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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 skull relative to 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.

Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.

This document describes a medical device, the Anjon Bremer Halo System, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device. Therefore, the questions related to acceptance criteria, study details for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance, and effect sizes are not applicable to the content provided.

The document focuses on:

• Device Description: The Anjon Bremer Halo System is composed of transcutaneous bone anchorage elements (titanium threaded skull pins) and extracutaneous bridge elements (crown or ring) for cervical spine immobilization and therapeutic traction.
• Indications for Use: To provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
• Predicate Devices: The device acts as its own predicate (K171863) and is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin (K915800) and the Bremer Halo System Titanium Skull Pin (K993099).
• Non-Clinical Testing: This section outlines the engineering and biocompatibility tests performed on the Anjon Bremer Halo System to ensure its safety and performance. This includes:
  • Testing of Skull Pins to failure under load (ASTM F1541).
  • Biocompatibility assessment (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity testing per ISO 10993).
  • Testing of the Halo for deformation under load (ASTM F1831).
  • Product and sterile barrier stability testing per ISO 11607-2, including post-gamma irradiation and accelerated aging.
  • Sterilization validation using the VDmax25 method (ISO 11137).
• Conclusion: Based on the non-clinical testing and comparison to predicate devices, the Anjon Bremer Halo System is concluded to be substantially equivalent.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device, as the provided text pertains to a traditional mechanical medical device.

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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.

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:

2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. 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.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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