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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:

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.

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The restor3d Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

The proposed ADI Cervical Interbody Fusion Device is a sterile, single use implant grade titanium alloy (Ti-6Al-4V) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant is intended to be used with cleared fixation devices such as an anterior cervical plate system. The ADI 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, a circular window for the packing of graft material, a threaded hole for insertion, teeth on the surfaces of the perimeters to aid expulsion resistance, and side windows on the walls of the implant.

The provided text describes a 510(k) premarket notification for a medical device, the ADI Cervical Interbody Fusion Device. However, it does not contain information about an AI/ML-based device or any study that proves an AI/ML device meets acceptance criteria.

The document focuses on the substantial equivalence of a physical medical implant (a cervical interbody fusion device) to a predicate device. The performance testing mentioned (ASTM F2077-18, ASTM F2267-04) relates to the mechanical properties of the implant, such as static and dynamic compressive strength, torsional strength, wear analysis, expulsion resistance, and subsidence testing.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document does not discuss:

• Acceptance criteria for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Sample sizes for test or training sets related to AI/ML data.
• Data provenance for AI/ML training/testing (e.g., country of origin, retrospective/prospective).
• Number of experts or their qualifications for establishing ground truth for AI/ML.
• Adjudication methods for AI/ML ground truth.
• MRMC studies or effect sizes for human readers with/without AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
• How ground truth for training sets was established for an AI/ML model.

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