(143 days)
The Neurostructures Cavetto® [MAX] Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. 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 Neurostructures Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Neurostructures Cavetto® [MAX] Cervical Cage System is intended to be used with supplemental fixation.
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® [MAX] Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
This document (K181590) describes a 510(k) premarket notification for a medical device called the "Neurostructures Cavetto® [MAX] Cervical Cage System." The FDA's letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about a study that proves the device meets acceptance criteria in the way typically associated with AI/ML device performance studies (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement).
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Technological characteristics: Similarities in indications for use, principles of operations, implant material, sterility, surgical approach, and structural support mechanism.
- Performance data: An engineering comparison of material showing mechanical equivalence to the primary predicate device, and bacterial endotoxin testing.
Therefore, it's not possible to fulfill the request for information on acceptance criteria and study details related to a device's performance in terms of diagnostic accuracy or comparative effectiveness with human readers, as this type of information is not present in the provided document.
To directly answer your specific points based only on the provided text:
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A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe performance criteria or results in terms of diagnostic accuracy, sensitivity, specificity, or other metrics typical for AI/ML devices. The "performance data" mentioned refers to mechanical equivalence and endotoxin testing, not clinical or diagnostic performance against a ground truth.
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Sample sizes used for the test set and the data provenance:
- Not applicable. No test set of clinical data is described. The "performance data" refers to engineering comparisons and lab testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by experts is mentioned, as there is no test set for clinical performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set is described.
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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. No MRMC study or AI assistance is mentioned. This device is an intervertebral fusion device, not a diagnostic AI tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for clinical performance is described. The "ground truth" for the mechanical comparison would be the established properties of the primary predicate device.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm.
§ 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.