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SC+ Machine and SC+ Dialysate Cartridge:

The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.

SC+ Blood Tube Set:

The SC+ Blood Tubeset is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tubeset is compatible only with the SC+ Hemodialysis System

The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.

The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following: conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37oC and subsequently de-aerated within the machine before entering the cartridge.

The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.

This document is a 510(k) Premarket Notification from the FDA, outlining the substantial equivalence determination for the Quanta SC+ Hemodialysis System. It does not contain the type of acceptance criteria and study data typical for an AI/ML medical device submission, which would include metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML component. The information provided heavily focuses on the comparison of a hemodialysis machine and its components to predicate devices based on technological characteristics and general performance testing (e.g., dialysate quality, electrical safety, biocompatibility, sterilization, human factors).

To directly address your prompt, using only the provided text, I must state that the document does not contain the requested information about an AI/ML enabled device's acceptance criteria and study as described. It's a regulatory clearance for a traditional medical device, not an AI/ML diagnostic or prognostic tool.

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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks.

The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.

The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).

The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.

The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.

The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.

The provided document, a 510(k) Summary for the DORA Disposable A.V. Fistula Needle Sets, details the premarket notification of intent to market the device and its substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already approved device, rather than proving novel effectiveness through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of:

• A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device. This document is for a physical medical device (AV fistula needle sets).
• Sample sizes for a test set (for AI/ML validation). The testing described is for physical characteristics and biocompatibility, not for a 'test set' in the AI/ML sense.
• Data provenance for a test set (for AI/ML validation). Not applicable to a physical medical device.
• Number of experts and their qualifications for establishing ground truth. Not applicable.
• Adjudication method for a test set. Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Not applicable.
• Standalone (algorithm only) performance. Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data). Not applicable.
• Sample size for training set. Not applicable.
• How ground truth for training set was established. Not applicable.

Instead, the document focuses on non-clinical testing and substantial equivalence to a predicate device.

Here's what the document does provide regarding acceptance criteria and performance:

1. Acceptance Criteria (via Standards Compliance and Performance Testing) and Reported Device Performance:

The acceptance criteria for this device are demonstrated through adherence to various international and national standards, as well as the successful completion of specific non-clinical performance tests. The reported performance is that the device "met all design specifications" and "is similar as that of the predicate device" or "acceptable."

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: Not explicitly stated with specific numbers (e.g., "n=X needles were tested"). The document generally states "Non clinical tests were conducted" and "The test results demonstrated...". For a 510(k) submission for a physical device, detailed sample sizes for each specific test are typically found in the full technical documentation, not summarized in the 510(k) summary as it is here.
• Data Provenance: The tests were conducted internally by Bain Medical Equipment (Guangzhou) Co., Ltd. or by test labs they contracted. The document implicitly indicates the tests originate from China (Guangzhou) as that's the manufacturer's location. The tests are "non-clinical" and likely conducted in laboratory settings, not on patient data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical medical device. "Ground truth" in this context refers to compliance with established engineering and biocompatibility standards, not expert human interpretation for a diagnostic or AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

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:

• No, a MRMC study was not done. This device is a physical medical instrument, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For physical devices, the "ground truth" is adherence to predefined engineering specifications, internationally recognized standards (ISO, ASTM, USP), and established safety and performance benchmarks (e.g., sterilization effectiveness, material strength, biocompatibility profiles). It's a truth based on physical and chemical properties and their interaction, rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

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The OLPur H2H Hemodiafiltration (HDF) Module is indicated for use, with a UF controlled hemodialysis machine that provides ultrapure dialysate in accordance with current ANSI/AAMI/ISO standards, for treatment of patients with chronic renal failure as prescribed by a physician. The OLPur MD 220 Hemodiafilter is indicated for use for hemodiafiltration of patients with chronic renal failure. The OLPur MD 220 Hemodiafilter is only to be used with the OLpur H2H Hemodiafiltration Module. Selection of patients, as well as treatment operating parameters, are a medical decision and the responsibility of the prescribing physician.

The H₂H™ Hemodiafiltration Module is a programmable electro-mechanical medical device designed to work in conjunction with and in close proximity to a hemodialysis machine during patient treatments. Upon installation, the H₂H Module is placed next to the hemodialysis machine (which can be on either side depending upon type and model of the hemodialysis machine) and is connected to the clinic's water supply, drain, and electricity.

The H₂H Hemodiafiltration Module serves two basic functions. The Module's primary function is to generate on-line substitution fluid for hemodiafiltration. The H₂H Module does this by ultrafiltering dialysate, provided by the hemodialysis machine, through a reusable substitution filter. The secondary function of the H₂H Hemodiafiltration Module is to serve as a substitution filter reprocessing machine. These steps are performed when the H₂H Hemodiafiltration Module is not connected to the hemodialysis machine. More detailed descriptions of the device, its accessories and how the system functions can be found in Section 11 (Device Description) of this submission.

The provided text is a 510(k) summary for the Nephros OLpūr® H₂H H₂H Hemodiafiltration (HDF) Module and OLpūr MD 220 Hemodiafilter. It focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.

However, this document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial report or performance study with detailed results against defined benchmarks. Instead, it refers to "Bench Analyses performed on the subject devices" in Section 18 and "clinical data supporting substantial equivalence" in Section 20 of the full application, which are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from the given 510(k) summary.

Here's what can be gathered and what is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics with numerical targets within this summary. Substantial equivalence is the overall goal, meaning the device performs as safely and effectively as predicate devices.
• Reported Device Performance: The summary states, "The proposed device has the same technological characteristics and is similar in design as compared to the predicate devices and already approved kidney dialysis therapy." This is a general statement of equivalency rather than specific performance numbers against acceptance criteria. The full submission's Section 18 and 20 would contain these details.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in this 510(k) summary.
• Data Provenance: Not specified in this 510(k) summary.

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 specified in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified in this 510(k) summary.

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

• This device is a medical module and hemodiafilter, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers improving with AI is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is a physical medical device (hemodiafiltration module and filter), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable in this context. Its performance would be evaluated during its operation in conjunction with a hemodialysis machine.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not specified in this 510(k) summary. Given the nature of the device, ground truth would likely refer to performance metrics like filtration efficiency, ultrafiltration control accuracy, biocompatibility, and microbiological purity, established through bench testing and potentially in vivo studies (though clinical data reference focuses on substantial equivalence).

8. The sample size for the training set

• Not applicable/specified. This is a physical medical device, not an AI/machine learning model that typically has a "training set."

9. How the ground truth for the training set was established

• Not applicable/specified for the same reasons as point 8.

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The Nipro Transducer Protector TP-SURE is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

The Nipro Transducer Protector TP-SURE consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.1 um. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

The TP-SURE is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.1 µm hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

The devices are packaged sterile and labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician.

The provided text is a 510(k) Summary for the NIPRO Transducer Protector TP-SURE. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria or an analytical study that rigorously proves the device meets such criteria as would typically be described in a research paper or a detailed performance validation report.

The document states that "Performance testing was conducted to verify that the device is safe and effective for its intended use" and that "The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO Transducer Protector TP-SURE performs equivalent to the predicate device and is safe and effective when used as intended." This general statement indicates that tests were performed, but it lacks the specifics requested in your prompt.

Therefore, for almost all of your requested information, the answer is "Not provided in the document."

Here's a breakdown of what can be extracted or inferred, and what is not provided:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in a tabular format. The general criteria are implied to be "safe and effective for its intended use" and "performs equivalent to the predicate device."
• Reported Device Performance: No specific quantitative performance metrics (e.g., filtration efficiency, pressure drop, burst strength) with their respective values are provided.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not provided.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable, as this device does not involve expert interpretation or diagnosis for "ground truth." The performance testing would be against engineering specifications for physical characteristics and filtration efficacy.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable, as this device does not involve expert interpretation or diagnosis.

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

• MRMC Study: No. This is a medical device (a transducer protector) that does not involve AI assistance or human interpretation in its function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable in the context of an "algorithm." The device's performance is inherently "standalone" in its mechanical and filtration function.

7. The type of ground truth used

• Type of Ground Truth: For a physical device like this, "ground truth" would typically be established through engineering specifications, validated test methods (e.g., for filtration efficiency, material compatibility, pressure resistance), and compliance with relevant standards. The document mentions "Biocompatibility testing" and "performance testing" which would fall under this category, but specific details of the ground truth (e.g., exact pore size verification, bacterial challenge results) are not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a manufactured physical good, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.

In summary, the provided document focuses on regulatory approval (510(k) clearance) based on substantial equivalence to a predicate device and general statements about performance and biocompatibility testing, rather than detailed analytical study results proving specific acceptance criteria.

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