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When used as a cervical intervertebral body fusion device, the Breckenridge implant is intended for spinal fusion procedures to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Breckenridge device is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.

When used as a cervical intervertebral fusion device, the C-Thru™ Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The C-Thru™ Spacers are intended for use with supplemental fixation and autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate the fusion.

The Solitaire®-C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire®-C Cervical Spacer System is to be used with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The cervical intervertebral body PEEK spacers have a hollowed cut-out central area to accommodate autogenous and/or allogeneic bone graft. Furthermore, the upper and lower surfaces have a series of transverse slots or grooves to improve stability and fixation once the device is inserted. All implants in these systems are made of PEEK-OPTIMA®, tantalum, and titanium alloy (Ti-6AI-4V ELI). The spacer body, plates and screws are available in a variety of sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Solitaire-C spacer is a stand-alone device that must be implanted with the Solitaire-C titanium screws that are part of the system.

The Solitaire®-C Cervical Spacer System and C-Thru™ Anterior Spinal System implants are offered in sterile packed versions while the Breckenridge® Small Intervertebral Body Fusion is packaged non-sterile, to be sterilized by the end user.

This Traditional 510(k) is being submitted to seek clearance for the addition of allograft (cancellous and/or corticocancellous bone graft) indications to the aforementioned cervical intervertebral body PEEK spacer systems (both stand-alone devices and devices which require supplemental fixation).

The provided text is a 510(k) summary for medical devices (cervical intervertebral body fusion systems) and does not describe acceptance criteria for device performance in the context of an AI/ML algorithm or a study that evaluates such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices for expanded indications related to bone graft types.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and MRMC/standalone studies is not present in the document.

The document states:

• "The changes proposed did not require non-clinical testing in order to demonstrate substantial equivalence to the predicate devices."
• "Published retrospective clinical data for cervical interbody fusion devices similar to the subject devices was completed to support this Premarket Notification. The published clinical outcomes demonstrated that the use of allograft (cancellous and/or corticocancellous bone graft) in anterior cervical interbody fusion poses no new risks to patients. No changes were made to the existing devices; therefore, no additional testing was required or performed."

This indicates that no new performance studies (clinical or non-clinical) were conducted for the purpose of this 510(k) submission, as the submission primarily pertains to expanding the indications for use of existing devices to include allograft. Therefore, there are no specific device performance metrics or acceptance criteria presented in the context of a new study on the device's efficacy or safety.

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The Solitaire -C Cervical Spacer System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Cervical degenerative disc disease is defined as intractable radior myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The Solitaire -C Cervical Spacer is to be used with autograft and implanted via an anterior approach. The Solitaire-C spacer must be implanted with the Solitaire-C titanium screws that are part of the system. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The purpose of this submission is to gain market clearance for the Solitaire-C Cervical Spacer System. The Solitaire -C Cervical Spacer System consists of spacers and bone screws for stand-alone cervical intervertebral body fusion. The Solitaire -C spacer will be available in a variety of sizes, angles and footprints. This cervical spacer has a PEEK main body (PEEK-Optima LT1 per ASTM F-2026) with a titanium faccplate and band (Ti-6Al-4V ELI alloy per ASTM F-136), and tantalum markers (unalloyed tantalum per ASTM F-560). This device accepts titanium bone screws that are available in two diameters and multiple lengths.

The provided text describes a medical device, the Solitaire®-C Cervical Spacer System, and its clearance process. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML device performance.

The document K113796 is a 510(k) summary for a traditional medical device (cervical interbody fusion device), cleared in 2012. The "Performance Data" section details mechanical testing performed on the physical device to ensure its strength and suitability for its intended use, according to ASTM standards. This is standard for orthopedic implants, demonstrating the physical integrity and biocompatibility of the device itself.

There is no mention of an AI/ML component in this device, nor any discussion of diagnostic or prognostic performance metrics that would typically be associated with AI/ML devices (e.g., sensitivity, specificity, AUC). Therefore, the specific information requested about acceptance criteria, reported device performance (in terms of AI metrics), sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, ground truth types, and training set details are not applicable to the provided document.

To directly answer your request based on the absence of such information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing to established ASTM standards but does not present acceptance criteria or performance in a table format relevant to AI/ML. Mechanical testing "shows that the mechanical strength of the subject device is sufficient for its intended use," implying it met internal or regulatory mechanical performance criteria, but these are not specified quantitatively.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples for mechanical testing, not a digital test set for AI/ML.

3. 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 based on physical measurements and compliance with engineering standards, not expert medical interpretation of images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No AI component is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No AI component is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical testing, the "ground truth" is compliance with specified ASTM standards for static and dynamic compression, shear, torsion, subsidence, and expulsion, along with evaluation of screw back out, push through, and interconnection, and wear debris analysis.

8. The sample size for the training set: Not applicable. No AI component is described.

9. How the ground truth for the training set was established: Not applicable. No AI component is described.

In summary, the provided document describes the mechanical performance of a physical orthopedic implant and does not contain the type of information requested about AI/ML device performance and validation.

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