(77 days)
Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to an 11 mm carbon fiber rod or stainless steel tube.
Synthes Ti Universal Clamp is available in 2 sizes: four and six possible pin positions, which allow variable pin spreads in a two pin model. The device is manufactured from a Titanium Alloy.
This document describes a comparison between two medical devices, the Synthes Ti Universal Clamp and the Synthes Double Adjustable Clamp, to demonstrate substantial equivalence. However, the provided text does not contain the acceptance criteria or detailed study information typically requested for AI/ML device performance.
The input describes a medical device regulatory submission (510(k) Summary) for a physical orthopedic clamp. The "study" mentioned is a mechanical performance test to show equivalence between two physical devices, not a study evaluating an AI/ML algorithm's performance on medical imaging or clinical data.
Therefore, I cannot provide the requested information for an AI/ML device. The categories you've provided (acceptance criteria, sample size, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) are relevant to the evaluation of AI/ML software, not to the mechanical testing of orthopedic clamps.
Here's what I can extract from the provided text, interpreted in the context of a traditional medical device submission for a physical product:
Summary of Device Comparison (Traditional Medical Device)
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Mechanical Performance | The Synthes Ti Universal Clamp must demonstrate mechanical properties (e.g., strength, stability, durability) that are comparable or superior to the predicate device. | "Based on mechanical test results, the Ti Universal Clamp has been found to be substantially equivalent to the Double Adjustable Clamp." |
| Intended Use | The Synthes Ti Universal Clamp must have the same or a very similar intended use as the predicate device. | Both clamps are intended "for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation." |
| Design/Materials | Differences in design and materials must not raise new questions of safety or effectiveness. | Ti Universal Clamp: Titanium Alloy, 2 sizes (four and six pin positions), variable pin spreads. |
| Double Adjustable Clamp: Stainless Steel, 3 pin positions, variable pin spreads. |
Note: The exact quantitative mechanical acceptance criteria (e.g., specific load tolerances, fatigue cycles) are not provided in this summary but would be detailed in the full 510(k) submission.
2. Sample Size and Data Provenance:
- Sample Size: Not specified for the mechanical tests. The "samples" would typically refer to a batch of manufactured clamps subjected to testing.
- Data Provenance: Not explicitly stated, but given it's a Synthes (USA) submission, presumably the tests were conducted by or for Synthes, likely in the USA. It is inherently "prospective" in the sense that physical tests are conducted on manufactured samples.
3. Number of Experts and Qualifications:
- Not applicable in the context of mechanical testing. The assessment of "equivalence" is based on objective mechanical measurements and comparison against established performance standards or the predicate device's performance, not expert human interpretation. Engineering and quality control personnel would oversee the testing.
4. Adjudication Method:
- Not applicable. Mechanical tests yield objective data, often with pass/fail criteria or direct comparison against a specific value. There isn't a need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a mechanical device, not an AI/ML diagnostic or prognostic tool. MRMC studies are used to evaluate human reader performance with and without AI assistance.
6. Standalone Performance:
- No, not in the AI/ML sense. The "performance" here refers to the mechanical integrity and function of the physical clamp itself. Its "standalone performance" is its ability to meet engineering specifications during testing.
7. Type of Ground Truth Used:
- Engineering Specifications / Predicate Device Performance. The "ground truth" for mechanical testing is established by engineering principles, industry standards, and the demonstrated performance of a legally marketed predicate device (the Synthes Double Adjustable Clamp in this case).
8. Sample Size for the Training Set:
- Not applicable. This isn't an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable.
In conclusion, the document describes a regulatory submission for a physical medical device and its mechanical performance testing for substantial equivalence, not an AI/ML software device. Therefore, most of the questions posed are not relevant to the information provided.
§ 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.