(36 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
The provided document is a 510(k) summary for the Zimmer Periarticular Locking Plates, a device for internal fracture fixation. It describes the device, its intended use, comparison to predicate devices, and a general statement about performance data.
However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, a study proving device meeting criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The "Performance Data" section states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This is a high-level summary and does not provide any specific quantitative acceptance criteria or detailed study results.
Therefore, I cannot populate the table or provide answers to most of the questions based on the provided text.
Here's what can be inferred or directly stated from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: The document generally states "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." No specific metrics (e.g., tensile strength, fatigue life, torsional stability) or quantitative results are provided.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified quantitatively, only general statement of "safe and effective" based on non-clinical (laboratory) testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "non-clinical (laboratory) performance testing." It does not specify sample sizes for test sets, data provenance, or whether the study was retrospective or prospective.
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/Not mentioned. The testing described is "non-clinical (laboratory) performance testing," which typically involves mechanical or material property assessments, not expert-reviewed data where "ground truth" for diagnostic or clinical accuracy is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned for the same reasons as #3.
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
- No. This is a medical device (bone plate and screw system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. As this is a non-clinical, laboratory performance test of a physical device, the "ground truth" would likely refer to established engineering standards or physical test outcomes (e.g., measuring forces, displacements, fatigue cycles). Specific details are not provided.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not a machine learning model.
§ 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.