(79 days)
The I.T.S. Claviculatplate with Angular Stability is a titanium implant fracture fixation system for repairing fractures located from the middle third to the distal third of the clavicle. Indications for Use include metaphysial and diaphysial fracture fixation of acute fractures, malunions, and non-unions of the clavicle. Other indications include corrective osteotomy and open and closed fractures. The system is not intended for spinal use.
The I.T.S. Claviculaplate with Angular Stability is a low-profile universal left and right titanium plate with various length cortical and/or cancellous self-tapping stabilization screws. The claviculaplate is made from CP titanium according to ASTM F 67-00 and the screws are made from 6-4 alloyed titanium according to ASTM F 136-02. The plate and screws are surface conditioned with a TIODIZE, Type II preparation.
The provided document (K050862) is a 510(k) summary for a medical device called "Claviculaplate with Angular Stability." This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does not describe a study to prove the device meets acceptance criteria in the manner typically associated with clinical trials or performance evaluations of diagnostic or AI-driven systems.
Instead, the "acceptance criteria" for a device seeking 510(k) clearance are related to demonstrating substantial equivalence to an already approved predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences in technological characteristics do not raise new questions of safety or effectiveness.
Therefore, many of the requested points are not applicable to a 510(k) submission for a non-diagnostic, non-AI medical implant like a bone plate. I will address the relevant points and indicate when information is "not applicable."
1. A table of acceptance criteria and the reported device performance
For a 510(k) of a bone plate, the "acceptance criteria" are demonstrating substantial equivalence. The reported "performance" is that it is substantially equivalent to predicate devices.
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | The device's intended use (stabilize clavicle fractures, not for spinal use) is consistent with predicate bone plates. |
| Technological Characteristics: Similar to predicate device, or differences do not raise new questions of safety/effectiveness | The device is a "low-profile universal left and right titanium plate with various length cortical and/or cancellous self-tapping stabilization screws." It is made from CP titanium (ASTM F 67-00) and screws from 6-4 alloyed titanium (ASTM F 136-02), surface conditioned with TIODIZE, Type II preparation. These characteristics are similar to predicate devices (Synthes and Acumed bone plate systems). |
| Material Composition: Biocompatible and known in medical use | Plate from CP titanium (ASTM F 67-00), Screws from 6-4 alloyed titanium (ASTM F 136-02). These materials are standard for orthopedic implants and are found in predicate devices. |
| Functional Equivalence: Performs the same basic function | The device is intended for "fracture fixation of the clavicle," which is the same function as predicate bone plate systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. A "test set" in the context of diagnostic or AI performance evaluation is not relevant to this 510(k) submission. Substantial equivalence for this type of device is typically demonstrated through engineering analyses (mechanical testing, material characterization) and comparison to predicate device specifications, rather than clinical trial data. The document does not mention any clinical or comparative study data of this nature.
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)
- Not applicable. No "test set" with "ground truth" established by external experts for performance evaluation is mentioned in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No external adjudication method is mentioned or required for this type of 510(k) submission.
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
- Not applicable. This device is a bone plate, not a diagnostic or AI-assisted system. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone plate, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. "Ground truth" in the context of diagnostic or AI models is not relevant to this 510(k) submission for a bone plate. The "ground truth" for showing substantial equivalence relies on established standards for materials, manufacturing, and mechanical performance, and documented performance of legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This device is a bone plate and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this 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.