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IMPIX DLIF 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 DLIF 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 purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft. This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.

The provided text describes a 510(k) premarket notification for a medical device called the IMPIX DLIF Lumbar Interbody Device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical studies or specific acceptance criteria with defined performance metrics.

Based on the provided document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics in a way that would typically be seen in a clinical study report. Instead, it describes mechanical tests performed and implies that the device's performance in these tests was comparable to or within acceptable limits for similar predicate devices. The "reported device performance" is essentially the execution of these tests, with the conclusion that the device is "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document states:

• Sample Size for Test Set: Not explicitly stated for specific numerical outcomes. For non-clinical tests, it's typically a small number of devices per test (e.g., n=5 or n=10 per test condition). The summary only mentions "The following tests were conducted," implying a standard set of tests for interbody fusion devices.
• Data Provenance: The data is based on non-clinical laboratory testing performed in support of regulatory submission (510(k)). This is not human data (retrospective or prospective), but rather mechanical test data from the device itself. The country of origin for the testing is not specified, but the applicant is from France.

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

• Experts: Not applicable for non-clinical mechanical testing. Ground truth for mechanical tests is established by objective measurements against engineering standards (ASTM F2077, ASTM F2267).
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Mechanical tests have objective, quantifiable outcomes which don't require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No. This device is an interbody fusion device (an implant), not a software algorithm or an AI-powered diagnostic tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

• Ground Truth: For this device, the "ground truth" for demonstrating substantial equivalence relies on:
  • Engineering Standards: Conformance to recognized ASTM standards (F2077, F2267) for mechanical properties.
  • Material Specifications: Conformance to specified material standards (e.g., PEEK OPTIMA® LT1 (ASTM F2026), Tantalum (ISO 13782)).
  • Comparison to Predicate Devices: Demonstrating similar design, materials, and intended use as legally marketed predicate devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary for a physical medical implant. The "acceptance criteria" and "study" described are primarily related to non-clinical mechanical testing and material compatibility, demonstrating substantial equivalence to existing predicate devices rather than clinical performance against specific metrics with human data. Most of the requested information regarding AI performance, expert adjudication, or clinical study design is therefore not relevant or available in this context.

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