(205 days)
The Cutting Edge Spine Interbody Fusion Device (CES) is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
The CES device is intended to be used with autologous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal, retroperitoneal.or anterior approach. The CES-PLIF and CES-LIF are implanted in pairs, while the CES-TLIF, CES-CLIF and CES-RLF devices may be implanted singly or in pairs in the lumbosacral spine. The CES device is intended to be used with supplemental fixation.
The CES device is a family of PEEK-OPTIMA spacers offered in a variety of widths and lengths. There are five main configurations: CES-PLIF, CES-TLIF, CES-CLIF and CES-RLIF. The different configurations allow for multiple surgical technique options. The CES-PLIF, CES-LIF, CES-CLIF and CES-RLIF are generally rectangular in shape while the CES-TLIF is curved.
The CES implants are available in a range of sizes, as well as flat and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the spacers as an option to help allow for radiographic visualization. The hollow implants have holes through four sides for bone graft and an inserter instrument interface on the face. Teeth on top and bottom of the spacers improve fixation. The spacers themselves are made of biocompatible PEEK-Optima LT1 (per ASTM F2026-08) material and provided nonsterile for single-use.
The provided text describes the submission for a 510(k) premarket notification for the Cutting Edge Spine Interbody Fusion Device (CES). This device is an intervertebral body fusion device, which falls under a different category than AI/ML-driven diagnostic or therapeutic devices.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details), which are typically associated with performance studies for AI/ML medical devices, does not apply to this submission.
The 510(k) summary for the CES device focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, primarily through preclinical bench testing and adherence to FDA guidance for mechanical and material properties.
Here's why the specific questions about AI/ML performance studies are not relevant in this context:
- Device Type: The CES is a physical implant (a PEEK spacer) used in spinal fusion surgery, not a software algorithm that analyzes data or images.
- Regulatory Pathway: The 510(k) pathway for a device like this relies on demonstrating that it is as safe and effective as a predicate device, often achieved through materials testing, mechanical testing, and comparison of design features and indications for use. It does not typically involve clinical performance studies in the same way an AI diagnostic would.
- "Acceptance Criteria" for Predicate Devices: For mechanical devices like this, "acceptance criteria" generally refer to meeting specified engineering and materials standards (e.g., ASTM standards for mechanical strength, biocompatibility testing), rather than clinical accuracy metrics like sensitivity or specificity.
Instead, the document highlights the following performance aspects:
- Acceptance Criteria & Reported Performance (Paraphrased for this type of device):
| Acceptance Criteria (Type of Testing) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | Substantially equivalent performance characteristics to identified predicate devices as demonstrated by preclinical testing. |
| Static Compression | Testing conducted per ASTM F2077 |
| Static Compression Shear | Testing conducted per ASTM F2077 |
| Static Torsion | Testing conducted per ASTM F2077 |
| Dynamic Compression | Testing conducted per ASTM F2077 |
| Subsidence | Testing conducted per ASTM F2267 |
| Expulsion | Testing conducted per ASTM F2267 |
| Biocompatibility: | Made of biocompatible PEEK-Optima LT1 material (per ASTM F2026-08). |
| Material Properties: | Made of PEEK material, similar to predicate devices. |
| Design & Indications: | Similar shapes, sizes, and Indications for Use as predicate devices. |
- Sample Size used for the test set and data provenance: Not applicable. The "test set" here refers to preclinical bench testing of the device itself, not a dataset for an AI algorithm. The provenance is the testing laboratory.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for an AI algorithm is not relevant here. Ground truth for mechanical testing would be the physical measurement standards.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML device.
- If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
- The type of ground truth used: Not applicable in the AI/ML context. For this device, ground truth relates to meeting established mechanical and material engineering standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.