(68 days)
The MicroPower Hand Piece: High Speed Drill, functions as a powered instrument system consisting of drills, saws and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: orthopedic, arthroscopic, neurosurgical, otolaryngological, plastic/reconstructive, and oral/maxillofacial procedures.
The MicroPower Hand Piece High Speed Drill device description is identical to the MicroChoice product line cleared in the original submission except for the modifications which have been detailed in Section 9 of this submission. These modifications do not affect the device's intended use, fundamental scientific technology or performance specifications so that any new issues regarding safety and effectiveness are raised.
The MicroPower hand pieces are electric and based upon the existing Microchoice hand piece platform cleared under K971059. Both are pencil grip handhelds that are used in conjunction with the Advantage®, E9000® and PowerPro® controllers. A chord connects the hand pieces to the controllers that supply power to the device. The hand pieces have a lever that is used to actuate the device. The drills use a wide variety of bur guards, attachments, drill bits and burs. The saws use a wide variety of blades. The MicroPower drill and saws will use the same burs and blades that the current Microchoice hand pieces use.
The provided document describes a Special 510(k) submission for the Linvatec MicroPower Hand Piece High Speed Drill. This type of submission is for modifications to a manufacturer's own legally marketed device, asserting that the modifications do not affect the device's intended use, fundamental scientific technology, or performance specifications such that any new issues regarding safety and effectiveness are raised.
Therefore, the document does not present a traditional "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial or a performance study with quantitative metrics against pre-defined acceptance criteria for a novel device. Instead, the "study" alluded to is the testing performed to ensure the modifications do not raise new safety and effectiveness issues and the assertion of substantial equivalence to the predicate device.
Here's an attempt to answer your request based on the provided text, acknowledging the nature of a Special 510(k) submission for a modified device:
Acceptance Criteria and Study for Linvatec MicroPower Hand Piece High Speed Drill
The MicroPower Hand Piece High Speed Drill is a modification of an existing device (MicroChoice product line, cleared under K971059). The acceptance criteria and "study" are framed within the context of demonstrating that these modifications do not introduce new safety or effectiveness concerns, and that the modified device remains substantially equivalent to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from 510(k) nature) | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | No new issues regarding safety and effectiveness are raised by the modifications. | "The changes made to the Universal Drive System have been tested to assure that the proposed modifications do not raise any new issues regarding safety and effectiveness." |
| Intended Use | The device's intended use is not affected by the modifications. | "These modifications do not affect the device's intended use..." (The fields of application were slightly changed but still align with the functionality of a surgical drill system.) |
| Fundamental Scientific Technology | The fundamental scientific technology remains unchanged. | "...do not affect the device's ... fundamental scientific technology..." (Based on existing MicroChoice hand piece platform, electric, pencil grip, uses same burs and blades.) |
| Performance Specifications | The performance specifications are not affected by the modifications. | "...do not affect the device's ... performance specifications..." (Implied to be consistent with the predicate device.) |
| Substantial Equivalence | The modified device is substantially equivalent to the legally marketed predicate device (K971059). | "The MicroPower Hand Piece High Speed Drill is substantially equivalent in scientific technology, design and in indication for use to the MicroChoice Universal Drive System." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a separate "test set" with a numerical size. The "testing" refers to verification and validation activities conducted on the modified device itself.
- Data Provenance: Not applicable in the context of clinical data. The data provenance would be from internal engineering and design verification reports for the modified hand piece.
- Retrospective/Prospective: Not applicable to this type of submission. The evaluation is focused on the device's design and performance rather than clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document, as the submission does not involve clinical data with "ground truth" derived from expert consensus. The "ground truth" here is the established safety and effectiveness of the predicate device, and the demonstration that the modified device maintains those attributes.
4. Adjudication Method for the Test Set
- Not applicable. There is no mention of a formal adjudication method for a test set, as no clinical study or expert review of data is described. The "adjudication" is internal to the manufacturer's testing and review process, leading to the regulatory submission for substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or those involving human interpretation, to assess improvement with AI assistance. The MicroPower Hand Piece is a surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- No. This question is also not applicable as the device is a physical surgical hand piece, not an algorithm or a decision-support system.
7. The Type of Ground Truth Used
- The "ground truth" is implicitly the performance, safety, and effectiveness of the legally marketed predicate device (MicroChoice Universal Drive System, K971059). The Special 510(k) argues that the modified device maintains these established characteristics due to the nature of the modifications not raising new issues.
8. The Sample Size for the Training Set
- Not applicable. The concept of a "training set" is relevant for AI/machine learning models. The MicroPower Hand Piece is a mechanical/electrical surgical instrument, not an AI-driven device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reasons as #8.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).