(75 days)
The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand, and wrist. The two-part construct is specifically intended for Talonavicular, Calcaneocuboid, Metatarsocuneiform, Ankle, Capito-Lunate, and Triquetral-Hamate arthrodesis, as well as Metatarsal Osteotomies.
The EXTREMITY MEDICAL Screw and Washer System consists of two pieces, a Screw and a Washer, which couple together to provide stability and compression across an intended area of fusion.
The provided document describes a medical device, specifically the EXTREMITY MEDICAL Screw and Washer System, not an AI/ML-driven medical device. Therefore, many of the requested categories related to algorithms, AI performance, ground truth, and expert evaluation are not applicable.
However, I can extract the information pertinent to the acceptance criteria and the study performed for this device based on the document.
Acceptance Criteria and Device Performance for EXTREMITY MEDICAL Screw and Washer System
Given that this is a 510(k) submission for a traditional medical device (screws and washers), the acceptance criteria are generally based on demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and mechanical performance.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from "Statement of Technological Comparison" and "Non-clinical Testing") | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate device (EXTREMITY MEDICAL Screw and Washer System, K101700) | Met (Explicitly stated) |
| Design | Similar to predicate device | Met (Explicitly stated) |
| Materials | Similar to predicate device | Met (Explicitly stated) |
| Mechanical Properties | Equivalent mechanical properties to predicate device | Met (Demonstrated via bench testing) |
| Surgical Technique | Verification of surgical technique with new screw and washer options | Met (Verified via clinical simulations in cadavers) |
| Biocompatibility | (Inferred - standard for implantable devices, assumed to be covered by material similarity to predicate) | (Not explicitly detailed in summary, but assumed favorable as similar to predicate) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI/ML algorithm. The "test set" here refers to the samples used in bench testing and cadaver studies.
- Bench Testing: The document states "pull-out, torque and bending was performed." The specific number of screws/washers tested for each modality is not specified.
- Cadaver Studies: "Clinical simulations in cadavers were performed." The number of cadavers or specific procedures performed is not specified.
- Data Provenance: Not applicable in the context of AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data originated from in-vitro (bench testing) and ex-vivo (cadaver) studies conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is a mechanical device, not an AI/ML algorithm requiring expert ground truth for classification or detection. The "ground truth" for mechanical properties is established by engineering standards and measurements, and for surgical technique, by observed performance by qualified personnel (surgeons/engineers) during cadaveric trials. The specific number and qualifications of these personnel are not specified but would typically include bioengineers and orthopedic surgeons.
4. Adjudication method for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers for AI/ML ground truth. For this device, the "adjudication" would involve engineering analysis of the bench test data and expert assessment of the cadaveric simulations.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic tools, not for a mechanical bone fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This is a hardware medical device, not an algorithm.
7. The type of ground truth used
- Not applicable in the AI/ML sense. For this device:
- Mechanical performance: Ground truth is based on established engineering standards and measurements (e.g., specific force required for pull-out, torque values, bending resistance).
- Surgical technique: Ground truth is based on successful and stable fixation demonstrated in cadaveric models as assessed by trained professionals.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the AI/ML context.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a "training set" or require ground truth establishment in the AI/ML context.
Summary of the Study:
The study conducted to demonstrate the safety and effectiveness of the EXTREMITY MEDICAL Screw and Washer System was a non-clinical study. It consisted of:
- Bench testing: This involved mechanical testing such as pull-out, torque, and bending tests. The results of these tests were compared to the predicate devices to demonstrate equivalent mechanical properties.
- Clinical simulations in cadavers: These studies were performed to verify the surgical technique with the additional screw and washer options being introduced.
The conclusion drawn from these studies was that the device is substantially equivalent to its predicate device based on indications for use, materials, design, test data, and principles of operation. No clinical testing in live subjects was performed.
§ 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.