(67 days)
The I.T.S. Volar Radius Plate with Angular Stability is a titanium implant fracture fixation system for distal radius fractures of the wrist.
Indications for Use include comminuted extra and intra-articular distal radius fractures, failed original fracture fixation, osteotomy and repair of a distal radius malunion, and comminuted volar shearing fractures
The I.T.S. Volar Radius Plate system provides immediate stability, rapid recovery, and prompt wrist functionality.
The I.T.S. Volar Radius Plate with Angular Stability provides various width 4 and 6 hole standard plates, various width 8, 10, and 12 hole long plates, various length stabilization screws, and various length cortical fixation screws. The volar radius plates are made from CP Titanium according to ASTM F 67-00 and the screws are made from 6-4 Alloyed Titanium according to ASTM F 136-98.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
The provided documents do not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Instead, these documents are a 510(k) summary and the FDA's clearance letter for a medical device called the "Volar Radius Plate with Angular Stability." The 510(k) process is primarily a regulatory pathway in the US for demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trial data demonstrating performance against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from these documents. Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The documents do not define specific acceptance criteria (e.g., in terms of biomechanical performance, clinical outcomes, etc.) or report detailed device performance data against such criteria. The basis for clearance is "substantial equivalency" to predicate devices, not meeting novel performance benchmarks.
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. No test set or associated data (clinical or otherwise, beyond potentially design specifications or bench testing to demonstrate similarity to predicates) is described in these documents.
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. There is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication is described.
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 fracture fixation plate, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question is relevant for AI/software devices. This is a physical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For the substantial equivalency determination, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices. The applicant needed to demonstrate that the new device is as safe and effective as these legally marketed devices, based on similar design principles, materials, and intended use, rather than proving a new scientific assertion with a novel ground truth.
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is relevant here, as this is a physical medical device clearance, not an AI/ML product.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set is relevant.
Summary of what can be extracted from the documents:
The basis of approval for the I.T.S. Volar Radius Plate with Angular Stability was its substantial equivalency to existing legally marketed predicate devices:
- Avanta SCS/V Distal Radius Plate - Volar
- Hand Innovations DVR Plate
- Synthes Locking Distal Radius System 2.4
The 510(k) summary states that "The I.T.S. Volar Radius Plate is substantially equivalent to the Avanta, Hand Innovations, and Synthes fracture plating systems." This implies that the sponsor demonstrated similarity in terms of:
- Intended Use: Stabilizing distal radius fractures in the wrist with accurate retention of articular fracture elements.
- Technological Characteristics: Made from CP Titanium (plate) and 6-4 Alloyed Titanium (screws), similar to predicate devices.
- Performance: Likely demonstrated through bench testing (e.g., mechanical tests like fatigue, tensile, bending strength, but these specific results are not provided in the summary) to show comparable performance to the predicates. The FDA's clearance letter affirms this substantial equivalency finding.
§ 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.