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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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Endoform Silver Dermal Template is supplied sterile and is intended for single use in the management of the following wounds:

• partial and full-thickness wounds
• pressure ulcers
• venous ulcers
• diabetic ulcers
• chronic vascular ulcers
• tunnelled / undermined wounds
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
• trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
• draining wounds

Endoform Silver Dermal Template (Endoform Silver) is an advanced wound care dressing primarily composed of natural, non-reconstituted collagen retaining the native extracellular matrix associated macromolecules including fibronectin, glycosaminoglycans, laminin, and elastin. Endoform Silver is supplied as sterile intact or fenestrated sheets.

Endoform Silver contains approximately 12 µg/cm² (~0.3% w/w) ionic silver, intended to prevent microbial colonization of the dressing is effective against a broad spectrum of microbes, including Acinetobacter baumannii, Candida parapsilosis, Candida glabrata, Candida albicans, Escherichia coli, Methicillin Resistant Staphylococcus aureus (MRSA), coagulase-negative Staphylococci, group A (betahemolytic) Streptococci, Pseudomonas aeruginosa, Aspergillus niger, and Vancomycin Resistant Enterococci (VRE). The dressing provides sustained antimicrobial effectiveness within the dressing for up to 7 days.

Endoform Silver is derived from ovine (sheep) extracellular matrix and it retains the innate biological structure of the native extracellular matrix. When rehydrated with exudate or sterile saline, Endoform Silver transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.

The provided document is a 510(k) summary for the Endoform Silver Dermal Template, and it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study to prove device performance against specific acceptance criteria. Therefore, much of the requested information regarding a study design, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not available in this document.

However, I can extract information related to the non-clinical performance data and the comparison to the predicate device.

Here's a breakdown of the available information based on your request:

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

The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it states that "The acceptance criteria were met for all characteristics and comparison against the predicate and reference devices demonstrates equivalent performance" in the non-clinical testing section. The key performance claim for the subject device (Endoform Silver Dermal Template) is antimicrobial effectiveness.

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

• Sample Size: Not specified for non-clinical tests (e.g., number of dressings tested for antimicrobial effectiveness, physical properties, etc.).
• Data Provenance: The tests are "in vitro performance testing" and "performance bench testing." No information on country of origin of data is provided specifically for these lab tests, but the company (Aroa Biosurgery) is based in New Zealand. These are lab-based tests, not human data.

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. The non-clinical performance data (e.g., antimicrobial effectiveness, physical characteristics) are measured objectively in a lab setting, not by expert interpretation.

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

Not applicable. This concept pertains to human interpretation/adjudication in clinical studies, which is not described for the non-clinical tests presented.

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 a medical device (wound dressing) and the information provided refers to non-clinical performance, not an AI-driven diagnostic or assistive technology.

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

Not applicable. This device is not an algorithm. The testing described is "standalone" in the sense that the device's physical and antimicrobial properties are tested independently.

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

For the non-clinical tests:

• Antimicrobial Effectiveness: The "ground truth" is measured by objective laboratory methods against known microbial cultures (e.g., measuring zones of inhibition, reduction in microbial count).
• Physical/Compositional/Safety Tests: The "ground truth" is established by adherence to recognized industry standards (e.g., ISO standards, USP, ANSI/AAMI), which define acceptable ranges and methodologies for measurement.

8. The sample size for the training set

Not applicable. This document describes a medical device undergoing non-clinical performance testing and substantial equivalence review, not an AI model requiring a training set.

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

Not applicable, as it's not an AI model.

Summary of the Study and Substantial Equivalence:

The document describes a 510(k) premarket notification for the Endoform Silver Dermal Template. The "study" described is a series of non-clinical performance tests conducted to demonstrate that the device is substantially equivalent to a legally marketed predicate device, the PriMatrix Ag Antimicrobial Dermal Repair Scaffold (K100261). A reference device, the Endoform Dermal Template (K092096), was also used for comparison of non-antimicrobial characteristics.

The primary difference of the subject device from the reference device is the addition of ionic silver for antimicrobial properties. The key finding from the non-clinical performance data is that the silver content in Endoform Silver Dermal Template successfully inhibits microbial colonization of the dressing for up to 7 days, making it comparable to the antimicrobial claim of the predicate device. All other physical, compositional, and safety characteristics were shown to meet acceptance criteria and be equivalent to the predicate/reference devices.

Crucially, the document explicitly states in section 5.5: "Substantial equivalence was not based on an assessment of clinical performance data." This means that no human clinical trials were conducted or presented in this submission to demonstrate the device's effectiveness in wound management on patients; the FDA clearance was based on equivalence of technological characteristics and non-clinical performance data to existing devices.

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Endoform™ Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform™ Reconstructive Template is intended for single use only.

The Mesynthes Endoform™ Reconstructive Template (ERT) is a surgical mesh comprising either a single layer of decellularized extracellular matrix (ECM) or alternatively, multiple layers (2- to 10- layers) of ECM bonded together by dehydrothermal lamination and polyglycolic acid (PGA) suture material.

The provided text describes a 510(k) premarket notification for the Mesynthes Endoform™ Reconstructive Template surgical mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance against those criteria in the way a novel device might.

Therefore, the information you're requesting regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of specific performance metrics, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance does not apply directly to this 510(k) summary.

Instead, the submission focuses on demonstrating that the new device has "technological characteristics and substantial equivalence" to existing predicate devices.

Here's an breakdown based on the information provided, keeping in mind the nature of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the format of defined metrics and targets for clinical performance that the device directly "meets." Instead, the acceptance is based on demonstrating similarity to predicate devices through a series of non-clinical performance tests and animal testing.

The "performance" described is about demonstrating similarity or equivalence to predicates, rather than achieving specific quantitative clinical thresholds.

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

The document does not specify the exact sample sizes for the individual biophysical, biocompatibility, or animal tests. It only states that these tests were "performed on finished, terminally sterilized product" and in "a model of soft tissue reinforcement" for animal studies. The data provenance is implied to be from internal lab testing by Mesynthes Ltd.

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

This information is not applicable/not provided in the context of this 510(k) submission. "Ground truth" established by experts is typically relevant for studies validating diagnostic algorithms or clinical evaluations, which were not conducted here as per Section 9.

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

This information is not applicable/not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of this 510(k) submission.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on the impact of a device on human performance, often in diagnostic imaging, which is not relevant for a surgical mesh device.

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

This concept is not applicable to a surgical mesh device. Standalone performance refers to the accuracy of an automated system without human intervention, typically in AI/diagnostic applications.

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

For the non-clinical and animal studies, "ground truth" implicitly refers to the established scientific and engineering standards for measuring device properties (e.g., strength, biocompatibility), and histopathological or physiological assessment in animal models for tissue integration and inflammatory response. These are not typically established via expert consensus in the same way as clinical diagnostic accuracy.

8. The sample size for the training set

This information is not applicable/not provided. "Training set" is a concept related to machine learning and AI development, which is outside the scope of this medical device submission.

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

This information is not applicable/not provided for the same reasons as point 8.

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Endoform™ Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds:

• partial and full-thickness wounds .
• pressure ulcers .
• . venous ulcers
• diabetic ulcers .
• chronic vascular ulcers .
• tunneled/undermined wounds .
• surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, . wound dehiscence)
• trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
• . draining wounds

The Endoform™ Dermal Template is a wound care device comprised of one or two layers of ovine extracellular matrix and is supplied as a sterile perforated or non perforated sheet ranging in size up to 400 cm2.

The provided 510(k) summary for the Endoform™ Dermal Template (K101546) does not contain the detailed information necessary to complete the requested table and answer all questions.

This 510(k) document establishes substantial equivalence to a predicate device (Endoform™ Dermal Template, K092096) based on material composition, device characteristics, and intended use, and a declaration of conformity to design control requirements and a risk assessment. It explicitly states that the predicate device (K092096) "was shown to be safe and effective as a wound care product" after "extensive non-clinical testing to assess the biocompatibility and the performance of the device." However, the current submission (K101546) does not present new clinical or performance data for the device itself.

Therefore, many of the requested details, such as specific acceptance criteria, reported performance values, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available within this document.

Here's what can be answered based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not available in this document. The submission references non-clinical testing for the predicate device, but no details of a clinical test set for K101546 or its provenance are provided.
• Data Provenance: Not available in this document.

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

• Number of Experts: Not available in this document.
• Qualifications of Experts: Not available in this document.

4. Adjudication method for the test set

• Adjudication Method: Not available in this document.

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

• MRMC Study Done?: No. This device is a Dermal Template, not an AI-assisted diagnostic tool. An MRMC study is not applicable.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance Study Done?: Not applicable. This device is a wound care product, not an algorithm.

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

• Type of Ground Truth: Not available in this document. The document refers to non-clinical testing for the predicate device (K092096) to establish safety and effectiveness, but details of how "ground truth" was established for such testing are not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.

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

• How Ground Truth for Training Set was Established: Not applicable. This device is a medical device for wound care, not a machine learning algorithm.

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