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The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. The System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ALTA Anterior Cervical Corpectomy Spacer is a vertebral body replacement system manufactured from PEEK-OPTIMA LT120HA (HA PEEK) or titanium alloy (Ti6Al4VELI). The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy and graft windows to help facilitate bony integration. The HA PEEK spacers have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion and X-ray markers in the form of tantalum pins. The titanium alloy spacers have roughened superior and inferior surfaces to prevent migration/expulsion.

The provided text describes a 510(k) premarket notification for a medical device, the ALTA Anterior Cervical Corpectomy System. It is a submission for substantial equivalence to legally marketed predicate devices, not for a new AI/ML-based diagnostic or assistive technology requiring extensive clinical performance studies with human readers.

Therefore, many of the requested details, such as "acceptance criteria for device performance" in the context of an AI study, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or training set details, are not applicable to this specific submission as it pertains to a physical orthopedic implant device.

The relevant information from the document pertains to the device's physical and mechanical performance, not its diagnostic or interpretative accuracy.

Here's a breakdown of the applicable information based on the provided document, addressing the relevant parts of your request and noting what is not applicable:

1. A table of acceptance criteria and the reported device performance

Since this is a physical implant, the "acceptance criteria" are related to mechanical and material properties, and the "reported device performance" refers to the results of non-clinical (bench) testing.

2. Sample sizes 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 is not applicable in the context of an AI/ML test set. For physical device testing, "samples" refer to the number of devices or test coupons subjected to mechanical testing. The document states "The following analyses were conducted," implying standard mechanical testing as per the ASTM standards. The exact number of test samples (e.g., number of implants tested per condition for compression, torsion, subsidence) is not explicitly provided in this summary but would be detailed in the full test reports referenced by the ASTM standards.
• Data Provenance: Not applicable in the context of clinical patient data as no clinical studies were performed. The "data" comes from bench testing of the physical devices.

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)

• This question is not applicable. The "ground truth" for a physical orthopedic implant is established by engineering specifications, material standards, and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). It does not involve human expert consensus on medical images or diagnoses.

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth by reconciling discrepancies among human readers/experts. For a physical device's mechanical testing, there is no such adjudication process.

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

• This question is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms that assist human interpretation. This submission is for a physical implant, not a diagnostic or AI-assisted system.

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

• This question is not applicable. This refers to the performance of an AI algorithm in isolation. The product is a physical implant.

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

• For the non-clinical testing of this physical device, the "ground truth" is defined by engineering specifications, material properties, and relevant ASTM (American Society for Testing and Materials) standards (e.g., ASTM F2077 for compression/torsion and ASTM F2267 for subsidence) which dictate acceptable performance characteristics for spinal implants.

8. The sample size for the training set

• This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This question is not applicable. There is no "training set."

Summary of Device Performance Study:

The study proving the device meets its acceptance criteria is a non-clinical bench testing program.

• Tests Conducted: Static and dynamic compression per ASTM F2077, Static and dynamic torsion per ASTM F2077, and Subsidence per ASTM F2267.
• Results: The results of these evaluations indicated that the ALTA Corpectomy implants are equivalent to predicate devices.
• Clinical Studies: No clinical studies were performed as substantial equivalence was demonstrated through non-clinical testing and comparison to legally marketed predicate devices.

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The Half Dome Posterior Lumbar Intervertebral body fusion body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Half Dome implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The Half Dome Posterior Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The Half Dome cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.

This document describes the Half Dome Posterior Lumbar Interbody System, a medical device, and does not provide information about an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (such as AI performance, training/test sets, ground truth establishment by experts, adjudication, or MRMC studies) are not applicable.

The acceptance criteria and study information provided pertain to the non-clinical testing performed to demonstrate substantial equivalence to predicate devices, as is typical for 510(k) submissions of this nature where clinical studies are not performed.

Here's the information based on the provided text, focusing on the device's substantial equivalence:

1. A table of acceptance criteria and the reported device performance:

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

• Test Set Sample Size: Not explicitly stated in terms of a "sample size" for a clinical or AI test set. Non-clinical testing typically involves a set number of physical samples for each test (e.g., several implants for compression testing). The document does not specify the number of implants tested for each mechanical test.
• Data Provenance: The data is derived from non-clinical bench testing (mechanical tests) performed by the manufacturer, Astura Medical. There is no information on country of origin for this testing, nor is it retrospective or prospective in the clinical sense.

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. The ground truth for this device's acceptance is established through compliance with established ASTM standards for mechanical testing and comparison to legally marketed predicate devices, not through expert consensus on interpretation of data like in an AI/ML context.

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

• Not Applicable. Adjudication methods are relevant for clinical studies or expert consensus, which were not performed for this 510(k) submission.

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 MRMC study was performed.

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

• Not Applicable. This is not an AI-powered device.

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

• For the non-clinical tests, the "ground truth" is defined by the performance requirements and methodologies outlined in the specified ASTM standards (e.g., ASTM F2077, ASTM F2267) and the performance characteristics of the identified predicate devices. The substantial equivalence argument posits that if the new device performs within acceptable limits established by these standards and similar to the predicate devices, it is safe and effective for its intended use.

8. The sample size for the training set:

• Not Applicable. This is not an AI-powered device.

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

• Not Applicable. This is not an AI-powered device.

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