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It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

1. The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
   a. Patients having fractures of the thoracic and lumbar spine.
   b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
2. The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).
3. In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
   a. Patients receiving only autogenous bone graft.
   b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
   a. Patients having fractures of thoracic and lumbar spine.
   b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.

The provided text is a 510(k) summary for a medical device (spinal system) and letters from the FDA. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/software performance or diagnostic accuracy.

The "Performance Data" section ([1] on page 2) explicitly states: "Mechanical and dynamic testing of the Alpha Mirage® Top Tightening Spinal System constructs was performed as described in 510(k) applications K951846 and K930515. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device."

This indicates that the "performance data" refers to mechanical and biocompatibility testing for a physical spinal implant system, not a software device or AI algorithm with performance metrics like sensitivity, specificity, or AUC. The FDA letter ([2] on page 2) also classifies the device under regulations for physical spinal fixation devices, not software as a medical device.

Therefore, I cannot provide the requested information. The document does not describe:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy or software function.
2. Sample size used for a test set, data provenance, ground truth establishment, or expert involvement for AI/software evaluation.
3. Any information about MRMC comparative effectiveness studies or standalone algorithm performance.

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When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.

When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.

Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. The additional components presented in this submission are pedicle, laminar, thoracic and counter hooks. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.

The provided document is a 510(k) summary for the Aesculap Spine System® Evolution Additional Components, submitted in 1998. It primarily focuses on demonstrating substantial equivalence to pre-existing spinal fixation systems rather than proving device performance against specific acceptance criteria through a clinical study or even extensive standalone performance testing as would be expected for an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study proving performance are not applicable or not present in this type of regulatory submission for a medical device from that era.

Here's an attempt to answer based on the provided document, highlighting what is (and isn't) present:

Acceptance Criteria and Study to Prove Device Performance (Aesculap Spine System® Evolution Additional Components)

This submission demonstrates substantial equivalence of the Aesculap Spine System® Evolution Additional Components to previously marketed spinal implant systems. The "performance data" presented is primarily mechanical testing, typical for hardware medical devices, rather than a study proving performance against acceptance criteria as might be expected for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a traditional hardware device like this, "acceptance criteria" are often met by demonstrating adherence to recognized standards (like ISO for materials, or ASTM for mechanical testing) and by showing substantial equivalence to devices already legally on the market that have demonstrated safe and effective performance. Specific quantitative performance metrics for clinical outcomes against predefined thresholds are not typically part of a 510(k) summary for such devices.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device's test set. For mechanical testing, the "sample size" would refer to the number of components or constructs tested in a lab setting. This information (specific number of samples tested for ASTM F 1717-96) is not provided in the summary.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device. The "performance data" refers to in vitro mechanical testing.

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

Not applicable. This device is a physical spinal implant system, not a diagnostic AI/ML device requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication process is described for this type of mechanical device.

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

No. An MRMC study is relevant for AI/ML diagnostic tools that impact human reader performance. This is a spinal implant, so such a study was not performed or described.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical implant, not an algorithm. The "standalone performance" is related to its mechanical integrity, which was assessed via in vitro ASTM F 1717-96 testing. The results of this testing are not detailed in the summary, simply that it was performed.

7. Type of Ground Truth Used

Not applicable in the context of typical AI/ML ground truth.
For this device, "ground truth" would be established by:

• Adherence to material standards (ISO 5832/III).
• Results of mechanical testing (ASTM F 1717-96) demonstrating structural integrity and fatigue life, often compared against specified limits or predicate device performance.
• The established safety and effectiveness track record of the predicate devices to which it claims substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. As above, no training set for an AI/ML algorithm.

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