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The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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). It is indicated to be used with autograft bone. Patients should have received six months of non-operative treatment with the devices. The device is intended to be used with supplemental posterior fixation approved for use in the lumbar spine such as Alphatec Spine's Zodiac Polyaxial Spinal Fixation System and/or Illico Posterior Fixation System.

The Epicage System implants are manufactured from implant grade PEEK with a surgical grade titanium alloy pin and 2 tantalum beads to facilitate visualization. The delivery system contains portals in sizes to match the implants sizes and general surgical instruments to assist in preparation and device delivery. The portals are integral to the system and are considered an accessory (Class II) all other instruments are Class I. The system can be used with a mid-line portal for a modified TLIF procedure or an oblique portal for a traditional TLIF approach. The implants of the system are available non-sterilized.

The provided text describes a 510(k) summary for the "Epicage Interbody Fusion System." This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not involve a study evaluating the performance of a device against acceptance criteria in the context of diagnostic accuracy, human reader improvement with AI, or standalone algorithm performance.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this document. The document discusses engineering and material performance testing of the device itself, not a clinical study on diagnostic or treatment efficacy that would typically involve acceptance criteria for metrics like sensitivity, specificity, or reader improvement.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For mechanical and sterilization testing, the acceptance criteria are generally established by the referenced ASTM standards and by demonstrating substantial equivalence to the predicate device. The document states, "All testing passed the acceptance criteria and the results were substantially equivalent to the predicate device," but does not explicitly detail the numerical or qualitative thresholds for each criterion beyond meeting the standards.

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

Not applicable. The document describes non-clinical performance testing (mechanical, material, sterilization) rather than a clinical study with a patient test set.

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. Ground truth as typically defined for diagnostic device studies (e.g., expert consensus, pathology) is not relevant for this type of non-clinical engineering and materials testing. The "User Validation Cadaver Lab" involved "users" (likely surgeons or surgical residents) but their role was in evaluating usability, not establishing a diagnostic ground truth.

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

Not applicable. There was no clinical test set requiring adjudication in the context of diagnostic accuracy.

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 device is an interbody fusion system, not an AI-powered diagnostic tool, and therefore no MRMC study comparing human readers with and without AI assistance would have been performed or mentioned.

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

Not applicable. This device is a physical implant, not an algorithm.

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

For the non-clinical engineering tests, the "ground truth" or reference for comparison would be the established ASTM standards and the performance of the predicate device. For the "User Validation Cadaver Lab," the "ground truth" would be the subjective and objective evaluation of the device's handling and fit during simulated surgical procedures by the users. This is not "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm or a training set.

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

Not applicable.

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The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion. The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.

The provided text describes pre-clinical performance testing for the Epicage Interbody Fusion Device, which is intended for interbody fusion procedures. This device is a PEEK implant designed to provide mechanical support to the lumbar spine during biologic fusion.

Here's an analysis of the acceptance criteria and study to prove the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The text indicates that the device's performance was evaluated against established ASTM standards and a recognized protocol for expulsion testing. The reported performance is a qualitative statement of meeting these standards and being "substantially equivalent" to predicate devices. Specific quantitative acceptance criteria or performance metrics are not explicitly provided in the extract.

2. Sample Size and Data Provenance

The provided text focuses on pre-clinical bench testing. It does not describe a clinical study involving human patients. Therefore, there is no "test set" in the context of patient data nor data provenance from specific countries or retrospective/prospective collection methods. The "samples" would refer to the physical Epicage Interbody Fusion Device units used for mechanical testing. The specific number of devices tested for each type of performance test is not mentioned.

3. Number of Experts and Qualifications

This information is not applicable as the study described is pre-clinical bench testing of a mechanical device, not an evaluation requiring expert interpretation of medical images or patient outcomes.

4. Adjudication Method

This information is not applicable for the same reason as point 3. Bench testing results are typically based on objective measurements from laboratory equipment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text describes pre-clinical bench testing of a mechanical device. It does not involve human readers interpreting images or considering AI assistance.

6. Standalone Performance Study (Algorithm Only)

The device described is a physical medical implant (interbody fusion device), not a software algorithm. Therefore, "standalone" algorithm performance is not applicable. The performance testing focuses on the mechanical integrity and behavior of the implant itself.

7. Type of Ground Truth Used

The ground truth for the performance testing is based on the objective measurements obtained from standardized mechanical tests (ASTM standards and a recognized expulsion protocol). For example, the "ground truth" for static axial compression would be the force/displacement curves and failure points measured according to the ASTM F2077-03 standard. The study aims to demonstrate that the device's mechanical properties meet the expectations for its intended use and are comparable to predicate devices.

8. Sample Size for the Training Set

There is no "training set" in the context of an algorithm or machine learning model, as this is a physical medical device.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical medical device.

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