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The RELIANCE CERVICAL IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The Reliance Cervical IBF and Reliance Cervical IBF-HA implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The RELIANCE CERVICAL IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical disc disease (defined at neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The RELIANCE CERVICAL IBF System is to be used in patients who have six weeks of non-operative treatment.

The Reliance Cervical IBF System is comprised of implants and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the cervical spine. The spacer may be made of PEEK Optima LT1 or PEEK Optima LT1-HA with Tantalum markers. The Reliance Cervical IBF System may also include bone screws to secure the device to the vertebral body.

The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Cervical IBF System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and an animal study, rather than establishing acceptance criteria and detailed performance against those criteria in a clinical study with human subjects.

Therefore, many of the specific details requested in your prompt (such as acceptance criteria, sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed training set information) are not directly present in this regulatory submission.

However, I can extract and infer some information based on the provided text:

Key Takeaway from the Document:

The submission focuses heavily on substantial equivalence to previously cleared devices (K120396, K131429, and K142026) through mechanical testing and an animal study. It does not present detailed clinical efficacy or diagnostic performance data against specific acceptance criteria for a human clinical trial.

Here's the breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in terms of clinical outcomes for human subjects. However, the document mentions adherence to specific ASTM standards for mechanical testing. These standards implicitly define acceptance criteria for the mechanical performance of intervertebral body fusion devices.
• Reported Device Performance:
  • Mechanical Testing: Performed per ASTM F-2077 (Static and dynamic compression, static torsion, dynamic torsion), ASTM F-2267 (Expulsion), and ASTM Draft F-04.25.02.02 (Subsidence). The document states the device "was found to be substantially equivalent to itself" based on this testing, implying it met the performance expectations relative to its own prior clearance or the predicate devices. Specific quantitative results (e.g., maximum load, displacement) are not provided in this summary.
  • Animal Study: An "ovine fusion study was performed." No specific performance metrics or outcomes from this study are detailed in the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Mechanical Testing: Not specified in the summary. ASTM standards often specify the number of samples to be tested (e.g., n=6 for certain tests), but the exact count for this device is not here.
  • Animal Study: Not specified.
• Data Provenance: Not specified, but generally, studies for U.S. FDA submissions are conducted under appropriate Good Laboratory Practice (GLP) standards, which implies a controlled testing environment, likely in the US or a country with equivalent regulatory oversight. The animal study would be prospective in nature, as would the mechanical testing.

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: This information is not relevant to the type of studies described (mechanical testing and animal fusion study). These studies do not involve human expert interpretation for "ground truth" in the way a diagnostic AI device would. Mechanical tests rely on objective physical measurements and engineering analysis. Animal studies have veterinary pathologists or researchers assess outcomes.

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

• Not Applicable: No adjudication method is mentioned or relevant for mechanical testing or a preclinical animal study as described.

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 a mechanical device (cervical interbody fusion system), not an AI/diagnostic software. Therefore, an MRMC comparative effectiveness study for human readers with and without AI assistance is not applicable and was not performed.

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

• No: As this is a mechanical medical device, there is no "algorithm" or standalone AI performance to evaluate.

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

• Mechanical Testing: The "ground truth" is defined by the physical/mechanical properties and thresholds specified in the ASTM standards. Measurements are objective.
• Animal Study: The "ground truth" for fusion in the ovine study would typically be established through methods like histological analysis (pathology), radiographic evidence (e.g., CT scans), and potentially biomechanical testing of explanted specimens. The document does not specify which methods were used, but pathology/imaging are standard for fusion assessment.

8. The sample size for the training set

• Not Applicable: This is not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable: There is no training set for this device.

In summary, the provided document is a 510(k) summary for a cervical interbody fusion device, showcasing substantial equivalence primarily through non-clinical (mechanical) testing and a pre-clinical animal study. It does not include the types of clinical performance data, acceptance criteria, or study designs typically associated with AI/diagnostic devices that would involve human readers, ground truth consensus, or large human clinical cohorts.

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