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The RESOLUTE Threaded Cage System is intended to be used bilaterally for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment.

The Resolute Threaded Cage System intended to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Description

The Resolute Threaded Cage System implants are devices intended to serve as an intervertebral body fusion device. The implant is available in a range of diameters and lengths to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) described by ASTM F136. The implant is hollow to permit packing with autograft bone graft and/or allogeneic composed of cancellous and/or corticocancellous bone and a supplemental fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine to help promote intervertebral body fusion. The cylindrical surface has threads to assist in the interface with the vertebral endplates to prevent migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Resolute Threaded Cage System components with components from any other system or manufacturer. The Resolute Threaded Cage System components should never be reused under any circumstances

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the Life Spine Resolute™ Threaded Cage System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical performance data or acceptance criteria related to an AI/algorithm-based device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/algorithm performance. The "performance data" section refers to mechanical testing of the implant itself, not to the performance of any AI or algorithm.

To explicitly address the numbered points in the request:

A table of acceptance criteria and the reported device performance: Not applicable. The document discusses mechanical testing of the physical implant (Static Axial Compression, Static Axial Compression Shear, Dynamic Compression Shear & Dynamic Axial Compression testing) to demonstrate substantial equivalence to predicate devices, not performance against specific AI/algorithm acceptance criteria.
Sample sized used for the test set and the data provenance: Not applicable. No test set for an AI/algorithm is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI/algorithm test set is mentioned.
Adjudication method for the test set: Not applicable. No test set for an AI/algorithm is mentioned.
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 document is about a physical medical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document is about a physical medical implant.
The type of ground truth used: Not applicable. No ground truth for an AI/algorithm is mentioned.
The sample size for the training set: Not applicable. No training set for an AI/algorithm is mentioned.
How the ground truth for the training set was established: Not applicable. No training set for an AI/algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary pertain to the physical characteristics and mechanical performance of an intervertebral body fusion device and do not involve an AI or algorithm. Therefore, the requested information about AI acceptance criteria and study details cannot be extracted from this document.

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K Number

K112648

Device Name

ASFORA BULLET CAGE

Manufacturer

MEDICAL DESIGNS, LLC

Date Cleared

2012-03-13

(183 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K090048

Intended Use

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.

Device Description

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).

AI/ML Overview

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.

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