(359 days)
The OSSIOfiber™ Hammertoe Fixation System/ OSSIOfiber™ Hammertoe Fixation Implant is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The OSSIOfiber™ Hammertoe Fixation Systems\OSSIOfiber™ Hammertoe Fixation Implants include implants that have a ribbed design that is inserted between the proximal and middle phalanges, so the ribs fixate on the phalangeal canal of the toe. The OSSIOfiber™ Hammertoe fixation implants are made of OSSIOfiber " material which is 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 minerals 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™ Hammertoe Fixation Implants are supplied sterile, pre-mounted on an implant inserter, offered in straight and 10-degree variations, and are available in several sizes: 16-21 mm long and 2.5-3.2 mm nominal diameter.
The OSSIOfiber™ Hammertoe Fixation System is a sterile kit which includes in addition to the implant pre-mounted on an inserter, a drill bit and a k-wire which are the instrumentations required for the procedure.
The provided document is a 510(k) summary for the OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant. This document describes the device, its intended use, and the performance data used to demonstrate substantial equivalence to a predicate device.
Crucially, this document is NOT about an AI/ML-driven medical device. It's about a physical implant used for bone fixation. Therefore, most of the specific questions asked in the prompt, which are tailored for AI/ML device studies (e.g., sample size for training/test sets, expert adjudication, MRMC studies, ground truth establishment, etc.), are not applicable to the content of this document.
However, I can extract the relevant information regarding acceptance criteria and performance as presented in this document for a physical medical device.
Acceptance Criteria and Device Performance (for a physical medical device)
The acceptance criteria for this non-AI/ML device are primarily demonstrated through mechanical testing and biocompatibility. The study's goal was to show substantial equivalence to a predicate device, meaning its performance metrics should be comparable or superior to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter/Test | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Strength | Equivalent to or better than the predicate device (OSSIO™ Pin Product Family, K181180) | "Mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation." |
| Biocompatibility | Material must be well-established or identical to predicate; additional testing (cytotoxicity, pyrogenicity) performed | "Material biocompatibility for the implants and instruments was primarily established by use of material identical to the predicate or use of well-established material. Additional testing of cytotoxicity and pyrogenicity (LAL) testing was performed on final, finished products." |
| Degradation Profile | Sufficient mechanical stability over 12-week healing period; substantial degradation within ~18 months | In vitro degradation testing: Weight loss, decrease in molecular weight, flexural strength, shear strength, and pullout testing performed over 12 weeks. "Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies." |
| Corrosion Resistance | Stainless steel instruments must meet relevant acceptance criteria | "Stainless steel instruments were tested for resistance to corrosion and met the relevant acceptance criteria." |
| MR Safety | Device must be safely used in an MRI environment | "A rationale was provided to support the MR safe labeling of the device." |
| Sterilization | Device must be supplied sterile | Device and predicate are supplied sterile and sterilized by EtO. |
Since the prompt's specific questions are geared towards AI/ML device studies, and this document is for a physical implant, the following answers are either "Not Applicable" or infer what might be analogous in a non-AI context.
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 for Test Set: Not specified in terms of "samples" as it's a physical device being tested, not an algorithm. The testing involves flexural bending, shear, and pull-out tests on the implants. The number of samples for each mechanical test would typically be defined by engineering standards, but the exact count is not listed.
- Data Provenance: The preclinical studies were conducted by Ossio Ltd., an Israeli company. The document does not specify if the studies were retrospective or prospective, as these terms are less relevant for mechanical and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This is a physical device, so "ground truth" isn't established by human experts in the way it is for AI image interpretation. Ground truth for mechanical properties is established by physical measurement against engineering standards.
- The "experts" involved would be engineers and material scientists conducting the testing in a lab setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are relevant for human interpretation of data, particularly in AI studies where there might be disagreement on labels or classifications. For mechanical testing, no such adjudication is needed. Results are quantitative measurements.
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: MRMC studies are specific to AI-assisted human reader performance. This document concerns a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a physical implant; there is no algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Analogous Ground Truth: For this type of device, the "ground truth" for performance is based on established engineering standards and material science principles. For biocompatibility, it's based on ISO standards for biological evaluation of medical devices and comparison to well-characterized materials. For degradation, it's based on quantitative measurements of material properties over time in an in vitro environment. Comparison to the predicate device also acts as a benchmark.
8. The sample size for the training set
- Not Applicable: This is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set or AI model is involved.
§ 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.