(156 days)
The Battalion Universal Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
The Battalion Universal Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with allograft or autograft (e.g., Allogenic bone graft composed of cancellous and/or corticocancellous bone graft) and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in the following two material varieties:
- Polyetheretherketone (PEEK) with tantalum markers
- Commercially pure titanium coated polyetheretherketone (PEEK) with tantalum markers. .
All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580. All implants are provided sterile.
This system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of these instruments are made of surgical grade stainless steel (17Cr-4Ni) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before each use.
This document is a 510(k) premarket notification for a medical device called the "Battalion Universal Spacer System." It's a submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance data (mechanical testing and a cadaver study) rather than specific acceptance criteria for a diagnostic/AI device. Therefore, a table for "acceptance criteria and reported device performance" as typically seen for AI devices (e.g., sensitivity, specificity, AUC) is not directly applicable.
However, the "acceptance criteria" here relate to the device's mechanical integrity and biological safety, as demonstrated through adherence to specific ASTM standards and FDA guidance. The "device performance" refers to the results of these tests.
| Acceptance Criteria (Demonstrated Adherence) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| Dynamic and Static Axial Compression | Acceptable performance characteristics demonstrated |
| Dynamic and Static Axial Torsion | Acceptable performance characteristics demonstrated |
| Dynamic and Static Shear (per ASTM F2077, including Wear Particulate Analysis) | Acceptable performance characteristics demonstrated |
| Static Expulsion Testing (per ASTM F-04.25.02.02) | Acceptable performance characteristics demonstrated |
| Static Subsidence Testing (per ASTM F2267) | Acceptable performance characteristics demonstrated |
| Surgical Technique Validation: | |
| Surgical technique and implantation validation (cadaver study) | Validated |
| Biological Safety: | |
| Bacterial Endotoxin Testing (BET) (per ANSI/AAMI ST72) | Endotoxin levels are within acceptable limits |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of this device's non-clinical testing. The "test set" here refers to the samples used for mechanical and biological testing (e.g., individual implants for mechanical tests, cadavers for the cadaver study). Specific numbers are not provided in the summary.
- Data Provenance: Not explicitly stated for the cadaver study or the materials used in mechanical testing. The document is for a medical device (spinal spacer system), not a diagnostic or AI product, so traditional "data provenance" like country of origin for patient data is not relevant here. The studies are non-clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a physical implant, and its performance is evaluated through mechanical and cadaveric studies, not through expert-labeled ground truth like in an AI diagnostic study. The "ground truth" for mechanical testing is established by the defined ASTM standards and measurements, and for biological safety by the BET standard. The cadaver study would involve surgeons, but their role is for surgical technique validation, not "ground truth establishment" in the sense of a diagnostic interpretation.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1, 3+1 for imaging reads). The evaluations are based on objective physical measurements and established biological safety protocols.
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:
No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This is a physical medical device.
7. The Type of Ground Truth Used:
For this type of device, the "ground truth" is established by:
- Engineering Standards: For mechanical performance, the ground truth is defined by the requirements and measurement methods outlined in the cited ASTM standards (e.g., F2077, F-04.25.02.02, F2267). The device performs as expected if it meets these quantifiable engineering criteria.
- Biological Safety Standards: For bacterial endotoxin, the ground truth is defined by the acceptable limits specified in ANSI/AAMI ST72.
- Surgical Feasibility/Technique Validation: For the cadaver study, the ground truth relates to the successful and appropriate implantation of the device according to surgical principles and the company's intended technique.
8. The Sample Size for the Training Set:
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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.