(214 days)
The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.
The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.
The provided text describes a 510(k) premarket notification for the Apollo Spine Eclipse Vertebral Spacer-Cervical, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical testing and does not involve a study related to AI or a device that uses algorithms/software for performance evaluation.
Therefore, many of the requested points regarding AI/algorithm performance and clinical study design are not applicable to this submission.
Here's an analysis of the available information:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for the Eclipse Vertebral Spacer-Cervical, as presented in this 510(k) submission, are based on demonstrating mechanical equivalence to legally marketed predicate devices by conforming to established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices.
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria (based on ASTM Standards) | Reported Device Performance |
|---|---|---|
| Axial Compression Static | Adherence to ASTM F 2077 (Standard Test Method for Intervertebral Body Fusion Devices) | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." (Specific quantitative performance data is not provided in this summary.) |
| Axial Compression Dynamic | Adherence to ASTM F 2077 | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Compression-Shear Static | Adherence to ASTM F 2077 | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Compression-Shear Dynamic | Adherence to ASTM F 2077 | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Torsion Static | Adherence to ASTM F 2077 | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Torsion Dynamic | Adherence to ASTM F 2077 | "ASTM Standards F2077...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Subsidence | Adherence to ASTM F 2267 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices) | "ASTM Standards...F2667...were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
| Expulsion | Adherence to ASTM Draft F04.25.02.02 (Draft Standard for Expulsion Testing) | "ASTM Standards...and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document summarizes mechanical testing, not a clinical study involving human patients. Therefore, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not applicable in their traditional sense for clinical data. The "samples" would refer to the Eclipse Vertebral Spacer devices manufactured for testing. The summary does not specify the number of devices tested for each mechanical test. The testing was performed in the context of a premarket notification in the USA.
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. The "ground truth" for mechanical testing is established by the specified ASTM standards and the measurements obtained during testing in a laboratory setting by qualified engineers/technicians, not by medical experts forming a consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 (two readers, one adjudicator if there's a disagreement) are relevant for clinical studies involving reader interpretations, not for mechanical bench testing.
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 a passive implant (intervertebral spacer) and does not involve AI or software for interpretation, nor a human-in-the-loop scenario. The submission is for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this device does not incorporate an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the referenced ASTM standards (e.g., maximum load, cycles to failure, displacement limits). The device's performance is measured against these engineering specifications, and against publicly available data for predicate devices.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set or AI model involved.
§ 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.