(103 days)
The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- · Comminuted fractures
- · Supracondylar fractures
- · Intra-articular and extra-articular condylar fractures
- · Fractures in osteopenic bone
- Nonunions
- · Malunions
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
This is a 510(k) premarket notification for the Zimmer Periarticular Locking Plate System, which is a medical device for internal fracture fixation. The provided document is a regulatory submission, not a study report detailing acceptance criteria for an AI/CADe device. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics related to AI algorithm evaluation cannot be found here.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify "acceptance criteria" in the way it would for an AI algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, for a traditional medical device like a bone plate system, acceptance is based on demonstrating substantial equivalence to a predicate device and showing the device is safe and effective through non-clinical performance data.
| Acceptance Criteria (Implied for a 510(k) Submission) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Zimmer Periarticular Locking Plate System has the same intended use, similar performance characteristics, is manufactured from identical materials using identical processes, and is similar in design to the predicate devices (K070906). |
| Safety and Effectiveness Demonstrated by Performance Data | "The results of non-clinical testing show the proposed device is safe and effective." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is for a traditional medical device (bone plate system) and refers to non-clinical testing (likely mechanical and material property tests), not a clinical or AI algorithm performance study with a "test set" in the context of diagnostic or prognostic accuracy.
- The document implies laboratory-based non-clinical testing rather than human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment by human experts for a "test set" is described, as this is not an AI/CADe or diagnostic study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set 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 is not an AI-assisted diagnostic device; therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable (in the context of AI/diagnostic ground truth). The "ground truth" for this device would be established through engineering specifications, material standards, and biomechanical testing results, not through expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is validated.
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" for an AI algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a "training set" or corresponding 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.