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Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Cambria is an intervertebral fusion device intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. Implants are made from PEEK (polyetheretherketone) with radiographic markers and are generally box-shaped with a central canal for receiving bone graft. Cambria is offered in a variety of shapes and sizes to accommodate variations in patient anatomy.

This 510(k) summary describes a spinal intervertebral fusion device called Cambria. The provided text indicates that no clinical data or studies were required or performed to demonstrate substantial equivalence for this device. Instead, the substantial equivalence determination for Cambria was based on mechanical testing results. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth, and expert involvement for a clinical study is not applicable to this submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The submission states: "Clinical data was not required for this device." The performance data relied solely on mechanical testing. While mechanical testing would have specific acceptance criteria, these are not detailed in the provided 510(k) summary. The summary only broadly states: "Mechanical testing results indicated that Cambria possessed appropriate properties for its intended use and is substantially equivalent to predicate device(s)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No human clinical test set was used.

3. 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. No human clinical test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human clinical test set was used.

5. 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 device is a physical implant, not an AI or imaging device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the ground truth would be defined by engineering specifications and standards for intervertebral fusion devices, which are implied by the statement "appropriate properties for its intended use."

8. The sample size for the training set

Not Applicable. No training set for a clinical study or algorithm was used.

9. How the ground truth for the training set was established

Not Applicable. No training set for a clinical study or algorithm was used.

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