(75 days)
The IMSE P-TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). IMSEP-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. IMSEP-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Institute of Musculoskeletal Science and Education, P-TLIF is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. IMSE, P-TLIF is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Institute of Musculoskeletal Science and Education designed the IMSE, P-TLIF to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
The provided documentation describes the IMSE P-TLIF device, an intervertebral fusion device. The focus of the submission is to demonstrate substantial equivalence to predicate devices, primarily through nonclinical testing.
Here's an analysis of the acceptance criteria and the study results based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Static and Dynamic Compression Test (per ASTM F2077) | Met the acceptance criteria. |
| Static and Dynamic Compression Shear (per ASTM F2077) | Met the acceptance criteria. |
| Subsidence Test (per ASTM F2267) | Met the acceptance criteria. |
| Wear Debris (per ASTM F2077 and ASTM F1877) | Met the acceptance criteria. |
| Static Expulsion Test | Met the acceptance criteria. |
| Sterility Assurance Level (SAL) of 10^-6 (per ISO 17665) for Autoclaveable Implants | Validation testing conducted (using the half-cycle method) to achieve this SAL. |
| Sterility Assurance Level (SAL) of 10^-6 (per ISO 17665) for Autoclaveable Instruments and Case | Validation testing conducted (using the half-cycle method) to achieve this SAL. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify the sample size for the nonclinical tests (e.g., number of devices tested for compression, shear, etc.). It only states that these tests were performed to demonstrate substantial equivalence.
Similarly, the data provenance (e.g., country of origin, retrospective or prospective) is not mentioned for these nonclinical tests. As these are laboratory tests, provenance in the clinical sense is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies performed were nonclinical (mechanical and material testing), not clinical studies requiring expert ground truth for interpretation of patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the studies performed were nonclinical, not clinical studies requiring adjudication of outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not performed. The document explicitly states: "No clinical tests were performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device (IMSE P-TLIF) is a physical intervertebral fusion device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the nonclinical tests was based on standardized mechanical and material testing protocols (e.g., ASTM F2077, ASTM F2267, ASTM F1877, ISO 17665). The "ground truth" in this context refers to the specified performance parameters and thresholds defined within these standards, which the device had to meet.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
§ 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.