Test of Endotoxin and Bacteria Removal by SORB+ and HISORB+ Cartridges | AAMI/ANSI (Implied acceptance: Conformance to these standards for acceptable levels of endotoxin and bacterial removal) | Pass |
| Biocompatibility Validation of SORB + and HISORB + Cartridges | ISO 10993 (cytotoxicity, irritation or intracutaneous reactivity, and systemic toxicity (acute)). (Implied acceptance: Conformance to ISO 10993 for these biocompatibility aspects) | Pass |
| Validation Testing of SORB+ and HISORB+ Cartridges | Sorb Technologies published capacity specifications (Implied acceptance: The cartridges meet their published capacity specifications for urea-nitrogen removal. Specifically, SORB+ has a capacity of 9.5-23.5g urea-nitrogen, and HISORB+ has a capacity of 23.5-35.0g urea-nitrogen, for removing patient dialysis waste products within a usual dialysis procedure.) This also includes "effectiveness in purifying water or dialysate to safe levels for dialysis." | Pass |
| Comparison of Performance to Current SORB and HISORB Cartridges (in-vitro testing) | Substantial equivalency to the predicate devices (SORB and HISORB Cartridges) in in-vitro testing. (Implied acceptance: Performance is comparable to the predicate devices.) | Pass |
| Overall Conclusion: Substantial Equivalency to Predicate | "All testing verifies the substantial equivalency of these cartridges to the predicate, SORB and HISORB Cartridges, when used with the Renal Solutions Sorbent Dialysis system for acute and chronic hemodialysis." (Implied acceptance: No unexpected safety or effectiveness issues compared to the predicate.) | Pass |
2. Sample Size for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "test set" (i.e., the number of cartridges tested for each validation). It mentions "various weights [of REDY Chem™ dialysate] used individually and in combination" which hints at a testing regime, but no specific numbers.
The studies were in-vitro testing and "simulated patient use conditions." This suggests the tests were laboratory-based, not involving human patients directly. The provenance is not explicitly stated as retrospective or prospective due to the nature of the in-vitro testing. It would be considered prospective for the specific in-vitro tests conducted. There's no indication of country of origin for the data provided in this summary, but the submitter's address is in Oklahoma City, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the validation of a medical device like a sorbent cartridge, which relies on chemical and physical performance measurements rather than expert interpretation of images or clinical outcomes. The "ground truth" would be established by objective measurements against predefined chemical and physical standards or specifications, rather than expert consensus.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical events requiring consensus. For these device performance tests, the outcome is objective (e.g., meeting a chemical purity threshold, acceptable biocompatibility levels). Therefore, no adjudication method as described would be relevant or used in these validation tests. The results would be a direct measurement against a standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as this device is not an AI diagnostic tool and does not involve human readers for interpretation. The device's performance is measured directly (e.g., chemical capacity, purification levels).
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable in the context of this device. The device itself is a cartridge, not an algorithm. Its performance is inherently standalone (i.e., the cartridge's chemical and physical function) in that it performs its intended function independently of direct human intervention during the purification process. The "human-in-the-loop" would be the physician prescribing its use and monitoring the patient, but not directly interacting with the cartridge's internal chemical processes. The validation tests (e.g., capacity, biocompatibility) directly assessed the cartridge's standalone performance.
7. The Type of Ground Truth Used
The ground truth used for these tests was primarily:
- Objective Chemical and Physical Standards: Conformance to AAMI/ANSI standards for water purity, endotoxin/bacteria removal.
- Biocompatibility Standards: Conformance to ISO 10993.
- Manufacturer's Published Specifications: Sorb Technologies' published capacity specifications for urea-nitrogen removal.
- Predicate Device Performance: Comparison to the performance of the previously cleared SORB and HISORB Cartridges.
8. The Sample Size for the Training Set
This concept is not applicable. The device is a physical product (sorbent cartridge), not a machine learning model that requires a "training set." The development of the cartridges would have involved R&D, but the validation described herein does not fit the training/testing paradigm of AI/ML.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not applicable for this type of device.
Ask a specific question about this device
(72 days)
August 13, 1999 Regulatory Class: III 21 CFR §876.5870/Procode: 78 FLD Regulatory Class: II 21 CFR §876.5600
- Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
- Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.
Not Found
This document is a 510(k) clearance letter for the BioLogic-DT® System, which means it's a device that has been deemed substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence rather than extensive clinical studies that would establish acceptance criteria and performance against those criteria in the same way a Premarket Approval (PMA) would.
Therefore, the provided document does not contain the detailed information requested regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, or expert qualifications as it pertains to a direct performance study of the BioLogic-DT® System itself. The letter focuses on regulatory clearance based on substantial equivalence.
Here's an analysis based on the information provided and what is missing for each point:
1. A table of acceptance criteria and the reported device performance
- Information in document: Not present. The 510(k) clearance letter doesn't include performance data or acceptance criteria for the BioLogic-DT® System. It simply states that the device is "substantially equivalent" to predicate devices. The "Indications for Use" describe what the device is intended for, but not specific performance metrics or thresholds.
- Missing: Specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, removal rates for toxins, etc.) and the predefined acceptance criteria for these metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information in document: Not present. The document does not describe any specific clinical test set, its size, or its provenance.
- Missing: Details on a test set, including its size, whether it was retrospective or prospective, and its geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Information in document: Not present. Since no test set is described, there's no mention of experts establishing ground truth.
- Missing: Information about experts, their number, and their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information in document: Not present. No test set is described.
- Missing: Description of any adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Information in document: Not present. This document does not describe any MRMC studies, nor does it refer to an AI component for the device. The BioLogic-DT System appears to be a medical device for treatment (acute hepatic encephalopathy, drug overdose/poisonings), not an diagnostic AI tool.
- Missing: Any information related to MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information in document: Not present. The device is a treatment system, not an algorithm, so this concept is not applicable here.
- Missing: Not applicable for this type of device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Information in document: Not present. No study or ground truth is described.
- Missing: Information about ground truth.
8. The sample size for the training set
- Information in document: Not present. No training set is described.
- Missing: Sample size for a training set.
9. How the ground truth for the training set was established
- Information in document: Not present. No training set or ground truth described.
- Missing: Method for establishing ground truth for a training set.
Summary:
The provided document is a 510(k) clearance letter, which signifies that the BioLogic-DT® System has been found "substantially equivalent" to a legally marketed predicate device. This regulatory pathway primarily focuses on demonstrating that a new device is as safe and effective as an already cleared device, without requiring extensive de novo clinical trials to prove device performance against specific, novel acceptance criteria.
Therefore, the detailed information requested about acceptance criteria, study design, sample sizes, ground truth establishment, and expert qualifications is typically found in design validation documentation, clinical study reports, or a Premarket Approval (PMA) submission, none of which are present in this 510(k) clearance letter. The letter confirms the device's clearance for marketing based on equivalence, not necessarily on a detailed performance study as would be required for innovative, high-risk devices.
Ask a specific question about this device
(234 days)
BioLogic DT® System
Classification Name:
Sorbent Regenerated Dialysate Delivery System (per 21 CFR 876.5600
- Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure.
- Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.
The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machine and the single use BioLogic-DT-1000-TK (Treatment Kit). In many ways, it is similar to a standard hemodialysis machine in that blood is removed from the body, passed through a cellulosic dialyzer, and returned to the body. Within the dialyzer, diffusion causes many chemicals and toxins to pass from the dialysate surrounding the membranes. Depending on the binding characteristics of the sorbents in suspension in the dialysate, some chemicals remain at low concentration in the dialysate, and are therefore efficiently removed from the blood, while others reach concentrations similar to blood, and are therefore not removed from the blood. Like existing single-access dialysis systems, the BioLogic-DT System alternately withdraws and returns blood through a single-lumen catheter. Unlike standard dialysis machines, which use roller pumps to pass blood through the membranes, the DT applies an alternating pressure/ vacuum cycle to the sorbent suspension causing the alternating expansion and compression of the dialyzer's parallel plate cellulosic membranes. This expansion and compression of the membranes is used to pump blood through the system.
An improvement in software of the DT-1000 System mixes the sorbents before prime, obviating the need for the operator to shake the bag.
This document (K984546) describes a 510(k) submission for the BioLogic-DT System, an improved version of a sorbent-based blood treatment system. The improvements primarily concern a software change to automatically mix the sorbent suspension during device setup. The study focuses on this specific change and its impact on the device's performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Sorbent Mixing Effectiveness | |
| No sorbent clogging during Prime | 0% clogging in 7 repetitions |
| Free flow of sorbent through dialyzer | Achieved in all 7 repetitions |
| User Convenience | Simplifies setup for the user |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 7 repetitions of the DT System setup with automatic mixing.
- Data Provenance: Retrospective, internally generated by HemoCleanse Inc. The study described is non-clinical performance data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable for this type of non-clinical, performance-based study. The ground truth (clogging or free flow) was an observable physical outcome.
4. Adjudication Method for the Test Set
- Not applicable. The outcome was a direct observation of the device's physical performance (clogging vs. free flow).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study was not done. The study was a non-clinical evaluation of a device function.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, this was a standalone performance evaluation of the device's new automatic mixing function. The "algorithm" here refers to the software change that automated the mixing process. The study directly assessed the device's ability to mix the sorbent and prevent clogging without human intervention during the mixing step.
7. The Type of Ground Truth Used
- Direct Observational Outcome: The ground truth was the direct observation of "sorbent flow freely through the dialyzer" or "sorbent clogging."
8. The Sample Size for the Training Set
- The document does not explicitly mention a training set. The "software change" was implemented, and then its performance was tested with 7 repetitions. It's implied that any development and internal testing prior to this documented study would have involved some form of iterative development, but a formal "training set" in the machine learning sense is not described.
9. How the Ground Truth for the Training Set was Established
- As a formal "training set" is not explicitly mentioned, there's no information on how its ground truth would have been established. The development of the software change likely involved engineering and design principles, with internal validation steps rather than a distinct "training set" with ground truth in the context of supervised learning. The previous method's 1 out of 4 (25%) clogging rate served as a baseline or justification for the need for improvement.
Ask a specific question about this device
Page 1 of 1