(63 days)
This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.
The Acumed Suture Anchor is a single use implantable device used with non-absorbable, non-coated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136 and is provided non-sterile.
The provided text is a 510(k) summary for the Acumed Suture Anchor, a medical device. This type of regulatory submission focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than establishing de novo performance criteria through a study with specific acceptance criteria as would be done for novel devices or those undergoing extensive clinical trials.
Therefore, the document does not contain information regarding a study designed to establish acceptance criteria and prove the device meets them in the way described in the request. Instead, the core argument for clearance is based on the similarity to predicate devices.
Here's how to address the requested information based on the provided text, and where it falls short:
1. A table of acceptance criteria and the reported device performance
- Information Not Found: The document does not define specific performance acceptance criteria (e.g., tensile strength, pull-out force) for the Acumed Suture Anchor, nor does it report specific performance values from a dedicated study against such criteria. The submission relies on the assumption that its performance will be "similar" to predicate devices.
2. Sample sized used for the test set and the data provenance
- Information Not Found: No test set sample size or data provenance is mentioned because no performance study, in the sense of testing against acceptance criteria, is described for the Acumed Suture Anchor. The "data on file at Acumed" regarding sterilization mentions an SAL, but this is a process validation, not a device performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Information Not Found: This information is not applicable as no test set or expert-established ground truth is described for the device's functional performance.
4. Adjudication method for the test set
- Information Not Found: This is not applicable.
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
- Information Not Found: This is not applicable. The device is a physical bone anchor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Information Not Found: This is not applicable. The device is a physical bone anchor, not an algorithm.
7. The type of ground truth used
- Information Not Found: This is not applicable to a device clearance based on substantial equivalence to predicate devices for its functional performance. The "ground truth" here is essentially the regulatory acceptance of the predicate devices.
8. The sample size for the training set
- Information Not Found: This is not applicable. There is no mention of a "training set" as this is not a machine learning or diagnostic device.
9. How the ground truth for the training set was established
- Information Not Found: This is not applicable.
Summary of Device Acceptance Criteria and Study as per the Provided Text:
The Acumed Suture Anchor's acceptance and market clearance are not based on meeting new, device-specific performance acceptance criteria established through a dedicated study. Instead, its acceptance is based on demonstrating substantial equivalence to existing predicate devices.
The arguments for substantial equivalence are:
- Identical Indications For Use: "This device is identical in indication to the Mitek GII and SuperAnchor (K953877), the Zimmer Statak (K926384), and the Linvatec Revo (K941691)." Specifically, "This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle."
- Similar Design and Manufacturing Material: "This device is most similar in design to the Zimmer Statak and the Linvatec Revo devices in that all three are based on screw designs and are manufactured from titanium alloys. The Acumed Suture Anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136."
- Similar Surgical Techniques: "The Acumed Suture Anchor and the Mitek GII Anchor and SuperAnchor have similar surgical techniques."
- Sterilization Validation: Acumed has identified process parameters for steam sterilization providing an SAL of 10^-6, "as validated by data on file at Acumed." (This is a process validation, not a performance study of the anchor itself).
In essence, the "study" demonstrating this device meets "acceptance criteria" is the comprehensive review by the FDA (K980103) concluding that the Acumed Suture Anchor is substantially equivalent to legally marketed predicate devices, thereby assuming similar safety and effectiveness. No specific performance study to quantify device performance (e.g., pull-out strength in tissue) against predefined numerical acceptance criteria is detailed in this 510(k) summary.
§ 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.