(35 days)
ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
- comminuted fractures
- supracondylar fractures
- extra-articular fractures
- fractures in osteopenic bone
- nonunions
- malunions
Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
The Zimmer Plates and Screws System (ZPS) is a nonlocking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The ZPS Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation.
This document is a 510(k) Pre-market Notification for the Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers. It describes the device, its intended use, and a comparison to predicate devices. The document explicitly states that clinical data and conclusions were not needed for these devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone) is explicitly stated as not applicable or not needed in this document.
The document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical performance data.
However, I can extract the non-clinical performance data that serves in place of clinical studies to demonstrate device performance and substantial equivalence.
Here's a breakdown of what the document does provide in relation to performance:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table in the way one might expect for a clinical study with specific performance metrics (e.g., sensitivity, specificity). Instead, it relies on two primary non-clinical performance tests to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly that the subject device's performance should be "similar" or "substantially equivalent" to the predicate devices.
| Acceptance Criteria (Implicit from Equivalence Claim) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: Meet ISO 10993-1 and GLP | Biocompatibility testing on the plate, screw, and washer material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. |
| Mechanical Properties (Beam Bending): Similar mechanical properties to predicate devices. | Beam bending cross sectional analysis of the ZPS Plates and the predicate devices, Zimmer Plate and Screw System (K140508) and the TMP Micro-Plating System (K921458), resulted in similar mechanical properties. The subject and predicate devices are substantially equivalent. |
| Screws and Washers Equivalence: Substantially equivalent to predicate screws/washers and considered line extensions. | The subject screws are substantially equivalent to those cleared in K140508 and are a line extension to screw types already cleared in K140508. The subject washers are substantially equivalent to and are a line extension to the washer cleared in K140508. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of devices or units tested for the non-clinical tests. The tests were performed on "the plate, screw, and washer material" and "ZPS Plates" for beam bending. This would typically refer to a statistically sufficient sample for engineering tests, but the exact number isn't provided.
- Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Zimmer, Inc.) or a contract research organization. There is no mention of country of origin for this data beyond the manufacturer's location (Warsaw, IN). The data is by nature prospective for the purpose of this submission.
- Retrospective or Prospective: Prospective, as it was conducted specifically for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For non-clinical performance tests such as biocompatibility and mechanical testing, "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1) and objective measurements using calibrated equipment, not by expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation by multiple readers) or complex clinical outcomes. Non-clinical tests follow standardized protocols.
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 a medical device (bone plates and screws), not an AI/imaging diagnostic device. Clinical studies (including MRMC) were explicitly stated as "not needed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests:
- Biocompatibility: Established by adherence to ISO 10993-1 standards and the specific pass/fail criteria outlined within those standards and Good Laboratory Practices (GLP).
- Mechanical Properties: Established by quantitative measurements of specific mechanical parameters (e.g., stiffness, strength) through standardized engineering test methods (beam bending cross-sectional analysis). "Similar mechanical properties" to the predicate serve as the ground truth for equivalence.
8. The sample size for the training set
Not applicable. 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
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.