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Blustone Synergy lumbar implants (Basalt, Magma, Obsidian):

The Blustone Synergy lumbar 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 I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Sysergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Blustone Synergy cervical implants (Slate):

The Blustone Synergy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

The Blustone Synergy Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• Blustone Synergy cervical interbody fusion device(s), which may be implanted as a single 1) device via an anterior approach.
• 2. Blustone Synegy lumbar interbody fusion device(s), which may be implanted
  • bi-laterally in pairs via a posterior (PLIF) approach;
  • as a single device via a transverse (T-PLIF) approach;
  • as a single device via a lateral (LLIF) approach;
  • as a single device via a transforaminal (TLIF) approach

The Blustone Synergy System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

This FDA 510(k) K171893 document describes the Blustone Synergy Interbody Fusion System, which includes both lumbar and cervical implants. However, it does not contain information about formal acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, etc.), or a study evaluating such performance for a device that fits the description of an AI/ML medical device.

The document is a premarket notification for an intervertebral body fusion device made of PEEK material, intended to be implanted surgically. The non-clinical testing mentioned focuses on mechanical performance of the physical implant itself (e.g., static and dynamic compression, torsion, subsidence, expulsion) to demonstrate structural integrity and safety. These tests are standard for physical implantable medical devices.

Therefore, I cannot fulfill the request to provide information based on the typical acceptance criteria and study design for an AI/ML device because this document does not pertain to such a device. The questions you've asked (about sample size, data provenance, experts, MRMC studies, standalone performance, ground truth establishment) are relevant to AI/ML device performance evaluation, but this document describes a traditional medical device (an implant).

To directly answer your request based on the provided document, the following points can be made regarding the physical implant's evaluation, though they don't align with an AI/ML context:

1. Table of acceptance criteria and reported device performance: This document does not provide a table with quantitative acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it discusses mechanical testing standards. The "reported device performance" is essentially that the device performed equivalently to predicates in these mechanical tests.

   Acceptance Criteria (e.g., Mechanical Standard)	Reported Device Performance (as compared to predicates)
   ASTM F2077-14 (Static & Dynamic Compression)	Met, equivalent to predicates
   ASTM F2077-14 (Static & Dynamic Torsion)	Met, equivalent to predicates
   ASTM F2267-04(2011) (Subsidence)	Met, equivalent to predicates
   ASTM Draft Standard F-04.25.02.02 (Expulsion)	Met, equivalent to predicates

2. Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML device evaluation. The "test set" here refers to the physical devices subjected to mechanical testing. The document does not specify the number of individual implants tested for each mechanical test, nor does it refer to "data provenance" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the mechanical properties being measured, which are determined by physical tests and engineering standards, not expert clinical consensus.

4. Adjudication method: Not applicable. Adjudication is relevant for interpreting ambiguous or challenging cases in diagnostic AI, not for mechanical testing of an implant.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No. This type of study is for evaluating human interpretation with and without AI assistance, which is not relevant for a physical interbody fusion device.

6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used: For the mechanical tests, the "ground truth" would be the engineered specifications and the results obtained from standardized mechanical testing equipment. It's not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical interbody fusion device and details mechanical testing to establish substantial equivalence, not the performance of an AI/ML diagnostic or assistive device.

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