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OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® PR is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors. used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

The provided text describes the OrthADAPT® PR Bioimplant, a surgical mesh device, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity). This documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving device efficacy through a comparative performance study with predefined acceptance criteria for AI or diagnostic performance.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of study (e.g., an AI/diagnostic performance study).

Here's the information available from the text, framed within the requested table and addressing the other points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The "study that proves the device meets the acceptance criteria" in this context refers to the collective body of biocompatibility testing, biomechanical bench testing, and an animal implant study, all performed to demonstrate substantial equivalence to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "biocompatibility testing," "biomechanical bench testing," and "an animal implant study." The sample size for each of these tests is not quantified in the provided text.
• Data Provenance: Not explicitly stated. The document indicates the testing was conducted to support a submission to the FDA (U.S.). It does not specify the country of origin for the animal study or other testing data, nor whether the studies were retrospective or prospective.

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

• Not applicable. This device is a surgical mesh, not an AI or diagnostic device that relies on expert interpretation of results for "ground truth" establishment in a diagnostic accuracy study. The "ground truth" here is established through objective physical and biological tests (e.g., tensile strength for biomechanical performance, histological assessment in animal studies for tissue response).

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

• Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome.

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 a diagnostic device or an AI-assisted interpretation tool. It is a surgical implant.

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, pathology, outcomes data, etc)

• The "ground truth" for the performance evaluation of the OrthADAPT® PR Bioimplant is based on:
  • Biocompatibility Standards: Meeting established biological safety standards for medical devices.
  • Biomechanical Measurements: Objective quantitative measurements of mechanical properties (e.g., tensile strength, tear resistance) against performance requirements deemed suitable for its intended use and comparable to predicate devices.
  • In Vivo Animal Study Observations: Histological and functional assessments of tissue response, integration, and functionality in an animal model, conforming to expectations for surgical mesh.
  • Sterility and Endotoxin Testing: Objective laboratory tests (USP sterility testing, LAL endotoxin limit).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:

• Partial and full thickness wounds, .
• Draining wounds, .
• Pressure sores/ulcers, ◆
• Venous ulcers, .
• . Chronic vascular ulcers,
• Diabetic ulcers, .
• Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ●
• Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)

The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

Please note that the provided text describes a medical device called "Unite™ Biomatrix," which is a collagen-based wound dressing. It is not an AI/ML device, and therefore, many of the typical acceptance criteria and study details relevant to AI/ML device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable or present in this type of submission.

The document primarily focuses on establishing substantial equivalence to a predicate device for a wound dressing,
not on evaluating the performance of an algorithm.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

Device Name: Unite™ Biomatrix

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a wound dressing that establishes substantial equivalence to a predicate device, the "acceptance criteria" are not reported in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm. Instead, the acceptance criteria are implicitly met by demonstrating equivalence in design, materials, manufacturing controls, and intended use. The "device performance" in this context refers to its
similarity to the predicate device.

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

This information is not applicable/not provided in the context of this 510(k) submission for a wound dressing. There is no "test set" in the sense of a dataset for an AI/ML algorithm. The equivalence is based on physical and chemical characterization, and comparison of design, materials, and intended use to the predicate device.

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

This information is not applicable/not provided as there is no "test set" or "ground truth" establishment in the context of an AI/ML algorithm. The evaluation is chemical and physical testing, and comparison to regulatory standards and a predicate device.

4. Adjudication Method for the Test Set

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

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks, which is not the nature of this device.

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

No, a standalone performance study was not done. This concept is only applicable to AI/ML algorithms, which the Unite™ Biomatrix is not.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance would be defined by:

• Standardized chemical and physical testing results (e.g., USP sterility test, LAL endotoxin limit).
• Demonstration of material properties and design characteristics matching the predicate device.
• Compliance with general controls for medical devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided as the device is not an AI/ML algorithm and therefore does not have a "training set."

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

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

Summary of the Study:

The "study" described in the 510(k) submission for the Unite™ Biomatrix is not a clinical trial or an AI/ML performance study. Instead, it is a design verification and substantial equivalence demonstration study.

• Objective: To demonstrate that the Unite™ Biomatrix is substantially equivalent to the predicate device, DermADAPT™ Wound Dressing (K061494).
• Methodology: The submission focuses on comparing the new device to the predicate in terms of:
  • Device Description: Both are decellularized equatorial pericardium, crosslinked, and liquid chemical sterilized.
  • Material Composition: Equine pericardium.
  • Performance Characteristics: Meeting USP sterility, satisfying FDA LAL endotoxin limits. The document states, "Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use."
  • Intended Use/Indications for Use: The indications for use listed are identical to those of the predicate device.
• Conclusion: The FDA reviewed the submission and determined the device to be substantially equivalent to the legally marketed predicate device for the stated indications for use. This determination allows the device to be marketed.

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The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair,

OrthADAPT® is intended for one-time use only.

The OrthADAPT Bioimplant is a decellularized, equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

The provided text is a 510(k) summary for the OrthADAPT® Bioimplant, a surgical mesh. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.

The 510(k) summary clearly states:
"Supplier qualification activities, receiving controls, and design verification testing demonstrate that the modified OrthADAPT Bioimplant device is equivalent to the predicate device in terms of design, performance and intended use."

This indicates that the device was deemed "substantially equivalent" based on a comparison to an already cleared device (K043388), rather than through a new clinical or performance study with defined acceptance criteria for a novel device.

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The Pegasus Biologics DermADAPT™ Wound Dressing is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:

• Partial and full thickness wounds, .
• . Draining wounds,
• Pressure sores/ulcers, ●
• Venous ulcers, .
• Chronic vascular ulcers, .
• Diabetic ulcers, .
• Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
• Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)

The Pegasus Biologics DermADAPT™ Wound Dressing is a decellularized, equine pericardial implant that has been crosslinked and passed USP Sterility testing. The product is non-pyrogenic and supplied for single use only. The product must be rinsed prior to use following the procedure described in the IFU.

The provided text describes a 510(k) premarket notification for the DermADAPT™ Wound Dressing, a collagen-based wound dressing. However, it does not contain the specific information requested about acceptance criteria, performance data from a study, sample sizes, expert qualifications, or detailed study methodologies that would typically be found in a clinical trial report or a performance validation study for a device of this nature.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the DermADAPT™ Wound Dressing as would be seen in a clinical study comparing its efficacy to a gold standard or a defined benchmark.

Instead, the document highlights:

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

• Sample Size for Test Set: Not specified. The document only mentions "Biocompatibility testing and in vitro bench testing has been conducted," without any details on the number of samples or specimens tested.
• Data Provenance: Not specified. It's implied the testing was conducted by Pegasus Biologics, Inc., but no information on the country of origin of the data or whether it was retrospective or prospective is given. For biocompatibility and bench testing, this level of detail is often not included in a 510(k) summary unless a specific clinical study involving human subjects was performed.

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

Not applicable/Not specified. This information is typically relevant for studies involving subjective interpretation (e.g., image analysis, diagnostic performance). The tests mentioned (biocompatibility, biomechanical, sterility, endotoxin) are objective laboratory tests.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods are relevant for studies where subjective interpretations are made and need to be reconciled.

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

Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted.

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

Not applicable. This device is a physical wound dressing, not an algorithm.

7. The type of ground truth used

The "ground truth" for the tests mentioned are:

• Biocompatibility: Likely established through standardized tests (e.g., ISO 10993 series) with pre-defined pass/fail criteria.
• Biomechanical Performance: Established through "in vitro bench testing" likely against specified physical properties (e.g., tensile strength, absorption capacity, degradation rate) with pre-defined performance requirements for a wound dressing.
• Sterility and Endotoxin: Established by meeting USP (United States Pharmacopeia) standards for sterility and endotoxin levels.

8. The sample size for the training set

Not applicable. This device is a physical wound dressing, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable (as above).

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The OrthADAPT® Bioimplant (Surgical Mesh) is intended to be used for implantation to reinforce soft tissue including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar. Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

OrthADAPT® is intended for one-time use only.

The OrthADAPT Bioimplant is a decellularized equine pericardium. The OrthADAPT Bioimplant has been crosslinked and exposed to a liquid chemical sterillant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.

The provided text is a 510(k) summary for the OrthADAPT® Bioimplant, a surgical mesh. It describes the device, its intended use, and its substantial equivalence to predicate devices based on biocompatibility and performance testing. However, it does not contain the detailed acceptance criteria for a study, nor does it describe a study design that would directly assess and prove the device meets specific performance criteria.

The 510(k) summary states: "The results of biocompatibility and performance testing demonstrate that OrthADAPT is comparable to the predicate devices." This implies that some testing was done to establish substantial equivalence, but the specifics of that testing, including acceptance criteria, sample sizes, ground truth establishment, or any AI-related components, are not provided in this document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: The document does not list specific acceptance criteria or quantitative performance metrics for the OrthADAPT® Bioimplant.
2. Sample sizes used for the test set and the data provenance: No sample sizes for a test set are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: Not applicable as no such study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not mention any MRMC studies, nor does it involve AI assistance for human readers.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: The device is a physical surgical mesh, not an algorithm. Therefore, a standalone algorithm performance study is not relevant here.
7. The type of ground truth used: Not specified for any performance testing described.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established: Not applicable.

Summary:

The provided document describes a medical device (surgical mesh) and its regulatory clearance based on substantial equivalence. It does not provide the information typically associated with the performance evaluation of a diagnostic or AI-driven device, such as specific acceptance criteria and detailed study results. The "performance testing" mentioned is in the context of demonstrating comparability to existing predicate devices, rather than meeting predefined, quantitative acceptance criteria for a novel performance claim beyond what is typical for a surgical mesh.

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