(77 days)
This device is intended for anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.
The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile.
This document is a 510(k) summary for the Acumed Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the way one would for a novel AI/software medical device.
Therefore, many of the requested categories for AI/software device evaluation are not applicable or cannot be extracted from the provided text. The document describes a traditional hardware medical device (suture anchor), not a software or AI-driven device.
Here's an analysis based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This document is a 510(k) summary for a hardware device, not a performance study for an AI/software device. It doesn't present performance metrics like sensitivity, specificity, or accuracy against a defined acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no "test set" in the context of evaluating an AI or software device. The document mentions "data on file at Acumed" regarding steam sterilization validation, but this is a manufacturing process validation, not clinical performance data for a diagnostic or therapeutic AI.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, as understood in AI/software device evaluation, is not established or discussed for this hardware device.
4. Adjudication Method
Not applicable. There is no adjudication process described for a study evaluating AI or software performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human readers, which is not the subject of this 510(k).
6. Standalone (Algorithm Only) Performance Study
Not applicable. The Acumed Suture Anchor is a physical implant, not an algorithm.
7. Type of Ground Truth Used
Not applicable. There is no "ground truth" established in the sense of clinical diagnoses or outcomes to validate an algorithm. The 510(k) process for this device relies on demonstrating substantial equivalence to existing legally marketed predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness profiles.
8. Sample Size for the Training Set
Not applicable. There is no "training set" for a hardware medical device like this suture anchor.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or relevant for this type of device submission.
Summary of Relevant Information from the Provided Text for a Hardware Medical Device:
The document focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, which is the primary "study" for a 510(k) submission of this nature.
- Acceptance Criteria: The implicit acceptance criterion for a 510(k) is that the new device is "substantially equivalent" to predicate devices in terms of:
- Indications for use.
- Technological characteristics (e.g., material, design, sterilization).
- Safety and effectiveness.
- Study That Proves Device Meets Acceptance Criteria (in this context): The "study" is the comparison to predicate devices.
- Predicate Devices: Mitek GII Anchor, SuperAnchor, Linvatec Revo, and Zimmer Statak.
- Demonstration of Equivalence:
- Indications: The Acumed Suture Anchor has the "same indications" as the predicates (anchoring soft tissue to bone in rotator cuff repairs, and soft tissue repairs of the foot and ankle).
- Materials: Manufactured from titanium 6AL 4V ELI per ASTM F136, similar to predicates.
- Design: Screw-based design is "similar to the Linvatec Revo and the Zimmer Statak."
- Surgical Techniques: "Similar surgical techniques" to the Mitek GII Anchor and SuperAnchor.
- Sterilization: The document mentions "Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 10 as validated by data on file at Acumed." This is a validation of the sterilization process itself, not a comparative performance study in a clinical setting.
- Conclusion: "Based on the similarities between the Acumed Suture Anchor and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor is expected to be similar to the predicate devices mentioned above."
Essentially, the "study" for this 510(k) is a detailed comparison and justification, rather than a clinical trial or a performance evaluation against specific numerical thresholds in a test set. This is typical for Class II hardware devices seeking market clearance via the 510(k) pathway.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.