(43 days)
OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization implants, cast, brace).
OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The OSSIOfiber® Cannulated Trimmable Fixation Nail is a fixation device made of degradable poly (L-lactide-co-D.L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 10-70 mm long, and 2.80-4.60 mm nominal diameter (core diameter of 2.4-4.00 mm).
The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.
This document describes a medical device clearance rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, or standalone performance results) is not applicable or present in this provided text.
Based on the provided text, the device in question is the OSSIOfiber® Cannulated Trimmable Fixation Nail. This device is a bone fixation fastener, not an AI/ML powered medical device. The document is a 510(k) summary, which outlines the substantial equivalence of this new device to legally marketed predicate devices.
Here's the relevant information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for a physical medical device and not an AI/ML software, "acceptance criteria" here refers to the performance of the device in mechanical testing compared to a predicate device, rather than diagnostic accuracy metrics typically seen with AI. Specific numeric acceptance criteria are not explicitly stated in the summary, but the general criterion is "at least equivalent performance" to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent or superior flexural bending strength compared to predicate. | Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180). |
| Mechanical Performance: Equivalent or superior pull-out strength compared to predicate. | Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180). |
| Mechanical Performance: Equivalent or superior shear strength compared to predicate. | Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation compared to the predicate device (OSSIO® Pin Product Family, K181180). |
| Biocompatibility: Meet ISO 10993 standards and be rationally justified. | Biocompatibility was established primarily based on referenced ISO 10993 data from previously cleared predicate and reference devices (K181180, K190652) and a rationale. |
| Degradation Profile: Characterized in-vitro degradation similar to what is expected for the material. | The in-vitro degradation profile (i.e., change in material properties) was characterized. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies. |
| Safety and Effectiveness: Demonstrate substantially equivalent safety and effectiveness to the predicate. | Non-clinical testing data demonstrate that the OSSIOfiber® Cannulated Trimmable Fixation Nail has a substantially equivalent safety and effectiveness profile as the predicate device. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for the mechanical testing mentioned. The data provenance is pre-clinical studies and bench testing. The country of origin for the studies is not specified in this document.
- Data Provenance: Pre-clinical studies and in-vitro mechanical testing.
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 as this is a physical device being evaluated through mechanical and pre-clinical testing, not an AI/ML diagnostic device requiring expert ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No, an MRMC study was not done as this is not an AI/ML diagnostic device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests, the "ground truth" would be the measured physical properties (e.g., strength, stiffness) as determined by standardized laboratory methods, compared against the properties of the predicate device.
- For biocompatibility, the ground truth is established through adherence to ISO 10993 standards and a rationale.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
In summary, the provided text details the FDA clearance of a physical medical device based on its substantial equivalence to an existing predicate device, primarily through mechanical and biocompatibility testing, rather than a study for an AI/ML product.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.