(260 days)
The PEEK Cage for the Vertebral Spine NeoSpace PLIF, TLIF, and ALIF devices are indicated for spinal fusion procedures at one or two contiguous levels from L2-S1, in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have Grade 1 Spondylolisthesis at involved levels. Patients must have undergone a regimen of six months of non-operative treatment prior to treatment in the lumbar spine. The PLIF devices may be used singularly or in pairs. All lumbar devices are to be used with supplemental fixation cleared for use in the lumbar spine.
The Cervical devices are indicated for spinal fusion procedures at one level in the cervical spine from C3 to T1 for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients must have undergone a regimen of six weeks of non-operative treatment prior to treatment in the cervical spine. One cervical device is used per intervertebral space. All cervical devices are to be used with supplemental fixation cleared for use in the cervical spine.
All lumbar and cervical devices are intended for use with autogenous bone graft.
The PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE is an intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. Components are offered in a variety of shapes and sizes to meet the requirements of the individual patient anatomy. Components are manufactured from PEEK -Optima (per ASTM F2026).
The provided document describes a medical device called the "PEEK CAGE FOR THE VERTEBRAL SPINE NEOSPACE," an intervertebral body fusion device. The document focuses on establishing substantial equivalence for this device to legally marketed predicate devices, primarily through performance testing.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static Compression per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Static Compression-Shear per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Static Torsion per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Compression-Shear per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Dynamic Torsion per ASTM F2077 | Demonstrated substantially equivalent performance to predicate devices. |
| Subsidence Testing per ASTM F2267 | Demonstrated substantially equivalent performance to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that testing was performed on "worst case subject devices." However, it does not specify the exact number (sample size) of devices tested for each performance test.
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. It only mentions the submitter is from Brazil.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a mechanical performance study of a device, not an AI or diagnostic study requiring expert ground truth for interpretation of outcomes. The 'ground truth' for this type of study is the physical measurement against established ASTM standards and comparison to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for a mechanical performance study. Adjudication methods are typically used in clinical or diagnostic studies to resolve discrepancies in expert interpretations or assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the nature of this submission.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study (algorithm only without human-in-the-loop performance) was not done. This submission is for a physical medical implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for this mechanical performance testing is based on established engineering standards (ASTM F2077 and ASTM F2267) and comparison to the performance of legally marketed predicate devices. It is not expert consensus, pathology, or outcomes data in the typical sense for a diagnostic device.
8. Sample Size for the Training Set
This information is not applicable. The study is a mechanical performance test for a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned or required for this type of device submission.
§ 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.