(241 days)
The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM 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 ANATOMIC PEEK™ device is to be used with supplemental fixation. The ANATOMIC PEEK™ CERVICAL FUSION SYSTEM 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 ANATOMIC PEEK™ CERVICAL FUSION SYSTEM is designed for use as a cervical interbody fusion device. The device is manufactured from polyetheretherketone (PEEK OPTIMA™) and is to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC™ PEEK CERVICAL FUSION SYSTEM consists of hemi-cylindrical cages of various widths, heights and depths. 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.
The provided text is a 510(k) summary for the Medtronic Sofamor Danek ANATOMIC PEEK™ CERVICAL FUSION SYSTEM. This document describes a medical device and its clearance process, not an AI/ML powered device. As such, many of the requested fields are not applicable.
Here's the information that can be extracted or that is not applicable given the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal of Submission: To seek clearance for the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft. | The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in anterior cervical interbody fusion procedures to treat patients diagnosed with cervical disc disease, poses no new risks to patients. |
| Device Design/Components: No changes to the actual implants or existing devices. | No changes were made to the existing devices, nor were any new components added to the system. |
| Safety: Device (with allogenic bone graft) poses no new risks to patients. | "Published clinical outcomes demonstrated that the use of allogenic bone graft...poses no new risks to patients." |
| Equivalency: The design features, materials, manufacturing, and sterilization methods are equivalent to the previously cleared ANATOMIC PEEK™ CERVICAL FUSION SYSTEM components. | The submission concluded that the device is substantially equivalent to legally marketed predicate devices, with the exception of broadening the indications to include allogenic bone graft. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document refers to "Published retrospective clinical data," but does not provide details on the number of patients or studies.
- 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)
- Not applicable. This is a medical device clearance document, not an AI/ML study involving expert ground truth for interpretation. The "ground truth" here is established clinical outcomes data from published literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication method is described as this is not an AI/ML performance evaluation. The data is from published clinical studies.
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 is a medical device, not an AI/ML system. No MRMC study was performed involving AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (intervertebral body fusion device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: "Published clinical outcomes." This would typically refer to patient outcomes data, such as fusion rates, symptom improvement, or adverse event rates as reported in the medical literature.
8. The sample size for the training set
- Not applicable. This is a medical device and not an AI/ML system that undergoes a "training" process in the computational sense. The "training" in the context of device development would be the design and testing phases, which are not detailed as "training sets."
9. How the ground truth for the training set was established
- Not applicable. See point 8. The device's safety and effectiveness were established through non-clinical testing and referencing established clinical data of similar devices and procedures.
§ 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.