(140 days)
MODULIF-A is an interbody fusion device intended for spinal fusion procedures at one or two contiguous levels (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 have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal procedure at the involved level(s).
The device system is designed for use with supplemental fixation and with autogenous or allograft comprised of cancellous and / or corticocancellous bone graft to facilitate fusion. Patients should have six months of non-operative treatment prior to treatment with an interbody fusion cage. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device.
The Spinal Stability MODULIF-A is a modular interbody fusion cage intended for the treatment of degenerative disc disease in the lumbar spine used to provide structural stability in skeletally mature patients. The MODULIF-A device is composed of two endplates and a central spacer. The device may be implanted as a single construct via an anterior approach. The system is comprised of interbodies of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients and multiple surgical approaches.
The provided document is a 510(k) summary for the MODULIF-A Anterior Lumbar Interbody Fusion System. It states that no clinical studies were performed for this device. Therefore, the device's acceptance criteria and the study proving it meets them are established through non-clinical testing and comparison to predicate devices, rather than human clinical trials.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Static and Dynamic Compression per ASTM F2077 | Results indicate equivalence to predicate devices. |
| Static Torsion per ASTM F2077 | Results indicate equivalence to predicate devices. |
| Static and Dynamic Compression-Shear per ASTM F2077 | Results indicate equivalence to predicate devices. |
| Subsidence per ASTM F2267 | Results indicate equivalence to predicate devices. |
| Expulsion | Results indicate equivalence to predicate devices. |
| Sterility validation per ISO 17665-1: 2006 | Validated per standard. |
| Cleaning validation per AAMI TIR30 | Validated per standard. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the mechanical and material tests conducted according to ASTM and ISO standards. The data provenance is from non-clinical bench testing rather than human subjects or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the non-clinical tests is established by the specifications and requirements of the referenced ASTM and ISO standards, which are developed through a consensus process by experts in the relevant fields (e.g., materials science, biomechanics, sterilization). The document does not specify the individual experts involved in establishing these standards or the internal testing protocols.
4. Adjudication method for the test set
Not applicable. This concept typically applies to clinical studies where expert consensus is needed to determine outcomes or ground truth on patient data. For non-clinical bench testing, the results are objectively measured against the specified criteria of the test standards.
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
No. The document explicitly states: "No clinical studies were performed." This device is not an AI-assisted diagnostic tool, but rather an implanted medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an implanted medical device, not a standalone algorithm. Performance is assessed through non-clinical mechanical and material testing.
7. The type of ground truth used
The ground truth used for the device's performance evaluation is established by internationally recognized engineering and material standards (e.g., ASTM F2077, ASTM F2267, ISO 17665-1, AAMI TIR30). Compliance with these standards serves as the ground truth for the mechanical strength, durability, and biocompatibility of the device.
8. The sample size for the training set
Not applicable. This device is an implanted medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.