(27 days)
The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for use by trained medical personnel as an interface coupling device, to permit attachment to and operation of the Medtronic, Midas Rex "Legend" Bone Mill (BM1100) and Disposable Bowl Bone Mill (BM200) with an Anspach motor.
The Coupler is a simple attachment; comprised of a cylindrical housing with external locking feature, that when inserted into the bone mill, physically locks the coupler to the bone mill. The coupler is designed to attach and lock onto the Anspach spindle (drive shaft), to permit operation of the bone mill. There are two coupler designs; one for Black Max and one for Micro/Max/xMax and eMax. Attachment is a simple insertion/twist motion, to align cantilever tabs with the Bone Mill "D-lock" feature. A simple twist motion that depresses the two coupler cantilever tabs, unlocking coupler from the bone mill for easy removal.
The provided text describes the Anspach Coupler, a device designed to attach and lock onto an Anspach motor to permit operation of certain Medtronic, Midas Rex bone mills. It does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.
Instead, the document details the device's design, intended use, and a comparison table for demonstrating substantial equivalence to other Anspach Nosepiece Attachments for regulatory purposes. This is a common approach for Class II medical devices seeking 510(k) clearance, where the focus is often on demonstrating equivalence to a predicate device rather than conducting extensive performance studies with quantitative acceptance criteria in the manner of a new technology.
Therefore, many of the requested categories related to acceptance criteria, study performance, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable to the information provided in this 510(k) summary.
Here's a breakdown of the information that can be extracted and an explanation for what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functionality | Attach and lock onto the Anspach spindle (drive shaft). Permit operation of specific Medtronic, Midas Rex bone mills (BM1100, BM200). | "The coupler is designed to attach and lock onto the Anspach (drive shaft) spindle to permit operation of the Medtronic, Midas Rex 'Legend' Bone Mill (BM1100) and Disposable Bowl (BM200) with an Anspach motor." |
| Compatibility (Motors) | Use with Pneumatic & Electric motors | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Attachment Method | Tool-Less attachment | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Competitor Device Use | For use with Competitor Device(s) | Y (for Anspach Coupler) |
| Input Speed | 80-85k | 80-85k (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Operating Temperature (Max) | 120° Max | 120° Max (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Material Construction | Stainless steel construction | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Bearing Type | Corrosion resistant bearings | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Cleaning Method | Immersion cleaning | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Sterilization Method | Steam Sterilization, Sterrad sterilization | Y (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
| Serviceability | Not user/third-party serviceable; Anspach serviceable. | N (User Service/Repair), Y (Anspach Service/Repair) (for Anspach Coupler and Other Anspach Nosepiece Attachments) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document does not describe a formal "test set" with a specific sample size in the context of performance metrics that would typically apply to software or diagnostic devices. The evaluation here is based on design specifications and a comparison to predicate devices, not empirical performance data from a patient cohort.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As there is no "test set" in the context of performance metrics for this device, there are no experts establishing ground truth for such a set. The "ground truth" for this filing is based on engineering design, material science, and the functional requirements for mechanical compatibility and safe operation as outlined by Anspach and reviewed by the FDA.
4. Adjudication method for the test set:
- Not Applicable. No test set or corresponding adjudication method is detailed.
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 a mechanical attachment for surgical drills, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is based on engineering specifications and functional requirements for a mechanical device, verified through design, material selection, and internal testing (though specific testing details are not provided in this summary). It's also implicitly based on the established safety and effectiveness of the predicate devices (other Anspach Nosepiece Attachments and the bone mills it interfaces with). The FDA's substantial equivalence determination relies on assurance that the new device shares fundamental characteristics and functions without raising new questions of safety or effectiveness.
8. The sample size for the training set:
- Not Applicable. The concept of a "training set" is relevant for machine learning or AI models, which this device is not.
9. How the ground truth for the training set was established:
- Not Applicable. This device does not involve a training set as it's not an AI/ML product.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).