(41 days)
Synthes Small Combination Clamps – MR Safe are intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.
Synthes Small Combination Clamp -MR Safe is a component of an external fixation frame that forms a construct generally intended to treat the hand, wrist, mandible and foot. This device is intended for use in the MR environment. Frame components accept Synthes Ø4.0 mm carbon fiber rods, Synthes Schanz Screws in diameters of 4.0/4.0, 4.0/3.0 and 4/0/2.5 mm and Synthes Ø2.5 mm K-wires.
This 510(k) summary (K031724) describes a device, the Synthes Small Combination Clamp - MR Safe, which is a component of an external fixation frame. The submission focuses on demonstrating substantial equivalence to a predicate device, specifically regarding its "MR Safe" designation.
However, the provided text does not contain information regarding objective performance criteria, test results against those criteria, or details of a study that proves the device meets specific performance metrics.
The document primarily states that "Documentation is provided which demonstrates that the Synthes Small Combination Clamp -MR Safe is substantially equivalent to other legally marketed Synthes devices." The FDA letter confirms this substantial equivalence based on the provided indications for use.
Therefore, for the requested information:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The submission focuses on substantial equivalence based on prior marketed Synthes devices and the "MR Safe" designation, rather than specific performance metrics against a predefined set of acceptance criteria.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 relevant or mentioned, as this is a mechanical fixation device, not an AI/imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant or mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided document focuses on regulatory substantial equivalence for a medical device's physical properties and intended use, particularly its "MR Safe" designation, rather than presenting a performance study with quantitative acceptance criteria as would be found for a diagnostic or AI-powered device.
§ 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.