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The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

As an intervertebral body fusion device, the Biomet Lateral Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.

The purpose of this submission is the introduction of a new device for intervertebral body fusion and vertebral body replacement. The Biomet Lateral Spacer System is constructed of medical grade Polyetheretherketone (PEEK-Optima LT1 per ASTM F-2026) and tantalum (per ASTM F-560) radiographic markers, and is available in multiple lengths/widths/heights and lordotic angles to meet varying patient anatomies.

The provided text is a 510(k) Summary for the Biomet Lateral Spacer System, a medical device. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence based on technological characteristics and mechanical performance.

However, the 510(k) Summary does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/ML device evaluations. This document details mechanical testing of the device's structural integrity, not a clinical study or evaluation of a diagnostic or predictive AI algorithm's performance against specific clinical or analytical acceptance criteria.

The questions asked (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, ground truth for training set) are highly relevant to the evaluation of AI/ML-driven medical devices, especially those performing diagnostic or assistive functions. These types of details are absent from the provided text.

The Biomet Lateral Spacer System is a physical implant (intervertebral body fusion device), and its "performance data" refers to its mechanical strength and durability as assessed by engineering standards, not its diagnostic accuracy or the effectiveness of an AI component.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text, as the document describes a mechanical device assessment, not an AI/ML device study.

Here's the closest I can get to addressing your request, based on the document's content, while acknowledging the mismatch:

1. Table of "Acceptance Criteria" and Reported Device Performance (as per the document's context):

Explanation of the Mismatch:

• Acceptance Criteria: For a physical implant, "acceptance criteria" generally refer to meeting specified engineering standards (e.g., load-bearing capacity, fatigue life) under various conditions. The document states that "Mechanical testing shows that the mechanical strength of the subject device is sufficient for the intended use," implying these acceptance criteria were met, but it doesn't quantify them (e.g., "must withstand X Newtons of force"). It only lists the types of tests conducted (Static Axial Compression, Dynamic Axial Compression, etc.) according to specific ASTM standards (F-2077, F-2267, F-560, F-2026, and an ASTM Draft).
• Reported Device Performance: Instead of numerical performance metrics, the document provides a qualitative statement that the device's mechanical strength is "sufficient."

Regarding the other specific questions (2-9):

These questions are designed for AI/ML device studies and are not applicable to the type of device and evaluation described in the provided 510(k) summary.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical device testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically determined by engineering measurements and adherence to standards, not expert clinical consensus.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study evaluates human reader performance, usually with medical images, often with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm described.
7. The type of ground truth used: For mechanical testing, the "ground truth" is compliance with engineering specifications and stress tests, not clinical outcomes, pathology, or expert consensus in the diagnostic sense.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text describes the mechanical performance testing of a physical medical implant (Biomet Lateral Spacer System) to demonstrate its safety and effectiveness through substantial equivalence to predicate devices, based on established ASTM engineering standards. It does not contain information relevant to the assessment of an AI/ML medical device, which is what your questions seem to pertain to.

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