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The SYNSTER® CERVICAL CAGE are indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain 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. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The devices are intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. 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 SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF, and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE], which may be implanted
   As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach;
   Bi-laterally via a posterior (PLIF) approach;
   As a single device via a posterior transforaminal (PTLIF) approach;
   As a single device via a transforaminal (TLIF) approach.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE, RHEA® PLIF CAGE and TALON® TLIF CAGE components are made of polyether ether ketone (PEEK OPTIMA® LT1) that conforms to ASTM F2026, and is supplied as nonsterile and/or gamma sterile. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device. The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF, RHEA® PLIF CAGE and TALON® TLIF CAGE are implanted by using the instruments specially designed and manufactured from stainless steel materials that conform to ASTM F899.

The provided text describes a 510(k) submission for an intervertebral body fusion device, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against specific metrics for diagnostic accuracy.

Therefore, most of the requested information regarding diagnostic device performance, such as sample size, provenance, expert qualifications, and ground truth, is not available in the provided document. This submission primarily focuses on the mechanical and physical properties, sterility, and shelf life of the intervertebral cages, aiming to show they are equally safe and effective as pre-existing devices.

Here's the information that can be extracted or deduced from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. The tests mentioned (sterility, shelf life, mechanical) are typically performed on product samples in a laboratory setting, not on a "test set" of patients or data in the context of diagnostic accuracy.

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

• Not applicable / Not provided. This information is relevant for diagnostic devices that interpret images or other patient data, which is not the primary focus of this submission.

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

• Not applicable / Not provided. Similar to point 3, this is for diagnostic accuracy studies.

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:

• No. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant here.

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

• No. This is a physical intervertebral fusion device, not an algorithm.

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

• For mechanical and material tests: The "ground truth" is defined by the relevant ASTM and ISO standards' specifications and test methodologies.
• For sterility: The "ground truth" is defined by the ISO 11737-1 standard for demonstrating sterility assurance.
• For shelf life: The "ground truth" is determined by the stability of the device over time under specified conditions.

8. The sample size for the training set:

• Not applicable / Not provided. This concept applies to machine learning models, which are not part of this device submission.

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

• Not applicable / Not provided. This concept applies to machine learning models.

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