(114 days)
The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.
The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.
This document is a 510(k) premarket notification for the ALTA Cervical Interbody Spacer. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and efficacy through clinical trials. Therefore, the information typically requested about acceptance criteria and detailed study designs for AI/medical imaging devices is not present here.
Specifically for your questions:
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A table of acceptance criteria and the reported device performance
- This document does not contain quantitative acceptance criteria and reported performance metrics in the way one would see for an AI/imaging device. The device's "performance" is demonstrated through non-clinical mechanical testing, showing equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical "test set" data in the context of an AI/imaging device is provided. The non-clinical tests (static/dynamic compression, torsion, subsidence, expulsion) involve mechanical samples of the device itself.
- The document explicitly states: "No clinical studies were performed."
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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. There is no clinical test set requiring expert-established ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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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 is a medical implant, not an AI/imaging diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical implant, not an AI/imaging diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests, the "ground truth" is based on established ASTM standards for mechanical properties (e.g., F2077 for compression and torsion, F2267 for subsidence). The device's performance is compared against these standards or against the performance of predicate devices as per those standards.
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The sample size for the training set
- Not applicable. There is no AI model or "training set."
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How the ground truth for the training set was established
- Not applicable. There is no AI model or "training set."
Summary of Device Performance (from the provided text, related to non-clinical testing):
| Non-clinical Test Performed | Reported Device Performance |
|---|---|
| Static and dynamic compression per ASTM F2077 | Results indicate equivalence to predicate devices. |
| Static and dynamic torsion per ASTM F2077 | Results indicate equivalence to predicate devices. |
| Subsidence per ASTM F2267 | Results indicate equivalence to predicate devices. |
| Expulsion testing per ASTM F04.25.02.02 | Results indicate equivalence to predicate devices. |
Conclusion: The provided document describes a 510(k) submission for a cervical interbody spacer. The device received clearance based on demonstrating "substantial equivalence" to existing predicate devices, primarily through non-clinical mechanical testing and comparison of design, materials, and intended use. No clinical studies were performed, and thus, no data regarding acceptance criteria, test set, training set, expert consensus, or AI performance metrics are included.
§ 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.