(85 days)
The Synthes Metallic Spiked Washers are indicated for ligament reattachment or fixation.
The Synthes Metallic Spiked Washers are washers of various sizes with metal spikes arrayed around a center hole.
The Synthes Spiked Washers are available in either implant quality 316L stainless steel or CP titanium. The washer for use with 2.7 mm screws has an inner diameter of 3.2 mm and an outer diameter of 9.0 mm. The washer for use with 3.5 mm and 4.0 mm screws has an inner diameter of 4.0 mm and an outer diameter of 13.5 mm. The washer for use with 4.5 mm and 6.5 mm screws has an inner diameter of 5.5 mm and an outer diameter of 13.5 mm. The smaller washer has six spikes while the two larger washers with an outer diameter of 13.5 mm both have eight spikes.
The provided document, K013806, is a 510(k) Premarket Notification for the Synthes Metallic Spiked Washers, dated February 8, 2002. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a new clinical trial with specific performance criteria.
Therefore, the document does not contain acceptance criteria or a study designed to prove the device meets such criteria.
Here's why and what information is provided:
- Substantial Equivalence: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new characteristics do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device.
- No Specific Performance Study: The document explicitly states: "Documentation was provided which demonstrated the Synthes Metallic Spiked Washers to be substantially equivalent to other legally marketed devices." It does not describe a performance study with acceptance criteria as would be found in a PMA (Premarket Approval) submission or a device undergoing clinical trials to establish its efficacy and safety against predefined metrics.
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not applicable for a 510(k) submission focused on substantial equivalence.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that is available in the document:
- Device Name: Synthes Metallic Spiked Washers
- Indications for Use: The Synthes Metallic Spiked Washers are indicated for ligament reattachment or fixation.
- Materials: Stainless Steel and Titanium (either implant quality 316L stainless steel meeting ASTM F138 or CP Titanium meeting ASTM F67).
- Device Description: Washers of various sizes with metal spikes arrayed around a center hole.
- Washer for 2.7 mm screws: inner diameter 3.2 mm, outer diameter 9.0 mm, six spikes.
- Washers for 3.5 mm and 4.0 mm screws / 4.5 mm and 6.5 mm screws: inner diameter 4.0 mm / 5.5 mm, outer diameter 13.5 mm, eight spikes.
- Predicate Devices: Synthes Spiked Washer (K971447) and Synthes Titanium Locked Spiked Washer (K972778), highlighting similar indications, modifications, features, and size ranges.
- Sterilization: Provided either sterile or non-sterile. Non-sterile devices must be sterilized before use (parameters in Attachment I(b)), with steam sterilization recommended for a Sterility Assurance Level (SAL) of 10^-6. Intended for single use only.
Essentially, a 510(k) submission largely relies on comparing the new device against existing, cleared devices rather than conducting new performance studies with detailed acceptance criteria and ground truth establishment.
§ 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.