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The MicroPower Hand Piece: OralMax 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 field of application includes only oral/maxillofacial.

The MicroPower Hand Piece: Oral Max High Speed Drill device description MicroChoice product line cleared is identical to 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.

This document is a 510(k) premarket notification for a medical device, the MicroPower Hand Piece: Oral Max High Speed Drill. It declares that the device is substantially equivalent to a previously cleared predicate device (Universal Drive System, K971059) and does not contain information about a study proving the device meets specific acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence based on the device's design, intended use, and scientific technology being similar to a predicate device, rather than providing a performance study against acceptance criteria.

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The Universal Drive System 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, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

The Linvatec Universal Drive System is a modification of the Universal Drive System with the addition of three new handpieces used in large bone orthopedic procedures. The Universal Drive System was cleared under 510 (k) #K971059 on 6/18/97 for the following intended uses: Cutting of soft tissue and bone in Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

The Universal Drive System consists of an AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.

The modification will take place within the Universal drive console power unit. A software computer chip will be upgrade to allow the use of additional motorized handpieces for large in order to have more available current to drive the large bone handpieces.

Three handpieces used in large bone orthopedic procedures will be added to the system. The new handpieces include single trigger modular, dual trigger modular handpiece and an oscillating saw. These handpieces are similar in design to the Hall® Versipower® Plus handpieces. The handpieces will be sold with a detachable handpiece cord. The detachable handpiece cord will allow the handpieces run on the same console. The new handpieces will to perform as the Versipower® Plus handpieces described in the predicate information.

The accessories used with the system include shavers, blades, burrs, drills, and routers as described in 510(k)# K971059.

The Linvatec Universal Drive System's 510(k) submission (K981269) does not provide a table of acceptance criteria, device performance, or details about a specific study designed to prove the device meets acceptance criteria in the manner typically expected for AI/ML medical devices. This document is a premarket notification for a traditional medical device (a surgical drive system) submitted in 1998, long before AI/ML-driven device evaluation frameworks were established.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices of this type at that time.

Here's an analysis based on the provided text, addressing the points where information is available or applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission. The document states: "Testing has been done to prove safety and effectiveness of the devices," but it does not present a table of specific acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) or quantifiable performance metrics for the Universal Drive System. The "performance" in this context refers to its ability to perform its intended function similarly to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a mechanical surgical device, not a diagnostic or prognostic AI/ML device that would typically involve test sets of patient data. The "testing" mentioned would likely refer to engineering verification and validation tests (e.g., torque, speed, durability) in a lab setting, not a "test set" of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As above, this type of ground truth establishment is not relevant for a surgical drive system.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for AI-assisted diagnostic or prognostic tools where human readers interpret medical images or data. The Universal Drive System is a surgical instrument.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for a device like this would be established through engineering specifications, performance standards, and comparison to the functional capabilities of the predicate devices. For example, if the device is spec'd to provide a certain RPM or torque, the ground truth is that it should meet or exceed that.

8. Sample Size for the Training Set

Not applicable. A "training set" is a concept for AI/ML model development, not for a traditional mechanical surgical tool.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device-Specific Information from the Text:

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Linvatec Universal Drive System K971059, Hall® Versipower® Plus Large Bone Instrument System K895198, and 3M™ Maxi-Driver™ Electric Powered Instrument System K951118).

• Device Description: The Universal Drive System is a modification of an existing Linvatec system (cleared under K971059) with the addition of three new handpieces (single trigger modular, dual trigger modular, oscillating saw) and a software upgrade to the console to provide more current for large bone handpieces.
• Intended Use: Cutting of soft tissue and bone in Orthopedic, Oral/Maxillofacial, Otolaryngological, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures. The new handpieces specifically target "Large Bone Orthopedic Procedures."
• Substantial Equivalence Justification: The new handpieces are described as similar in design and performance to the Hall® Versipower® Plus handpieces. The document implicitly asserts the safety and effectiveness through this substantial equivalence claim and states that "Testing has been done to prove safety and effectiveness of the devices," without providing further details on the nature or results of these tests within the provided text.

In essence, the "study" proving the device meets acceptance criteria in this context is the company's internal engineering verification and validation testing, which supports the claim of substantial equivalence to already cleared devices. The FDA's acceptance of the 510(k) (K981269 letter) confirms that the device is substantially equivalent and can be marketed subject to general controls.

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