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510(k) Data Aggregation
(567 days)
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended to be used for the in vitro quantitative determination of potassium, in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
The potassium assay is used for the quantitation of potassium in human heparinized whole blood, heparinized plasma, or serum. Potassium measurements are used in the diagnosis and treatment of renal glomerular or tubular disease, adrenocortical insufficiency, diabetic ketoacidosis, excessive intravenous potassium therapy, sepsis, panhypopituitarism, in vitro hemolysis, hyperaldosteronism, malnutrition, hyperinsulinism, metabolic alkalosis and gastrointestinal loss.
The Piccolo® Potassium Test System is a single-use, disposable system used with the Piccolo Xpress® chemistry analyzer for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location. The Piccolo® Potassium Test System is designed to separate a heparinized whole blood sample into plasma and blood cells. The disc meters the required quantity of plasma and diluent, mixes the plasma with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted plasma mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer. Alternatively, the disc may also be used with serum.
The Piccolo Xpress® chemistry analyzer (previously cleared under K942782) is a portable clinical chemistry system designed to run only Piccolo test rotors. The instrument interacts with the rotor to move fluid across the sensors and generate quantitative results. Specimens are identified by scanning a barcode or by manually entering the information via the touchscreen. The Piccolo Xpress® chemistry analyzer has slots to accommodate the cartridges discs. The analyzer will determine the configuration of the system by detecting which discs are installed.
The Piccolo® Potassium Test System will be used with previously cleared rotor systems in a clinical laboratory setting or point-of-care location.
The Piccolo® Potassium Test System, used with the Piccolo® blood chemistry analyzer or the Piccolo Xpress® chemistry analyzer, is intended for the in vitro quantitative determination of potassium in heparinized whole blood, heparinized plasma, or serum in a clinical laboratory setting or point-of-care location.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (Implied by CLIA goals or standard practices) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within Run %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 2.79% | |
| - Control 2 (6.19 mmol/L) | 1.38% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.31% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.58% | |
| Total %CV (Plasma) | Lower is better | |
| - Control 1 (3.22 mmol/L) | 3.28% | |
| - Control 2 (6.19 mmol/L) | 1.65% | |
| - Plasma Pool 1 (3.22 mmol/L) | 2.89% | |
| - Plasma Pool 2 (5.42 mmol/L) | 1.89% | |
| Total %CV (Whole Blood, range 3.9-4.0 mmol/L) | Lower is better | 2.8% - 3.9% |
| Linearity | Deviation from linearity (DL) within ±0.5 mmol/L (per 42 CFR 493.931) | For all three matrices and various concentration ranges tested, the DL estimate was within +/- 0.31. R-square estimates were all > 0.98. RMSE estimates <= 0.32. |
| Limit of Quantitation (LoQ) | Not explicitly stated, but generally, the lowest concentration at which the device can reproducibly measure. | Determined to be 1.5 mmol/L. |
| Method Comparison (Accuracy vs. Siemens VISTA ISE) | Linear regression analysis (slope, intercept, R²) indicating strong correlation and minimal bias. Slope close to 1, Intercept close to 0, R² close to 1. | |
| - Site 1 Whole Blood (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.12, R²: 0.969 |
| - Site 1 Plasma (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.03, R²: 0.979 |
| - Site 1 Serum (N=178) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.98, Intercept: 0.06, R²: 0.979 |
| - Site 2 Whole Blood (N=130) | Slope ~1, Intercept ~0, R² ~1 | Slope: 0.99, Intercept: 0.13, R²: 0.969 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Precision (Plasma): Sample details (number of unique patient samples) are not explicitly stated, but the study used "Control 1, Control 2, Plasma Pool 1, Plasma Pool 2," indicating pooled or control materials. Tested over five days.
- Precision (Whole Blood): Four (4) fresh, lithium heparin whole blood samples. Each sample was replicated 16 times (N=16 for each sample type).
- Linearity: Whole blood, serum, and plasma samples of varying analyte levels that spanned the reportable range of the tests. Specific number of samples not given, but refers to "various concentration ranges tested."
- Limit of Quantitation (LoQ): Not specified beyond "four low level samples."
- Method Comparison:
- Site 1: 178 samples for Whole Blood, 178 for Plasma, and 178 for Serum.
- Site 2: 130 samples for Whole Blood.
- Provenance: Not explicitly stated, but the mention of "CLIA waived site" and "Moderately Complex Site" suggests the studies were conducted in the United States. The data appears to be prospective as it involves active testing of samples using the 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):
- The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic interpretation. This is an in vitro diagnostic device that quantifies potassium levels.
- For the analytical performance studies (Precision, Linearity, LoQ, Method Comparison), the "ground truth" or reference values are established by the comparative method device (Siemens VISTA ISE) and controlled materials with known concentrations. The studies were run by operators at different sites, including a CLIA waived site, indicating standard laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable to the evaluation of this in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where multiple readers interpret images, and discrepancies need to be resolved. For a potassium test, the output is a quantitative value, not subject to subjective interpretation requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers and AI assistance. This device is a quantitative assay, not an imaging or interpretative AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies (Precision, Linearity, LoQ, Method Comparison) represent the standalone performance of the device (Piccolo® Potassium Test System on the Piccolo Xpress® chemistry analyzer). While human operators physically load samples and start the tests, the analysis and quantification are performed by the device's integrated system (chemistry analyzer and reagent disc) without human interpretation steps that could be influenced by the device's output. The results presented are the direct output of the device compared against reference methods.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the analytical performance studies was established using:
- Comparative Method Device: Siemens Dimension Vista® Integrated System (Potassium ISE Test, K051087) as the reference method for the method comparison studies.
- Controlled Materials: For precision, control materials and plasma pools with known or expected potassium concentrations were used.
- Prepared Samples: For linearity, samples were prepared to span the reportable range. For LoQ, native blood samples were diluted to target concentrations.
8. The sample size for the training set:
- This device is an in vitro diagnostic assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the device would involve its chemical design, optical system calibration, and reagent formulation derived from extensive R&D, rather than a data-driven training set used for AI model development. Therefore, a specific "training set sample size" as typically understood for AI models is not applicable.
9. How the ground truth for the training set was established:
- As mentioned above, the concept of a "training set" and its "ground truth" for this type of in vitro diagnostic device (a chemical assay) is not directly analogous to AI/machine learning. The device's operational parameters and accuracy are established through its engineering design, chemical principles, and extensive internal validation and calibration processes during development and manufacturing. The comparisons to predicate devices and reference methods serve to validate its performance post-development.
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(380 days)
The Piccolo Medical SmartPICC System is indicated in adult patients for the positioning of Peripherally Inserted Central Catheters (PICC) with minimum lumen of 0.021". The SmartPICC system provides real-time catheter tip location information by using the patient's cardiac electrical activity (intravascular ECG signal). The SmartPICC system is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients when proper ECG detection is available. The SmartPICC system includes a supplemental intravascular ionic dilution feature that provides qualitative blood flow information to the user to aid catheter navigation.
Note: Use of the intravascular ECG (ivECG) technique to replace x-ray/fluoroscopy confirmation of tip placement is limited, but not contraindicated, for patients where alterations of cardiac rhythm change the presentation of the P-wave such as in atrial fibrillation, atrial flutter, severe tachycardia, pacemaker driven rhythm, and chronic obstructive pulmonary disease (COPD). In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional confirmation method (x-ray or fluoroscopy) is required to confirm catheter tip location.
The Piccolo Medical SmartPICC System is a device used by clinicians for guidance and positioning of commercially available central venous catheters. The reusable SmartPICC System consists of a computer tablet with data processing and display capabilities, a SmartPICC Controller data acquisition module, and a Kit that includes a single use sterile SmartPICC Stylet to enable the use of ivECG confirmation of final PICC tip location by the clinician who is placing the catheter. The SmartPICC System has a supplemental ionic dilution navigation feature to provide qualitative blood flow direction information which requires 5% Dextrose infusion utilizing a mechanical syringe driver, a sterile 20 ml disposable syringe, and tubing with extension set to provide constant flow rate infusion to the SmartPICC Stylet distal tip.
Additional components associated with the reusable system include a USB cable to connect the tablet to the controller and an external ECG (xECG) Trunk Cable to connect the xECG leads to the controller.
Additional accessories in the Stylet Kit include:
- Sterile Drape Clip to secure Stylet hub to sterile patient drape
- Sterile cover for the tablet
- Sterile scissors for opening sterile tubing pouch
- xECG Electrodes and Leads
- Instructions for Use
The Piccolo Medical SmartPICC System is intended to help position Peripherally Inserted Central Catheters (PICC) in adult patients by providing real-time catheter tip location information using intravascular ECG (ivECG) signals. It also includes a supplemental ionic dilution feature for qualitative blood flow information to assist catheter navigation.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage accuracy or precision target) for the performance of the SmartPICC system. Instead, the "Summary of Human Factors Testing" states that the simulated use testing "adequately reviewed" the device's application to ensure "safe, effective use" and demonstrated "suitability for its intended purpose." This suggests that the acceptance criteria for this study were likely qualitative and focused on the device's ability to facilitate correct PICC tip placement and user comprehension of the device's output.
While no precise performance metrics are given, the overall conclusion is that the device should "perform as intended" and is "substantially equivalent" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Effective Use | Demonstrated suitability for intended purpose through simulated use. Non-clinical data supports safety. |
| Proper PICC Tip Placement | System effectively aids in confirming tip location as an alternative to chest x-ray/fluoroscopy. |
| User Comprehension | Instructions for Use and hazard analysis considered adequate for safe and effective use. |
| Substantial Equivalence | Performance is substantially equivalent to the predicate device. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample size for the "Simulated Use / Human Factors Testing." It only mentions "Human Factors Testing."
- Data Provenance: The document does not specify the country of origin of the data nor if it was retrospective or prospective. Given it was "Simulated Use," it was likely prospective, but the location is not mentioned.
3. Number of Experts and Qualifications for Ground Truth in Test Set
The document does not specify the number of experts used to establish ground truth for the human factors/simulated use testing, nor does it detail their qualifications. It only states that the testing was conducted to evaluate the application of the system.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the "Simulated Use / Human Factors Testing."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance versus without. The study described is a "Simulated Use / Human Factors Testing," which focuses on the device's application and user interaction, not a reader study of clinical images.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop) performance study evaluating the accuracy of the ivECG signal interpretation or ionic dilution feature in isolation. The human factors testing involved the device being used by humans.
7. Type of Ground Truth Used (Test Set)
For the "Simulated Use / Human Factors Testing," the type of ground truth used is not explicitly stated. However, since the test aimed to confirm "PICC tip position," it can be inferred that the ground truth would have been the actual, verified PICC tip position established by a gold standard method during the simulation, although the specific method is not detailed. The comparison to chest x-ray or fluoroscopy confirmation suggests these are the accepted gold standards the device aims to emulate or provide an alternative to.
8. Sample Size for the Training Set
The document does not mention a training set sample size. The text indicates that "Clinical testing was determined to be not applicable for this 510(k) submission. Bench testing was sufficient to demonstrate substantial equivalence of the Smart PICC System to the predicate device." This suggests the device's performance was not primarily established through a machine learning model requiring a large training set, but rather through engineering and human factors validation demonstrating equivalence to a predicate device.
9. How Ground Truth for the Training Set Was Established
As no training set is described, the method for establishing ground truth for a training set is not applicable or provided in this document.
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(90 days)
The Piccolo Composite Proximal Tibia Plate System is intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused.
For Lateral Plates - non-unions, and factures including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
For Medial Plates - intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
The Piccolo Composite Proximal Tibia Plate System comprises implants (pre-contoured lateral and medial plates (in left and right configurations), and screws) in different dimensions, and instruments.
The Piccolo Composite proximal tibia plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK) and incorporate tantalum markers. The screws are made of titanium alloy.
The provided text is a 510(k) summary for a medical device (Piccolo Composite Proximal Tibia Plate System) and focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing. It does not contain information about studies involving human readers, AI, or diagnostic performance metrics typically associated with acceptance criteria for such studies.
Therefore, many of the requested sections about acceptance criteria, human reader performance, AI, and ground truth establishment cannot be answered from the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Mechanical Performance) | Reported Device Performance |
|---|---|
| Performed per ASTM F 382 (for plate static and dynamic bending) | Comparable to predicate devices |
| Screw pushout from the plate | Comparable to predicate devices |
| Screw insertion torque | Comparable to predicate devices |
| Screw pull out force | Comparable to predicate devices |
| Screw dimensional equivalence | Comparable to predicate devices |
2. Sample sized 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 document. The performance testing described is mechanical, not clinical, and thus terms like "test set" for human or AI performance or "data provenance" in this context are not applicable.
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 provided. The "ground truth" in this context refers to engineering standards and comparisons to predicate devices, not expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Arbitration methods are typically used for clinical studies with human observers, which is not the type of study 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
There is no indication that an MRMC comparative effectiveness study was done. This document describes the mechanical testing of a bone plate system, not a diagnostic or AI-assisted device. Therefore, no information on AI assistance or human reader improvement is available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no indication that a standalone algorithm performance study was done. The device is a physical bone plate system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the mechanical performance testing appears to be established engineering standards (ASTM F 382) and performance data from legally marketed predicate devices.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is not applicable to the mechanical performance testing described for this physical device.
9. How the ground truth for the training set was established
This information is not provided. The concept of a "training set" and its ground truth is not applicable to the mechanical performance testing described for this physical device.
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(245 days)
The PICCGuard device is indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.
The PICCGuard is a two-piece plastic housing with locking barb that inserts through a hole in the bottom housing. After inserting the shaft of the catheter and Luer hub with needleless connector attached, the two halves slide together, and the barb is pushed through the hole in the bottom housing. Once the barb is inserted, the housing is locked. When a healthcare provider needs intravenous access, medical scissors can be used to disconnect the lid from the locked portion. The PICCGuard is then removed giving access to the needleless connector, and the health care provider can administer medications per normal routine.
The provided text is a 510(k) summary for the PICCGuard device. It describes the device, its intended use, and compares it to predicate devices. However, this document primarily discusses nonclinical performance testing related to biocompatibility and basic functional tests. It does not describe a study that proves the device meets acceptance criteria related to its primary indication as a tamper-evident enclosure in the context of improving human reader performance or a standalone algorithm performance.
Specifically, there is no mention of a device that uses an AI algorithm or requires human "readers" or experts to establish ground truth in the way described in the prompt's questions (e.g., related to image interpretation). The PICCGuard is a physical device intended to demonstrate tampering, not an AI-powered diagnostic or interpretive tool.
Therefore, many of the requested details about acceptance criteria and studies (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI models) are not applicable to the information provided in this 510(k) summary.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a "Functional Testing Results Summary Table" that aligns with this request for specific functional aspects of the physical device.
| Test | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| Removal of Device to Confirm Tamper Evident | The device shall show signs of being tamper with and shall break near the locking tab. | "All samples Passed" (implies all samples showed signs of tampering and broke near the locking tab) | Pass |
| Repeated Removal of PICCGuard from PICC lines | The catheter shows no sign of leakage after assemble / disassemble / flush cycles. | "All samples Passed" (implies no leakage was observed) | Pass |
| Removable of Wings by Medical Scissors | The tabs of the device shall easily be cut by medical scissors | "All samples Passed" (implies the tabs were easily cut) | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size for Functional Tests: The document states "All samples Passed" for the functional tests. However, the number of samples tested is not explicitly stated.
- Data Provenance: Not specified, but given the nature of a physical device functional test, it would likely be laboratory-based and not involve patient data or geographical provenance in the typical sense for AI/diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical tamper-evident enclosure, not a diagnostic tool requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for its functional performance is based on direct observation of physical characteristics (breaking, no leakage, ease of cutting).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Not applicable, as there's no subjective interpretation or complex data requiring adjudication.
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. This is not an AI device or a diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional tests, the "ground truth" was the direct physical demonstration of the device's characteristics:
- Tamper evidence: Visual confirmation of breaking near the locking tab.
- No leakage: Visual confirmation after assembly/disassembly/flush cycles.
- Ease of cutting: Confirmation that medical scissors can easily cut the tabs.
8. The sample size for the training set:
- Not Applicable. This device is not an AI model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI model or training set, this question is irrelevant.
Additional Information from the Document:
- Clinical Studies: "No clinical studies were conducted."
- Biocompatibility Testing: The document lists several ISO 10993 standards and provides a summary table for biocompatibility tests (cytotoxicity, irritation, skin sensitization), all concluding that the Test Article meets acceptance criteria. These are standard tests for medical devices that contact the body.
- Intended Use/Indications: The device is "indicated for use as a tamper evident enclosure for the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports."
- Comparison to Predicate Devices: The document focuses on comparing the PICCGuard's regulatory class, classification name, product code, review panel division, intended use, use environment, and patient population to predicate devices. The key difference highlighted is the PICCGuard's role as an accessory providing a tamper-evident feature, which is not the primary function of the direct predicate (a PICC catheter). A reference predicate (a tamper-evident cap) is mentioned for its similar tamper-evident claim.
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(76 days)
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The Lapidus plates are indicated for fusion and arthrodesis of the 1st tarsometatarsal joint (Lapidus Fusions).
The Piccolo Composite Lapidus Plate System comprises implants (plates and screws), and a set of instruments.
The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy.
The screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.
This document is a 510(k) premarket notification for the "Piccolo Composite® Plate System" and primarily focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this submission.
However, I can extract the relevant performance criteria and summary from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Evaluation Type) | Reported Device Performance |
|---|---|
| Static Bending (per ASTM F 382) | Comparable to predicate devices |
| Dynamic Bending (per ASTM F 382) | Comparable to predicate devices |
| Bacterial Endotoxin Testing | Conducted (implied acceptable) |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes the mechanical testing and material compatibility of an orthopedic plate system, not an AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus.
4. Adjudication method 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: Not applicable, as this is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used:
- Mechanical Performance: Established through standardized engineering tests (ASTM F 382) for static and dynamic bending. The "ground truth" here is the measured mechanical properties of the device and its predicate devices.
- Biocompatibility: Established through bacterial endotoxin testing.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.
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(186 days)
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:
• replacing maxillary lateral incisors and mandibular incisors,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.
The Piccolo Implants and Accessories is a threaded root-form dental implant and abutment system.
The implants are Ø3.0 mm in diameter with lengths of 8.5, 10, 11.5, 13 and 15 mm. There is a standard version and a MSC version with a 1 and 3 mm machined surface coronal region respectively. The rest of the body has a roughened surface. The system has an external hexagonal implant-abutment interface.
The following abutments are included in the range: Cover Screws, Healing Abutments (all made from commercially pure titanium (CPTi)), Gold Abutments (made from gold alloy), Passive Abutments and Compact Conical Abutments (both made from titanium alloy). All abutments (except the onepiece abutments) are used with a titanium alloy retaining screw.
The provided text is a 510(k) summary for a medical device (Piccolo Implants and Accessories) and details its substantial equivalence to predicate devices. It does not describe an acceptance criteria and study as typically conducted for performance claims of AI/ML or diagnostic devices. Instead, it focuses on non-clinical performance and material equivalence.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on demonstrating substantial equivalence through engineering analysis, dimensional analysis, dynamic compression-bending tests, and material/sterilization/packaging equivalence to predicates, rather than a clinical performance study with human readers, AI assistance, or expert ground truth.
However, I can extract the information that is present concerning performance data and equivalence.
Acceptance Criteria and Device Performance (Based on Non-Clinical Data)
| Acceptance Criteria Category | Reported Device Performance / Method of Proof |
|---|---|
| Material Equivalence | The device is manufactured from the same material (CPTi - cold worked for implants, CPTi, Titanium alloy, Gold alloy for abutments) using the same manufacturing method as predicate devices (K163060, K163634). Biocompatibility is also established in accordance with ISO 10993-1 and ISO 10993-5 (Cytotoxicity testing) for the same materials. |
| Dimensional & Design Equivalence | The implants are Ø3.0 mm in diameter with lengths 8.5, 10, 11.5, 13, and 15 mm, with an external hexagonal implant-abutment interface, and have both standard and MSC versions with varying machined surface coronal regions. This was compared to the primary predicate (K163060) which also has Ø3.0 implants, and a reference device (K163634) which has Ø3.25 tapered implants with similar shape, lengths, thread, flutes, taper, apex, collar, and connection interface. Dimensional analysis was performed. |
| Mechanical Performance | Dynamic compression-bending to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) was performed. No specific performance metrics (e.g., fatigue cycles, load limits) are presented in this summary, but the test was used to demonstrate equivalence. |
| Sterilization | The sterilization method (Gamma radiation) is the same as predicate devices (K163060, K163634) and was validated per ISO 11137-1 and ISO 11137-2. Moist heat sterilization for end-user sterilized devices was validated per ISO 17665-1 and ISO 17665-2. The Limulus Amebocyte Lysate (LAL) test for bacterial endotoxin (USP 39-NF 34 <85>) was conducted. |
| Packaging & Shelf Life | Packaging is the same as predicate devices and was validated per ISO 11607. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life. |
Study Details (Based on Information Provided)
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical tests (engineering analysis, dimensional analysis, dynamic compression-bending tests, biocompatibility testing, sterilization validation, packaging validation) and comparison to predicate devices, not a clinical "test set" of patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication was performed.
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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 is a submission for a dental implant and accessories, which are physical medical devices, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical "ground truth." For non-clinical tests, "ground truth" would correspond to established engineering standards (e.g., ISO 14801 for fatigue testing, ISO 11137 for sterilization) and established material properties, which serve as the reference for successful performance.
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The sample size for the training set: Not applicable. This is not an AI/ML device submission.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device submission.
Summary of what was done:
The submission uses non-clinical data including:
- Engineering analysis
- Dimensional analysis
- Dynamic compression-bending tests to ISO 14801 for mechanical performance.
- Biocompatibility testing to ISO 10993-1 and ISO 10993-5.
- Sterilization validation to ISO 11137-1, ISO 11137-2, ISO 17665-1, and ISO 17665-2, and bacterial endotoxin testing (USP 39-NF 34 <85>).
- Packaging validation to ISO 11607 and accelerated aging per ASTM-F-1980 to demonstrate a 5-year shelf life.
The primary method of demonstrating device performance and meeting the implicit "acceptance criteria" of safety and effectiveness for a 510(k) submission is through "substantial equivalence" to legally marketed predicate devices, particularly K163060 (Southern Implants Deep Conical Implants and Accessories) and K163634 (Southern Implants External Hex Implants and Accessories), and K120414 (Astra Tech AB OsseoSpeed™ Plus). The submission highlights that the subject device shares the same intended use, similar technological characteristics, same materials, manufacturing methods, sterilization methods, and packaging as the predicate devices.
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(264 days)
PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement.
PiCCO Catheters are indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
The PiCCO Catheter uses a thermistor to measure the blood temperature change during thermodilution. This thermistor is located in one of the two catheter lumen. The second catheter lumen ends in a Luer-Lock for connection to a pressure monitoring kit.
The thermistor is connected to a patient monitor via a dedicated plug.
The placement of the catheter into a large arterial vessel is done using the Seldinger Technique and is intended to use of up to 10 days.
The PiCCO Catheter Sets contain the following parts:
- PiCCO Catheter,
- Guidewire with dispenser and advancer,
- Introducer needles,
- Dilator (exception: the 3F Set does not include a dilator).
Five PiCCO Catheter models are available which differ in diameter and length. The PiCCO catheter set contains accessories fitting to the respective PiCCO catheter model in size.
The Catheter Set is packed into a preformed blister (PET), sealed with a Tyvek® lid and EtO sterilized.
The provided text describes a 510(k) submission for the PiCCO Catheter, which is a thermodilution probe. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, study design for proving performance, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission as presented. The document focuses on demonstrating that the new device is as safe and effective as an already legally marketed predicate device, primarily through non-clinical performance and biocompatibility testing, along with a comparison of technological characteristics.
Here's an analysis of the provided text in response to your request, indicating where information is not applicable (N/A) to this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one would for a new device's efficacy study. Instead, it states that various tests were conducted and their results "demonstrate that the functionality and performance characteristics of the device are comparable to the predicate device."
For instance, performance testing for mechanical properties (e.g., gauging, leakage, separation force) were conducted against standards like ISO 594-1:1986 and ISO 594-2:1998, and shelf life testing was conducted according to ISO 10555-1:2013. The acceptance criterion for these tests is simply compliance with the applicable standard or demonstrated comparability, rather than specific quantitative performance targets against clinical metrics.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility (ISO 10993-1) | Compliant (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Chemical Characterization, Hemolysis, Pyrogenicity tests passed) |
| Performance Testing (ISO 594-1, ISO 594-2) | Compliant (Gauging, Liquid Leakage, Air Leakage, Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking tests passed) |
| Shelf Life (ISO 10555-1) | Supports 60 months expiry (Accelerated aging data) |
| Guidewire Friction Force | Testing conducted (Result not quantified but implied compliant) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant |
| Functionality and Performance | Comparable to 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)
- Sample Size:
- No specific sample sizes for clinical test sets are mentioned as clinical data were not required.
- For biocompatibility and performance testing, the sample sizes would be those dictated by the respective ISO standards for material and device testing. These are not explicitly stated in the document.
- Data Provenance:
- The testing was performed according to international standards (e.g., ISO, IEC). The location where the tests were physically performed is not specified, but the device owner is PULSION Medical Systems SE in Germany.
- The data is non-clinical performance data from laboratory and material tests, not patient data.
- It is prospective in the sense that these tests were conducted specifically for this submission.
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)
N/A. This is a non-clinical 510(k) submission. The "ground truth" for the test set is established by the specifications of the standards (ISO, IEC) for material and device performance, not by expert medical opinion in a diagnostic or clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Since this is a non-clinical submission, there is no "adjudication" of results in the sense of multiple clinical reviewers reaching consensus. Test results are objective measurements against defined 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
N/A. This device is a physical catheter, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical catheter and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is based on adherence to recognized international standards and specifications for medical device materials (biocompatibility) and functional performance (e.g., mechanical integrity, shelf-life, EMC). There is no clinical ground truth (like pathology or outcomes data) directly used for this submission to prove efficacy, as clinical data was not required.
8. The sample size for the training set
N/A. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
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(30 days)
The Piccolo Composite Proximal Femur Nails are indicated for the treatment of stable and unstable proximal femur fractures (pertrochanteric, intertrochanteric high subtrochanteric fractures, and combinations of these fractures), including, fractures resulting from trauma, nonunions, pathological fractures, impending pathological fractures, tumor resections, and revision procedures.
The Piccolo Composite Nailing System includes nails, screws and a set of instruments.
The Piccolo Composite nail indicated for treatment of the proximal femur is a cylindrical rod. Nail mid-shaft diameter is 11mm, with the proximal end diameter of up to 17mm. Nail lengths are 180mm, 200mm, and in the range of 300 – 460mm. The nail provides for holes at the proximal and distal sections, designed for the insertion of a lag screw and interlocking screws. The lag screw is of 10.4mm diameter, with its length being in the range of 80mm to 110mm. The nails (and, optionally, the lag screws) are made of carbon fiber reinforced polymer and incorporate small amount of titanium/titanium alloy. Tantalum markers are embedded within the carbon fiber reinforced polymer, where applicable, to enable visualization during imaging. The distal screws, and, optionally, the lag screws, are made of titanium alloy.
The provided text describes a 510(k) premarket notification for a medical device, the Piccolo Composite® Nailing System, which is an intramedullary fixation rod. The document primarily focuses on demonstrating substantial equivalence to predicate devices. It does NOT contain information related to software or AI-driven devices, and therefore, does not discuss acceptance criteria, study methodologies, or performance results in the context of AI or machine learning.
The 510(k) summary (pages 3-5) highlights:
- Intended Use/Indications for Use: Treatment of stable and unstable proximal femur fractures.
- System Description: Includes nails, screws, and instruments made of carbon fiber reinforced polymer with titanium/titanium alloy components and tantalum markers.
- Substantial Equivalence: Claimed based on intended use, design, materials, technological characteristics, and principles of operation being similar to predicate devices.
- Performance Characteristics: Mentions "static and dynamic bending of implants construct" and "bacterial endotoxin testing" were conducted, and results were "comparable to those of predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria, study design, or performance metrics for an AI/software device as the provided document pertains to a physical medical implant device and does not involve AI or software performance evaluation.
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(92 days)
The Piccolo Composite foot and ankle plates are indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bone fragments in adult and adolescent (12 - 21 years) patients, including the foot and ankle, and including in osteopenic bone.
The MTP plates are indicated for treatment of deformations, fractures, nonunions and replantations of the 1st metarsophalangeal joint and 1st metatarsal bone.
The Piccolo Composite MTP Plate System comprises implants (plates and screws), and a set of instruments.
The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The screws are made of titanium alloy. Both non-locking and locking 2.7mm screws are available, in various lengths. Cannulated Lag Screws are also provided.
The provided text describes a 510(k) premarket notification for a medical device called the "Piccolo Composite® Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria in a clinical study sense with AI algorithms.
Therefore, the information requested in your prompt (Acceptance Criteria, Study details, Sample sizes, Expert qualifications, Adjudication method, MRMC studies, Standalone performance, Ground truth, Training set information) is not applicable to this document. The document outlines:
- Device Name: Piccolo Composite® Plate System
- Manufacturer: CarboFix Orthopedics, Ltd.
- Regulation Number: 21 CFR 888.3030 (Single/Multiple Component Metallic Bone Fixation Appliances And Accessories)
- Regulatory Class: Class II
- Product Code: HRS
- Indications for Use: Fixation of osteotomies, fusions, fractures, nonunions, malunions, and replantations of small bone fragments in adult and adolescent (12-21 years) patients, including the foot and ankle, and in osteopenic bone. Specifically, MTP plates are indicated for the 1st metatarso-phalangeal joint and 1st metatarsal bone.
- Predicate Devices: Primarily previous versions of the Piccolo Composite® Plate System (K102597, K120409, K130061, 143496, 160002), and additional predicates from Synthes and Tornier (OrthoHelix Surgical Designs Inc.).
- Substantial Equivalence Claim: Based on intended use, design, materials, technological characteristics, and principles of operation, and performance characteristics including static and dynamic bending (evaluated per ASTM F 382).
The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing, specifically mechanical testing per ASTM standards, rather than clinical trials or AI algorithm validation studies.
Here's a breakdown of why your specific questions cannot be answered by this document:
- Acceptance Criteria/Reported Performance: The document only states that performance characteristics were "comparable to those of predicate devices (as applicable)" and "demonstrating that the device is safe and effective for its intended use" based on tests like ASTM F 382. It does not provide a table of numerical acceptance criteria or reported device performance metrics from a clinical study, as these are not required for this type of submission for a bone fixation device.
- Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth/Training Set: These concepts are relevant to the validation of AI/ML-based medical devices or complex diagnostic devices, often involving human readers interpreting data. This document describes a mechanical implant, not an AI algorithm. Therefore, there are no "test sets," "training sets," "experts establishing ground truth," "adjudication methods," or "MRMC studies" in the context of human interpretation of medical images or data. The "ground truth" for this device's performance would be engineering specifications and mechanical test results (e.g., force at failure, fatigue life).
In summary: The provided text is a regulatory clearance letter for a mechanical medical device (bone plate system), not an AI-powered diagnostic or therapeutic device. Thus, the questions related to AI/ML validation methodologies are not applicable. The "proof" of meeting acceptance criteria for this device came from engineering and mechanical testing, not clinical studies involving expert readers or AI algorithms.
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(56 days)
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.
The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.
The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec
The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.
The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.
The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).
This document describes a 510(k) premarket notification for "PICC Maximal Barrier Nursing Kits" by Navilyst Medical, Inc. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
The document primarily focuses on a packaging change for the kit and vendor changes for several kit accessories. It does not detail new device performance, clinical studies for efficacy, or the development of an AI/ML model. Therefore, many of your requested points regarding acceptance criteria, study details for device performance (beyond packaging integrity), expert adjudication, AI/ML impact, and ground truth establishment are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance / Supporting Information |
|---|---|
| Packaging Integrity and Sterility (New Packaging Configuration) | The performance evaluation was conducted in accordance with: - AAMI/ANSI/ISO 11607-1 Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems, and packaging systems (2006) - AAMI/ANSI/ISO 11607-2 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (2006) The document states "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit." (Specific test results or quantitative performance metrics for packaging integrity are not provided in this summary but are implied to meet the standards.) |
| Equivalence to Predicate Device (Overall) | "The proposed PICC indications for use, technological characteristics, materials and operating principles are identical." "The performance evaluation... is the result of design verification and validation activities, and risk assessment." "Based on results of packaging testing performed according to recognized standards, the proposed PICC Maximal Barrier Nursing Kit is determined to be substantially equivalent to the predicate PICC Maximal Barrier Nursing Kit." |
2. Sample size used for the test set and the data provenance
Not applicable. This submission is for packaging and accessory vendor changes, not a new device requiring a clinical test set with patient data. The "test set" here refers to samples of the new packaging and components subjected to engineering and packaging validation tests. Specific sample sizes for these engineering tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This pertains to a packaging and component change, not a diagnostic or AI device requiring adjudication of results.
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. There is no mention of AI or machine learning in this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no mention of AI or machine learning in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this submission, "ground truth" relates to the compliance of the new packaging and components with established engineering and regulatory standards (e.g., sterility, seal integrity, material compatibility).
8. The sample size for the training set
Not applicable. There is no mention of AI or machine learning, and therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no mention of AI or machine learning, and therefore no training set or ground truth for it.
Summary of Device and Changes:
The device, "PICC Maximal Barrier Nursing Kits," includes various PICC catheter types (BioFlo Hybrid, BioFlo, Xcela Hybrid, Xcela) packaged with procedural aides and maximal barrier precautions. The "indications for use, technological characteristics, materials and operating principles are identical" to the predicate device. The only "differences" are a packaging change (outer tray with Tyvek lid replaced with a Tyvek/Nylon Pouch) and changes in vendors for "several kit accessories." The entire submission focuses on demonstrating that these changes do not alter the substantial equivalence to the predicate device, primarily through performance testing of the new packaging configuration against recognized international standards.
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