(200 days)
The TiDAL Osteotomy Wedges are intended to be used for internal bone fractures or osteotomies in the ankle and foot, such as:
- Cotton (opening wedge) osteotomies of the medial cuneiform
- Evans lengthening osteotomies.
The TiDAL Osteotomy Wedges are intended for use with ancillary plating fixation.
The TiDAL Osteotomy Wedges are not intended for use in the spine.
The proposed ADI TiDAL Osteotomy Wedge is a sterile, single use medical grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights. The ADI TiDAL Osteotomy Wedge is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as Cotton (opening) osteotomies of the medical cuneiform and Evans (lengthening) osteotomies. The TiDAL Wedge device is comprised of a single, continuous piece of titanium alloy fabricated via additive manufacturing. The ADI device has a porous structure throughout the body of the implant and a circular window for the packing of graft material, a threaded hole for insertion (Evans implant only), and a strike plate for implant positioning.
This document is a 510(k) Summary for a medical device called the "ADI TiDAL Osteotomy Wedge." It describes the device's characteristics, intended use, and the performance testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided text to answer your questions regarding acceptance criteria and the study that proves the device meets them:
Important Note: This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, not necessarily on proving direct clinical efficacy or performance against specific, pre-defined clinical acceptance criteria in the manner one might see for a novel AI/software device. The performance tests described here are primarily benchtop engineering tests to show the device's mechanical properties are comparable to the predicate, rather than human-centric clinical studies.
Based on the provided information, the acceptance criteria and study details are primarily related to the mechanical performance of the physical osteotomy wedge, not an AI or software device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical thresholds for success, nor does it report the exact measured device performance values for each test. Instead, it states that "Comparative functional performance testing" was conducted and concludes that the device is "substantially equivalent" to the predicate based on these tests.
The types of performance tests conducted are:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Strength: | Comparative to Predicate: |
| Static compressive strength (per ASTM F2077-18) | Device was tested, and results supported substantial equivalence. |
| Dynamic compressive strength (per ASTM F2077-18) | Device was tested, and results supported substantial equivalence. |
| Static compression shear strength (per ASTM F2077-18) | Device was tested, and results supported substantial equivalence. |
| Wear Analysis: | Comparative to Predicate: |
| Comparative wear analysis following dynamic compression | Device was tested, and results supported substantial equivalence. |
| Expulsion: | Successful/Comparable: |
| Expulsion testing | Device was tested, and results supported substantial equivalence. |
| Biocompatibility: | Acceptable: |
| Device material (Ti-6Al-4V) is medical grade. | Material is a commonly accepted medical grade titanium alloy. |
The "reported device performance" is implicitly that the device performed comparably or acceptably in these tests, allowing the FDA to determine substantial equivalence. Specific numerical results are not included in this summary.
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: The document does not specify exact sample sizes (e.g., number of wedges) for each of the performance tests. This information is typically detailed in the full 510(k) submission, not the summary.
- Data Provenance: The tests are benchtop mechanical tests, not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" do not apply in the typical sense. These tests would have been performed in a laboratory setting, likely in the US (given the company's US address).
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)
This section is not applicable as the "test set" refers to physical device testing (mechanical properties), not diagnostic imaging or clinical data requiring expert human interpretation or "ground truth" establishment in a medical context. The "experts" involved would be engineers or technicians performing and evaluating the physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple human experts independently evaluate cases and resolve discrepancies. The tests described are objective, physical 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
This is not applicable. The device is a physical osteotomy wedge, not an AI or software product for diagnostic assistance. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these performance tests is established by engineering standards and specifications (e.g., ASTM F2077-18). The "truth" is whether the device's mechanical properties (strength, wear, expulsion resistance) meet or are comparable to those of the predicate device, as measured by standard laboratory equipment and protocols.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.