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The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in the following orthopedic surgical procedures:

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

This document is a 510(k) Premarket Notification for a medical device, the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver. It states that the proposed device is substantially equivalent to a previously cleared predicate device (K170501) with the same name. Therefore, the information provided focuses on demonstrating this equivalence rather than establishing novel acceptance criteria or conducting studies to prove the device meets them from scratch.

However, based on the type of information typically required for such submissions and what is presented, we can infer some aspects and highlight what is not explicitly stated in terms of acceptance criteria and a detailed study report.

Here's an analysis based on the provided text, focusing on the requested categories:

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

The document does not present specific quantitative acceptance criteria in a table format, nor does it explicitly report numerical performance against such criteria. Instead, it states that "Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver performs as intended and is substantially equivalent to the predicate device."

Inferred Performance/Criteria (based on "Verification Testing" and "Validation Testing"):

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 does not specify the sample sizes used for any of the verification or validation tests. It also does not mention the country of origin or whether the data was retrospective or prospective. The statement about "clinical data in the literature" implies external, possibly previously published data, rather than specific new test set provenance.

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 entire section is not applicable to this type of device submission. This device is a surgical implant (suture anchor), not an AI/diagnostic software. Therefore, there's no "ground truth" to be established by experts in the context of diagnostic performance. The "ground truth" for this device relates to its mechanical properties, biocompatibility, and sterilization, which are evaluated through laboratory and material testing.

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

This is not applicable as there is no diagnostic test set or expert adjudication process for this device.

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 is not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.

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

This is not applicable. This device is a surgical implant without an algorithmic component.

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

For this type of device, the "ground truth" is typically defined by:

• Engineering specifications and standards: These define acceptable ranges for mechanical strength, material composition, and dimensional accuracy.
• Biocompatibility standards: ISO 10993 series and other relevant standards define acceptable biological responses to the materials.
• Sterilization validation standards: These ensure the device is sterile according to established protocols.
• Clinical literature: As indicated, "clinical data in the literature" was used to support the indications, implying that established clinical outcomes data informed the acceptability of the device's intended use and performance profile.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device that requires a training set.

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

This is not applicable for the same reason as above.

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The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

This document is a 510(k) Pre-market Notification for a medical device, specifically a suture anchor, and not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study design for AI/ML devices, ground truth establishment, and expert involvement is not applicable.

The document discusses the substantial equivalence of the "CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver" to a legally marketed predicate device. The performance data section outlines the types of engineering and biological tests conducted to demonstrate the device's reliability, strength, and safety, not the performance of an AI algorithm.

To directly answer your prompt based on the provided text, but with the understanding that this is not an AI/ML device:

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

The document describes the types of tests performed but does not provide specific numerical acceptance criteria or reported performance values for each test. It states that testing was completed to demonstrate the device "performs as intended and is substantially equivalent to the predicate device."

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

• Sample Size: Not specified for any of the individual tests. The document only mentions "Completed testing includes the following" list.
• Data Provenance: Not specified. It's implied this is internal company testing, but no details on country of origin or retrospective/prospective nature of data are provided (as these are not relevant for a hardware/biomaterial device).

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

• Not Applicable. This is a hardware medical device (suture anchor), not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Ground truth for this device would be established through engineering and biological test standards and measurements (e.g., tensile strength, material composition analysis, sterility testing results).

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for establishing expert consensus on medical image interpretations or diagnoses, which is not relevant for the testing of a suture anchor.

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. This is not an AI/ML device. MRMC studies are not applicable.

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

• No. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this type of device is established through:
  • Engineering test standards and specifications: e.g., defined strength requirements, material properties.
  • Biological/Chemical test standards: e.g., endotoxin limits, biocompatibility standards.
  • Functional performance assessments: e.g., how the device behaves during simulated use (reliability, cyclic loading).

8. The sample size for the training set:

• Not Applicable. This is a hardware medical device and does not have a "training set" in the context of AI/ML.

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

• Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The device's performance is validated against established scientific and engineering principles, and industry standards for medical devices.

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