(167 days)
ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication 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 Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
The Zimmer Plates and Screws System (ZPS) is a non-locking, 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 provided document describes the Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates and Screws (K140508). This is a medical device, and the submission focuses on demonstrating its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, and reader studies is not explicitly available in this type of regulatory submission.
However, based on the "Performance Data (Nonclinical and/or Clinical)" section, we can infer some aspects of what served as "acceptance criteria" for the non-clinical testing performed.
Here's an attempt to answer your questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a non-clinical evaluation for substantial equivalence, the "acceptance criteria" are implied by the comparison to predicate devices and recognized standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet requirements of ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). | Biocompatibility testing on the plate and screw material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed. |
| Performance (Plates): Demonstrate comparable or superior strength to predicate devices (e.g., via four-point bend testing / beam bending cross-sectional analysis). | Four-point bend testing and/or beam bending cross-sectional analysis conducted on both the subject non-sterile ZPS plates and their respective predicate devices demonstrated that, in all cases, the subject ZPS plates were superior in strength. |
| Performance (Screws): Equivalency to previously cleared sterile ZPS screws (K112885). | The non-sterile ZPS screws are identical to the sterile ZPS screws cleared under K112885. Because the sterilization status for these metal devices does not affect the performance testing, no additional testing beyond the data included in K112885 was required. This implies their performance is accepted as equivalent to the predicate sterile screws, which were presumably cleared based on their own performance data. |
| Material: Identical or substantially equivalent materials to predicate devices. | "The ZPS Plates/Screws are similar in intended use, basic shape, compatible screw diameters, materials and performance characteristics to the predicate devices." (Implied acceptance is material equivalency to predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- Biocompatibility: The document states "Biocompatibility testing... was conducted." It does not specify the number of samples or animal subjects used, as is common for a summary of this type.
- Performance (Plates): The document refers to "four point bend testing and/or the beam bending cross sectional analysis." It does not specify the number of plates tested.
- Performance (Screws): No new testing was performed for the screws, as they were deemed identical to a previously cleared device.
- Data Provenance: Not specified in the provided text, but non-clinical testing is typically conducted in a laboratory setting. This is not clinical data; it's laboratory performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone fixation system (plates and screws), not a diagnostic algorithm or imaging device where "ground truth" would be established by experts. The "ground truth" for non-clinical performance refers to the actual physical properties and behavior of the device under testing conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of results.
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 or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" would be:
- Biocompatibility: Standardized assay results compared against pass/fail criteria per ISO 10993-1.
- Performance (Plates): Measured mechanical properties (e.g., strength, stiffness) obtained from standardized test methods such as four-point bend testing, compared against predicate device performance.
8. The sample size for the training set
Not applicable. This is not a device employing machine learning or AI that would require 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.