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The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.

This document describes the SAHARA Stabilization System, an intervertebral body fusion device. The acceptance criteria and supporting study are related to the mechanical performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that "mechanical tests were performed" and that the system "has demonstrated substantial equivalence to the identified predicate devices" based on material, design, and mechanical performance. It does not provide specific numerical values for the acceptance criteria or the reported performance for each test. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device's performance must be at least as safe and effective as the legally marketed predicate devices.

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

This information is not provided in the document. The study described is a series of mechanical tests, not a clinical study involving human data.

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

This information is not applicable as the described study involves mechanical testing, not a clinical study requiring expert assessment of ground truth.

4. Adjudication method for the test set

This information is not applicable as the described study involves 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a series of mechanical tests of an intervertebral body fusion device, not an AI-assisted diagnostic or imaging system.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through industry standards and mechanical testing protocols (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these criteria and the performance of predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical implant and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable.

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The SAHARA Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Lumbar implants are 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 or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (at angles > 15°) must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

The subject of this 510(k) submission is the Sahara Stabilization System. The implants function as an expandable intervertebral body fusion devices to provide support and stabilization to the lumbar segments of the spine. The implants are manufactured from Titanium (ASTM F1472, F67) and Cobalt Chrome (ASTM F1537).

This is a 510(k) premarket notification for a medical device called the SAHARA Stabilization System. It primarily outlines the device's substantial equivalence to previously cleared predicate devices. The information provided is typical for regulatory submissions and does not detail a clinical study of the type that would typically generate acceptance criteria and performance data for an AI/ML powered device.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) nor does it report such performance data. It focuses on mechanical testing.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set for performance evaluation is described.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is not an AI/ML powered diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an implanted medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

What can be extracted/inferred from the document:

• Device Name: SAHARA Stabilization System
• Device Type: Intervertebral body fusion device
• Regulatory Class: Class II
• Predicate Devices: K2M Chesapeake (K092211, K120031, 142487), K2M Santorini (K111294), Globus Rise (K113447), Wenzel Spine Vari-Lift-L (K100820). The primary predicate is K2M Chesapeake (K092211).
• Non-clinical Performance Evaluation: Mechanical testing (static compression, static torsion, static compression shear, dynamic compression, expulsion, and subsidence) and a cadaver implantation study were performed. The conclusion was that the proposed implants were substantially equivalent to predicate devices in design, function, intended use, materials, and size based on these tests. These tests would have acceptance criteria related to biomechanical properties, but they are not detailed in this summary.
• Ground Truth for Mechanical Testing: The "ground truth" for mechanical testing would be the engineering specifications and performance expectations established for spinal implants, often based on industry standards (e.g., ASTM standards for titanium and cobalt chrome) and comparisons to the predicate devices.
• Training Set for Mechanical Testing: Not explicitly stated as a "training set," but the design and materials used would be based on established engineering principles and data from previous successful spinal implants (including the predicate devices).

In summary, this document is for a traditional medical device (spinal implant) and does not contain the type of AI/ML-specific performance evaluation and acceptance criteria requested in the prompt.

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