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The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The TranS1 Interbody Fusion System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autograft and/or allograft comprised of cancellous and/or coricocancellous bone graft, and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

The TranS1 Interbody Fusion System is used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. The devices are designed to be used in conjunction with supplemental spinal fixation instrumentation. The subject devices are multiple component systems comprised of single-use implants designed to treat the lumbar spine.

The TranS1 Interbody Fusion System lumbar implants are fabricated from PEEK (ASTM F2026) with Tantalum (ASTM F560) x-ray markers. The TranS1 Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

I am sorry, but the provided text only discusses the FDA's 510(k) clearance for the TranS1 Interbody Fusion System, which is a medical device used for spinal fusion procedures. It specifies the intended use, material composition, and references performance testing conducted according to ASTM standards for static and dynamic mechanical properties, as well as subsidence and expulsion.

However, the text does not contain any information about an AI/ML powered device, acceptance criteria related to AI/ML performance metrics (e.g., accuracy, sensitivity, specificity), or any study details proving an AI/ML device meets such criteria.

Therefore, I cannot fulfill your request for information about:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes and data provenance for a test set for an AI/ML device.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC study for an AI/ML device.
6. Standalone performance for an AI/ML algorithm.
7. Type of ground truth used for an AI/ML device.
8. Sample size for the training set for an AI/ML device.
9. How ground truth was established for the training set for an AI/ML device.

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The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.

The provided document describes the 510(k) Pre-market Notification for the TranS1® Interbody Fusion System. This submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve a study related to AI or a software device, and therefore many of the requested criteria are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical interbody fusion implant, not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" are related to mechanical performance for safety and effectiveness as defined by ASTM standards.

Note: The document states "All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards." This indicates that the device's performance satisfied the established benchmarks for mechanical integrity.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set: The "test set" in this context refers to the samples of the TranS1® Interbody Fusion System that underwent mechanical testing. The document does not specify the exact number of units tested for each mechanical test.
• Data Provenance: The mechanical testing was "performed per ASTM standards," implying controlled laboratory conditions. There is no information regarding country of origin for "data" in the sense of patient data, as this was not a clinical study. It was a pre-market submission based on engineering and materials testing. The study was not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable (N/A): For mechanical testing of an implant, the "ground truth" is defined by the objective physical properties and performance against established ASTM standards. There are no human experts involved in establishing a "ground truth" for interpretive data in this type of submission. The standards themselves, and the engineers verifying compliance, serve this role.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical readings or image analysis. This is not relevant for mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• Not Applicable (N/A): An MRMC study is a clinical study format involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a physical medical implant and does not involve AI or diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable (N/A): This question pertains to AI algorithm performance. The TranS1® Interbody Fusion System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Standards and Performance Metrics: The "ground truth" for the device's performance is adherence to the validated mechanical test standards (ASTM F2077-11, ASTM F2267-04, etc.) and meeting the predefined requirements within those standards. This is an objective and quantitative ground truth established by engineering principles.

8. The Sample Size for the Training Set

• Not Applicable (N/A): There is no "training set" in the context of mechanical testing for a medical implant like this. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable (N/A): As there is no training set, this question is not applicable.

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