(90 days)
The Synthes Calcaneal Plate is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
The Synthes Calcaneal Plate is a flat metal plate with multiple arms that can accommodate a variety of screws. It designed to be applied to the lateral side of the calcaneus and comes in right and left versions.
This document is a 510(k) premarket notification for a medical device called the Synthes Calcaneal Plate. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given text.
The document states: "Documentation was provided which demonstrated the Synthes Calcaneal Plate to be substantially equivalent to another legally marketed device." This implies that the primary "study" was a comparison to a predicate device, focusing on material, design, and intended use, rather than a clinical performance study with specific metrics like accuracy, sensitivity, or specificity.
Here's what can be extracted based on the provided text, and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to a legally marketed predicate device | Device was found to be "substantially equivalent" to legally marketed predicate devices for its stated indications for use. |
| Material: Stainless Steel | Device is made of Stainless Steel. |
| Indications for Use: Fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus. | Device's intended use matches the stated indications. |
| Design: Flat metal plate with multiple arms, accommodates various screws, applied to lateral side of calcaneus, comes in right and left versions. | Device description aligns with the design. |
Missing: The document does not specify quantitative performance acceptance criteria (e.g., specific thresholds for fracture fixation strength, bone healing rates, complication rates, or imaging accuracy) because it's a substantial equivalence submission.
2. Sample size used for the test set and the data provenance
- Missing. The document does not describe a clinical "test set" in the context of device performance metrics. Its equivalence claim relies on comparing characteristics to existing devices, not on new clinical data from a specific patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Missing. Not applicable as a clinical performance study with a test set and ground truth established by experts is not detailed.
4. Adjudication method for the test set
- Missing. Not applicable.
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 fixation plate, not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing/Not applicable in the traditional sense. For a substantial equivalence claim, the "ground truth" is typically conformance to established standards for materials, manufacturing, and comparison to the predicate device's proven safety and efficacy profile. There's no clinical "ground truth" derived from patient outcomes or expert consensus described here.
8. The sample size for the training set
- Missing. Not applicable, as this is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Missing. Not applicable.
§ 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.