Search Results
Found 3 results
510(k) Data Aggregation
(100 days)
Fixated Asfora BULLET CAGE® (FABC)
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.
Ask a specific question about this device
(183 days)
ASFORA BULLET CAGE
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.
Ask a specific question about this device
(219 days)
ASFORA BULLET CAGE SYSTEM
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.
Ask a specific question about this device
Page 1 of 1