(328 days)
The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) 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 radios. Patients should have received 6 months of non-operative treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine ENZA®- O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) is intended to be used with additional FDAcleared supplementary fixation systems. The Camber Spine ENZA®- O Titanium Lateral Anterbody Fusion (ALIF) must be used with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The Camber Spine Technologies ENZA®-O Titanium ALIF is a lumbar interbody fusion device that has a hollow chamber to permit packing with autogenous graft material or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The superior and inferior surfaces of the device have a rough surface to help prevent movement of the device while fusion takes place. Additionally, the device has integrated fixation through superior anchoring plates. These implants may be implanted via an anterior oblique lateral approach. Patients with previous non-fusion spinal surgery at the treated level may be treated.
Camber Spine ENZA®-O device body is additively manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F3001-14. The internal device components (anchor plates, deployment ram, assembly pin and retention blocking screw) are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136. The internal sheer pin component is manufactured from PEEK per ASTM F2026.
This FDA 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance. It focuses on the substantial equivalence of a physical medical device (an intervertebral body fusion device) to previously cleared predicate devices through mechanical testing.
Therefore, I cannot provide the requested information, as it is not present in the provided text.
The document discusses:
- Device: ENZA®-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
- Purpose: A lumbar interbody fusion device for skeletal maturity patients with degenerative disc disease.
- Acceptance Criteria (for mechanical performance): Not explicitly stated with numerical values, but the text mentions "Mechanical testing, including static and dynamic compression shear, static and dynamic axial compression per ASTM F2077, as well as expulsion have been performed on the subject ENZA®-O interbody devices. The results have shown them to be substantially equivalent to the predicate interbody devices." This implies that the device's mechanical performance, when tested against these standards, was deemed comparable to the predicate devices.
- "Study" (Performance Testing): "Mechanical testing, including static and dynamic compression shear, static and dynamic axial compression per ASTM F2077, as well as expulsion have been performed on the subject ENZA®-O interbody devices."
- Reported Device Performance: "The results have shown them to be substantially equivalent to the predicate interbody devices."
The following information is NOT available in the provided text:
- A table of acceptance criteria and the reported device performance: While mechanical testing is mentioned, specific numerical acceptance criteria and reported performance values are not provided.
- Sample size used for the test set and the data provenance: No information on the number of devices tested or the origin of any test data.
- Number of experts used to establish the ground truth... and qualifications: This is irrelevant as it's a physical device, not an AI/ML diagnostic.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance of the predicate device, not expert consensus, pathology, or outcomes data.
- Sample size for the training set: Not applicable (not an AI/ML device).
- 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.