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The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 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 with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and autogenous bone graft size. All components are manufactured from medical grade polyetheretherketone (PEEK LT1).

The request asks for acceptance criteria and study details for the provided text, however, the text describes a medical device (Vault ALIF System) and its 510(k) summary, not a study evaluating an AI/ML device against acceptance criteria. Therefore, most of the requested information is not applicable.

Here's an analysis of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated as specific performance metrics and thresholds in the context of an AI/ML device. For this physical medical device, the acceptance criteria are inherent in demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical mechanical testing.
• Reported Device Performance: The document states that the "results of this testing indicate that the Redesigned Vault ALIF System is equivalent to predicate device." Specific numerical performance metrics (e.g., stiffness values, fatigue cycles) are not provided in this summary.

• Dynamic axial compression per ASTM F2077
• Dynamic shear compression per ASTM F2077 | The Redesigned Vault ALIF System is equivalent to the predicate device in terms of dynamic axial compression and dynamic shear compression. Specific numerical results are not provided in this summary. |

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

• Not Applicable. This document describes a physical medical device (intervertebral body fusion device), not an algorithm or AI/ML device that would use a "test set" of data. The "testing" referred to is mechanical testing of the physical implant.

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

• Not Applicable. This pertains to an AI/ML medical device and ground truth establishment, which is not described in this document.

4. Adjudication method for the test set:

• Not Applicable. Pertains to an AI/ML medical device, not a physical implant.

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 relevant for AI/ML diagnostic or assistive devices, not for a physical surgical implant. The document explicitly states: "No clinical studies were performed."

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

• Not Applicable. This refers to AI/ML algorithm performance, which is not the subject of this 510(k) summary.

7. The type of ground truth used:

• Not Applicable. Pertains to an AI/ML medical device. For this physical device, the "ground truth" related to its performance is established through standardized mechanical testing (ASTM F2077) and comparison to a legally marketed predicate device.

8. The sample size for the training set:

• Not Applicable. This applies to AI/ML algorithms, not a physical medical device.

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

• Not Applicable. This applies to AI/ML algorithms, not a physical medical device.

Summary of Device and Study Information from the Text:

• Device Name: Vault ALIF System (Redesigned)
• Device Type: Intervertebral Body Fusion Device with Integrated Fixation, Lumbar (Physical implant)
• Purpose of Submission: Special 510(k) for a redesigned system.
• Substantial Equivalence to Predicate: Spinal USA Vault ALIF System - K103369
• Basis for Equivalence: Intended use, design, mechanical safety and performances, materials, packaging, and sterilization methods.
• Non-Clinical Tests Performed:
  • Dynamic axial compression per ASTM F2077
  • Dynamic shear compression per ASTM F2077
• Test Results: Indicate the Redesigned Vault ALIF System is equivalent to the predicate device.
• Clinical Tests: None performed.
• Ground Truth (for substantial equivalence): Established through non-clinical mechanical testing and comparison of results to a legally marketed predicate device, demonstrating mechanical equivalency as per FDA guidelines for intervertebral body fusion devices.

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The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.

The Vault ALIF System is intended for use at either one level 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 with autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.

The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from medical grade polyetheretherketone (Peek LTI). The products are supplied clean and "NON-STERILE".

The provided document describes the mechanical testing and substantial equivalence determination for the Vault ALIF System, an intervertebral body fusion device. It does not contain information about an AI device or a study involving human readers or ground truth for AI. Therefore, I will respond to the prompt by extracting the available information related to the device's acceptance criteria and the study (mechanical testing) demonstrating it meets these criteria, while noting the absence of AI-specific details.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Vault ALIF System, an intervertebral body fusion device, underwent mechanical testing to demonstrate its safety and effectiveness. The acceptance criteria were primarily based on showing substantial equivalence to existing predicate devices in terms of mechanical strength and functional characteristics.

1. Table of Acceptance Criteria and the Reported Device Performance:

Mechanical Test Conclusion:

The mechanical test results concluded that the Vault system is as safe as the predicates based on its similar design, identical materials, and superior mechanical strength. It is as effective as the predicate due to the same intended use, indications for use, and equivalent bone port opening.

The following information regarding AI device testing is not applicable to the provided document, as it describes a non-AI medical device and its mechanical testing for regulatory clearance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable to this document, as it describes mechanical testing of a physical device, not an AI algorithm evaluated with a dataset.

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 to this document. Ground truth for mechanical testing is based on engineering standards and measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable to this document. Adjudication methods are relevant for human interpretation of data, not mechanical properties of a device.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as this document pertains to a physical medical device and not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable to this document. This refers to AI algorithm performance, which is not described here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established by the precise measurements and calculations derived from standardized test methods (e.g., ASTM F2077, F2267) and engineering principles, which define what constitutes a "passing" or "equivalent" performance. This is not comparable to expert consensus or pathology data for AI systems.

8. The sample size for the training set
Not applicable to this document, as there is no AI algorithm training described.

9. How the ground truth for the training set was established
Not applicable to this document, as there is no AI algorithm training described.

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