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The D4000/D4000A System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include Arthroscopic, Foot, Hand, Medial Sternotomy, Neurological, Orthopedic, Otolaryngological, Oral/Maxillofacial, Plastic/Reconstructive, and Spinal surgical procedures.

The D4000/D4000A Drive System console functions as a powered instrument console for driving powered instruments and accessories used in the cutting of soft tissue and bone at the surgical site. The D4000/D4000A Drive System console is a non-sterile device and must be located in a non-sterile area of the operating suite. Additionally the D4000A console offers an irrigation pump that, when used with tubing sets, provides a sterile fluid supply to the blades, burs, and drill bits, at the surgical site, for lavage and cooling. The handpiece, handpiece cord, and irrigation tube sets are sterile. The handpiece is used in the sterile field with the cord connected to the console. The irrigation tube set is used on the handpiece in the sterile field with the cassette connected to the console. The footswitch is non-sterile and placed on the floor. The console provides two handpiece drive ports that are used with a variety of handpieces. Handpiece functionality can be controlled directly by the handpiece, and/or by a corded footswitch or wireless footswitch. Handpiece speed, direction, user settings, irrigation flow rate, and footswitch settings are controlled with the touch-screen displays. The D4000/D4000A is a rebranded update to the Advantage Turbo Drive System (D3000), which shares the same intended use, indications for use, conditions of use, and fundamental scientific technology with the predicate device. The D4000/D4000A powers a reduced set of the same handpieces, to the same performance specifications, as the D3000. Where applicable, these handpieces can also be activated by the same footswitches used in the previous system. The D4000/D4000A software was rewritten in order to accommodate the new internal circuitry layout and to support additional integrated components (i.e. touchscreens, wireless footswitch transceiver, etc.) as well as to send direct signal to 24k when shaver is operating. Further, the D4000 and D4000A are the same device except for the fact that, like the D3000, the D4000A incorporates a low-flow purpose of optional handpiece irrigation. The D4000A also includes a "Prime Button" on the front panel that is associated with the low-flow pump.

This is a 510(k) summary for a medical device (D4000/D4000A Drive System), not a study evaluating an AI device or presenting acceptance criteria for an AI algorithm. Therefore, much of the requested information (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or present in this document.

However, I can extract the general acceptance criteria and the type of study performed for this device based on the provided text.

Acceptance Criteria and Study for the D4000/D4000A Drive System:

This document describes a medical device clearance process for a powered surgical instrument system, the D4000/D4000A Drive System, rather than an AI algorithm with specific performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here refer to demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device (ConMed Linvatec's Advantage Turbo Drive System, K050519) and meets safety and performance standards relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the traditional sense of an AI test set with case counts. The "test set" here refers to the device itself and its components undergoing engineering and functional testing. The document does not specify a numerical sample size for components or systems tested.
• Data Provenance: Not applicable. The "data" are results from internal engineering verification and validation tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth for this type of device (a powered surgical instrument) is established through engineering specifications, performance standards, and comparison to existing devices, not through expert consensus on medical images or clinical outcomes in the same way an AI diagnostic tool would. Design and testing would involve engineers and potentially medical professionals for usability/functional feedback, but not "experts establishing ground truth" in the AI context.

4. Adjudication method for the test set:

• Not applicable. This concept (e.g., 2+1, 3+1) is specific to situations where multiple human readers are interpreting data to form a consensus ground truth. Here, compliance is determined by meeting engineering specifications and regulatory requirements.

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, an MRMC study was not done. This type of study applies to diagnostic AI systems and is not relevant to a powered surgical instrument.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a console for powered surgical instruments; it is not an algorithm that operates in a standalone diagnostic capacity. Its function inherently involves human interaction (a surgeon operating the handpiece).

7. The type of ground truth used:

• The "ground truth" for this device's performance evaluation is based on:
  • Engineering Specifications: The device must meet predefined electrical, mechanical, and software performance criteria.
  • Regulatory Standards: Compliance with relevant medical device regulations (e.g., electrical safety, EMC, quality systems).
  • Predicate Device Performance: The new device must perform comparably to the legally marketed predicate device (Advantage Turbo Drive System, K050519) for its stated functions.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning. The software was rewritten to accommodate new hardware and features, suggesting a development and testing process, but not an AI training process.

9. How the ground truth for the training set was established:

• Not applicable, as there is no AI training set.

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