(270 days)
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
The Anjon Bremer Halo System consists of transcutaneous bone anchorage elements, and extracutaneous bridge elements, which provide fixation of the torso to immobilize the cervical spine when used with a frame or surgical table adaptor. The transcutaneous bone anchorage elements are titanium threaded skull pins, of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor. All materials are MRI/CT conditional.
The provided text is a 510(k) summary for the Anjon Bremer Halo System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove acceptance criteria for device performance in the context of clinical metrics like sensitivity, specificity, accuracy, or similar performance measures often associated with AI/ML devices.
Therefore, many of the requested sections about acceptance criteria and study details for an AI/ML device are not applicable to this document. The Anjon Bremer Halo System is a medical device (a halo system for cervical spine immobilization and traction), not an AI/ML diagnostic or prognostic tool.
Here's a breakdown based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics like accuracy, sensitivity, or specificity for a clinical task. Instead, the "acceptance criteria" for regulatory clearance through a 510(k) pathway are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is not in clinical outcomes, but rather in the form of technological characteristics comparison.
| Characteristic | Anjon Bremer Halo System (Subject Device) | Primary Predicate (K915800) | Reference Predicate (K993099) | Performance Met? |
|---|---|---|---|---|
| Product Name | Anjon Bremer Halo System | Bremer Halo System Cervical Traction Skull Pin | Bremer Halo System Titanium Skull Pin | Yes |
| Product Code | JEC | JEC | JEC, HWC | Yes |
| Regulation # | 21CFR 888.3040 | 21CFR 888.3040 | 21CFR 888.3040 | Yes |
| Class | II | II | II | Yes |
| Prescription or O-T-C? | Prescription | Prescription | Prescription | Yes |
| Provided Sterile or Non-sterile? | Non-sterile | Sterile | Sterile | No (Difference noted, but not considered a barrier to PREDICATE EQUIVALENCE based on the conclusion) |
| Indications for Use | Intended for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition | Intended for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition | Intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization for treatment of patients for healing and rehabilitation of cervical spinal cord injuries | Yes (Subject device matches Primary Predicate, Reference Predicate is complementary) |
| Components | Crown (Metal), Adjustable Ring (Metal), Positioning Pins (Polymer), Positioning Pads (Polymer), Plastic molded vest (Polymer), Vest liner (synthetic lambskin), Rod superstructure (metal) with halo clamps (polymer), Threaded screw skull pin (Alloy), Torque Limiter (Polymer) | Halo Crown (Metal), Adjustable Halo Ring (Metal), Positioning Pins (Polymer), Positioning Pads (Polymer), Plastic molded vest (Polymer), Vest liner (synthetic lambskin), Rod superstructure (metal) with halo clamps (polymer), Threaded screw skull pin (Alloy) | Halo Crown (Metal), Adjustable Halo Ring (Metal), Positioning Pins (Polymer), Positioning Pads (Polymer), Plastic molded vest (Polymer), Vest liner (synthetic lambskin), Rod superstructure (metal) with halo clamps (polymer), Threaded screw skull pin (Alloy), Torque Limiter (Polymer) | Yes (Components are largely identical or comparable) |
| Accessories | Torque wrench, Head spoon, ICU Fast Release Bolts, Mayfield Adapter Set | Torque wrench, Head spoon, ICU Fast Release Bolts, Mayfield Adapter Set | Not applicable (Reference Predicate is a skull pin, not the full system) | Yes (Matches Primary Predicate) |
| Sterilization Methodology | Not applicable | Ethylene Oxide | Ethylene Oxide | No (Difference noted, but not considered a barrier to PREDICATE EQUIVALENCE based on the conclusion. It likely suggests a different sterilization strategy by Anjon that wasn't detailed here but was acceptable to FDA.) |
| MRI Safety | MR Conditional | MRI Compatible | MRI Compatible | Yes (MR Conditional is a specific rating that is acceptable) |
| Material Composition | 356-T-6 aluminum, Wrought Titanium-6Aluminum-4Vanadium ELI, Aluminum 6061-T6, Nylon 66 resin containing 50% Long Glass, and Resinol type A (LPDE) | (Implicitly similar or equivalent materials as per predicate) | (Implicitly similar or equivalent materials as per predicate) | Yes (Claimed similar/equivalent) |
Study that Proves the Device Meets Acceptance Criteria:
The "study" presented is a 510(k) Substantial Equivalence Comparison, not a clinical trial or performance study against specific clinical endpoints. The document implicitly claims "acceptance" of the device by the FDA through the 510(k) clearance process, which is based on demonstrating that the device is as safe and effective as a legally marketed predicate device. This is achieved by comparing technological characteristics and indications for use.
The conclusion states: "The Anjon Bremer Halo System is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin predicate device (Primary Predicate - K915800) and Bremer Halo System Titanium Skull Pin (Reference predicate - K993099). In addition to conclusions from performance data comparisons, the devices have the same "Indications for Use," and are available by prescription only, and are for single use only."
The "performance data comparisons" mentioned in the conclusion would refer to analyses (not explicitly detailed in this summary) that demonstrate the subject device performs similarly to the predicate devices with respect to mechanical properties, material properties, and functionality relevant to cervical spine immobilization and traction. This likely includes bench testing for strength, durability, torque characteristics, and material biocompatibility, rather than clinical efficacy data for patients.
Regarding the specific questions that are not applicable to this type of device and submission:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device and submission. There is no "test set" of clinical data in the context of an AI/ML device. The "data" involves device specifications and material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth is established with expert readers.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical ground truth for an AI/ML device. The "ground truth" for this submission is the accepted safety and effectiveness of the legally marketed predicate devices, against which the subject device is compared via its technical specifications and intended use.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.