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The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures:
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Superior Capsule Reconstruction (Glenoid Only)
Hip: Acetabular Labral Repair
Knee: MCL, LCL, Iliotibial Band Tenodesis
Foot/Ankle: Lateral Stabilization, Medial Stabilization

The proposed GRYPHON™ Flex Knotless PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed GRYPHON Anchor family. The proposed product is a knotless anchor intended for fixation of soft tissue to bone in various soft tissue repair procedures. In its finished good configuration, the proposed device is a two-piece design; comprised of a permanent implant (anchor) component and a disposable (inserter) component. The 2.7mm anchor implant is preloaded on the inserter and a Nitinol distal tip retains the suture and the anchor while the device is malleted into the bone. The design offers surgeons maneuverability within the joint space. The disposable inserter will be offered in two design configurations, straight or curved to accommodate varying anatomies.
The proposed GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors will be available in a 2.7 mm size, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material.
Both the GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "GRYPHON™ Flex Knotless PEEK Anchor" and "GRYPHON™ Flex Knotless Biocomposite Anchor."

This document does not describe a study that uses AI or machine learning. It describes the non-clinical verification activities performed for a physical medical device (suture anchor), focusing on its mechanical properties, sterilization, and biocompatibility. Therefore, it does not include the information requested regarding acceptance criteria and studies for AI/ML device performance, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment, or training set details.

The acceptance criteria mentioned in the document relate to the physical and biological performance of the anchor, not to the performance of a diagnostic or predictive algorithm.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies that prove an AI/ML device meets those criteria based on the provided text, as the text describes a physical medical device, not an AI/ML system.

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The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone:

• Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair
• Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis
• Foot/Ankle: Achilles tendon repair

The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor- dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). The proposed HEALIX ADVANCE SP BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. The dilator is comprised of Non-absorbable PEEK (Polyetheretherketone). The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

The provided text describes a medical device, the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device explicitly meets such criteria with numerical performance data.

The "Non-clinical Testing" section outlines the types of tests performed and generally states that "Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero." However, it does not provide:

• Specific numerical acceptance criteria (e.g., minimum fixation strength, maximum cyclic migration).
• Reported numerical performance results of the HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor from these tests.
• Details of any statistical study that would compare these numerical results against predefined acceptance criteria.

Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria and study particulars because the necessary information is not present in the provided text.

Based on the available information, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: The tests are described as "in-vitro" and "non-clinical," which implies laboratory testing of the device itself rather than human or animal studies. The country of origin of the data is not specified, but the applicant (Medos International SARL) is based in Switzerland, and the testing was likely conducted in a similar regulated environment.

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

• This question is not applicable as the "test set" described relates to in-vitro mechanical and material properties of the device, not a diagnostic or clinical outcome requiring expert consensus. The "ground truth" here would be the physical measurements and material properties of the device itself.

4. Adjudication method for the test set:

• Not applicable for in-vitro mechanical testing.

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 device is a surgical anchor, not an AI-powered diagnostic or assistive tool.

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

• This question is not applicable. The device is a physical surgical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be the objective physical and material properties of the device measured through standardized laboratory tests (e.g., force, torque, displacement).

8. The sample size for the training set:

• This question is not applicable. The device is a physical surgical implant, which does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable for the same reason as above.

Additional Information from the text:

• Sterilization Validation: Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL (Sterility Assurance Level) of 1 x 10^-6.
• EO Residuals: Tested per AAMI/ANSI/ISO 10993-7:2008.
• Non-pyrogenic: Determined to be non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP using the bacterial endotoxin testing (BET) method.

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