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Peri-Strips Dry is intended to reinforce staple lines during lung and bronchus resections including; pneumonectomy, pneumoreduction, pneumectorny, segmental resections), wedge resections, blebectomies, lobectomies, bullectomies, bronchial resections and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Peri-Strips is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. Peri-Strips can be used to reinforce staple lines during lung resections including pneumonectorny, pneumoreduction, pneumectorny, lobectomies, segmentectomies (segmental resections), wedge resections, bullectornies, blebectomias, bronchial resections, and other lung incisions and excisions of lung and bronchus. It can also be used for the reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding. Other soft tissue deficiencies amenable to repair with Peri-Strips include defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias). Peri-Strips may be used with anastomotic staplers (when tissue division is desired) or with non-anastomotic staplers (when no tissue division is desired) according to the above indications.

Peri-Strips (sleeve and strip) and Peri-Strips Dry are surgical mesh patches derived from bovine pericardium that is cross-linked with glutaraldehyde.

Peri-Strips comes in two configurations: Peri-Strips-sleeve and Peri-Strips-strip. Each unit of Peri-Strips-sleeve is composed of two strips of bovine pericardial tissue. After the final manufacturing step, each strip of pericardium is sewn to a polyolefin strip with polypropylene suture to create a tubular sleeve. The tubular configuration facilitates usage of the product with surgical staplers. The polyolefin strip and sutures are removed after the Peri-Strips-sleeve is secured in place. Peri-Strips-strip is a flat piece of bovine pericardium that is sutured to the stapler by the surgical team.

For Peri-Strips Dry (PSD), the bovine pericardial patch is manufactured in the form of a strip and undergoes an additional manufacturing step of dehydration by vacuum drying. The strip is affixed to the surgical stapler with the aid of a hydrogel (PSD Gel) supplied with the product.

Product may be treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20-25°C, rinsed with deionized (DI) water, and neutralized with citrate solution, followed by a final DI water rinse.

This document is a 510(k) Summary of Safety and Effectiveness for Bio-Vascular, Inc.'s Peri-Strips devices. It is a premarket notification for a medical device seeking substantial equivalence to predicate devices and focuses on expanding the indications for use. As such, it does not contain the level of detail regarding acceptance criteria and specific study results that would typically be found in a clinical trial report or a more extensive study submission.

Here is an analysis based on the provided text, noting where specific information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., minimum burst strength, leak pressure, etc.) are not provided. The "reported device performance" is largely qualitative and comparative to predicate devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "bench testing and animal testing" but does not give the number of samples or animals used.
• Data Provenance: Not specified, but given the context of a 510(k) submission, the testing would likely have occurred in a controlled lab or animal research setting. The country of origin is not mentioned. It is prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or specified. The testing described (bench and animal) would not typically involve human experts establishing ground truth in the way a clinical study with medical image interpretation would. The evaluation of safety and efficacy would be based on scientific and engineering principles.
• Qualifications of Experts: Not applicable or specified.

4. Adjudication Method

• Adjudication Method: Not applicable. The studies described are bench and animal tests, not clinical evaluations requiring adjudication of human expert opinions.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: Not applicable. This is a physical medical device (surgical mesh), not a software algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "bench testing" and "animal testing," the ground truth would be based on objective physical measurements and observations (e.g., mechanical properties, biocompatibility, tissue response, healing, absence of adverse events in animal models relative to predicate devices). The document states "Specifications of NaOH-treated and non-NaOH-treated tissue are identical," suggesting that the ground truth for equivalence was based on meeting defined product specifications.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The device is not an AI/ML algorithm that requires a training set. The manufacturing process and design were developed based on established scientific principles and prior versions of the device, rather than a data-driven training process.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process are based on conventional engineering and biological principles, with "ground truth" being established through quality control, design verification, and validation testing.

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CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.

Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Supple Peri-Guard is intended for repair of pericardial structures and 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, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).

CV Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.

Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.

Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.

The provided 510(k) summaries (K983602 for CV Peri-Guard, Vascu-Guard, and Supple Peri-Guard) do not describe a study involving acceptance criteria in the typical sense of a diagnostic or AI device performance study. Instead, these summaries focus on establishing substantial equivalence to predicate devices by comparing the technological characteristics of a modified manufacturing process (1M NaOH treatment).

The acceptance criteria here are implicitly met by demonstrating "no significant difference" in various tests between the NaOH-treated pericardium and the control (non-NaOH-treated) pericardium. The study performed is a series of laboratory and animal tests to support the safety and effectiveness of the modified product.

Here's a breakdown of the information requested, based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The documents do not specify the exact sample sizes used for each individual test (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing). The data provenance is implied to be from in vitro laboratory testing and in vivo animal testing. No country of origin for the data is explicitly stated, but the applicant is based in the USA. The studies would be considered prospective in the context of evaluating the new manufacturing process.

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

This type of study (material characterization and animal testing for substantial equivalence) does not typically involve "experts establishing ground truth" in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical, chemical, and biological properties, which are assessed by standard laboratory methodologies. The interpretation of animal testing results would be done by qualified veterinarians and pathologists, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a study that involves human interpretation requiring adjudication. Performance is based on objective laboratory measurements and animal observations.

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

No. This is not a diagnostic device or an AI system that would typically undergo an MRMC study. The study compares material properties and biological responses of a physical patch, not human reader performance with or without AI assistance.

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

Not applicable. This device is a physical patch material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this study is derived from:

• Objective laboratory measurements: For physical characteristics (shrink, suture, thickness) and chemical/biological properties (bioburden, sterility, pH, pyrogen, chemical residuals).
• Animal testing results: For biocompatibility and inflammation, which would involve macroscopic and microscopic observations by trained personnel (e.g., pathologists).

The comparison is made against the control samples (non-NaOH-treated pericardium), which represent the established predicate device's characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no "training set."

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

Not applicable. There is no training set for this type of device evaluation.

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Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.

Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.

The provided text describes a 510(k) summary for the Ocu-Guard Supple Orbital Implant Wrap, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way that might be seen for a new, complex algorithm or diagnostic device.

Therefore, many of the requested categories for acceptance criteria and study design are not directly applicable or extractable from this type of regulatory submission. The submission is primarily interested in showing that a modification to an existing product (adding a 1M NaOH treatment) does not negatively impact its safety or effectiveness compared to the previous version of the product.

Here's an attempt to answer as much as possible based on the provided text, with clarifications where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes for the "test" (NaOH-treated) and "control" (non-NaOH-treated) groups for the various tests (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical, biocompatibility, animal testing).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a manufacturing change, the data would typically be generated by the manufacturer (Bio-Vascular, Inc.) during product development and testing, implying a prospective and in-house provenance.

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

This concept is not applicable to the type of device and study described. The "ground truth" here is objective laboratory measurements (e.g., shrink, suture strength, pH values) and observations in animal models by scientists/technicians, not expert medical opinion on, for example, diagnostic images.

4. Adjudication method for the test set

Not applicable. This device's evaluation is based on objective measurements and animal studies, not subjective assessments requiring adjudication among experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/imaging device.

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

Not applicable. This is not an AI/imaging device.

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

The "ground truth" for this evaluation was based on a combination of:

• Physical property measurements: Shrinkage, suture retention, thickness.
• Biochemical/Microbiological assays: Bioburden, sterility, pH, pyrogen, chemical analysis.
• Biological responses in animal models: Biocompatibility and inflammation, observed in animal testing.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses training sets. The study described involves comparing two versions of a physical medical device.

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

Not applicable, as there is no training set mentioned for this product.

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

For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).

Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.

Supple Peri-Guard® is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.

The provided text describes two devices: "Peri-Guard Repair Patch" and "Supple Peri-Guard Pericardium," both with the same 510(k) number K983162. The information regarding their acceptance criteria and studies is identical across both entries, as they are essentially the same device with a minor manufacturing difference.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The text mentions "samples" of NaOH-treated and control pericardium were subjected to various tests.
• Data Provenance: Not explicitly stated but clinical data is alluded to by "animal testing" and "biocompatibility" but no human data is provided. The bovine pericardium for the device is procured from cattle originating in the United States and the study was conducted by the manufacturer, Synovis Surgical Innovations, based in St. Paul, MN. This suggests it is likely a retrospective study based on laboratory and animal testing, not a prospective human clinical trial.

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

• Not applicable as this study does not involve human readers evaluating images or data against a ground truth established by experts. It's a laboratory and animal study comparing physical, chemical, and biological properties of a medical device.

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study that involves expert adjudication of findings.

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

• No, an MRMC comparative effectiveness study was not done. This study focuses on the material properties and biological response to the modified implant, not on human interpretation or decision-making with or without AI assistance.

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

• Not applicable. This device is a surgical mesh, not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" in this context refers to the established standards for material properties, biocompatibility, and safety within a controlled laboratory and animal testing environment. This includes:
  • Physical measurements: Shrinkage, suture retention, thickness.
  • Chemical analyses: pH, chemical residuals.
  • Biological assays: Bioburden, sterility, pyrogenicity, biocompatibility (e.g., inflammatory response in animal models).
  • Comparison to predicate device/control: The non-NaOH-treated pericardium serves as the primary control or "ground truth" against which the modified device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set:

• Not applicable. This study does not involve a training set as it is not an AI/algorithm study.

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

• Not applicable as there is no training set for this type of device study.

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The Flo-Thru is indicated for use in coronary artery or peripheral vascular procedures. The device shunts blood at the anastomotic site which provides a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis. The device is removed just prior to the final suturing of the vessel.

The sterile, single-use Flo-Thru Intraluminal Shunt (FTIS) is a one-piece radiopaque silicone tube with atraumatic bulbs shaped at each end. Openings at the bulbs allow blood to flow through the shunt and distal to the anastomotic site. A radiopaque tab, which identifies the outer diameter of the bulbs, is attached to the shunt by a tether to facilitate positioning and removal of the shunt.

The provided text describes a medical device, the Flo-Thru Intraluminal Shunt, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology typically associated with AI/algorithm-based device studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies).

The text focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than proving specific performance metrics against pre-defined acceptance criteria through detailed clinical or performance studies.

Therefore, many of the requested fields cannot be filled from the provided text.

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

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

Missing Information (Not available in the provided text):

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

• Not specified. The text mentions "functional testing" but provides no details on sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. This device is a mechanical shunt, not an AI or diagnostic imaging device that typically requires expert ground truth for performance evaluation in the way described.

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

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm-based device. Functional testing was done on the physical device. The "standalone" performance here would refer to the device itself as described in the table above.

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

• For the functional tests, the "ground truth" would be the engineering specifications and performance benchmarks of the predicate devices. For sterility, it would be lab tests proving sterility. For radiopacity, it would be observation under fluoroscopy or X-ray. The document doesn't detail the how for each test.

8. The sample size for the training set

• Not applicable. This is not a machine learning device.

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

• Not applicable. This is not a machine learning device.

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For use as a dural substitute for the closure of dura mater during neurosurgery.

Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.

The provided text describes a 510(k) submission for a dural repair patch, Dura-Guard, and its substantial equivalence to a previously marketed device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/medical device performance study with specific metrics like accuracy, sensitivity, specificity, etc.

The document focuses on:

• Device Description: Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
• Technological Characteristics Comparison: The submission primarily compares a new version of Dura-Guard (treated with 1M NaOH) to an older version (not treated with 1M NaOH). The comparison is based on physical properties (shrink, suture, thickness), bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing.
• Conclusion: The manufacturer believes the NaOH-treated product performs similarly to the non-NaOH-treated product and poses no additional safety or effectiveness concerns.
• FDA Clearance: The FDA found the device substantially equivalent to pre-amendments devices.

Therefore, I cannot populate the requested table and sections. The information needed to address your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI model evaluation) is not present in the provided text, as this is a traditional medical device submission, not an AI/ML-based diagnostic device.

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CV Peri-Guard™ is intended for use as a patch for intracardiac, great vessel, valve repair and suture line buttressing (i.e. atrial septal defect (ASD) patch, atrial patch, valve annuloplasty, coronary graft buttress). May be used for repair of ventricular septal defect (VSD) using either a single patch or reinforced patch technique. May also be used in other applications exposed to peak systolic pressure using a reinforced patch technique (i.e. ventricular aneurysm patch, aortic graft suture line buttress).

CV Peri-Guard™ is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.

CV Peri-Guard™ - Cardiovascular Patch. CV Peri-Guard is composed of bovine pericardium, crosslinked with glutaraldehyde. Available in configurations ranging from 1 cm x 1 cm to 14 cm x 16 cm.

The provided document is a 510(k) premarket notification for a medical device (CV Peri-Guard™ Cardiovascular Patch) and its associated FDA clearance letter. It does not contain the detailed information necessary to fully address all aspects of your request, particularly regarding specific acceptance criteria and the comprehensive study design typically associated with AI/ML device evaluations.

Here's an analysis based on the available information, highlighting what can be extracted and what is missing:

The device, CV Peri-Guard™, is a cardiovascular patch made of bovine pericardium. The premarket notification is for an extension of indications for use in intracardiac and great vessel repair. The core argument for substantial equivalence is based on the device's similarity to existing predicate devices (Gore-Tex Cardiovascular Patch, Peri-Guard, and Vascu-Guard) and a history of safe and effective use of the base material.

Missing Information (Crucial for an AI/ML context):

• No AI/ML device: This document describes a traditional medical device (a surgical patch), not an AI/ML diagnostic or predictive device. Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.
• Quantitative Acceptance Criteria: The document focuses on demonstrating substantial equivalence to existing devices rather than meeting specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy thresholds) that would define "acceptance criteria" for an AI/ML system. The "acceptance criteria" here are qualitative and relate to the overall safety and effectiveness compared to predicates.
• Detailed Study Design for Performance Metrics: While studies are mentioned (calcification, canine, clinical report), the methodology, statistical analysis, and specific performance outcomes in a quantifiable manner (e.g., "device performed at X% sensitivity") are not provided.

Based on the available information, here is an attempt to populate the table and answer the questions, with explicit notes about missing or non-applicable data:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in a quantifiable number.
  • For the Calcification Studies: "Peri-Guard and Supple Peri-Guard have been evaluated in a proven model for calcification: the juvenile rat subcutaneous mode." No specific number of rats/samples is provided. Clinical evaluation involved "mittal valve annulus position, and other intracardiac patch positions" with outcome "up to a mean of 17 months post-op." The number of patients is not specified.
  • For Canine Studies: "A Canine implant study." Single study mentioned, but sample size (number of canines or implants) not specified.
  • For Clinical Report: "The clinical data, gathered under the Peri-Guard Retrospective study protocol." No specific number of patients or cases is mentioned.
• Data Provenance:
  • Country of Origin: Not specified. Implicitly, as the submitting company is US-based and FDA is the regulatory body, some studies might be US-based, but this is not confirmed.
  • Retrospective or Prospective:
    • Clinical Report: Explicitly states "Retrospective study protocol."
    • Other studies (Calcification, Canine): Not specified, but likely experimental laboratory/animal studies.

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

• Not Applicable in the context of an AI/ML device. The "ground truth" here relates to biological and clinical outcomes assessed through animal models, pathology (in calcification studies), and clinical evaluation. The evaluations would have been conducted by relevant scientific and medical professionals (e.g., pathologists, surgeons, veterinarians), but no specific "expert panel" for establishing a diagnostic ground truth for a test set is described, as would be common for AI/ML performance assessment.

4. Adjudication method for the test set

• Not Applicable. As this is not an AI/ML device assessing a "test set" for diagnostic accuracy, no adjudication method (like 2+1 or 3+1 consensus) for expert decisions is described. The "judgement" of the device's performance is based on direct measurement, observation, and clinical outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI-assisted device. An MRMC study is not relevant.

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.

7. The type of ground truth used

• Expert Consensus: Not explicitly described for a specific "ground truth" decision-making process.
• Pathology: Likely used in the calcification studies ("juvenile rat subcutaneous mode," "glutaraldehyde-treated control").
• Outcomes Data: Yes, this is a primary ground truth.
  • Clinical outcomes (e.g., clinical insignificance of calcification, safe and effective performance over time, "no calcification related to the Peri-Guard patch up to a mean of 17 months post-op" from the clinical report).
  • In vivo animal model outcomes (canine study showing similar performance to ePTFE).
  • Biocompatibility testing results.

8. The sample size for the training set

• Not Applicable in an AI/ML context. This device does not have a "training set." The "experience" or "data" is derived from historical use of the base material and predicate devices, as well as the studies mentioned.

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

• Not Applicable. No training set exists for this type of device. The "ground truth" for the overall understanding of the material's performance (analogous to how a training set might inform an AI model) comes from decades of historical clinical use of processed bovine pericardium and predicate devices, as well as the preclinical and clinical studies conducted.

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For use as a dural substitute for the closure of dura mater during neurosurgery.

Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.

The provided text does not contain information about acceptance criteria or a study proving that the Dura-Guard device meets acceptance criteria in the manner requested by the prompt. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance acceptance criteria and a study to meet them.

Specifically, the document states:

• "Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles." This indicates that some testing was done and a comparison was made between treated and untreated samples of the device, but it does not specify quantitative acceptance criteria for these tests.
• "Biocompatibility testing also showed no significant difference between the test and control articles." Again, testing was performed, but no acceptance criteria are provided.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or MRMC studies for a performance study.

Here's a summary of what is available regarding testing, and an explanation of why the requested information cannot be provided based on the input:

Acceptance Criteria and Reported Device Performance

Study Details (Information Not Available in the Provided Text)

1. Sample size used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's "acceptance" is based on physical material properties and biocompatibility, not expert-adjudicated images or clinical outcomes in the way implied by "ground truth" for AI/human reader studies.
3. Adjudication method: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a dural repair patch, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant and was not performed.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
6. The type of ground truth used: For material properties, the "ground truth" is measured physical properties. For biocompatibility, it's the results of standard biological tests. There's no "expert consensus" or "pathology" in the context of device performance in the way described for AI/diagnostic studies.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating that the device (Dura-Guard subjected to antibiotics) is substantially equivalent to an existing predicate device (Dura-Guard not subjected to antibiotics) by showing "no significant difference" in critical performance characteristics. It doesn't detail performance against specific, predefined acceptance thresholds which is often found in performance studies for novel devices or software.

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Ocu-Guard™ and Supple Ocu-Guard™ are indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the Implant. Ocu-Guard and Supple Ocu-Guard allow for tissue ingrowth through the vascularization process and protect the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard and Supple Ocu-Guard also allow for muscle reattachment to facilitate motility of the implant.

Ocu-Guard™ Orbital Implant Wrap and Supple Ocu-Guard™ Orbital Implant Wrap. Both products are composed of bovine pericardium, cross-linked (tanned) with glutaraldehyde.

Ocu-Guard and Supple Ocu-Guard will be available in configurations ranging from 4cmx4cm to 10cmx16cm.

Ocu-Guard and Supple Ocu-Guard will also be available as a "pre-formed" wrap. The "pre-formed" wrap will be available in configurations which will fit implant spheres ranging from 14 mm to 22 mm in size.

This 510(k) submission (K973552) for Ocu-Guard™ and Supple Ocu-Guard™ Orbital Implant Wrap does not contain detailed acceptance criteria or a specific study proving the device meets stated acceptance criteria in a format directly comparable to modern AI/ML device submissions. Instead, it relies on a demonstration of substantial equivalence to predicate devices. Therefore, the requested output in the format of acceptance criteria and device performance based on a standalone study cannot be fully extracted.

However, based on the provided text, we can infer the principles of acceptance and the types of studies performed to support the claim of substantial equivalence.

Here's an interpretation of the document in the requested format, with explanations where direct information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Rabbit Ocular Implant Studies: Sample size is not specified. Likely retrospective, as it refers to a "study" without details on its design or start/end dates for this specific 510(k). Data provenance: Not specified (but likely within the US given the submission to FDA).
• Canine Implant Studies: Sample size is not specified. Likely retrospective. Data provenance: Not specified.
• Clinical Report: "Preliminary clinical data" is mentioned, sample size not specified. Likely retrospective from existing clinical use of the bovine material (Peri-Guard and Supple Peri-Guard). Data provenance: Not specified.

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

This document does not describe "ground truth" in the context of expert consensus as relevant to AI/ML devices. The "truth" here is established through pre-clinical (animal) studies and preliminary clinical observations by researchers/clinicians, which are then evaluated by the FDA for substantial equivalence. No specific number or qualification of experts establishing ground truth in this manner is provided.

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

Not applicable. The studies mentioned (animal, preliminary clinical) are experimental observations rather than assessments requiring adjudication of interpretations of data by multiple human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission predates the widespread use of sophisticated AI in medical devices and does not involve human readers interpreting images with or without AI assistance. The focus is on the material's biological and physical performance.

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

Yes, in a sense, the animal studies (Rabbit Ocular Implant, Canine Studies) and the biocompatibility testing can be considered "standalone" evaluations of the device material's performance independent of human intervention in its function. These studies assess the biological and physical properties of the material itself.

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

The "ground truth" for demonstrating substantial equivalence is primarily derived from:

• Histopathological or gross observation in animal studies (e.g., tissue integration, inflammatory response).
• Biocompatibility testing results (standard tests for cytotoxicity, sensitization, irritation, etc.).
• Mechanical and physical testing results of the material characteristics.
• Clinical observations/outcomes data from the "preliminary clinical data" and "history of safety and effectiveness" for the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The "history of safety and effectiveness" and predicate device data can be conceptualized as a vast "experience base" rather than a formally labeled training set.

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

Not applicable, as no training set for an algorithm is involved. The "ground truth" for the historical data of processed bovine pericardium (Peri-Guard, Supple Peri-Guard) would have been established through extensive preclinical and clinical use, including pathology, clinical outcomes, and long-term safety monitoring over two decades (since 1982).

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