(35 days)
The Power System Handpiece is intended for use for holding and delivering power to surgical accessories (i.e. burrs, drills).
Aesculap's modified Power System Handpiece is a stainless steel device used for holding and delivering power to surgical accessories (i.e. burrs, drills.) The device has an overall length of 230 mm with a shaft angle of 21°. The handpiece holds drills and burrs with a shank diameter of 2.35 mm and a length of 180 mm. The device is connected to an electro-surgical motor unit via a power drive cable. The Power System Handpiece is compatible with Aesculap's Elan-E and Microtron power units. The Internal gear ratio is 1:2, allowing the device to run at speeds of 0-36,000 rpm with the Elan-E and 0-54,000 rpm with the Microtron power unit.
This 510(k) submission (K960473) describes a modification to an existing device, the Aesculap Power System Handpiece. The modification is an increase in the length of the handpiece shaft from 75mm to 125mm. The submission primarily relies on equivalence to predicate devices and adherence to international standards rather than a detailed clinical study with acceptance criteria in the traditional sense of a new medical device.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Interface coupling meets German DIN standard 13940 | Meets DIN 13940 |
| Interface coupling meets International Standards Organization standard ISO 3964 | Meets ISO 3964 |
| No change in intended use | Intended use remains "for holding and delivering power to surgical accessories (i.e. burrs, drills)" |
| Device functions comparably to predicate devices (Aesculap K770428, Hall Surgical K864929, Midas Rex K900388) | The only modification is shaft length, which is comparable to those offered by Hall Surgical and Midas Rex. The internal gear ratio and speed capabilities are also detailed, implying functional equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of patient data or clinical outcomes. The performance data mentioned relates to compliance with engineering standards for the device's interface coupling. Therefore, there's no information about sample size or data provenance in that regard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for this submission appears to be adherence to established engineering standards (DIN and ISO) and functional equivalence to predicate devices, rather than a clinical ground truth requiring expert consensus on patient data.
4. Adjudication Method for the Test Set
Not applicable. There's no clinical test set or adjudication process described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This submission does not include an MRMC comparative effectiveness study. It's for a modified surgical instrument, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an AI-based device, so this type of study is not relevant or performed.
7. Type of Ground Truth Used
The "ground truth" implicitly used is:
- Compliance with established engineering standards: Specifically German DIN standard 13940 and International Standards Organization standard ISO 3964 for the interface coupling.
- Functional equivalence to predicate devices: The modified device's design, function (e.g., speed capabilities, ability to hold accessories), and intended use are considered substantially equivalent to previously cleared devices.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding ground truth establishment process.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which are primarily technical standards and substantial equivalence) is the technical evaluation and comparison presented in the 510(k) submission itself.
- Evidence for meeting DIN 13940 and ISO 3964: The document states, "However, the interface coupling on the Power System Handpiece meets the requirements of German DIN standard 13940 and International Standards Organization standard ISO 3964." This indicates the manufacturer conducted internal testing or design verification to confirm compliance with these standards.
- Evidence for substantial equivalence: The document explicitly compares the modified device to predicate devices (Aesculap K770428, Hall Surgical K864929, and Midas Rex K900388). The key argument is that "Aesculap believes that the Power System Handpiece presented in this submission is substantially equivalent in design, function, and intended use to the presented devices." The only noted difference, the shaft length, is argued to be comparable to competitor's offerings, thus maintaining equivalence. The unchanged intended use and the internal gear ratio/speed capabilities also support this claim of substantial equivalence.
Essentially, for this type of device modification, the evidence for safety and effectiveness (and thus meeting "acceptance criteria") relies on demonstrating that the changes do not introduce new questions of safety or effectiveness and that the device still functions as intended and meets relevant technical specifications, similar to legally marketed predicate devices. No formal clinical study with patient data is described or required for this type of submission.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.