(65 days)
The Cogent Mcd-LIF XL is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
The Cogent Med-LIF XL includes additional sizes to the Cogent Med-LIF system. The Cogent Med-LIF XL is an interbody fusion device intended to stabilize the spinal segment to promote fusion. The Cogent Med-LIF XL consists of two PEEK spacers with axial voids to contain bone graft material, a titanium linkage that connects the PEEK spacers, angular antimigration teeth, and tantalum x-ray markers.
The Cogent Med-LIF XL is available in various sizes to accommodate varying patient anatomy. The implants come in two lordotic options. 0° (parallel) and 6° (lordotic). The parallel implants are available in heights ranging from 8mm to 16mm and the lordotic implants are available in heights ranging from 10mm to 16mm. All implants are 15mm wide and are available in three lengths; 28, 30 and 32mm.
The Cogent Med-LIF XL implants may be inserted via an open or minimally invasive approach and may be placed as a single implant or as two units bilaterally in the same intervertebral space.
The Cogent Med-LIF XL implants are non-sterile and are to be sterilized by the end user.
The document provided is a 510(k) premarket notification from the FDA for a medical device called Cogent Med-LIF XL, an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. As such, much of the requested information regarding acceptance criteria, study design, and human reader performance is not available in the provided text.
Based on the available information, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide a direct comparison of the Cogent Med-LIF XL's performance against specific numerical benchmarks. Instead, it relies on demonstrating substantial equivalence through bench testing to a legally marketed predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical performance comparable to predicate device for intervertebral body fusion devices. | "Mechanical and non-clinical testing of the Cogent Med-LIF XL device indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate." |
| Compliance with ASTM F2077 (Static Shear Compression and Dynamic Shear Compression). | Bench tests were conducted per ASTM F2077, indicating successful completion of these tests. |
| Biocompatibility of materials. | Manufactured from polyetheretherketone (PEEK) as per ASTM F2026, titanium alloy (Ti-6Al-4V) per ASTM F1472, and tantalum per ASTM F560, all standard biocompatible materials. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided because no clinical studies were performed. The submission relies solely on non-clinical (bench) testing. Therefore, there is no test set in the context of clinical data, and no data provenance from human subjects.
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 information is not applicable as no clinical studies were performed, and thus no ground truth based on expert review of patient data was established for a test set. The evaluation was limited to bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical studies were performed to generate a test set requiring adjudication.
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
This information is not applicable as this is a mechanical intervertebral body fusion device, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or assessment of AI assistance for human readers was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a mechanical intervertebral body fusion device, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for this submission is based on engineering standards and performance established by the predicate device. For the bench tests, the "ground truth" would be the fulfillment of the specified ASTM F2077 mechanical testing requirements, and the "truth" that the device performs comparably to the predicate.
8. The sample size for the training set
This information is not applicable as no machine learning or AI models were used. The device is a physical implant, not a software algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as no machine learning or AI models were used, and therefore no training set was established.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" conducted for the Cogent Med-LIF XL device was exclusively non-clinical bench testing.
- Tests Performed:
- ASTM F2077 - Static Shear Compression
- ASTM F2077 - Dynamic Shear Compression
- Purpose: To demonstrate mechanical performance and substantial equivalence to the predicate device (Cogent Med-LIF System, K132738).
- Outcome: The non-clinical testing "indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
- Materials Testing: The materials (PEEK, Ti-6Al-4V, Tantalum) were specified to conform to their respective ASTM standards (F2026, F1472, F560), implying their suitability and established performance.
- Absence of Clinical Data: The submission explicitly states, "No clinical studies were performed." The FDA's 510(k) clearance in this case is based on the device having the same indications for use, technological characteristics, and comparable performance through non-clinical testing as a legally marketed predicate device.
§ 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.