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Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.

Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.

The provided text describes the non-clinical testing performed on the Endoform Dental Membrane to demonstrate its safety and performance. However, it does not include information about acceptance criteria for all the tests, nor does it detail a study that defines "device performance" in terms of clinical or comparative effectiveness against specific criteria in the way you've outlined.

Based on the available text, here's a breakdown of the information that is present, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document details numerous non-clinical tests. For many, it states that the device "met the pre-defined specification" or "meets the specification," but it often does not explicitly list the numerical acceptance criteria in this summary. The table below compiles the criteria where they are explicitly mentioned.

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

The document describes several non-clinical tests but does not explicitly state the specific numerical sample sizes for each test set. It mentions "All EDM devices" or "all samples" in some contexts.

For the Animal Performance Testing:

• Sample Size (Test Set): Not explicitly stated how many animals were used, but it was an ovine (sheep) defect model study using "selected timepoints (week 4, 8 and 16)".
• Data Provenance: Prospective animal study conducted in an ovine (sheep) defect model. The country of origin is not specified, but the applicant's address is New Zealand.

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

This information is not provided in the document. The non-clinical tests described rely on validated laboratory methods and specifications, which are based on scientific standards rather than expert consensus on a test set in the way clinical diagnostic devices might.

For the animal study, the assessment criteria (resorption, cellular infiltration, inflammatory response, retention of bone grafting material, hard tissue infill) would likely be evaluated by veterinarians or pathologists, but the number and qualifications of these experts are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided as the document focuses on laboratory and animal study results rather than human-read test sets.

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

No. A MRMC comparative effectiveness study was not performed or described. The document explicitly states: "Clinical data was not required to demonstrate substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a bioabsorbable extracellular matrix (Endoform Dental Membrane), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the various tests conducted for the Endoform Dental Membrane is based on:

• Validated Test Methods: For biochemical content (collagen, GAG, DNA), physical properties (moisture, DSC, permeability, suture retention, modulus, thickness), residual substances (Tx-100, EDTA, PAA), bioburden, endotoxin, and shelf-life. These are quantitative measurements against predefined specifications.
• Standards Compliance: For biocompatibility (ISO 10993 series), sterilization (ISO 11135), and packaging (ASTM standards).
• Histopathological and Macroscopic Assessment: For the animal performance study, evaluating resorption, cellular infiltration, inflammatory response, and bone graft retention based on examinations at specific time points. This likely involves expert evaluation of tissue samples, but it's not "expert consensus" on a diagnostic task, rather assessment of biological outcomes compared to a reference device.
• "Critically sized" defects: The animal study also demonstrated that untreated controls did not completely regenerate bone, indicating the defects were appropriately sized for evaluating the device's performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

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OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one time use.

OviTex PRS (Long-Term Resorbable) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.

This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered 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

The document states: "New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.

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

• Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
• Biocompatibility Assessment: Not specified.
• Implantation Study: Not specified.

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 is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.

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

Not applicable for the types of studies 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

No, an MRMC study was not done. This device is a surgical mesh, not an AI/ML diagnostic tool.

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

Not applicable. This is not an algorithm or software device.

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

• Bench Testing: Engineering specifications and standardized test methods.
• Biocompatibility: ISO 10993 standards and toxicological risk assessment.
• Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary Table (Limited Information Available from Document):

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