(83 days)
The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Rotator cuff tear repairs । - Biceps tenodesis . Foot and Ankle - Lateral instability repairs/reconstructions - Elbow - Ulnar or radial collateral ligament reconstructions - - Tennis elbow repair - - Biceps tendon reattachment - Knee 1 - Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
The provided document describes a medical device, the Multitak Suture System™, but it does not contain the type of AI/ML-related performance data (e.g., accuracy, sensitivity, specificity) requested in the prompt. Instead, it describes a physical medical device and its mechanical performance testing.
Therefore, I cannot provide the information requested in the format of AI/ML acceptance criteria and study details. The document is primarily a summary of safety and effectiveness for a physical surgical anchor system, focusing on its intended use and mechanical pullout strength compared to a predicate device.
Here's an overview of what is available in the given text, rephrased to fit the context of device performance, even though it's not AI/ML performance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: Pullout tension equal to or better than the predicate device (Multitak SS Suture System). | Mechanical Performance: "Results demonstrated that the performance of the Multitak Suture System was equal to or better than the performance of the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "cadaver bone". No specific number of samples or cadavers is provided.
- Data Provenance: The test was performed on "cadaver bone." The country of origin is not specified. It is an experimental, prospective test of the device's mechanical properties.
3. 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. This is a mechanical performance test, not a diagnostic or interpretation study. "Ground truth" would be the measured pullout strength.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is a mechanical performance test, not a study requiring adjudication of expert opinions. The ground truth is directly measured physical force.
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 physical device; there are no "human readers" or "AI assistance" involved in its direct mechanical performance testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is not an algorithm. Its performance is entirely "standalone" in the sense that its mechanical properties are inherent to the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the performance test was the measured pullout tension (force) in cadaver bone, compared against established values or performance of a predicate device.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set."
In summary: The provided text details a physical medical device and its mechanical performance testing against a predicate device, not an AI/ML system, thus it lacks the specific AI/ML and diagnostic study details requested in the prompt.
§ 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.