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SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. SportMesh™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.

The provided text describes a 510(k) premarket notification for a surgical mesh device, not an AI/ML medical device. Therefore, a direct application of the requested acceptance criteria for AI algorithms is not possible. The document focuses on demonstrating substantial equivalence to predicate devices through material composition, intended use, and performance data, rather than AI performance metrics.

However, I can extract the information relevant to the device's "performance" as presented and the study that "proves" it meets the criteria, reinterpreting the request for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For a physical medical device like this, the "test set" would refer to the samples of the device itself undergoing testing. The document states "A collection of tests has been conducted," but does not specify the number of samples for biocompatibility or mechanical testing. Data provenance is also not specified beyond the general statement that tests were conducted.

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

This concept is not applicable to this type of device submission. Ground truth for a physical medical device typically comes from objective measurements in a lab setting (e.g., mechanical testing, chemical analysis) or animal/human studies for biocompatibility, not expert consensus in the way it's used for AI models to interpret images or other data.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used in AI performance studies to resolve disagreements among human labelers for establishing ground truth, a process not described here for a surgical mesh.

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 to AI systems where the AI's impact on human reader performance is being evaluated. This document pertains to a physical surgical mesh.

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

No, a standalone study was not done. This term specifically refers to the performance of an AI algorithm without human involvement, which is not relevant to a surgical mesh.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

• Objective Laboratory Measurements: For mechanical properties (e.g., tensile strength, degradation rate – though not explicitly listed as specific metrics, implied by "appropriate mechanical properties").
• Standardized Biocompatibility Assays: According to ISO 10993 standards. This involves in vitro and in vivo tests to assess material interaction with biological systems.
• Material Characterization: Chemical composition and structural analysis to confirm it's "identical" to the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable to this type of device submission. "Training set" refers to data used to train an AI model.

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

This concept is not applicable to this type of device submission.

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Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.

Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.

The provided text describes a 510(k) premarket notification for the Sportmesh™ device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with defined endpoints and acceptance thresholds.

Therefore, the document does NOT contain information regarding:

• A table of acceptance criteria and reported device performance in the way typically found for novel device approvals.
• Sample sizes for a test set, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
• Standalone algorithm performance.
• Training set size or how ground truth for a training set was established.

Instead, the submission relies on:

Acceptance Criteria and Device Performance (as demonstrated for 510(k) pathway):

The "acceptance criteria" in this context are primarily demonstrating equivalence to already approved predicate devices concerning safety and effectiveness. The "performance" is shown through the successful completion of specific tests and comparisons.

• Biocompatibility safety studies: Conducted according to ISO 10993 standards.
• Mechanical testing: Conducted in accordance with the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance."
  The results "demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair."
  Based on these comparisons and performance tests, the conclusion is that Sportmesh™ is substantially equivalent and "presents no new concerns about safety and effectiveness." |

Study Details (as per the provided document):

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

   • Not applicable/Not provided. The document describes premarket notification for a Class II medical device (Sportmesh™) via the 510(k) pathway. This pathway establishes substantial equivalence to predicate devices, and typically does not require a formal "test set" with a specified sample size in the context of clinical performance evaluation in the same way a PMA (Premarket Approval) submission would. Instead, testing focused on biocompatibility and mechanical properties. The data provenance is implied to be from Artimplant AB's internal testing as part of their submission process.

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

   • Not applicable/Not provided. Ground truth in the sense of expert consensus on clinical outcomes for a "test set" is not detailed in this 510(k) summary. The "ground truth" for the performance tests would be the established ISO 10993 standards for biocompatibility and specific mechanical test parameters outlined in the FDA's guidance for surgical mesh, which are objectively measurable, rather than expert-derived clinical ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not provided. No clinical adjudication method is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done.

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

   • Not applicable. This is a surgical mesh, not a software algorithm.

6. The type of ground truth used:

   • The "ground truth" for the performance evaluation primarily consisted of established regulatory standards and guidance documents. For biocompatibility, this was ISO 10993 standards. For mechanical properties, it was FDA guidance for surgical mesh. These are objective, measurable criteria, not expert consensus or pathology on a clinical dataset.

7. The sample size for the training set:

   • Not applicable/Not provided. The concept of a "training set" is not relevant for this type of device and submission, which involves physical material testing and comparison to predicates, not machine learning.

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

   • Not applicable/Not provided. See point 7.

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