(29 days)
The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws
The provided text describes a 510(k) submission for a medical device (Mini MaxLock Extreme® Plating System), which is a premarket notification to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.
For this type of device (bone fixation appliances), the FDA review primarily focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new, standalone performance study in the way one might for a diagnostic AI algorithm. The 510(k) summary explicitly states:
"Calculations and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised."
This means that a direct "acceptance criteria" and "device performance" in terms of clinical outcomes or diagnostic accuracy were not established or tested in this submission. Instead, the acceptance criteria were implicitly met by demonstrating mechanical equivalence to an already approved device.
Therefore, many of the requested points regarding acceptance criteria, study details, and ground truth establishment are not applicable to this specific 510(k) submission.
Here's an breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: Substantial equivalence in terms of strength, indications, design, and materials to the predicate device (OrthoHelix Mini MaxLock Extreme® Plating System K120157). | Performed calculations and finite element analysis (FEA) comparing the strength of the subject and predicate devices. Results support substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No human or animal test set data was used. The study relied on computational analysis (calculations and Finite Element Analysis).
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. No expert-established ground truth was required for this type of substantial equivalence demonstration. The "ground truth" was derived from engineering principles and comparison to the predicate device's established properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication was involved as no patient data or expert review was part of this submission.
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 hardware device (bone plating system), not an AI diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Engineering Equivalent. The "ground truth" for showing substantial equivalence was the known mechanical properties and performance of the predicate device, as assessed through engineering calculations and finite element analysis.
8. The sample size for the training set
- Not Applicable. No machine learning or AI models were involved; therefore, no training set was used.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 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.