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The S-LIF™ Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).

The SpineFrontier S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of body fusion donoo intents, using autogenous bone graft to facilitate fusion. Skeletally mature pationto, asing autogenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. The system is (DDD) at one of two of two of PEEK Optima®, with a fixed width and various comprised of dovious fiace of a vide of a wide variety of patients. lengins and heights to in the analoms on the superior and inferior surfaces that will resist device movement following implant

Here's an analysis of the provided text regarding the acceptance criteria and study for the S-LIF™ Intervertebral Body Fusion Device:

Interpretation of the Provided Text:

The provided document is a 510(k) summary for a medical device. For such devices, particularly Class II, the "acceptance criteria" and "study" typically refer to the demonstration of substantial equivalence to a previously legally marketed device (predicate device), rather than a clinical trial demonstrating efficacy against a specific performance metric in a clinical context. The "studies" are primarily non-clinical bench testing to show that the new device performs comparably to the predicate and meets relevant engineering standards. This is a crucial distinction.

Therefore, the table will reflect the comparison against predicate devices and the type of testing performed, not clinical performance metrics in the way one might expect for a diagnostic AI device.

Acceptance Criteria and Device Performance for S-LIF™ Intervertebral Body Fusion Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Test Set): Not applicable in the context of clinical data. For the mechanical tests, the sample size would refer to the number of devices or test articles subjected to each standard. This information is not provided in the summary.
• Data Provenance: The "data" in this context refers to the results of non-clinical mechanical testing. The origin would be the testing laboratory. This specific information (country, retrospective/prospective) is not provided as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This question is not applicable to this type of device submission. There was no "ground truth" to be established by clinical experts in the context of this 510(k) summary, as it relied on non-clinical comparative testing and existing FDA guidance.

4. Adjudication Method for the Test Set

• This question is not applicable as there was no clinical test set requiring expert adjudication. The "adjudication" was effectively by the comparison of test results to established engineering standards and predicate device performance.

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, an MRMC comparative effectiveness study was not done. This type of study (evaluating human reader performance with/without AI assistance) is characteristic of AI/CADe devices, not an intervertebral body fusion device.
• "Clinical data was not required for this device."

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this submission was based on:
  • Engineering Standards: Established benchmarks and methodologies outlined in standards like ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F-04.25.02.02.
  • Predicate Device Performance: The established performance and safety profiles of the legally marketed predicate devices (K072289, K071795, K072791).
  • FDA Guidance: Compliance with the "Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007."

8. The Sample Size for the Training Set

• This question is not applicable. This is a physical medical device, not an AI or machine learning algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable as there was no training set for an AI/ML algorithm.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria was a non-clinical substantial equivalence comparison. This involved:

• Documentation Review: Comparison of the S-LIF™ device's indications for use, function, operating principles, and materials (PEEK Optima®) to those of three predicate devices (SpineFrontier Inc., Dorado Intervertebral Body Cage K072289; Nuvasive CoRoent System K071795; Synthes Spine Oracle Spacer K072791). The conclusion was that these characteristics were "substantially equivalent."
• Mechanical Bench Testing: The S-LIF™ Intervertebral Body Fusion Device underwent mechanical testing according to recognized ASTM standards:
  • ASTM F2077-03 (Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression)
  • ASTM F2267-04 (Subsidence Under Static Axial Compression)
  • ASTM Draft Standard F-04.25.02.02 (Static Expulsion)

The overall conclusion was that the device met the criteria defined in the FDA's guidance document for intervertebral fusion devices and was "substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing)." The submission explicitly states, "Clinical data was not required for this device."

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