(116 days)
Shoulder Indications: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair and capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist Indications: Scapholunate ligament reconstruction.
Elbow Indications: Tennis elbow repair, biceps tendon reattachment, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee Indications: Extra-capsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
This product is preloaded with suture for use at the discretion of the physician.
The device is a resorbable screw and washer assembly. The screw measures 12.5mm in length and 2.25mm in diameter. The washer is oval shaped and measures 7mm along the long axis with two spikes to hold the soft tissue in place. The device is fully cannulated to accommodate the driver mechanism. The device may be used with any legally marketed suture (size 1 or 2) for secondary reattachment of soft tissue.
The provided document is a 510(k) premarket notification for a medical device: "Soft Tissue Screw and Washer". This type of submission focuses on proving substantial equivalence to existing legally marketed devices, rather than conducting new clinical trials to establish safety and effectiveness from scratch.
Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical performance studies, is largely not applicable or not present in this document.
Here's an breakdown based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for clinical outcomes. The overarching acceptance criterion for a 510(k) is substantial equivalence to predicate devices. This means the device must be as safe and effective as a legally marketed device.
- Reported Device Performance: The document states: "Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices." No specific quantitative performance data from this mechanical testing (e.g., tensile strength, fixation strength relative to predicates) is provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Test Set Sample Size: Not applicable. The document explicitly states: "Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices." Therefore, there was no clinical test set in the traditional sense.
- Data Provenance: Not applicable for clinical data. For non-clinical (mechanical) testing, the provenance of materials or internal laboratory data is not specified.
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 as no clinical testing was performed and therefore no ground truth based on expert review of clinical data was established for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical testing was performed and therefore no adjudication of clinical outcomes was necessary.
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 device is a physical resorbable screw and washer, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic performance, typically for imaging devices or software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for substantial equivalence in this context would be the established safety and effectiveness of the predicate devices, which were approved based on their own data or prior substantial equivalence. For the mechanical testing performed, the "ground truth" would be the performance characteristics of the predicate devices against which the new device was compared. However, details of these comparisons are not provided in this summary.
8. The sample size for the training set
- Not applicable as no machine learning algorithm was involved.
9. How the ground truth for the training set was established
- Not applicable as no machine learning algorithm was involved.
In summary, this 510(k) submission relied on non-clinical (mechanical) testing and comparison to predicate devices to demonstrate substantial equivalence, rather than new clinical trials or AI performance studies.
§ 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.