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The Aevumed PHANTOM™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all Digits, Digital Tendon Transfers

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

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed PHANTOM™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM™ Suture Anchors are available in diameter sizes: 3.5mm and 4.5mm. They are offered sterile and are for single use only.

The document provided is an FDA 510(k) clearance letter for the Aevumed PHANTOM Suture Anchors. This type of device (a bone fixation fastener) is a physical implant and not an AI/ML-driven diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI performance, sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training and test sets, and training set size) are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Aevumed RAPID Suture Anchors, K223878) based on non-clinical performance and material characteristics, rather than diagnostic accuracy or AI effectiveness.

Here's an analysis based on the information provided, tailored to a medical device clearance:

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a non-clinical mechanical testing study. This involved direct comparative testing of the Aevumed PHANTOM™ Suture Anchor against its primary predicate device, the Aevumed RAPID™ Suture Anchor (K223878).

• Tests performed: Insertion testing, cyclic tensile testing, and static tensile testing.
• Key finding: The Aevumed PHANTOM™ Suture Anchor demonstrated "significantly higher pullout strength" in comparison to the predicate RAPID™ Anchor.
• Conclusion drawn: The data supports the relative safety of the device and demonstrates that it performs as intended and comparably (or superiorly in key mechanical aspects) to the predicate device.

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

• Sample Size: The document does not specify the exact number of devices (suture anchors) used in the non-clinical mechanical tests. These tests typically involve a statistically significant number of samples to ensure repeatability and reliability of the results.
• Data Provenance: The data is generated from laboratory-based non-clinical mechanical testing. This means the "data provenance" isn't in terms of patient population (e.g., country of origin, retrospective/prospective) but rather controlled experimental conditions.

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

• Not Applicable. For a physical medical device like a suture anchor, "ground truth" for non-clinical mechanical testing is established by engineering standards and validated testing methodologies, not by expert interpretation of patient data or images. The "ground truth" would be the measured physical properties (e.g., pullout strength).

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, this device does not involve human interpretation of data for its primary evaluation for 510(k) clearance. Mechanical tests have quantitative outputs, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. An MRMC effectiveness study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. This is not applicable to a physical implantable device like a suture anchor.

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

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence for this device is based on objective engineering and mechanical performance data (e.g., measured pullout strength, tensile strength, and material properties) obtained from non-clinical laboratory testing, alongside adherence to established standards for biocompatibility and sterilization.

8. The Sample Size for the Training Set:

• Not Applicable. This device is not an AI/ML model, so there is no "training set."

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

• Not Applicable. There is no training set for this type of device.

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The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
· Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair.
· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

The Aevumed PHANTOM ™ Anchor with HS Fiber ™ suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM ™ Anchor with HS Fiber ™ are pre-loaded with or without needles. The Aevumed PHANTOM ™ Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.

The provided text is a 510(k) Premarket Notification for a medical device (AEVUMED PHANTOM Suture Anchors). This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text DOES NOT contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML-based medical devices. The document is for a traditional mechanical medical device (suture anchors) and the "NON-CLINICAL TESTS" section only mentions mechanical testing (Torsional Strength, Driving Torque, Pullout Strength) as the basis for substantial equivalence.

Therefore, I cannot extract the information required by your request, as the request pertains to the evaluation of an AI/ML device, and the provided document describes a non-AI/ML device.

Here's what I can tell you from the document regarding the "study" that proves the device meets the acceptance criteria, even though it's not an AI/ML study:

• Study Type: Non-clinical mechanical testing.
• Tests Conducted: Torsional Strength, Driving Torque, and Pullout Strength.
• Purpose: To demonstrate substantial equivalence to the predicate device (Arthrex Corkscrew FT) by showing comparable mechanical performance.
• Ground Truth: The mechanical properties of the predicate device serve as the de facto "ground truth" for comparison.
• Acceptance Criteria: While specific numerical acceptance criteria are not explicitly listed in this summary, the implication is that the Aevumed PHANTOM™ Suture Anchors must perform comparably to the predicate device in these mechanical tests to establish substantial equivalence.

To directly answer your numbered points based on the provided text, I must state that this information is not available for an AI/ML device study:

1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML study. The document mentions mechanical tests (Torsional Strength, Driving Torque, Pullout Strength), but doesn't provide a table of acceptance criteria or specific numerical performance results for these non-clinical tests. It only states they were tested.
2. Sample sized used for the test set and the data provenance: Not applicable for an AI/ML study. For the mechanical tests, the sample sizes and provenance of the test articles are not specified in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML study. Ground truth for mechanical testing is based on physical measurements, not expert consensus.
4. Adjudication method for the test set: Not applicable for an AI/ML study.
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 is a mechanical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
7. The type of ground truth used: For this mechanical device, the "ground truth" is likely defined by the established mechanical standards and performance of the predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

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