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Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

This FDA 510(k) clearance letter and supporting summary for the Endoform™ Reconstructive Template – PLGA device does not involve artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested elements for AI/ML device validation are not applicable.

The device is a traditional medical device (surgical mesh) and its substantial equivalence is demonstrated through non-clinical performance data and comparison to a predicate device. There is no mention of an algorithm, AI assistance, or human readers.

However, I can extract the information relevant to its acceptance criteria and the study that proves it meets those criteria, based on the provided document.

Acceptance Criteria and Study Proof for Endoform™ Reconstructive Template – PLGA

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is related to meeting performance specifications and demonstrating biocompatibility and safety comparable to a predicate device, rather than diagnostic accuracy metrics. The "study" refers to non-clinical testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests conducted and the conclusion that the device meets specifications, rather than providing specific numerical acceptance criteria and results in a table format common for AI/ML.

For this device, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "substantially equivalent" to the predicate device and meeting recognized standards.

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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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Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.

Enivo™ is a surgical drainage system intended for the removal of surgical and bodily fluids from a closed wound. The system can be used in both home and healthcare environments. The system includes two primary components: - A vacuum device unit that includes a single-use, portable, and battery-powered vacuum device that provides continuous operation for up to 30 days and a disposable exudate reservoir. - a removable silicone drainage catheter

The provided document is a 510(k) summary for the Enivo™ device, which is a powered suction pump. It outlines the device's intended use and compares it to a predicate device (SOMAVAC Device, K222856) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

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

The document does not provide a table with explicit acceptance criteria (e.g., minimum vacuum pressure, maximum flow rate) and corresponding measured device performance values. Instead, it lists various types of non-clinical tests that were conducted to demonstrate that "the device performs as intended" and "no new types of risk to the patent have been introduced by these differences." Without specific criteria, it's impossible to create such a table.

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

The document lists only non-clinical (bench) testing. Therefore, there is no "test set" in the context of patient data (e.g., diagnostic images, clinical samples), nor is there data provenance related to patient demographics or study design (retrospective/prospective). The tests listed are primarily engineering and performance evaluations.

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 question is not applicable. The studies conducted are non-clinical engineering and performance tests, not studies requiring expert interpretation of patient data to establish ground truth.

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

This question is not applicable. There is no "test set" in the context of patient data that would require an adjudication method.

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

This question is not applicable. The Enivo™ device is a powered suction pump, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

This question is not applicable. The Enivo™ device is a hardware device; it does not involve algorithms or AI for standalone performance evaluation in this context.

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

For the non-clinical tests conducted, the "ground truth" would be established by:

• Voluntary Standards: Compliance with recognized standards like IEC 60601-1, ISO 10993-1, ISO 20697, ASTM F1929, etc.
• Engineering Specifications: Internal design specifications for vacuum pressure, flow rate, battery life, mechanical strength, alarm thresholds, etc.
• Test Method Requirements: The specifications and procedures defined in the various ASTM and ISO standards for package integrity, sterilization, biocompatibility, etc.

8. The sample size for the training set

This question is not applicable. The Enivo™ device is not an AI/machine learning device, so there is no concept of a "training set" in this submission.

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

This question is not applicable as there is no training set mentioned or implied for this device.

Summary of Acceptance Criteria and Supporting Studies (Based on available information):

Due to the nature of the device (a powered suction pump) and the 510(k) submission type, the acceptance criteria are based on compliance with recognized consensus standards and internal engineering performance specifications rather than clinical performance metrics typically seen for diagnostic or AI-powered devices.

The document lists a comprehensive set of non-clinical tests to demonstrate substantial equivalence by showing that the device meets safety and performance requirements and does not introduce new risks compared to the predicate device. However, specific numerical acceptance criteria and reported values for each test are not detailed in this summary.

In essence, the "acceptance criteria" can be inferred as "compliance with the listed standards and satisfactory performance per internal specifications," and the "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed.

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Myriad™ Particles is indicated for use in the management 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, partial-thickness burns, and skin tears)
• · draining wounds

Myriad™ Particles is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.

The provided document is a 510(k) premarket notification for a medical device called "Myriad™ Particles." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through the kind of study described in the prompt.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies. The key points from the document that illustrate this are:

• No Clinical Performance Data Used for Substantial Equivalence: Section 5.6 explicitly states: "Substantial equivalence was not based on an assessment of clinical performance data." This means a human clinical study to prove performance was not conducted for this 510(k) submission.
• Focus on Substantial Equivalence through Technological Characteristics and Non-Clinical Data: The document relies on comparing the technological characteristics of Myriad™ Particles to its predicate device (Endoform™ Dermal Template) and presenting non-clinical (bench and biocompatibility) testing. The primary difference highlighted is the device presentation (powder vs. sheet format).
• No mention of AI/ML components: The device is a wound dressing, and there is no indication that it incorporates any artificial intelligence or machine learning components. Therefore, an MRMC comparative effectiveness study or standalone algorithm performance assessment would not be applicable.

In summary, the provided text does not describe a study designed to prove the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would. It focuses on demonstrating substantial equivalence to an existing device through non-clinical means.

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Symphony™ is indicated for 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

Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm².

The provided text is a 510(k) summary for the device "Symphony™," a wound dressing. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, and performance characteristics, rather than evaluating an AI/ML medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set details for AI/ML models is not present in this document.

However, I can extract the information related to the device's performance and the non-clinical testing performed to establish its substantial equivalence.

Here's an analysis of the provided text, addressing the points where information is available and noting where it is not:

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

The document presents a comparison table between the Symphony™ device (Subject Device) and the predicate device (Endoform® Topical Matrix). This table implicitly shows the acceptance criteria by listing the parameters and the expected range/value for both the subject and predicate devices.

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Endoform Restella 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.

Endoform Restella is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with absorbable polyglycolic acid (PGA) and non-absorbable polypropylene (PP) suture material for use in plastic and reconstructive surgery. The 3-ply devices are available in sizes up to 400 cm² in arced rectangle, contour, and oval shapes.

The provided text is a 510(k) summary for the medical device "Endoform Restella." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device for FDA clearance.

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

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 (e.g., number of devices, number of tests performed) for the bench testing.
The data provenance is from non-clinical bench testing. The text does not provide country of origin or whether it's retrospective or prospective, though bench testing is inherently prospective in nature.

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

This information is not provided in the document. Bench testing typically relies on predefined engineering specifications rather than expert consensus on a 'ground truth' in the same way clinical data would.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods are typically relevant for human-interpreted data (e.g., imaging studies, clinical endpoints), not for objective bench test results like mechanical strength or endotoxin levels.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical mesh; the concept of "human readers" and "AI assistance" is not relevant to its type of evaluation.

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

This question is not applicable to this medical device. The "Endoform Restella" is a physical surgical mesh, not an algorithm or AI performing a task. Its performance is evaluated through physical and material properties, not by an algorithm's output.

7. The type of ground truth used

The ground truth used for the non-clinical performance evaluation was based on product specifications and the characteristics of the predicate device. The device was deemed acceptable if it met these predefined specifications and demonstrated equivalence in key properties to the legally marketed predicate.

8. The sample size for the training set

This information is not applicable/not provided. The "Endoform Restella" is a physical device, not a machine learning algorithm that requires a "training set."

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

This question is not applicable to this medical device.

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Endoform Reconstructive Template – Non-Absorbable is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists.

Endoform Reconstructive Template – Non-Absorbable is indicated for use in the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices laminated with non-resorbable polypropylene (PP) suture material in a variety of sizes for use in soft tissue reconstruction. Devices up to 400 cm² are available in thicknesses from 1- through 10- ply, and larger devices up to 1000cm2 are available in 4-, 6-, and 8-ply presentations.

This document describes the Endoform Reconstructive Template - Non-Absorbable, a surgical mesh. The submission (K181935) is a 510(k) premarket notification for a line extension to increase the maximum device size.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document states that the performance specifications for the device have not changed and that the device meets these specifications. The specific quantitative values of these specifications are not provided in this summary.

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 for test set: Not explicitly stated. The document refers to "Bench testing and validation" and "results of verification and validation testing" without providing specific sample numbers for each test.
• Data provenance: Not explicitly stated, but the company is Aroa Biosurgery Ltd. located in New Zealand. These would be non-clinical, laboratory-based tests.

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 device is a surgical mesh, and the testing described is non-clinical (bench testing) for physical properties, not a clinical study involving radiologists or medical image interpretation.

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

Not applicable. Adjudication methods are typically for clinical studies involving multiple reviewers/experts, which is not the case here.

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/software device, and no MRMC study was 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.

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

For the non-clinical performance data, the "ground truth" would be established by:

• Engineering specifications and standards for mechanical strength and dimensional properties.
• Validated laboratory assays for endotoxin levels and biocompatibility (as carried over from the predicate device).

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of physical device testing.

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

Not applicable. There is no training set.

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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 Topical Matrix is indicated for 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 Topical Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen designed to cover, protect, and provide a moist wound environment. The device is supplied in a variety of sizes and thicknesses which can be trimmed by the surgeon to meet the individual patient's needs.

The provided document is a 510(k) summary for the Endoform Topical Matrix. It does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria using performance data. Instead, it argues for substantial equivalence based on similarities to a predicate device and a reference device, along with the device's technological characteristics.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth, and expert involvement are not available in this document as it relies on a different pathway for clearance (substantial equivalence to existing devices rather than a de novo performance study against defined acceptance criteria).

However, I can extract the information that is present:

Device: Endoform Topical Matrix

1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria nor reported device performance against those criteria. The clearance is based on substantial equivalence.

2. Sample size used for the test set and the data provenance
Not applicable. Substantial equivalence was not based on a new clinical performance study. The document mentions "literature review" for in vivo use, but does not provide details on specific sample sizes or data provenance for that review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment activity for a test set is described.

4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is 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
Not applicable. This device is a medical matrix, not an AI-powered 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 or AI device.

7. The type of ground truth used
Not applicable. No specific ground truth methodology for a performance study is described. The basis for clearance is substantial equivalence to a predicate device already on the market.

8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/machine learning device.

9. How the ground truth for the training set was established
Not applicable. No training set is described.

Summary of Information Available in the Document:

Basis for Clearance: Substantial Equivalence to Predicate Device (Endoform Dermal Template, K092096) and Reference Device (Endoform Plastics and Reconstructive Matrix, K162461).

Argument for Equivalence:

• Raw Material: Identical (ovine forestomach tissue).
• Tissue Processing: Identical.
• Intended Use: Identical.
• Indications for Use: Identical.
• Technological Characteristics: The only difference is the Endoform Topical Matrix is a multi-layer device with a proprietary 'lug lamination' process, which was previously cleared via the reference device (K162461).

Non-Clinical Performance Data:

• Warranted Testing: "no additional bench performance testing was warranted" because the subject and predicate devices are made of identical material and the multi-layer design was cleared via the reference device.
• Existing Evidence: Mentions that the use of collagen wound dressings is well-established in clinical use and studies, and the collagen matrix used in all Aroa Biosurgery Endoform devices has been previously studied in in vivo models and is in wide-spread clinical use.
• In vivo evaluation: "evaluated via a literature review to demonstrate that the subject device is appropriate for the proposed indications based on equivalence to commercially available devices with equivalent composition and indications." (No specific details of the literature review are provided, such as sample size or data provenance).

Clinical Performance Data:

• "Substantial equivalence was not based on an assessment of clinical performance data."

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Endoform® Plastics and Reconstructive Matrix 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.

Endoform® Plastics and Reconstructive Matrix is an advanced collagen matrix comprised of natural >70%, non-reconstituted collagen. Endoform® Plastics and Reconstructive Matrix is designed to be fixed, via sutures, staples or tacks to the surrounding tissue, at the discretion of the attending physician for applications in plastic and reconstructive surgery. For example, the device can be surgically implanted to reinforce damaged or ruptured soft tissue membranes and reinforce muscle flaps. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed by surgeons to meet the individual patient's needs. Endoform® Plastics and Reconstructive Matrix is laminated via a proprietary process termed 'lug lamination', which is a physical means of fabricating the devices, such that the individual sheets of the device are physically bonded to one another as opposed to using embroidery to sew the laminate of collagen matrix sheets.

The provided text describes a 510(k) premarket notification for a medical device (Endoform® Plastics and Reconstructive Matrix) and primarily focuses on proving its substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as a predicate device, rather than proving de novo safety and efficacy through extensive clinical trials for novel devices.

Therefore, the information you've requested about acceptance criteria, efficacy studies, expert adjudication, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission as it is not a study proving the device meets acceptance criteria for a novel AI/software medical device.

The "acceptance criteria" presented here are in the context of bench testing and biocompatibility, not "device performance" in the sense of diagnostic accuracy or clinical outcomes that typically require such detailed study methodologies.

Let's break down what is available in the provided document, and then explain why the requested information is absent.

1. Table of acceptance criteria and reported device performance (based on the provided text):

The document does not explicitly present acceptance criteria in a quantitative table with corresponding "reported device performance" in the way one would for a diagnostic or AI device's clinical performance. Instead, it describes bench tests performed to demonstrate that the device meets "all product specifications for the intended use." The "acceptance criteria" for these tests would be the pre-defined product specifications, which are not detailed numerically in this summary.

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

• Sample Size: The document does not specify the sample sizes used for each of the bench tests mentioned (tensile strength, suture retention, etc.).
• Data Provenance: Not applicable in the context of this submission. The tests are bench tests of the manufactured device, not retrospective or prospective clinical data from human patients.

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

• Not applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not being established for bench tests of a surgical mesh. The "truth" for these tests are the physical/material properties of the device itself.

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

• Not applicable. This concept is for clinical or image-based studies where human readers might disagree. Bench tests rely on standardized measurement methods.

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 device is a surgical mesh, not an AI or diagnostic tool. No MRMC study was performed or required.

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.

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

• For the bench tests, the "ground truth" refers to the established physical and chemical properties measured according to standardized methods. For biocompatibility, it's assessed against ISO 10993-1 standards and by leveraging the established safety of a reference device. For the overall submission, the "ground truth" for substantial equivalence relies on the regulatory approval and safety profile of the predicate device.

8. The sample size for the training set:

• Not applicable. There is no AI model or algorithm being trained for this device.

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

• Not applicable. There is no training set for this device.

Explanation of the 510(k) Process and Why This Information is Absent:

The document is a 510(k) Pre-Market Notification. For a device submitted under a 510(k), the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This means the device is as safe and effective as another legally marketed device, and does not raise new questions of safety and effectiveness.

• No De Novo Clinical Efficacy Study: The document explicitly states: "There was no clinical testing required to support the indications for use as they are equivalent to the predicate device." This is a key characteristic of the 510(k) pathway for devices like surgical meshes that are considered "well-understood" and have similar predicate devices.
• Focus on Bench Testing and Biocompatibility: The "performance testing" described is confined to bench tests (tensile strength, suture retention, etc.) and biocompatibility. These tests confirm that the manufacturing process is consistent and that the material properties are similar to the predicate, and that the material does not pose new biological risks.
• Leveraging Predicate Device Data: The safety and performance of the proposed device are "based on the in vivo performance of the predicate and reference devices." This means the FDA relies on the existing track record and regulatory history of the predicate devices rather than requiring new, extensive clinical trials for the new device.
• Not an AI/Software Device: The concepts of "multi-reader multi-case studies," "standalone algorithm performance," "training set," and "adjudication methods" are typically relevant for Software as a Medical Device (SaMD) or AI-powered devices where the performance criterion is diagnostic accuracy, image interpretation, or clinical decision support. The Endoform® Plastics and Reconstructive Matrix is a physical surgical mesh, not a software product.

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