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510(k) Data Aggregation
(151 days)
TriMed Nitinol Staple System
The TriMed Nitinol Staple System is intended for use in fractures, osteotomy, and arthrodesis of the following areas of the body: small bones in the hand and foot.
The TriMed Staple is a sterile, non-bioabsorbable, implantable device designed to address common types of deformity corrections, fractures and osteotomies in extremities amenable to staple fixation, all depending on the size, shape, and location of the fractured bone and bone fracture fragments. TriMed Staples are manufactured from medical grade Nitinol. Two types of staple leg configuration are available; symmetrical and asymmetrical. The staple is implanted with a set of re-usable instruments designed for: preparation of the implant site and insertion of the implant into bone.
Here's a breakdown of the acceptance criteria and study information for the TriMed Nitinol Staple System based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (TriMed Nitinol Staple System). It focuses on demonstrating substantial equivalence to a predicate device, not necessarily on a novel AI or diagnostic system. Therefore, some of the requested information (like expert consensus, AI assistance, human readers, training sets) is not applicable to this type of device and submission. The questions related to these aspects will be marked as "Not Applicable".
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for clinical accuracy or performance metrics as would be typical for an AI diagnostic device. Instead, it describes performance tests conducted to demonstrate equivalence to a predicate device. The goal is to show the device performs similarly or within acceptable limits compared to the predicate in mechanical and material properties.
| Acceptance Criteria (Implied by equivalence testing) | Reported Device Performance (Compared to Predicate K112794) |
|---|---|
| Equivalent or acceptable Pull-Out Fixation Strength | Testing conducted, results compared to predicate |
| Equivalent or acceptable Elastic Static Bending | Testing conducted, results compared to predicate |
| Equivalent or acceptable Constant Amplitude Bending Fatigue | Testing conducted, results compared to predicate |
| Equivalent or acceptable Corrosion Susceptibility | Testing conducted, results compared to predicate |
| Equivalent or acceptable Titanium Oxide Layer Thickness (Quantified) | Testing conducted, results compared to predicate |
| Quantification of Transformation Temperature (At) | Testing conducted, results reported (implied comparison to known Nitinol properties or predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes (e.g., number of staples tested) for the mechanical and material tests. It mentions "TriMed conducted the following tests," implying laboratory testing on physical device samples.
- Sample Size: Not specified.
- Data Provenance: The tests were conducted by TriMed, Inc. and are laboratory/benchtop tests, not clinical data from patients.
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 mechanical implant, not a diagnostic or AI device requiring expert interpretation of results or ground truth establishment in a clinical context.
4. Adjudication method for the test set
Not Applicable. This is a mechanical/material performance evaluation, not a clinical study requiring adjudication of diagnostic findings.
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 implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a mechanical implant, not an algorithm.
7. The type of ground truth used
For the mechanical and material tests, the "ground truth" is defined by the established scientific engineering principles and material specifications for Nitinol implants, as well as the performance characteristics of the predicate device (K112794). The goal is to show that the new device meets these engineering benchmarks or performs equivalently to the already cleared predicate.
8. The sample size for the training set
Not Applicable. This is a medical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not Applicable. This is a medical implant, not a machine learning model.
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