(54 days)
The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (L1-L2 to L5-S1) for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The PSX Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the lumbar spine.
The subject PSX Interbody System is a lordotic expandable lumbar intervertebral body fusion system designed to be inserted through a posterior surgical approach. The subject interbody spacers are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The PSX System consists of a variety of shapes and sizes of interbody spacers, inserters, trials, and general instruments to create lordotic expansion, restore sagittal alignment, and provide indirect decompression. Implants are offered with anti-migration teeth and gritblast treatment on the bone-contacting endplate surfaces.
The prompt asks for details about the acceptance criteria and study proving a device meets them. However, the provided text is an FDA 510(k) clearance letter for the "PSX Interbody System," a spinal fusion device. This document is a regulatory approval, not a clinical study report or a detailed technical specification of an AI/ML device.
Therefore, the requested information, specifically regarding:
- Acceptance criteria and device performance table (for an AI/ML device)
- Sample size and data provenance for a test set (for AI/ML)
- Number and qualifications of experts for ground truth (for AI/ML)
- Adjudication method (for AI/ML)
- Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML)
- Standalone (algorithm-only) performance (for AI/ML)
- Type of ground truth (for AI/ML)
- Training set sample size (for AI/ML)
- Ground truth establishment for training set (for AI/ML)
None of this information is present in the provided FDA 510(k) document because the PSX Interbody System is a physical medical device (intervertebral body fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) device.
The document states:
- "Nonclinical testing performed on the PSX Interbody System supports substantial equivalence to other predicate devices."
- "The following testing was performed: Static and Dynamic Axial Compression (per ASTM F2077), Static and Dynamic Compression Shear (per ASTM F2077), Push-out/Expulsion, Subsidence analysis."
- "The results demonstrate that the subject PSX Interbody System is substantially equivalent to other predicate devices for nonclinical testing."
- "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
This clearly indicates that the predicate pathway for this device relied on non-clinical bench testing to demonstrate substantial equivalence to existing devices, not on a clinical or AI/ML performance study as implied by the prompt's specific questions.
Conclusion: The provided text does not contain the information necessary to answer the questions about acceptance criteria and study details for an AI/ML device's performance evaluation. The device described, the PSX Interbody System, is a physical implant, and its clearance was based on non-clinical, mechanical testing.
§ 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.