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The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® Spinal System consists of PEEK cages, titanium alloy cages and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

This document is a 510(k) summary for the CAPSTONE® Spinal System, which is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or a clinical trial report would.

Therefore, the input document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies typically found in clinical evaluation reports for novel devices or software.

The document states:

• "Documentation, including mechanical test result, was provided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08, K082342 SE 09/15/08) as well as the VERTE-STACK® Spinal System devices (K062073 SE .08/14/06)."

This clearly indicates a predicate comparison approach, not a de novo clinical study with specific acceptance criteria as requested. The "acceptance criteria" here is substantial equivalence to the predicate devices based on mechanical testing and material properties, not clinical performance metrics against a defined standard.

In summary, the provided document does not contain the information needed to fill out the requested table and answer the detailed questions about clinical study design and performance metrics.

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The PEEK PREVAIL™ Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft. The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK Optima and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.

The provided text is a 510(k) premarket notification for a medical device, the PEEK PREVAIL™ Cervical Interbody Device. It primarily focuses on demonstrating substantial equivalence to previously approved devices, rather than presenting a study with specific acceptance criteria and detailed performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and performance statistics is not available in the provided document.

Here's an analysis of what information can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. 510(k) submissions for devices like interbody fusion devices often rely on demonstrating substantial equivalence to predicate devices through material properties, design features, and possibly biomechanical testing, rather than clinical trials with explicit acceptance criteria for diagnostic accuracy or clinical outcomes in the same way an AI/software device would. The document does not specify any performance metrics or acceptance criteria for the PEEK PREVAIL™ device itself.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided in the context of this 510(k) submission. This document describes a physical medical device (an intervertebral body fusion device) and not a software algorithm that would typically have a "test set" in the sense of AI/ML evaluation. The submission relies on establishing substantial equivalence to existing devices through design, materials, and intended use, rather than a clinical study requiring test sets of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided. Ground truth establishment by experts is a concept relevant to evaluating diagnostic devices or AI algorithms. For this physical interbody fusion device, "ground truth" in the AI sense is not relevant.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are used in studies involving expert review, typically for diagnostic accuracy or outcome assessment in clinical trials or AI performance evaluations, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable/not provided. MRMC studies are typically used for evaluating the effectiveness of diagnostic imaging devices or AI tools, often comparing human reader performance with and without AI assistance. This document does not describe such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. This document pertains to a physical medical implant, not a standalone algorithm.

7. The Type of Ground Truth Used

This information is not applicable/not provided. For a physical implant, "ground truth" as it relates to expert consensus, pathology, or outcomes data in the context of device performance claims isn't specified in this substantial equivalence document. Clinical outcomes for such devices are typically established through post-market surveillance or larger clinical trials that are beyond the scope of a 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The PEEK PREVAIL™ Cervical Interbody Device is a physical implant.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As above, this concept applies to AI/ML development, not the submission for a physical interbody fusion device.

Summary of Device and 510(k) Submission:

The provided document (K073285) is a 510(k) premarket notification for the PEEK PREVAIL™ Cervical Interbody Device.

• Device Description: An intervertebral body fusion device with internal screw fixation, "I-Beam" shaped, made from PEEK Optima with tantalum radiopaque markers and a Nitinol screw locking mechanism. It's intended to be radiolucent and used with autograft.
• Indications for Use: Anterior cervical interbody fusion in skeletally mature patients with cervical disc disease at one level (C2-C3 to C7-T1), defined by intractable radiculopathy/myelopathy with herniated disc/osteophyte formation causing nerve root/spinal cord compression. Must be used with ZEPHIR® Anterior Cervical Screws and autograft, implanted via an open, anterior approach, after six weeks of non-operative treatment.
• Substantial Equivalence: The submission demonstrates substantial equivalence to previously approved devices, including the AFFINITY® Anterior Cervical Cage, BAK/C® Cervical Interbody Fusion System, VERTE-STACK® Spinal System, and VENTURE™ Anterior Cervical Plate System. This is the primary method of approval for this device, emphasizing similarity in materials, design, and intended use to already cleared predicate devices.

Conclusion:

The provided 510(k) submission document for the PEEK PREVAIL™ Cervical Interbody Device focuses on demonstrating substantial equivalence to already approved predicate devices. It does not contain information about acceptance criteria, specific performance metrics, or study designs involving test sets, ground truth establishment, or human reader performance comparisons, as typically requested for AI/ML or diagnostic imaging device evaluations.

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