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510(k) Data Aggregation
(93 days)
EL CAPITAN Anterior Lumbar Interbody Fusion System
The El Capitan Anterior Lumbar Interbody System 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 radiosraphic studies. These DDD patients may also have up to Grade I spondylolisthesis 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 (0) months of non-operative weatment 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) and the Oblique interbody devices 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 Anterior Lumbar Interbody 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 2-piece 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 is a 510(k) Summary for the EL CAPITAN Anterior Lumbar Interbody Fusion System. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test/training sets, expert qualifications, or adjudication methods cannot be extracted from this document.
However, the document does list non-clinical tests that were conducted to establish substantial equivalence. These tests serve as the basis for the device meeting performance acceptance criteria in a non-clinical context.
Here's a breakdown of the requested information based on the provided text, with explicit notes about what is not available:
1. A table of acceptance criteria and the reported device performance
The document lists the types of non-clinical tests performed, and states that the results "indicate that the El Capitan implants are equivalent to predicate devices." This implies that the acceptance criteria for these tests were met by demonstrating equivalence to the legally marketed predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Equivalent biological response and mechanical properties to predicate devices made of PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy (Ti6-AL4-V ELI), and Nitinol #1. | Device materials (PEEK-OPTIMA LT120HA, Tantalum, Titanium Alloy, Nitinol #1) are similar to predicate devices, indicating equivalent performance. |
| Mechanical Performance: | |
| Static Compression (per ASTM F2077) performance equivalent to predicate devices. | Results of static compression testing indicate equivalence to predicate devices. |
| Dynamic Compression (per ASTM F1717) performance equivalent to predicate devices. | Results of dynamic compression testing indicate equivalence to predicate devices. |
| Static Compression Shear (per ASTM F2077) performance equivalent to predicate devices. | Results of static compression shear testing indicate equivalence to predicate devices. |
| Dynamic Compression Shear (per ASTM F1717) performance equivalent to predicate devices. | Results of dynamic compression shear testing indicate equivalence to predicate devices. |
| Subsidence (per ASTM F2267) performance equivalent to predicate devices. | Results of subsidence testing indicate equivalence to predicate devices. |
| Expulsion performance equivalent to predicate devices. | Results of expulsion testing indicate equivalence to predicate devices. |
| Overall Equivalence: | |
| Substantially equivalent to predicate devices in terms of intended use, design, materials used, mechanical safety, and performances. | Astura Medical concluded the device is substantially equivalent to predicate devices based on similarities in principles of operation, technology, materials, and indications for use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available as the summary explicitly states "No clinical studies were performed." The non-clinical tests would involve physical device samples, but the number of samples used for each test is not specified. The provenance of the test data would be the laboratory where the non-clinical mechanical testing was performed, but this is not mentioned.
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)
This information is not applicable as no clinical studies were performed and thus no human expert-established ground truth was required for the presented non-clinical equivalence testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies involving human interpretation or adjudication were performed.
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
This information is not applicable as no clinical studies, especially those involving AI assistance or human readers, were performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device described is a physical interbody fusion system, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is established by adherence to recognized ASTM standards (e.g., F2077, F1717, F2267) and by comparing the performance results to established performance characteristics of the predicate devices. This represents a laboratory-based, standard-driven performance benchmark rather than a medical ground truth (like pathology or outcomes data).
8. The sample size for the training set
This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.
9. How the ground truth for the training set was established
This information is not applicable as no clinical studies were performed, and therefore, no training set for a clinical algorithm was used.
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