(57 days)
The CORNERSTONE® PSR device is indicated for 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 herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.
The PERIMETER® C Spinal System is intended to be used 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 who have had six weeks of nonoperative treatment. Cervical discase is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and implanted via an open, anterior approach.
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 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 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 autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft 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 CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation, and is to be implanted via an open, anterior approach. The CORNERSTONE® PSR devices are manufactured from medical grade polyetheretherketone (PEEK) material with tantalum or titanium alloy (Ti-6Al-4V) pin markers.
The PERIMETER® C Spinal System consists of spacers of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be used with supplemental fixation in all procedures. PERIMETER® C Spinal System is used with instrumentation that enables the surgeon to implant the devices via an open, anterior approach. The subject PERIMETER® C devices are manufactured from medical grade titanium alloy (Ti-6Al-4V) or polyetheretherketone (PEEK) material with tantalum pin markers.
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. The implant is "I-Beam" shaped with a two screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The subject PEEK PREVAIL® Cervical Interbody device implant is manufactured from medical grade polyetheretherketone (PEEK) material and contains tantalum radiopaque markers. The subject device also contains a Nitinol screw locking mechanism and uses bone screws made of grade titanium alloy (Ti-6Al-4V).
The provided text is a 510(k) Summary for a medical device submission, focusing on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving performance against those criteria. In the context of a 510(k) submission, the "acceptance criteria" are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" here primarily refers to the justification of this substantial equivalence.
Here's an analysis of the provided information, framed by your request.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance" for a 510(k) device like this fusion system is achieving substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance/Justification |
|---|---|
| Safety and Effectiveness | Demonstrated to be equivalent to previously cleared predicate devices through materials, design, indications for use, and manufacturing. |
| Material Conformance | PEEK conforms to ASTM F2026; Titanium Alloy conforms to ASTM F136; Tantalum conforms to ASTM F560; Nitinol conforms to ASTM F2063. This ensures materials are suitable for surgical implant applications. |
| Expanded Indications for Use | To allow the use of allogenic bone graft (cancellous and/or corticocancellous) as an alternative graft material. This expanded indication is identical to that granted to the primary predicate, ANATOMIC PEEK Spinal System (K130177). |
| No New Risks | "The clinical data demonstrated that the use of allogenic bone graft... poses no new risks to patients." |
| No Changes to Existing Devices | "No changes were made to the existing devices, nor were any new components added to the system." (Except for the expanded graft material option). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Published retrospective clinical data for the cervical interbody fusion devices were provided in support of this application."
- Sample size: Not explicitly stated. The document refers to "clinical data" in general, not a specific sample size for a new study.
- Data provenance: "Published retrospective clinical data". The country of origin is not specified.
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)
This type of information (number and qualifications of experts for ground truth) is typically relevant for diagnostic AI/ML devices where expert consensus labels are critical. For a device like an intervertebral body fusion system, ground truth would be established through clinical outcomes, pathology, or successful fusion rates in a clinical study. The document refers to "clinical data" but does not detail how specific ground truth was established by experts in the context of a new test set for this 510(k). The "ground truth" for proving safety and effectiveness of the expanded indication would implicitly be successful clinical outcomes (e.g., fusion, lack of complications) from the retrospective data using allogenic bone graft.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of this 510(k) submission. Adjudication methods like 2+1 or 3+1 are common in studies for diagnostic devices where multiple readers interpret images, and a tie-breaking mechanism is needed to establish a "ground truth" label. This document refers to retrospective clinical data rather than a new reader study.
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
There is no indication that an MRMC comparative effectiveness study was done, nor is there any mention of human readers or AI assistance. This device is a physical implant, not a diagnostic imaging or AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical interbody fusion device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the retrospective clinical data that supports the expanded indication, the implicit ground truth would be outcomes data (e.g., successful fusion, absence of adverse events, patient recovery) from patients who received allogenic bone graft in cervical interbody fusion procedures. The document states the data "demonstrated that the use of allogenic bone graft... poses no new risks to patients."
8. The sample size for the training set
Not applicable. This 510(k) submission does not describe the development of an AI/ML algorithm that would typically involve a training set. The "study" mentioned refers to retrospective clinical data used to support the safety and effectiveness of using an allogenic bone graft, not to train a model.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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.