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PERI-GUARD is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, scrotal, and umbilical hernias).

SUPPLE PERI-GUARD is intended for use as a prosthesis for soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral. incisional, inguinal, lumbar, scrotal, and umbilical hernias).

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25℃ (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

The provided document is a 510(k) summary for medical devices, specifically Peri-Guard and Supple Peri-Guard surgical meshes. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for AI/ML performance.

Therefore, the information required to answer your prompt regarding acceptance criteria and performance studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, ground truth establishment, training set details) is not present in the provided text. The document focuses on demonstrating the safety and effectiveness of a material and physical design change (sterilization method and packaging) for a surgical mesh, not on evaluating the performance of an AI-driven medical device.

To directly address your request for a table of acceptance criteria and study details, based solely on the provided text, I must state that this information is not available.

The document details non-clinical bench testing and animal studies to support the substantial equivalence claim for the modified surgical mesh. These studies are focused on material properties, biocompatibility, and physical performance of the mesh, and not on the performance of an AI model.

Here's how I would summarize the relevant information from the document, while acknowledging the absence of AI/ML-specific details you requested:

Acceptance Criteria and Device Performance (as described for the surgical mesh, not an AI device):

The document does not present a table of quantitative acceptance criteria for the mesh's performance in the way one would for an AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, it discusses the equivalence of the modified device to its predicate through various non-clinical and animal studies. The overall "acceptance criterion" implicit in a 510(k) is the demonstration of substantial equivalence to a predicate device, meaning the new device is as safe and effective as the legally marketed predicate.

Reported Device Performance (for the surgical mesh):

The document states that the results of performance testing demonstrate that the modified PERI-GUARD and SUPPLE PERI-GUARD devices are substantially equivalent to the predicate devices.

Specific performance aspects evaluated include:

• Bench Testing: Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing.
  • Conclusion: The results of these tests support substantial equivalence.
• Animal Studies:
  • Implantation (Porcine incisional hernia repair model for 6 months per ISO 10993-6): "No test material-related changes among clinical observations, bodyweights, veterinary physicals, clinical pathology parameters, mortality, significant macroscopic or microscopic differences, tensile or burst strength, or clinical performance between the subject and predicate devices..."
    • Conclusion: "The subject and predicate devices performed equivalently and had an equivalent safety profile in the in vivo porcine model for incisional hernia repair."
  • 3-week Rat Calcification Potential Study: "No significant mineralization was noted microscopically for either the subject or predicate device."
    • Conclusion: "No significant difference in calcification potential."
• Biocompatibility: Demonstrated biocompatibility in accordance with ISO 10993-1:2018 for a permanent implant, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, genotoxicity, implantation, hemolysis, and subchronic toxicity endpoints.
• Shelf Life: 1-year shelf life claim supported by aging testing.
• Sterilization and Packaging: Validation per ISO 11137 parts 1 and 2 (sterilization) and ISO 11607-1 (packaging integrity, supported by ASTM F88-15 and ASTM F2096-11).
• Human Factors Testing: Confirmed that redesigned packaging allows for aseptic transfer without compromising sterility and does not impact the tissue patch surface.

Detailed breakdown of AI/ML specific information (Not Found in these documents):

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. Studies conducted were animal (porcine and rat) and bench tests.
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 the mesh's performance attributes (e.g., tensile strength, burst strength, calcification) is established through standardized laboratory and animal model measurements, not expert consensus interpreting images/data.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance relies on direct physical measurements (e.g., tensile strength, burst strength), chemical analysis (e.g., residuals), and histopathological evaluation in animal models. It's not a diagnostic AI that generates predictions requiring expert-adjudicated ground truth labels.
8. The sample size for the training set: Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary is for a traditional medical device (surgical mesh) and lacks any information pertaining to AI/ML device performance, acceptance criteria, or study methodologies.

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VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.

VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F). VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. VASCU-GUARD is MR Safe. VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.

The provided text is a 510(k) summary for the VASCU-GUARD Vascular Repair Patch. It describes the device, its intended use, and comparison to predicate devices, along with performance data. However, this document does not contain information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the context of an AI/ML medical device.

The performance data listed (Visual, Suture retention, Dimensional, Burst strength, Collagenase digestion, Denaturation Temperature, Water Permeability, Pliability, Chemical and heavy metal residuals, Bioburden, Pyrogenicity/Endotoxins, Temperature Excursion Testing, Biocompatibility Assessment) are for physical and material properties of the vascular repair patch itself, not for an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for an AI/ML device, as the supplied text pertains to a physical medical device (a vascular repair patch) and not an AI/ML product.

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PERI-GUARD is intended for repair of pericardial structures. PERI-GUARD is also intended for use as a patch for intracardiac defects, great vessel, septal defects and annulus repair, and suture-line buttressing.

SUPPLE PERI-GUARD is intended for use as a prosthesis for pericardial closure.

PERI-GUARD Repair Patch (PERI-GUARD) and SUPPLE PERI-GUARD Repair Patch (SUPPLE PERI-GUARD) are derived from bovine pericardium procured from cattle originating in the United States. The pericardium is crosslinked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25°C (68-77°F).

PERI-GUARD and SUPPLE PERI-GUARD are terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.

PERI-GUARD and SUPPLE PERI-GUARD are MR Safe.

PERI-GUARD and SUPPLE PERI-GUARD utilize animal tissue; patient must be informed prior to any procedure.

This is a 510(k) premarket notification for the PERI-GUARD Repair Patch and SUPPLE PERI-GUARD Repair Patch. This document describes the device, its intended use, and the performance data provided to demonstrate substantial equivalence to predicate devices. The submission focuses on changes to packaging and sterilization parameters, with a reliance on historical data for many performance aspects.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "device performance" results for each criterion in the typical sense of a clinical or standalone performance study. Instead, it lists various performance tests conducted to support substantial equivalence. The "reported device performance" is implicitly that the devices "meet" or "demonstrate equivalence" to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each performance test. It mentions "aging testing" for shelf life, but without a specific sample size. The studies are non-clinical (laboratory/bench testing, in vitro), not based on patient data. Therefore, questions about country of origin and retrospective/prospective nature are not applicable in this context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a submission for a medical device (a patch), and the evaluation is based on non-clinical performance data and substantial equivalence to existing devices, not on diagnostic accuracy against a "ground truth" established by human experts.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical medical device, not an AI/software as a medical device (SaMD) that involves human readers or AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy. For the performance tests listed, the "ground truth" or reference standards are the established industry standards, test methodologies (e.g., ASTM, ISO), and the performance characteristics of the predicate devices. For example, for "Burst Strength," the "ground truth" would be the measurement obtained using a validated testing procedure, and the performance would be compared to that of the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

PSDV-SG can be used for reinforcement of staple lines during bariatric, gastric, small bowel, colon and colorectal procedures.

PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG) is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the United States.

The product consists of a loading unit which includes two (2) buttresses, one for the anvil (ANV) and one for the cartridge (CART) side of the stapler. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch.

PSDV-SG utilizes animal tissue; patient must be informed prior to any procedure.

PSDV-SG is provided sterile and intended for single use. Sterilization occurs via ethylene oxide. The bovine pericardium buttress and acrylic adhesive are intended for permanent implant.

This document is a 510(k) summary for a medical device called PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (PSDV-SG). It describes the device, its intended use, comparison to predicate devices, and performance data.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

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

The document lists various assessments for design verification. It doesn't present these as formal "acceptance criteria" with specific pass/fail values in a table, but rather as "assessments" with the general outcome mentioned as "Testing passed the acceptance criteria" for biocompatibility and "demonstrate the performance of the PSDV-SG device is substantially equivalent to the predicate devices" for bench testing.

Based on the text, here's a conceptual table:

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

• Sample Sizes: The document does not specify sample sizes for any of the tests (bench studies, biocompatibility, human factors, or surgeon validation). It broadly mentions "testing" or "studies" without numerical details.
• Data Provenance: The document implies that the data was generated by Synovis Life Technologies, Inc. (now Baxter International Inc.) as part of their 510(k) submission. There is no information about the country of origin of the data explicitly stated. The studies are pre-clinical bench studies and validation studies, which are typically conducted in a controlled environment as part of product development, not necessarily from a "retrospective" or "prospective" clinical data sense.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • For the "Human Factors Study," "user comprehension" was assessed, implying user participants, but not "experts" in the sense of ground truth establishment.
  • For the "Surgeon Validation," "surgeons" were involved, but their number and specific qualifications (e.g., years of experience, specialty) are not provided. They were involved in assessing functionality and satisfaction, not necessarily establishing a "ground truth" that would be typical for, say, an AI model's diagnostic accuracy.

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

• Not applicable / None specified. The studies described (bench, biocompatibility, human factors, surgeon validation) do not involve subjective interpretation of medical images or data requiring an adjudication method common in diagnostic accuracy studies. They are focused on physical and functional performance, safety, and usability.

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 MRMC study was done. This device is a surgical mesh for staple line reinforcement, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

• Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI. Standalone performance for an algorithm is not relevant here.

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

• Not applicable in the typical sense of diagnostic "ground truth." For this device, "ground truth" relates to the functional performance of the device against engineering specifications, biocompatibility standards, and usability criteria.
  • For bench testing, the "ground truth" is likely defined by engineering specifications and comparative performance to predicate devices.
  • For biocompatibility, the "ground truth" is defined by the passing criteria of the ISO 10993-5 standard.
  • For human factors, "ground truth" is user comprehension and ability to use the device as intended.
  • For surgeon validation, "ground truth" is customer satisfaction and functionality assessment by the surgeons.

8. The sample size for the training set:

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

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

• Not applicable. As above, no training set for an AI/ML algorithm.

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The Flow COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The Flow COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the Flow COUPLER Device is used in conjunction with the Flow COUPLER Monitor, the Flow COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The Flow COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.

The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.

The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.

The provided document is a 510(k) Premarket Notification from the FDA for the GEM™ Flow COUPLER™ Device and System. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics of a new device.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, ground truth establishment, and expert involvement are not explicitly present in the provided text. The document states that the modified Flow Coupler device is considered substantially equivalent to its own predicate (K142609), which is the GEM Flow COUPLER Device and System.

Here's an attempt to answer the questions based on the information available:

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

The document does not provide a table with quantitative acceptance criteria and reported device performance in the way a clinical study or performance verification study for a new device might. Instead, it states that "functional specifications were not affected by the line extension" for the 4.0mm Flow COUPLER. The acceptance criteria would broadly be that the modified device performs equivalently to the predicate device across the listed tests.

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

The document mentions "bench testing on the 4.0mm Flow COUPLER line extension," but it does not specify the sample size for any of these tests. The data provenance is not mentioned, but given it's a submission to the US FDA and the company is based in the US, it's highly likely the testing was conducted in the US. The nature of "bench testing" implies it's a prospective series of tests performed on physical devices.

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 in the document. For bench testing of physical properties, "experts" in the clinical sense are typically not involved; rather, engineering and quality assurance personnel conduct the tests against specifications.

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

This information is not provided. Adjudication methods are highly relevant for clinical studies or studies involving human interpretation. For bench testing of functional specifications, the results are usually objective measurements against predefined engineering tolerances.

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 study or AI assistance in this document. The device is a mechanical coupler with an ultrasonic Doppler probe, not an AI diagnostic tool.

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

This is not applicable. The device is not an algorithm, but a physical medical device. It has a "standalone" function in the sense that the Doppler probe detects blood flow independently, but it is not an AI algorithm.

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

For the bench tests, the "ground truth" would be the engineering specifications and established functional parameters of the predicate device or industry standards for similar devices. For example, for "ring retention" or "probe signal," there would be quantifiable metrics and tolerances that the device must meet.

8. The sample size for the training set

There is no mention of a training set. This type of test is for a physical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned.

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The Flow COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The Flow COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the Flow COUPLER Device is used in conjunction with the Flow COUPLER Monitor, the Flow COUPLER System is intended to detect blood flow and confirm vessel patency intraoperatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The Flow COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.

The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.

The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.

The provided text describes the GEM™ Flow COUPLER™ Device and System, which is a medical device for microvascular reconstruction procedures. However, the document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a clinical study or AI model performance evaluation.

Therefore, the requested information categories regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication, and MRMC/standalone studies cannot be fully provided based on the given document.

The document indicates that this device is an update to an existing device (K132727 and K093310). The "acceptance criteria" discussed are largely related to ensuring the new version retains the safety and effectiveness of the previous version and that manufacturing and design changes (like an extended size range) do not negatively impact performance.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI model or a specific clinical trial outcome (e.g., sensitivity, specificity, AUC). Instead, it discusses the validation of functional specifications for a line extension.

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

Not applicable. The document discusses "bench testing" for a device line extension, not a test set for an algorithm or a clinical study. No information on sample size or data provenance in this context is provided.

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. This is not a study involving expert-established ground truth for a test set.

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

Not applicable. This is not a study involving an adjudicated test set.

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 document does not mention an MRMC study or AI models. It pertains to a physical medical device.

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

No. This document does not discuss an algorithm or standalone performance.

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

For the bench testing, the "ground truth" would be the engineering specifications and expected performance benchmarks for each test (e.g., a certain force for probe separation, a clear probe signal). For the risk assessment, it would be the identified hazards and their severities. This is not clinical ground truth.

8. The sample size for the training set

Not applicable. This document does not describe a training set for an AI model.

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

Not applicable. This document does not describe a training set for an AI model.

In summary: The provided text is a regulatory clearance document for a medical device (GEM™ Flow COUPLER™ Device and System) based on substantial equivalence. It details manufacturing, design, and functional testing to support modifications to an existing device, rather than providing the kind of performance data usually associated with acceptance criteria for a new AI-powered diagnostic or prognostic tool.

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The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Postoperatively, blood flow can be detected on an as needed basis for up to 7 days. The FlowCOUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

The Flow COUPLER System consists of a Flow COUPLER Device and a Flow COUPLER Monitor. The Flow COUPLER Device is a sterile, single-use implantable pair of rings molded out of high density polyethylene with six stainless steel pins on each ring. The Flow COUPLER Device is designed to serve as a mechanical, sutureless device for connecting veins or arteries. A probe-holder feature is molded on one Flow COUPLER ring and serves as the press-fit point of attachment for a pre-attached 20 MHz Doppler probe. The Doppler probe connects to the Flow COUPLER Monitor unit, via the external lead.

The Flow COUPLER Monitor and Doppler probe is a pulsed Doppler ultrasound system designed for the detection of blood flow in vessels. An audible ultrasonic signal is produced when the Doppler probe detects blood flow.

The Flow COUPLER Device and System has been specifically designed for use in end-to-end anastomosis of blood vessels and the detection of blood flow at the anastomotic site. On an as needed basis, blood flow can be detected for up to 7 days. The Flow COUPLER rings are intended to be a permanent implant. The Flow COUPLER probe is not intended to be a permanent implant; the probe should be removed, by gentle traction on the external lead, 3 to 14 days post-operatively.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a direct performance table. Instead, it focuses on demonstrating substantial equivalence to a predicate device by verifying that modifications did not affect functional specifications and that the device meets relevant standards.

However, based on the types of testing performed, we can infer the performance areas that would have had internal acceptance criteria:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a sample size for the non-clinical testing performed. It refers to "testing" performed to verify functional specifications.
• Data Provenance: The data provenance is not explicitly stated beyond being "non-clinical testing on the modified device." There's no mention of country of origin or whether it was retrospective or prospective, though "non-clinical" usually implies laboratory or bench testing rather than human clinical trials.

3. Number of Experts and Qualifications for Ground Truth

• The document does not refer to experts establishing ground truth for any test set in the context of this 510(k) submission. The testing described is primarily engineering and materials-based to confirm functional specifications and safety, not related to expert interpretation of diagnostic output.

4. Adjudication Method for the Test Set

• Not Applicable: Since no human interpretation or diagnostic ground truth establishment is described, no adjudication method is mentioned or relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

• No: The document does not mention or describe an MRMC comparative effectiveness study. This submission is for a device that detects blood flow, not an imaging or diagnostic algorithm that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

• The device being submitted (GEM Flow COUPLER) is a hardware device (coupler with an integrated Doppler probe and a monitor unit). While the monitor unit processes the Doppler signal, the submission focuses on the device's functional specifications and safety. Therefore, a standalone "algorithm only" performance study, as typically understood for AI/software, is not applicable to this type of device and is not mentioned. The "detection of blood flow" is an inherent function of the Doppler technology, not a distinct AI algorithm.

7. Type of Ground Truth Used

• The ground truth for the non-clinical testing appears to be based on engineering specifications and established regulatory standards. For example, for "Doppler probe signal functionality," the ground truth would be the expected and accurate detection of a simulated or actual blood flow signal. For electrical safety, the ground truth is conformance to IEC 60601-1 standards. For biocompatibility, it's conformance to ISO 10993-1. These are not typically "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. Sample Size for the Training Set

• Not Applicable / Not Mentioned: This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" of the device is through its design, manufacturing to specifications, and calibration, not through data input.

9. How Ground Truth for the Training Set was Established

• Not Applicable / Not Mentioned: As this is not an AI/ML device with a training set, the concept of establishing ground truth for a training set does not apply.

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The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.

The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.

The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Synovis Vascular Probe / Vascular Probe ES
Predicate Device: Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K910682

This submission focuses on a change in a component (new vinyl resin in the colorant of the polyurethane coating) of an already marketed device, rather than a completely new device. Therefore, the "study" described is primarily a series of verification and validation tests to ensure the new component does not negatively impact the pre-established safety and performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text does not specify the exact number of units or samples used for biocompatibility and tensile strength testing. It states "Testing conducted" and "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin."
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Synovis Surgical Innovations. Given it's a 510(k) submission for a component change, the data would be prospective for the specific tests, as they were conducted to evaluate the impact of the new resin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable (N/A). This submission is not a clinical study involving human assessment or interpretation for diagnostic accuracy. The "ground truth" for the tests performed (biocompatibility, tensile strength) is based on established scientific protocols and engineering standards, not expert clinical consensus on individual cases.

4. Adjudication Method for the Test Set

• Not applicable (N/A). As mentioned above, this is laboratory and bench testing, not a study requiring adjudication of clinical data or expert opinions. The results are objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Vascular Probe is an surgical instrument, not a diagnostic device of that nature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No, a standalone algorithm performance study was NOT done. This is relevant for AI/ML-driven diagnostic devices. The Vascular Probe is a physical surgical tool.

7. The Type of Ground Truth Used

• Laboratory Standard / Engineering Specification:
  • For Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).
  • For Tensile Strength: Conformance to "current Vascular Probe finished device specifications."

8. The Sample Size for the Training Set

• Not applicable (N/A). This device does not involve algorithms or machine learning that would require a "training set." The tests are designed to verify material properties and biological compatibility.

9. How the Ground Truth for the Training Set Was Established

• Not applicable (N/A). See the answer to point 8.

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