(86 days)
The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures, joint fusions, and reconstruction of the bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.
The Life Spine Foot and Ankle Plating System is system of plates and screws for fixation and reconstruction of the foot and ankle. The implant is fabricated and manufactured from the following:
- Titanium (Ti 6A1-4V ELI)
- Stainless Steel (316L)
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Foot and Ankle Plating System components with components from any other system or manufacturer. The Foot and Ankle Plating System components should never be reused under any circumstances.
The provided document is a 510(k) premarket notification for the Life Spine Foot and Ankle Plating System. This type of FDA submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria for device performance. Therefore, many of the requested data points related to clinical study design, AI performance, and ground truth establishment are not applicable to this document.
However, I can extract information related to the engineering and bench testing performed to support substantial equivalence.
Here is the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Analysis performed | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Torsional strength (Bench Top Validations) | Demonstrated substantial equivalency to predicate devices. |
| Mechanical Strength | Bending strength (Bench Top Validations) | Demonstrated substantial equivalency to predicate devices. |
| Mechanical Strength | Axial pullout (Bench Top Validations) | Demonstrated substantial equivalency to predicate devices. |
| Structural Integrity | Finite Element Analysis (FEA) | Included to demonstrate substantial equivalency to predicate devices. |
| Design Equivalence | Engineering Rationale | Included to demonstrate substantial equivalency to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for individual bench tests (e.g., number of plates tested for torsional strength). The document generally refers to "Bench Top Validations" without providing specific numbers of samples.
- Data Provenance: The tests are "Bench Top Validations," meaning they were conducted in a laboratory setting. There is no information regarding country of origin or whether the tests were retrospective or prospective, as these terms are not applicable to 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 device is hardware and does not involve AI or a diagnostic interpretation that would require human expert ground truth. The "ground truth" for the performance data is the physical measurement of mechanical properties compared against established engineering standards or predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See 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
- Not Applicable. This is a hardware device (bone plating system) and does not involve AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (bone plating system) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance data (e.g., torsional strength, bending strength, axial pullout), the "ground truth" is established by standard engineering testing methodologies and comparison to similar predicate devices, and likely against internal specifications derived from mechanical requirements for bone fixation. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not Applicable. This is a hardware device and does not involve an AI system requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.