(219 days)
The Asfora Bullet Cage™ (ABC) is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two levels from L2 to S1. The DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ABC cage devices are used with autogenous bone graft and are implanted via an open posterior approach. Patients should have had at least six (6) months of non-operative treatment prior to implant.
The Asfora Bullet Cage™ is comprised of two hollow, threaded, self-tapping titanium fusion devices (cages) with closed tapered medial ends. The distal end has a small orifice that can be closed with a threaded cap. There are six equidistant slit apertures along the longitudinal axis of the device for placement of autogenous bone graft material. The cage has large cutting threads, angled toward the proximal end. The Asfora Bullet Cage™ is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm). This device, with associated instrumentation is intended for use in posterior lumbar interbody fusion to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space.
The provided document is a 510(k) summary for the Asfora Bullet Cage™. It details device description, indications for use, and a statement of substantial equivalence to predicate devices. However, the document does not contain information about:
- Specific acceptance criteria for device performance (e.g., success rates, mechanical thresholds in a clinical context).
- Any studies involving patient data or device performance against such criteria. The "testing" mentioned in the summary refers to technical characteristics comparison, not clinical or performance outcome studies that would generate the requested metrics.
- Sample sizes for test or training sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/device performance study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Specific types of ground truth used (e.g., pathology, outcomes data).
Therefore, based only on the provided text, it's not possible to answer most of the prompt's questions as they pertain to clinical performance studies or AI/device performance metrics against acceptance criteria. The document describes a device comparison/equivalence filing, not a study demonstrating performance against specific clinical acceptance criteria.
The "study" that proves the device meets acceptance criteria, in this context, is the assessment of substantial equivalence to predicate devices. This is based on comparing technical characteristics and intended uses, implying that if the device is substantially equivalent to legally marketed and safe predicate devices, it also meets the necessary safety and effectiveness "acceptance criteria" for market clearance via the 510(k) pathway.
Here's an attempt to answer the questions based only on the available text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (INTER FIX™ Threaded Fusion Device and Ray TFC™ Device) in terms of technical characteristics and intended uses. | "Testing and comparison of technological characteristics and intended uses found that all components of the Asfora Bullet Cage™ are equivalent to the predicates." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No information provided in the document regarding a test set or data provenance for performance evaluation. The "testing" refers to technical comparisons, not clinical performance data from patients.
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)
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This is a medical device clearance document, not an AI performance study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device clearance document, not an AI performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior marketing clearance.
8. The sample size for the training set
Not applicable. No training set is described for device performance evaluation.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
§ 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.