(67 days)
The devices are intended for soft tissue-to-bone suture fixation for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs), Foot and Ankle (Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Hallus valgus reconstructions), Elbow, Wrist, and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Tennis elbow repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repairs).
The Statak Soft Tissue Attachment Device anchor has a diameter of 2.5 mm, is self-tapping, self-drilling, and fully threaded. A double strand, braided, nonabsorbable Size No. 2-0 suture is attached to an eyelet at the end of the anchor. A disposable driver which can be attached to a powered handpiece holds the excess suture and delivers the anchor directly into the bone. When the driver is removed, the suture strands are left emerging from the bone. The strands are then used to secure the soft tissue to the bone.
This document is a 510(k) premarket notification for a medical device, the Statak® Soft Tissue Attachment Device. It describes the device's technical specifications, intended use, and a summary of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of AI/ML performance evaluation.
Here's an analysis of what information is present and what is missing based on your request:
Analysis of Available Information:
This document focuses on the regulatory submission for a physical medical device (soft tissue anchor), not an AI/ML-driven device. As such, many of the requested categories related to AI/ML model evaluation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of document for a conventional medical device.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as formal, quantitative acceptance criteria in numerical terms in this summary. Instead, the "acceptance" is implicitly defined by the comparison to a predicate device and the "as well as" performance.
- Reported Device Performance:
- Performance Claim: "The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure."
- Test Method: "tension loading the suture in the hand bones of cadaver specimens."
- Comparison: Compared to "a suture-only tenodesis procedure in similar bone."
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 mentions "cadaver specimens" and "similar bone" but does not provide a number.
- Data Provenance: "cadaver specimens." No country of origin is specified. The study is inherently ex vivo (on cadaveric tissue), not retrospective or prospective in the clinical sense.
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 or Not present. This device's performance is measured mechanically (tension loading), not through interpretation by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable or Not present. No expert adjudication is involved in assessing a mechanical property.
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 not an AI/ML device, so no MRMC study involving human readers and AI assistance would be performed.
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 (expert consensus, pathology, outcomes data, etc)
- Type of "Ground Truth" (or reference standard): The "ground truth" for this performance test is the mechanical strength/resistance to tension of a "suture-only tenodesis procedure." This is a direct mechanical measurement on cadaveric bone.
8. The sample size for the training set
- Not applicable or Not present. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable or Not present. There is no training set for a non-AI/ML device.
Summary Table of Available Information (Adapted for this Device Type):
| Criterion/Information Request | Provided Information from Document |
|---|---|
| Acceptance Criteria | - Implicit Acceptance Criterion: Performance "as well as" a predicate or comparator procedure (suture-only tenodesis). |
- Specific Quantitative Criterion: Not explicitly stated (e.g., "must withstand X Newtons of force"). |
| Device Performance | - "The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure." - Test Method: Tension loading the suture in hand bones of cadaver specimens. |
| Test Set Sample Size | Not specified (mentioned "cadaver specimens"). |
| Data Provenance (Test Set) | Cadaver specimens. Ex vivo. |
| Number & Qualifications of Experts (Test Set Ground Truth) | Not applicable (performance measured mechanically, not interpreted by experts). |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study (AI vs. Human) | Not applicable (not an AI/ML device). |
| Standalone Performance (Algorithm Only) | Not applicable (not an AI/ML device). |
| Type of Ground Truth (Test Set) | Direct mechanical measurement (tension loading) in comparison to a reference standard (suture-only tenodesis) on cadaveric bone. |
| Training Set Sample Size | Not applicable (not an AI/ML device). |
| How Ground Truth for Training Set Established | Not applicable (not an AI/ML device). |
Conclusion:
The provided document is a regulatory submission for a traditional, physical medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, much of your requested information, which pertains to the evaluation methodology for AI/ML performance, is not relevant or present in this context. The document confirms that the Statak device performed "as well as" a comparator procedure in cadaveric tests, but lacks the detailed, quantitative metrics and study design elements typically found in AI/ML validation.
§ 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.