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IMPIX Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.

IMPIX Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The IMPIX Lumbar Cage is bi-convex in the sagittal plane. It possesses teeth on both superior and inferior surfaces that assist in the anchorage and stability of the device to the bone of the vertebrae. The upper and lower aspects of the IMPIX-L are open, to allow the surgeon to pack the device with bone graft prior to insertion. Lateral holes exist to allow bone growth through the device. In order to the varying morphology of patients, the IMPIX Lumbar Cages are available in various sizes. The IMPIX Lumbar Cage is machined from PEEK OPTIMA LT1.

The provided text describes a 510(k) premarket notification for IMPIX Lumbar Interbody Devices. This submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials. Therefore, the information typically found in acceptance criteria and detailed study descriptions for a device that demonstrates performance against specific metrics with human involvement (like AI-assisted diagnostics) is not present.

Here's an analysis based on the available text:

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

   • Acceptance Criteria: The primary acceptance criterion for this type of device (intervertebral body fusion device) is demonstrating substantial equivalence to a predicate device, primarily through mechanical testing and material equivalence. The text mentions "required mechanical strengths" as the benchmark.
   • Reported Device Performance:

     Performance Aspect	Reported Performance
     Mechanical Strength	"IMPIX Lumbar Interbody Fusion devices meet required mechanical strengths."
     Material	Manufactured from PEEK OPTIMA LT1 (same as predicate).
     Indications for Use	Same as predicate device.
     Design (IMPIX-LA, IMPIX-LAD, IMPIX-TLIF)	Different from the predicate in design, but still deemed substantially equivalent based on testing.

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: Not explicitly stated for mechanical tests. The "cadaver trial" would have involved a small number of cadavers, but the exact count is not provided.
   • Data Provenance: Not specified for the mechanical tests. The cadaver trial likely took place where the manufacturer (MEDICREA Technologies, France) or its contact (Donald W. GUTHNER, PA, USA) conducted R&D.

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 as this is a mechanical device submission, not a diagnostic device requiring expert interpretation of images. The "ground truth" here is mechanical integrity and adherence to ASTM standards.

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

   • Not applicable. The "test set" primarily refers to mechanical testing according to ASTM standards, which are objective measurements, not subjective evaluations by experts needing adjudication.

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

   • Not applicable. This is a medical implant, not an AI-powered diagnostic device. No MRMC study was conducted.

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

   • Not applicable. This is a medical implant, not an AI or algorithm-based device.

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

   • The "ground truth" for this device's performance is based on engineering standards and mechanical testing results (e.g., meeting requirements for axial compression, compressive shear, resistance to subsidence, and expulsion as defined by ASTM F2077 & ASTM F2267). For substantial equivalence, the "ground truth" is also the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. There is no training set for this type of device.

In summary, the 510(k) submission for IMPIX Lumbar Interbody Devices relies on demonstrating that the new devices are substantially equivalent to a previously cleared predicate device (IMPIX Lumbar Interbody Device, K072226) through mechanical testing and material similarity, as opposed to extensive clinical testing with patient outcomes or expert reviews.

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