(20 days)
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.
The XPS Curved Bur consists of a cutting tip connected to a flexible bur shank which is surrounded by a stationary outer cannula. The flexible shank and cutting tip are rotated by a surgical drill motor.
This document is a 510(k) summary for the Medtronic Xomed XPS Curved Bur. It establishes substantial equivalence to a predicate device, focusing on functional characteristics rather than specific performance metrics that would require a study with acceptance criteria. As such, the provided text does not contain the information requested regarding acceptance criteria and a study to prove the device meets them.
Here's a breakdown of why the requested information cannot be extracted from the given text:
- No Acceptance Criteria or Performance Metrics: The document's purpose is to demonstrate "substantial equivalence" based on similar intended use, technology, and materials, not to define specific performance benchmarks (like accuracy, precision, speed, etc.) that the device must meet through testing.
- No Study Described: There is no description of any study (clinical, laboratory, or otherwise) that was conducted to evaluate the performance of the XPS Curved Bur against predefined acceptance criteria. The "study" mentioned is the 510(k) review itself, which compares the new device to a predicate.
- No Data Provenance, Expert Information, or Ground Truth: Since no performance study is described, there's no mention of sample sizes, data origin, experts involved in establishing ground truth, or adjudication methods.
- No MRMC or Standalone Performance: These terms are relevant to diagnostic or AI-assisted devices, neither of which the XPS Curved Bur is.
- No Training Set Information: This is also not applicable to a purely mechanical surgical instrument.
The document primarily relies on a table comparing the new device's characteristics to the predicate device's characteristics to demonstrate substantial equivalence, rather than providing a performance study.
Therefore, the table below will be largely empty as the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| No specific performance metrics or acceptance criteria are provided in the document. | N/A | N/A |
| Intended Use / Indications for use | Incising or removing bone in the ear, nose, or throat area | Incising or removing bone in the ear, nose, or throat area |
| For use with a surgical drill per 21 CRF § 874.4140 | Yes | Yes |
| Maximum rotational speed | 80,000 RPM | 80,000 RPM |
| Bur guard integrated into design or available as an accessory | Yes | Yes |
| Direct patient contacting materials | Stainless Steel and medical polymer | Stainless Steel, 6/6 nylon thread, and medical polymer |
| Blades / burs biocompatible | Yes | Yes |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable, as no performance test set is described. The 510(k) submission process did not involve a test set for performance evaluation in the context of this document.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no performance test set with ground truth established by experts is described.
4. Adjudication method for the test set:
- Not applicable, as no performance test set and corresponding ground truth adjudication are described.
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 MRMC study was done. This device is a surgical bur, not an AI-powered diagnostic or assistance tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a mechanical surgical instrument, not an algorithm.
7. The type of ground truth used:
- Not applicable, as no performance study requiring ground truth is described. The "ground truth" in the context of this 510(k) summary is the established safety and effectiveness of the legally marketed predicate device to which the XPS Curved Bur is compared.
8. The sample size for the training set:
- Not applicable, as no algorithm or training set is involved.
9. How the ground truth for the training set was established:
- Not applicable, as no algorithm or training set is involved.
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.