(183 days)
The Asfora Bullet Cage® 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 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). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
The Asfora Bullet Cage (ABC) is a threaded titanium alloy interbody fusion device (cage) with a threaded titanium end cap. The ABC is a threaded, self-tapping, bullet-shaped, hollow-body, device designed to immobilize adjacent vertebrae and promote arthrodesis (fusion) across the disc space. The Asfora Bullet Cage is available in ten sizes: 5 diameters (10mm, 12mm, 14mm, 16mm, and 18mm) and 2 lengths (21mm or 25mm).
The provided text is related to a 510(k) submission for a medical device called the "Asfora Bullet Cage™ System, Intervertebral Body Fusion Device." This submission is a request for substantial equivalence to previously cleared devices.
Key takeaway: This document is a 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, not on a new, formal study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested points below about specific performance metrics and study design are not applicable to this type of regulatory submission. The document explicitly states: "No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required."
Here's a breakdown based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not explicitly stated for new device performance) | Reported Device Performance (Not explicitly stated for new device performance) |
|---|---|---|
| Substantial Equivalence (Primary Goal of 510(k) Submission) | The device should be "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976... or to devices that have been reclassified..." This implies that the device's technological characteristics, intended use, and safety and effectiveness profile should be similar to authorized predicate devices, posing no new questions of safety or effectiveness. | The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to the predicate devices outlined in the submission (K090048, Asfora Bullet Cage System and P950019/S9 Ray TFC Threaded Fusion Cage). The conclusion from Medical Designs, LLC was "based upon the devices’ similarities in principles of operation, technology, materials and indications for use." The FDA's clearance letter confirms this determination. |
| Functional and Safety Testing | Implicitly, the device should meet the functional and safety standards expected for such an intervertebral body fusion device. While specific criteria aren't provided for this submission for new testing, the previous predicate devices would have met these. | The document explicitly states: "No significant changes to the design of the device were made. Risk assessment was performed which concluded no additional testing was required." This indicates that the device's performance is assumed to meet existing standards based on its similarity to the predicate devices and the lack of significant design changes. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This 510(k) submission is for substantial equivalence without new performance testing. There is no "test set" of patients or data from a clinical study for this specific submission to demonstrate novel device performance. The clearance is based on comparison to predicate devices, which would have undergone their own testing previously.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: As there was no specific "test set" or clinical study for this submission, there was no ground truth to be established by experts for new performance data. The regulatory decision was made by FDA reviewers (e.g., Mark N. Melkerson, Director Division of Surgical, Orthopedic and Restorative Devices).
4. Adjudication method for the test set
- Not Applicable: No clinical or performance study with a test set requiring adjudication was conducted for this 510(k) submission.
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 device is an implantable medical device (intervertebral body fusion device), not an imaging or AI-assisted diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant to its evaluation, and no such study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is an implantable medical device, not an algorithm. Standalone algorithm performance is not relevant to this submission.
7. The type of ground truth used
- Not Applicable (in the context of new device performance): The "ground truth" for this 510(k) submission is the pre-existing FDA clearance and established safety and effectiveness of the identified predicate devices. The new device demonstrates "substantial equivalence" to these known safe and effective devices.
8. The sample size for the training set
- Not Applicable: This is an implantable medical device. The concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.
§ 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.