(77 days)
The Cancellous Screw Washers designed for use in conjunction with cancellous bone screws. These implants are intended for fracture fixation of the metatarsals, and tarsal bones.
The proposed device, the Cancellous Screw Washer claims substantial equivalence to a currently marketed device, Synthes Screw Washer. The Synthes Screw Washer and the proposed device are available in either Titanium or Stainless Steel. Both function as added support under bone screw head and have no significant design differences.
Based on the provided K9634 Cancellous Screw Washer 510(k) Summary, it is not possible to describe acceptance criteria and a study proving the device meets them in the way typically expected for an AI/CAD medical device.
The provided document describes a Class II surgical instrument (Cancellous Screw Washer) and its 510(k) submission for market clearance. This type of device does not involve algorithmic performance, image interpretation, or human-in-the-loop interaction in the same way an AI/CAD system would.
Therefore, many of the requested categories are not applicable to this specific device and document.
Here's a breakdown of why and what information can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the AI/CAD context. For a surgical washer, "acceptance criteria" typically relate to manufacturing specifications (material strength, dimensions, sterilization compatibility, biocompatibility) rather than diagnostic performance metrics like sensitivity, specificity, or AUC.
- The document states "no significant design differences" to a predicate device (Synthes Screw Washer) and claims substantial equivalence. This is the primary "acceptance criteria" for a 510(k) for this type of device: demonstrating equivalence to a legally marketed predicate.
- Reported Device Performance: The document doesn't explicitly list performance data beyond functional claims (added support under bone screw head). Equivalence is demonstrated by similarity in materials, design, and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of diagnostic data for a surgical washer. Performance is typically assessed through engineering bench testing, biocompatibility studies, and documented manufacturing controls. Such details are not provided in this summary.
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. "Ground truth" in the diagnostic sense is not relevant for this device. Ground truth for a surgical washer would be established through engineering standards, clinical consensus on a safe and effective design, and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set for diagnostic performance exists.
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 passive surgical implant, not an AI/CAD diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No algorithm is involved.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth (in a very loose sense for a medical device): The "ground truth" for a surgical washer's safety and effectiveness is established by:
- Engineering Standards: Meeting material specifications, mechanical strength, and dimensional tolerances.
- Biocompatibility Standards: Demonstrating the material (Titanium or Stainless Steel) is suitable for implantation.
- Clinical Efficacy/Safety of Predicate: The fact that the substantially equivalent predicate device (Synthes Screw Washer) is already legally marketed and presumed safe and effective.
- Intended Use Compatibility: The device is designed for use with cancellous bone screws, implying its form and function align with established surgical practices for fracture fixation.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm exists.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists.
In summary, the provided document describes a 510(k) submission for a conventional medical device (surgical washer) based on substantial equivalence to an existing predicate device. The framework of acceptance criteria and study design requested is specifically tailored for AI/CAD systems and is not relevant to this type of product.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.