(34 days)
The STABILIZATION SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
- Fractures management in the foot and hand
- Fixation of bone fragments in long bones or small bones fractures
- Arthrodesis in hand, foot or ankle surgery
The size of the chosen screw should be adapted to the specific indication.
The STABILIZATION SCREW is a cannulated compression screw with a nonthreaded shaft, allowing optimal compression. It also has a self-tapping screw tip. It is provided in diameters 3.0 mm and 4.3 mm and in length from 10 mm to 34 mm for the 3 mm and from 22 mm to 60 mm for the 4.3 m. The STABILIZATION SCREW is made from Titanium alloy (Ti-6A1-4V ELI).
The provided document is a 510(k) premarket notification for a medical device called the "STABILIZATION SCREW." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically seen in a PMA (Premarket Approval) submission.
Therefore, the document does not contain the level of detail requested for acceptance criteria, device performance, or a comprehensive study plan with statistical outcomes, sample sizes, and expert qualifications in the way a clinical trial report would.
However, I can extract information related to the type of studies performed and their conclusion regarding equivalence.
Here's a summary based on the provided text, addressing the points you requested where information is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or specific numerical performance metrics for the STABILIZATION SCREW. Instead, it states that the mechanical properties were shown to be "equivalent" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical properties equivalent to predicate devices as per ASTM F543-02 standard | Torsional, pullout, and 3-point bending tests showed mechanical properties are equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Torsional and pullout strength tests" and "3-point bending tests" were carried out. It does not specify the sample sizes used for these mechanical tests or the provenance of the data (e.g., country, retrospective/prospective). These are typically bench testing results.
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)
This is not applicable as the studies described are mechanical bench tests, not clinical studies involving human observers or "ground truth" as typically understood in a diagnostic accuracy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for mechanical bench testing.
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 document is for a medical implant (bone fixation screw), not an AI-powered diagnostic device. No human reader involvement or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical tests, the "ground truth" would be the physical measurements obtained from testing the screws against the specified ASTM standard (ASTM F543-02) and comparing them to predicate devices. There is no biological or diagnostic "ground truth" in this context.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for mechanical bench testing of this type of device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Study (from Section I. Summary of Studies):
- Study Type: Mechanical testing.
- Tests Performed: Torsional strength, pullout strength, and 3-point bending tests.
- Standard Followed: ASTM F543-02 (Standard Specification and Test Methods for Metallic Medical Bone Screws).
- Conclusion: "Results have shown that mechanical properties of the STABILIZATION SCREW are equivalent to the predicate devices."
The core of this 510(k) submission relies on demonstrating substantial equivalence in terms of design, material, indications for use, dimensions, and comparable mechanical performance to already legally marketed devices.
§ 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.