(116 days)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are radiolucent implantable devices manufactured from PEEK and tantalum (marker material). The implants are available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® 41-TLIF Convex Oblique device, InFill® 43-TLIF Contour Oblique, InFill® 44-TLIF Contour Oblique and the InFill® 60-ALIF are provided sterile, for single use only.
Here's a breakdown of the acceptance criteria and study information for the InFill® Interbody Fusion Devices, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Performance Area) | Performance Standard / Test Type | Reported Device Performance |
|---|---|---|
| Mechanical Stability | Static Compression (ASTM F2077) | "All necessary performance testing... has been completed" |
| Dynamic Loading | Dynamic Compression (ASTM F2077) | "All necessary performance testing... has been completed" |
| Resistance to Subsidence | Static Subsidence (ASTM F2267) | "All necessary performance testing... has been completed" |
| Resistance to Expulsion | Expulsion (Specific ASTM standard not specified) | "All necessary performance testing... has been completed" |
| Substantial Equivalence | Comparison to predicate devices for: | Determined to be substantially equivalent to existing legally marketed devices. |
| - Intended Use | Similar | |
| - Principal of Operation | Similar | |
| - Technological Characteristics (Shape, bone-implant surface, bone graft support, primary implant material, surgical approach) | Similar (as illustrated in the technical characteristics table) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information regarding the sample size used for the test set (if applicable to the type of testing performed, i.e., clinical trials) or the data provenance (country of origin, retrospective/prospective). The performance data cited refers to mechanical testing, not clinical studies with patients.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The submission describes a device for intervertebral body fusion, and the testing outlined is primarily mechanical. There is no mention of establishing ground truth by expert consensus related to clinical outcomes or imaging interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. The data presented is from mechanical performance testing, not studies requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems that assist human readers in interpreting medical images. The device in question is an implantable medical device, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI system was not done. The device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be the physical measurements and observations of the device's performance against established ASTM (American Society for Testing and Materials) standards. These standards define the acceptable range or thresholds for properties like compression strength, subsidence, and expulsion resistance.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this device is a physical implant and not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information 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.