(100 days)
The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.
The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a threaded titanium alloy interbody fusion cage and two optional fixation screws. The implants are available in an assortment of diameter and length combinations to accommodate a variety of anatomic requirements. The instrumentation for implantation is manufactured from medical grades of stainless steel per ASTM F899 with some having silicone handles.
This document is a 510(k) premarket notification for the Fixated Asfora BULLET CAGE® (FABC) system, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for an AI/ML device or conducting a study to prove it meets them. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.
Here's the information that can be extracted from the provided text, categorized as per your request, with "N/A" for those not relevant to this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (related to substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical testing of worst case FABC System devices according to ASTM F2077 (static & dynamic compression, static & dynamic compression shear, static torsion). | Mechanical test results demonstrate that FABC System performance is substantially equivalent to the predicate devices. |
| Evaluation of subsidence properties according to ASTM F2267. | Subsidence properties were evaluated according to ASTM F2267. |
| Evaluation of expulsion according to the ASTM draft standard. | Expulsion was evaluated according to the ASTM draft standard. |
| Intended use: Same as predicate devices. | The FABC System possesses the same intended use as predicate devices. |
| Basic design: Similar to predicate devices (cage with integrated fixation). | The FABC System possesses a similar basic design to predicate devices. |
| Material: Same as predicate devices (titanium alloy). | The FABC System is made of titanium alloy (ASTM F136), same material as predicate devices. |
| Sizes: Comparable to those offered by predicate systems. | The FABC System offers sizes comparable to those offered by the predicate systems. |
| Differences from predicate devices: Must not raise new questions of safety and effectiveness. | Differences were shown not to raise new questions of safety and effectiveness. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This refers to mechanical testing of "worst case FABC System devices." The specific number of devices tested is not provided in this summary.
- Data Provenance: The document does not specify the country of origin of the data or whether the mechanical testing was retrospective or prospective. It is generally understood that such testing would be conducted in a laboratory setting by the manufacturer.
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)
- N/A. This is a medical device (implant) submission, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is derived from standardized mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. As this is not an AI/ML device with human interpretation, an adjudication method is not relevant.
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
- N/A. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance testing, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices (ASTM F2077, ASTM F2267, and an ASTM draft standard for expulsion). These standards define the methods and criteria for evaluating the physical properties of the device.
8. The sample size for the training set
- N/A. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- N/A. This is not an AI/ML 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.