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The Jewel Soft Tissue Reinforcement Device is a single-use device intended for reinforcement of soft tissues that are undergoing reconstruction surgery, utilizing autograft or allograft soft tissue grafts, or are to be repaired by suture or other fixation devices during ligament repair surgery. This includes reinforcement of extra-articular ligaments such as, but not limited to, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament.

The Jewel Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other extra-articular ligaments. Sutures, or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the reconstruction or repair.

The Jewel Soft Tissue Reinforcement Device is a woven tubular implantable device intended to provide support for soft tissues where weakness exists including soft tissues that have been repaired using suture or other fixation devices during ligament repair surgery. The tubular structure of the implant is designed to allow insertion of an allograft or autograft inside the mesh structure; or alternately for reinforcement of the native tissue. The Jewel Soft Tissue Reinforcement Device is a gamma sterilized, single use, permanent implant manufactured from Polyester (Polyethylene Terephthalate; PET) a nonabsorbable material that has a long history of use in the orthopedic market. The Jewel Soft Tissue Reinforcement Device is treated with an atmospheric gas plasma process to improve surface wettability of the mesh structure. The Jewel Soft Tissue Reinforcement Device is MRI safe.

This document is a 510(k) clearance letter for a medical device called the "Jewel Soft Tissue Reinforcement Device" (K242237). It is not a study proving the device meets acceptance criteria related to an AI algorithm. Instead, it describes a medical device for use in surgery and provides information about its mechanical and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested elements for describing an AI study's acceptance criteria and performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document. This document pertains to a physical surgical mesh device, not an AI software device.

However, I can extract the information that is present about the device's performance testing and acceptance criteria as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the series of tests were "successfully completed" and "The results demonstrate that the Jewel Soft Tissue Reinforcement Device... provides adequate mechanical properties for its intended use." The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not provided in this summary, nor are the specific numerical results. The fundamental acceptance criterion for 510(k) clearance is "substantial equivalence" to a legally marketed predicate device, implying that the performance must be no worse than the predicate device for safety and effectiveness.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing was conducted by the manufacturer, Xiros Limited.

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

• Not Applicable. This is not an AI device clearance based on clinical image interpretation or diagnosis. The "ground truth" here refers to the physical properties of the device measured in performance tests rather than expert interpretation of data.

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

• Not Applicable. See point 3.

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, Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• The "ground truth" for this device's evaluation is based on engineering and material science measurement standards and biocompatibility standards. For example, "Ultimate Tensile Strength" would be measured according to an established test method (e.g., ASTM standards) to determine its actual value, which is then compared to an acceptable range or the predicate device's performance.

8. The sample size for the training set

• Not Applicable. This is not an AI device with a training set.

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

• Not Applicable. This is not an AI device with a training set.

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