(90 days)
The Bremer Halo System Titanium Skull Pins are intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, which provide cervical immobilization necessary for healing and rehabilitation of cervical spinal cord injuries.
The Bremer Halo System Titanium Skull Pin described in this submission is a modification of the previously cleared Bremer Halo System Sterile Cervical Traction Skull Pin, The modified pin is longer than the previously cleared pin and the tip is a drill bit rather than a pointed tip. The Bremer Halo System Titanium Skull Pin is manufactured from implant grade titanium alloy that conforms to ASTM standard F-136.
The provided text describes a 510(k) submission for a medical device (Bremer Halo System Titanium Skull Pin) and focuses primarily on its substantial equivalence to an existing device rather than a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI device is not available in the given document.
However, I can extract the relevant information that is present and indicate where information is missing based on the prompt's requirements.
Here's a breakdown of what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Hypothesized) | Reported Device Performance |
|---|---|
| Material Conformance | Manufactured from implant grade titanium alloy conforming to ASTM standard F-136. |
| Mechanical Performance | "Testing was presented to evaluate the performance characteristics of the Bremer Halo System Titanium Skull Pin." (Specific results not detailed in this summary.) |
| Design Equivalence | Modified pin is longer and has a drill bit tip compared to the previously cleared pin with a pointed tip. (This is a design characteristic, not a performance metric in the same vein as clinical efficacy). |
| Intended Use Equivalence | Intended for use in conjunction with Bremer's Halo System cervical traction devices and accessories, providing cervical immobilization for spinal cord injuries. This matches the predicate device's intended use. |
| Substantial Equivalence | Based on equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin. |
| (Other performance metrics) | Not specified in the summary. |
Explanation: The document explicitly states that the device's substantial equivalence is "based on an equivalence in intended use, materials, design, and relative indications and contraindications to the existing Bremer Halo System Sterile Cervical Traction Skull Pin." This implies that the 'acceptance criteria' are primarily related to matching or demonstrating comparable characteristics to the predicate device, rather than achieving specific quantitative performance thresholds like an AI system might. "Testing was presented to evaluate the performance characteristics," but the results of this testing against specific, quantified acceptance criteria are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document refers to "testing" but does not specify the sample size of any test sets (e.g., number of pins tested, number of simulated applications, etc.) nor the provenance of any data used for such tests. Given the nature of the device (a mechanical titanium skull pin), "test set" here would refer to the physical units tested, not a clinical data set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable to this type of device submission. This information is typically relevant for AI/ML devices where expert review is needed to establish ground truth for training or evaluating diagnostic accuracy. For a mechanical device like a skull pin, "ground truth" would be established through material science tests, mechanical load tests, and design validation, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable and not available. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, typically for diagnostic AI. For a mechanical device, performance is evaluated against engineering specifications and standards, not through physician adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable and not available. MRMC studies are specific to evaluating diagnostic AI systems, comparing human reader performance with and without AI assistance. This device is a mechanical medical implant, not a diagnostic AI system.
6. Standalone (Algorithm Only) Performance Study
This is not applicable and not available. This concept is for AI algorithms. The device is a physical, mechanical skull pin.
7. Type of Ground Truth Used
The "ground truth" for this device would have been established through engineering specifications, material standards (e.g., ASTM F-136), mechanical testing results (e.g., strength, fatigue), and biocompatibility data. The document mentions conformance to ASTM standard F-136 for the material and that "Testing was presented to evaluate the performance characteristics," implying engineering and material science tests rather than pathology, outcomes data, or expert consensus in a clinical diagnostic sense.
8. Sample Size for the Training Set
This is not applicable and not available. Training sets are used for machine learning algorithms. This device is a mechanical component, not an AI system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable and not available. As there is no training set mentioned for an AI algorithm, the method for establishing its ground truth is irrelevant here.
§ 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.