(154 days)
The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Choice Spine Acapella Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetherethertone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Acapella Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Acapella One implants (K132582). The material used to construct the anchors is titanium alloy Ti-6Al-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which has a long history of safe and effective use in orthopedic implants. The locking pins are composed of nitinol per ASTM F2063, which has a long history of safe and effective use in orthopedic implants. The Acapella Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.
The provided document is a 510(k) premarket notification for the Acapella Cervical Spacer System, which is an intervertebral body fusion device. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data with acceptance criteria for device performance in diagnosis or treatment.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
- Sample size used for the test set or data provenance for such a study.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone (algorithm only) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- How the ground truth for the training set was established.
Instead, the performance data presented is focused on mechanical testing to demonstrate the structural integrity and equivalence of the device.
Here's the information that is available in the document regarding the device's technical performance:
Acceptance Criteria and Reported Device Performance (Mechanical Testing)
The document states: "The results of this non-clinical testing show that the strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." This implies that the acceptance criteria for these mechanical tests were that the device's performance should be comparable or equivalent to the predicate devices. Specific numerical acceptance criteria are not provided, nor are the specific numerical results of the tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent strength to legally marketed predicate devices | "The strength of the Cervical Spacer System is substantially equivalent to the legally marketed predicate devices." (No specific numerical values provided) |
Study Details (Mechanical Testing):
- Type of Study: Non-clinical mechanical testing.
- Tests Performed:
- Static axial compression per ASTM F2077-11
- Static compressive shear per ASTM F (standard number incomplete in document)
- Static torsion per ASTM F2077-11
- Static subsidence per ASTM F2267-04
- Static expulsion per ASTM F-04.25.02.02 (draft)
- Dynamic axial compression bending per ASTM F2077-11
- Dynamic compressive shear per ASMT F2077-11
- Dynamic torsion per ASTM F2077-11
- Custom static tension testing
- Sample Size: Not specified for each test.
- Data Provenance: Not applicable in the context of mechanical testing.
- Ground Truth: The "ground truth" for mechanical testing is established by the specified ASTM standards, which define the testing methodology and expected performance characteristics for such devices.
- Training Set: Not applicable as this is not an AI/algorithm-based device and no training set would be used for mechanical testing.
- Adjudication/Multi-reader/Standalone: Not applicable for mechanical testing.
In summary, this document demonstrates substantial equivalence through mechanical testing according to recognized standards, rather than through clinical studies involving diagnostic accuracy or clinical outcomes.
§ 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.