(69 days)
Synthes 2.4 mm Titanium Locking Screws are intended for use in primary or secondary closure / repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
The Synthes 2.4.mm Ti. Locking Screws feature a self-tapping tip, cruciform recess, and have a flat head profile with rounded edges. They are available in lengths ranging from 8 mm to 24 mm.
This document is a 510(k) summary for a medical device called "Synthes 2.4 mm Titanium Locking Screws". It does not contain information about acceptance criteria, study performance, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details that would typically be found in a study proving a device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices in the US. This pathway generally relies on demonstrating that the new device is as safe and effective as an already legally marketed device, rather than requiring extensive clinical trials with pre-defined acceptance criteria for performance.
Therefore, I cannot provide the requested information from the given text.
However, based on the provided text, I can extract the following relevant details about the device:
- Device Name: Synthes 2.4 mm Titanium Locking Screws
- Intended Use: For use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
- Classification: Class II, § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation Fastener.
- Predicate Device: Synthes 2.4 and 3.0 mm Titanium Locking Screws
- Material: Titanium
To answer your specific questions, if this were a document about AI/ML device performance, the requested information would look something like this (hypothetically, not from the provided text):
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sensitivity | ≥ 90% | 92.5% |
| Specificity | ≥ 80% | 85.2% |
| AUC | ≥ 0.90 | 0.93 |
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: 500 cases
- Data Provenance: Retrospective, collected from 3 hospitals in the United States and 2 hospitals in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: 3
- Qualifications: All were board-certified radiologists with subspecialty training in musculoskeletal imaging, each with ≥ 10 years of experience reading chest radiographs.
4. Adjudication method for the test set
- Adjudication Method: 2+1. Initial labels were provided by two independent experts. In cases of disagreement, a third, senior expert independently reviewed the case and provided the tie-breaking decision.
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
- MRMC Study: Yes
- Effect Size: Human readers demonstrated a statistically significant improvement in AUC from 0.78 (without AI assistance) to 0.85 (with AI assistance), representing an average increase of 0.07 AUC (95% CI: 0.05-0.09, p
§ 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.