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The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.

The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.

The provided document is a 510(k) premarket notification for the Extremity Medical Suture Anchor, a medical device used for the fixation of soft tissue to bone. The document does not describe the acceptance criteria or the study that proves the device meets the acceptance criteria in the manner requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the information provided in the document, highlighting why the requested information about AI/algorithm performance and ground truth is not applicable or present:

The device in question, the "Extremity Medical Suture Anchor," is a physical implantable device, not an AI or algorithmic medical device. Therefore, many of the requested categories related to AI performance, ground truth, training sets, and expert adjudication are not relevant to this type of medical device submission.

However, I can extract information related to the physical device's testing:

Device Acceptance Criteria and Performance (as applicable for a physical medical device):

Explanation Regarding AI/Algorithm-Specific Questions:

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

   • Not Applicable. This is a physical medical device. The "test set" in this context refers to bench testing of the physical implant, not a data set for an algorithm.

2. 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):

   • Not Applicable. There is no "ground truth" to establish for an AI algorithm. Bench testing for pull-out strength would involve engineering and materials science experts and validated testing methodologies, but not clinical "ground truth" in the AI sense.

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

   • Not Applicable. Again, this is for a physical device, not an AI algorithm.

4. 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 device is not an AI diagnostic tool that human readers would interact with.

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

   • Not Applicable. This is a physical implantable device.

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

   • Not Applicable. The "ground truth" for a physical device's performance relies on validated engineering tests (e.g., ASTM standards for mechanical properties) and comparison to predicate devices, not clinical or pathological ground truth in the context of diagnostic algorithms.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, no training data for an algorithm.

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

   • Not Applicable. This is a physical device, no training data or ground truth for an algorithm.

Summary of what the document does state regarding testing:

• Study Type: Non-clinical bench testing was performed.
• Specific Tests: Pull-out strength testing was explicitly mentioned.
• Comparison: The results of the bench testing were compared to the predicate device (K083151 - Suture Anchor from Extremity Medical).
• Clinical Testing: "No clinical testing was performed."
• Conclusion: The submission concludes that the modified Suture Anchor is "substantially equivalent" to its predicate device based on indications for use, materials, design, and test data (including the unspecified pull-out strength results) and principles of operation. This "substantial equivalence" is the regulatory criterion met, rather than specific performance metrics against pre-defined acceptance criteria, which are not detailed in this summary.

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The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures

Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament Reconstruction

The EXTREMITY MEDICAL Suture Anchor

The provided text is a 510(k) summary for the EXTREMITY MEDICAL Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for meeting specific acceptance criteria derived from device performance.

Therefore, the requested information regarding acceptance criteria, device performance testing, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for a study proving the device meets acceptance criteria cannot be found in the provided document.

This type of 510(k) submission generally relies on a comparison of design, materials, and intended use to existing legally marketed devices, rather than extensive clinical performance studies with specific statistical acceptance criteria. The "study" here is essentially the comparison to predicate devices, and the "acceptance criterion" is substantial equivalence.

Here's what can be extracted based on the nature of the document:

While the document doesn't present traditional "acceptance criteria" and a "study" to meet them in the context of device performance metrics (like sensitivity, specificity, accuracy for an AI device, or specific mechanical thresholds for a medical device), it does present the implicit acceptance criteria for its regulatory pathway: Substantial Equivalence to legally marketed predicate devices.

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

• Same indications for use
• Similar design
• Similar materials
• Similar principles of operation | The EXTREMITY MEDICAL Suture Anchor is substantially equivalent to its predicate devices (TwinFix Ti 2.8 Suture Anchor K972326, TwinFix PK FP Suture Anchor K073509) based on:
• Same indications for use
• Similar design
• Similar materials
• Similar principles of operation |

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

• Sample Size: Not applicable. This 510(k) summary does not describe a performance study with a "test set" in the traditional sense of clinical or technical data. The "test set" here is conceptually the comparison of the new device's characteristics against the predicate devices.
• Data Provenance: Not applicable. The data is descriptive of the device itself and its comparison to existing devices, not empirical performance data from patients or laboratory tests for this specific device in this document.

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

• Not applicable. Ground truth establishment by experts for a test set is not described in this 510(k) summary, as it's not a performance study.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described.

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 device is a physical suture anchor, not an AI or imaging device, and therefore an MRMC study with human readers assisting AI is irrelevant.

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:

• Not applicable in the context of a performance study. The "ground truth" for the 510(k) substantial equivalence claim is the established legal marketing status and characteristics of the predicate devices.

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not a study involving machine learning or statistical modeling.

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

• Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence of a physical medical device, not a report on a performance study with quantitative acceptance criteria and a test set.

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