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The Genesys Spine Apache® Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The Genesys Spine Apache Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine interbody fusion device, which may be implanted as a single device via:

• Bi-laterally via a posterior (PLIF) approach
• As a single device via a transforaminal (TLIF) approach or
• As a single device via an anterior/anterolateral (ALIF) approach or
• As a single device via a lateral (LLIF) approach.
  The Genesys Spine Apache Interbody Fusion System implants are manufactured from implantable, medical grade Ti-6Al-4V ELI titanium alloy per ASTM F136. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices.

The provided text is a 510(k) premarket notification for the "Genesys Spine Apache Interbody Fusion System," which is a traditional medical device (an intervertebral body fusion device), not an AI/ML software device.

Therefore, the following information is not present in the document:

1. Table of acceptance criteria and reported device performance: This would typically involve metrics like sensitivity, specificity, AUC, etc., which are not relevant to a physical spinal implant.
2. Sample size used for the test set and data provenance: No test set of clinical data for AI/ML performance is mentioned.
3. Number of experts used to establish ground truth and qualifications: Not applicable for a physical implant.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as this is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable. Device safety and efficacy for a physical implant are typically assessed through material properties, mechanical testing, and clinical outcomes.
8. Sample size for the training set: Not applicable as there is no AI/ML model to train.
9. How ground truth for the training set was established: Not applicable.

Instead, the document primarily focuses on regulatory approval based on substantial equivalence to previously cleared predicate devices. It mentions:

• Mechanical performance data: Stating "Not Required" as cross-sectional area calculations, FEA analysis, and projected area calculations showed that a new "worst-case device" was not created. The Finite Element analysis tool used was validated by the predicate system's mechanical test data. This indicates that the performance assessment relied on engineering analysis and comparison to established mechanical properties of similar devices, rather than clinical study of AI/ML diagnostic accuracy.

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