(29 days)
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments.
The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.
The provided text is a 510(k) summary for the CarboClear® Lumbar Cage System, a medical device for intervertebral body fusion. It describes the product, its intended use, and claims substantial equivalence to predicate devices, but it does NOT contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical performance study for an AI/ML device would.
Therefore, I cannot provide the requested table or specific points related to acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document. The 510(k) process for this type of device (an intervertebral body fusion device) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than novel clinical performance studies with acceptance criteria in the sense typically applied to diagnostic AI.
Here's what I can extract based on the provided information, but it won't fulfill all your requested points:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate mechanical performance. | "Performance characteristics included finite element analysis with supportive testing according to ASTM F2077 and expulsion test. The results of the analysis/tests are comparable to those of the predicate devices, demonstrating substantially equivalent mechanical performance of the subject device." |
| Intended Use/Indications for Use matching predicates. | The intended use and indications for use for the CarboClear® Lumbar Cage System are described and implicitly accepted as equivalent to predicate devices to demonstrate substantial equivalence. (e.g., "intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD)... at one or two contiguous levels from L2 to S1... with supplemental fixation cleared for use in the lumbosacral spine.") |
| Material, design, dimensions, technological characteristics, and principles of operation are substantially equivalent to predicates. | "The intended use, design, material, dimensions, technological characteristics, and principles of operation of the subject CarboClear® Lumbar Cage System are substantially equivalent to those of the predicate devices." |
Explanation of Limitations:
- No explicit "acceptance criteria" for clinical performance: This document is a 510(k) summary for a physical implant, not an AI/ML diagnostic. The "acceptance criteria" here are geared towards demonstrating safety and effectiveness based on equivalence to existing devices, primarily through mechanical testing and comparison of features, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI clearances.
- No "study" in the sense of AI/ML clinical validation: The "study" mentioned is primarily focused on mechanical performance (finite element analysis, ASTM F2077 testing, expulsion test) to ensure the device is physically robust and performs similarly to predicate devices. There is no mention of a human-in-the-loop study, a standalone algorithm performance study, or a study involving human readers or expert radiologists to establish ground truth for clinical diagnostic performance.
Regarding your specific points where information is not available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable in this context. The "test set" here refers to mechanical testing, not a clinical data set for performance evaluation in the AI/ML sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not expert consensus on medical images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical performance, the ground truth would be the established engineering standards (e.g., ASTM F2077) and physical measurements. For the overall device, the ground truth for safety and effectiveness is established by comparison to legally marketed predicate devices that have a history of safe and effective use.
- The 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 (not an AI/ML device).
In summary, the provided document details the regulatory clearance of a physical medical implant based on substantial equivalence to predicate devices, supported by mechanical testing. It does not provide the type of performance evaluation details typically associated with AI/ML diagnostic software.
§ 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.