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510(k) Data Aggregation
(127 days)
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is intended to be used with additional FDA-cleared supplementary fixation systems.
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion system must be used with bone grafting material (autograft only).
The Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion is an Interbody Fusion Device that has a hollow chamber to permit packing with bone graft to facilitate fusion. The superior and inferior surfaces of the device have a pattern of teeth to provide increased stability and to help prevent movement of the device has a built-in fixation mechanism that is manually deployed into the vertebral bodies by the operating surgeon.
The provided text describes the Camber Spine Technologies ENZA Zero-Profile Anterior Interbody Fusion device and its clearance by the FDA. It includes a 510(k) summary and non-clinical performance testing information.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device was tested against acceptance criteria defined by predicate device performance. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it makes a general statement about meeting them.
| Acceptance Criteria (Not explicitly stated quantitatively, but implied to be "defined by predicate device performance") | Reported Device Performance |
|---|---|
| Mechanical Soundness comparable to predicate devices | "Testing performed indicate that the ENZA Zero-Profile Anterior Interbody Fusion is as mechanically sound as predicate devices." |
| Static Compression per ASTM F2077-14 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Static Compression-Shear per ASTM F2077-14 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Dynamic Compression per ASTM F2077-14 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Dynamic Torsion per ASTM F2077-14 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Dynamic Compression-Shear per ASTM F2077-14 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Expulsion per ASTM F2267-04 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Subsidence per ASTM F2267-04 standards | "The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Wear characteristics comparable to predicate devices | "Wear testing was also performed to evaluate wear particulate. The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
| Blade deployment performance | "Additionally, blade deployment testing was conducted to evaluate blade performance. The results demonstrate that the acceptance criteria defined by predicate device performance were met." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for any of the non-clinical tests (e.g., how many devices were tested for static compression). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) as these are non-clinical engineering tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring expert human assessment for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as the evaluation involved non-clinical performance testing of a physical device, not interpretation of clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance:
This information is not applicable. The document describes the clearance of an intervertebral body fusion device, which is a physical implant, not an AI or imaging diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. See point 5.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests was the performance of legally marketed predicate devices as defined by the relevant ASTM standards (ASTM F2077-14 and F2267-04). This implies that "ground truth" was established based on established engineering benchmarks and typical performance of similar, already-cleared devices.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" in the context of non-clinical mechanical testing of a medical device. This term is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. See point 8.
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