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510(k) Data Aggregation
(308 days)
Locking Plates and Screws Systems is intended to provide fixation during fractures, fusions, and osteotomies. Locking Plates and Screws Systems is indicated for the clavicle, and small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Locking Plates and Screws Systems consists of metal locking plates, metal locking screws and non-locking metal screws, of which the metal locking plates offered are divided into ordinary type and limited-contact type. The locking plates are made of pure titanium material (TA3G per ASTM F67), and the metal bone screws are made of titanium-alloy (TC4 per ASTM F136). The product surface is color anodized, and the delivery state of the product is non-sterile.
This document from the FDA is a 510(k) clearance letter for a medical device called "Locking Plates and Screws Systems". It determines that the device is substantially equivalent to legally marketed predicate devices. The document details the device's indications for use, technological characteristics, and results of non-clinical testing to support its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table labeled "acceptance criteria" against "reported device performance" in a quantitative manner as one might expect for a digital diagnostic device. However, it implicitly uses the Safety and Performance Based Pathway (SPBP) criteria and comparison to predicate devices as its acceptance framework, with compliance to recognized standards as the performance measure.
Here's a reconstructed table based on the provided text, focusing on the mechanical performance aspects:
| Acceptance Criteria (from SPBP or Predicate) | Reported Device Performance (Subject Device) | SE Discussion (Performance Met) |
|---|---|---|
| Mechanical Performance: | ||
| Static Four-Point Bending (ASTM F382) | Test conducted according to FDA-recognized ASTM F382 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Driving Torque (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Torsional Strength (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Axial Pullout Testing (ASTM F543) | Test conducted according to FDA-recognized ASTM F543 | Test results meet SPBP path requirements or are similar to predicate device results (Note No.6) |
| Material: | ||
| Plates: Within SPBP path list material (e.g., ASTM F67, F136, F1472, F1295, F138, F139, F1537) | TA3G conforms to ASTM F67; TC4 conforms to ASTM F136 | Materials used are within the SPBP path list (Note No.2) |
| Screws: Within SPBP path enumerated material range | TC4 conforms to ASTM F136 | Materials used for bone screws are within the SPBP path enumerated material range (Note No.5) |
| Sterilization: | ||
| Sterilization parameters within SPBP path listing criteria (e.g., ISO 17665-1, ISO 11135-1, ISO 11137-1) | Sterilization Validation testing conducted according to ISO 17665-1 | Source criteria for recommended sterilization parameters are within SPBP path listing criteria (Note No.7) |
| Biocompatibility: | ||
| Biocompatibility endpoints according to ISO 10993-1 | Cytotoxicity test conducted according to ISO 10993-1 | Same (Biocompatibility Evaluation) |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the non-clinical mechanical performance tests (e.g., number of plates or screws tested). It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical, in-vitro tests on the device itself, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation is based on non-clinical, in-vitro mechanical and material testing, not on clinical data requiring expert human assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable for the same reason mentioned in point 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:
This is not applicable. The device (Locking Plates and Screws Systems) is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" for the non-clinical testing is based on:
- Engineering standards and specifications: Mechanical properties are evaluated against established ASTM standards (F382, F543) and parameters defined by the Safety and Performance Based Pathway.
- Material specifications: Material composition is verified against ASTM standards (F67, F136).
- Sterilization standards: Sterilization efficacy is assessed against ISO 17665-1.
- Biocompatibility standards: Biocompatibility is evaluated against ISO 10993.
These standards serve as the objective "ground truth" to determine if the device performs as expected and is safe.
8. The sample size for the training set:
This is not applicable as the device is a physical medical implant and does not involve machine learning models that require training data.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of device.
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