(149 days)
The EL CAPITAN Anterior Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN system implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws.
When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices and EL CAPITAN X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.
The EL CAPITAN X spacer may only be used with titanium alloy screws.
The EL CAPITAN Anterior Lumbar Interbody Fusion devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The provided text describes the EL CAPITAN Anterior Lumbar Interbody Fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets specific acceptance criteria based on performance in a clinical or diagnostic context.
The document discusses the regulatory clearance (K222554) of an intervertebral body fusion device and summarizes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this is not a study that proves a device meets acceptance criteria in the sense of a clinical performance study with defined metrics for accuracy, sensitivity, or specificity. Instead, it's a regulatory summary demonstrating mechanical and material equivalence.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as they are not applicable to the type of information presented.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity as would be relevant for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the successful completion of the non-clinical tests listed, demonstrating mechanical and material equivalence to predicate devices. The "reported device performance" is that it passed these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Compression ASTM F2077 | Passed / Results indicate equivalence to predicate devices |
| Dynamic Compression ASTM F2077 | Passed / Results indicate equivalence to predicate devices |
| Static Compression Shear ASTM F2077 | Passed / Results indicate equivalence to predicate devices |
| Dynamic Compression Shear ASTM F2077 | Passed / Results indicate equivalence to predicate devices |
| Subsidence ASTM F2267 | Passed / Results indicate equivalence to predicate devices |
| Expulsion | Passed / Results indicate equivalence to predicate devices |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The tests are non-clinical (mechanical, material, etc.), not based on a "test set" of patient data for performance evaluation.
- Data Provenance: Not applicable. These are laboratory test results, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in the context of expert consensus or pathology is relevant for clinical or diagnostic studies. For these non-clinical mechanical tests, the "ground truth" is defined by the ASTM standards and engineering principles. The tests themselves provide the data.
4. Adjudication method for the test set
- Not applicable. There is no expert adjudication process for these non-clinical mechanical tests as there would be for subjective clinical assessments. The results are objective measurements against defined standards.
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. The device is an intervertebral body fusion device, not a diagnostic tool or AI-assisted system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Not applicable in the conventional sense (expert consensus, pathology, outcomes data). For these non-clinical mechanical tests, the "ground truth" is implied by the established ASTM standards and measurable physical properties.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm.
§ 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.