(45 days)
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
| Test Conducted | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gamma Sterilization Validation | Not explicitly stated, but implied to meet sterilization standards for medical devices. | Accepted (All testing passed) |
| Sterile Package Performance Validation | Not explicitly stated, but implied to meet packaging integrity standards for sterile medical devices. | Accepted (All testing passed) |
| Static Axial Compression (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static axial compression. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Static Torsion (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static torsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Static Shear (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for static shear. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Axial Compression (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic axial compression. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Torsion (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic torsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Dynamic Shear (ASTM F2077) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for dynamic shear. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Subsidence (ASTM 2267) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for subsidence. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Expulsion (ASTM Draft F04.25.0202) | Not explicitly stated, but implied to meet or exceed the predicate device's performance for expulsion. | Passed acceptance criteria; substantially equivalent to predicate device. |
| Epicage Portal Evaluation | Not explicitly stated, but implied to meet functional and safety requirements for the delivery system portals. | Passed acceptance criteria. |
| User Validation Cadaver Lab | Not explicitly stated, but implied to demonstrate usability and safety in a simulated surgical environment. | Passed acceptance criteria. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.