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The MOBIS®II ST Spinal Implant is indicated for intervertebral body 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 at the involved level(s). MOBIS®II ST Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The MOBIS®II ST Spinal Implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The MOBIS®II ST Spinal implants have a hollow, slightly curved frame with areas of an open-pore titanium grid structure. Restoration of the intervertebral space can be achieved by the large selection of implants that, at the same time, offers a high degree of intraoperative flexibility. In addition to straight implants, the MOBIS®II ST cage is also available with a 5° lordotic angle. Due to its design, the implant can be aligned with the anterior curvature of the intervertebral body and so is suited for unilateral, dorsal access (TLIF) in the L2 to S1 region of the spine.

This document is a 510(k) summary for the MOBIS®II ST Spinal Implant. It does not describe a study involving an AI/ML powered device, but rather a medical device (spinal implant). As such, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable in the terms of typical AI system performance metrics (e.g., sensitivity, specificity, AUC). For this medical device, acceptance criteria are based on mechanical safety and performance, demonstrating equivalency to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable as this is a mechanical engineering study, not a study involving a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of devices tested, which is not specified but would typically follow ASTM standards for such tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to the physical properties and performance measured by standardized tests, not expert interpretation of data.

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

Not applicable. Mechanical tests have objective outputs based on engineering principles and standards, not adjudication among human observers.

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

Not applicable. This is not an AI-powered device, and no human reader study was conducted.

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

Not applicable. This is a physical spinal implant, not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing is established by the specified ASTM (American Society for Testing and Materials) standards and the physical measurements obtained during the tests.

8. The sample size for the training set

Not applicable. There is no training set for a physical medical device.

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

Not applicable. There is no training set.

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When used as an intervertebral fusion device, the MOBIS® II devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the MOBIS® II devices is a hollow structural frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on what's available and noting what's not explicitly stated:

Based on the provided 510(k) summary for the MOBIS® II intervertebral fusion device, the acceptance criteria and study details are primarily focused on mechanical performance testing to demonstrate substantial equivalence to predicate devices, rather than clinical efficacy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for MOBIS® II (Implicit from substantial equivalence claim):
The device's mechanical performance, specifically for static and dynamic compression and subsidence properties, must be equivalent to or better than previously cleared predicate devices (MOBIS®, PEEK TETRIS™, and Python) when tested according to relevant ASTM standards.

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

• Sample Size: Not explicitly stated for each mechanical test. The text mentions "worst case MOBIS® II" was tested, implying a representative sample but not a specific number of units tested.
• Data Provenance: The study was conducted by the device manufacturer, SIGNUS Medizintechnik GmbH, based in Alzenau, Germany. The testing was likely performed in a lab setting, not using patient data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable: This device is an intervertebral fusion device, not an AI or diagnostic imaging device. The "ground truth" for its performance is established through objective mechanical testing against engineering standards. Experts were not involved in establishing a "ground truth" in the way they would be for evaluating diagnostic accuracy or clinical outcomes.

4. Adjudication Method

• Not Applicable: As this is a mechanical performance study, there's no "adjudication method" in the context of human expert review of cases. The results are quantitative measurements against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is not an MRMC study. MRMC studies are typically performed for diagnostic imaging devices to assess how AI assistance impacts human reader performance.

6. Standalone (Algorithm Only) Performance Study

• No: This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The performance study focused on the mechanical integrity of the implant itself.

7. Type of Ground Truth Used

• Mechanical Engineering Standards: The "ground truth" for the device's performance is objective mechanical measurements validated against established ASTM standards (ASTM F2077 for static and dynamic compression; ASTM F2267 for subsidence properties). The performance is then compared to accepted limits or to the performance of predicate devices that have already met regulatory requirements.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.

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

• Not Applicable: (See point 8).

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