(56 days)
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
The Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.
This 510(k) summary describes a medical device, the Synthes Spherical Washers, and its intended use. However, it does not contain any information about acceptance criteria, device performance testing, or study details such as sample sizes, ground truth establishment, or expert involvement.
The document is a premarket notification for a Class II medical device, which typically involves demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific performance metrics and acceptance criteria in the same way a PMA device might.
Therefore, for almost all of your requested information, the answer is that the document does not provide it.
Here's a breakdown of what can be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Response: Not provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance data against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Response: Not provided in the document. This type of information is not typically part of a 510(k) summary for a mechanical device like a washer, which relies on design specifications and material properties rather than clinical imaging data sets.
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)
- Response: Not applicable/Not provided. The regulatory submission for a spherical washer does not typically involve expert review of a "test set" in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Response: Not applicable/Not provided.
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
- Response: Not applicable. This device is a mechanical implant (spherical washer), not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Response: Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Response: Not applicable. For this type of device, "ground truth" would relate to its mechanical properties and biocompatibility, which are assessed through engineering tests and material specifications, not through clinical diagnostic "ground truths."
8. The sample size for the training set
- Response: Not applicable/Not provided. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Response: Not applicable/Not provided.
Summary of what the document does provide:
- Device Name: Synthes Spherical Washers
- Intended Use: To prevent a screw head from breaking through the cortex of the bone by distributing forces/load over a large area during fracture fixation of large (long) bones and bone fragments. Also, to prevent screw head projection when inserted at an acute angle (e.g., in ankle arthrodesis).
- Predicate Device: Synthes 13.0 mm Washer
- Classification: Class II
- Regulatory Basis: Substantial Equivalence to a predicate device. This means the device met the requirements by demonstrating it is as safe and effective as a legally marketed device that does not require PMA. This typically involves performance bench testing, material characterization, and comparison of design to the predicate, rather than clinical trials with specific performance metrics like sensitivity/specificity.
§ 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.