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The Leva® Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva® Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva® Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva® Inserter Instrument. Both the fixed and expandable implants are provided in different heights and shapes (convex or lordotic) to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

This document describes a 510(k) premarket notification for the Leva® Spacer System, specifically a line addition including new 10° lordotic implant sizes. It is a medical device, not an AI/ML product, and therefore the standard AI/ML acceptance criteria and study aspects you've asked for (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set sample size) are not applicable or described in this document.

The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, which is the relevant "performance data" for this type of medical device.

Here's an attempt to answer your questions based on the provided text, primarily focusing on what is present. Much of your requested information is for AI/ML devices and is not found in this document for a physical medical implant.

1. Table of acceptance criteria and the reported device performance

Since this is not an AI/ML device, the "acceptance criteria" discussed are primarily about mechanical performance and substantial equivalence to legally marketed predicate devices, rather than statistical performance metrics like sensitivity, specificity, or AUC.

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: This information is not provided in the document. The testing involved mechanical measurements on the device itself, not clinical data or data from a "test set" in the AI/ML sense.
• Data Provenance: Not applicable. The "data" refers to mechanical test results from the fabricated implants, not patient data.

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)

Not applicable. "Ground truth" in the context of this device refers to established mechanical engineering standards and the performance of predicate devices, not expert human assessment of images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no "adjudication" in the AI/ML sense for mechanical testing.

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

No. This is a physical medical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating the safety and effectiveness of this device (a physical implant) is based on established mechanical engineering standards (ASTM F2077, ASTM F2267) and comparison to the performance of legally marketed predicate devices. These standards dictate acceptable performance parameters for intervertebral body fusion devices.

8. The sample size for the training set

Not applicable. There is no "training set" for physical implant device testing in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned or implied in the context of this device's evaluation.

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The Leva™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Leva™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

The Leva™ Spacer System is a lumbar intervertebral body fusion device fabricated from unalloyed commercially pure (Class II) titanium per ASTM F67. The device is available in both expandable and fixed configurations. The expandable device is provided in a collapsed form and is expanded to a predefined height in-situ using the Leva™ Inserter Instrument. Both the fixed and expandable implants are provided in different heights to accommodate the anatomical needs for a range of patients. The implants are designed to accommodate autogenous bone graft material. The implants have curved endplates to conform to the bony endplates of the patient and ridges on the endplates to resist expulsion.

This document is a 510(k) summary for the Leva™ Spacer System, an intervertebral body fusion device. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study to prove the device meets acceptance criteria related to a diagnostic or AI algorithm.

Therefore, many of the requested criteria for AI or diagnostic devices (such as reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) are not applicable to this submission content.

However, I can extract information relevant to the device's performance data based on the provided text, which serves as the "study that proves the device meets acceptance criteria" in the context of a 510(k) for a physical medical implant.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The tests refer to "constructs previously tested" and "mechanical testing," which implies physical samples were used, but the number of samples is not provided.
• Data Provenance: Not specified, but generally, such biomechanical testing is conducted in a laboratory setting, not with human patient data or specific country of origin. It would be prospective testing of device prototypes.

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

• Not applicable. This relates to diagnostic/AI performance, not the biomechanical testing of an implant. The "ground truth" here is the physical performance under specified load conditions, as defined by ASTM standards.

4. Adjudication Method for the Test Set

• Not applicable. This relates to diagnostic/AI performance. The "adjudication" for mechanical testing would be the compliance of test results with the specified ASTM standards and internal acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical intervertebral body fusion device, not a diagnostic or AI system.

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

• Not applicable. This is a physical intervertebral body fusion device.

7. The Type of Ground Truth Used

• For the biomechanical tests, the "ground truth" is the established performance metrics and acceptance limits defined by the referenced ASTM international standards (ASTM F2077, ASTM F2267) for intervertebral body fusion devices. These standards specify how to conduct the tests and what constitutes acceptable performance for such devices.

8. The Sample Size for the Training Set

• Not applicable. This typically refers to machine learning models. For a physical device, "training set" doesn't directly apply in the same way. The design iterations and preliminary testing during development could be considered analogous, but no specific "training set size" is provided.

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

• Not applicable. As above, for a physical device, there isn't a "training set" in the context of ground truth establishment similar to AI/diagnostic devices. The design process and adherence to engineering principles and regulatory standards guide the development and testing.

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