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The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.

The provided text is a 510(k) summary for the ELAN 4 Air Motor System, a pneumatic cranial drill motor. It does not describe a study involving an AI or algorithm-based device, human readers, or a test set with expert ground truth establishment. Instead, it describes a medical device (a surgical drill) and its performance validation through design verification and biocompatibility testing.

Therefore, I cannot answer your request as the information you've asked for (acceptance criteria for an AI/algorithm, sample size for AI test and training sets, expert consensus for ground truth, MRMC study, etc.) is not contained within the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices (other surgical drills) based on:

• Indications for Use: The ELAN 4 Air Motor System is intended for high-speed cutting, sawing, and drilling of bone in various surgical fields.
• Technological Characteristics: Comparison of components, power source (pneumatic vs. electric), operating speeds, rotation, materials, and control mechanisms.
• Performance Data (Design Verification): Functional testing to ensure the device performs as intended and safely meets specifications over time. These tests are explicitly listed as "Pass: All requirements met."
• Biocompatibility: Confirmation that materials used are safe for patient contact.

To reiterate, the provided text does not describe the kind of study you are asking about, which typically pertains to diagnostic or assistive AI software rather than mechanical surgical instruments.

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Aesculap's Microspeed Uni is intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

The Microspeed Uni is an electronic, high-speed motor system, which allows high-speed dissection up to 80,000 rpm while also allowing low speed cutting up to 40,000 rpm. The control system reduces heating to a minimum at high torque. The low speed motor can make use of all Aesculap Intra-handpieces (K953968) for adapted power at minimum weight. All HiLAN (K980686 and K973736) and Microspeed (K003612) handpieces can also be used for high-speed dissection with the Microspeed Uni. This allows universal use of one motor system during the entire procedure. All functions of the Microspeed Uni can be controlled from the sterile field by the foot control as well as the hand control for easy handling.

The Microspeed Uni Motor System is a medical device. The provided text indicates that the device's substantial equivalence was demonstrated by compliance with recognized consensus standards. Therefore, an in-depth study of the device’s performance against acceptance criteria as might be seen for a novel AI/ML device is not explicitly described in the provided text.

Here's an analysis based on the information given, framed to address your request for acceptance criteria and study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The document describes compliance with recognized standards and comparison to predicate devices, not a clinical trial with a test set of data in the context of AI/ML performance.

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

Not applicable. The ground truth for this type of device is established through engineering and safety standard compliance, and comparison to existing, legally marketed predicate devices, not expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no test set of data requiring adjudication in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an electric surgical motor system and does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is not an algorithm; it is a physical surgical motor system.

7. The Type of Ground Truth Used

The ground truth or basis for acceptance relies on:

• Compliance with recognized consensus standards: This serves as an objective measure of safety and performance against established engineering and electrical standards.
• Substantial equivalence to legally marketed predicate devices: This implies that the device's performance is deemed acceptable because it is functionally similar to devices already found safe and effective by the FDA.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. There was no training set for an AI/ML algorithm.

Summary of the Study:

The "study" or justification for the device's acceptance is primarily a comparison to predicate devices and compliance with international and national safety and performance standards.

• Predicate Devices: The Microspeed Uni Motor System was compared to the Aesculap Microspeed EC (K003612) and the Stryker Total Performance System (K943589).
• Technological Characteristics: The manufacturer stated that the Microspeed Uni offers "similar operating speeds, power sources, and attachments" and uses "the same or similar" materials as the predicate devices.
• Performance Data/Standards Compliance: Although no specific performance standards under Section 514 of the Food, Drug and Cosmetic Act were promulgated for this device type at the time, the device demonstrated compliance with several recognized consensus standards:
  • IEC60601-1: General requirements for safety of medical electrical equipment.
  • IEC60601-1-2: Electromagnetic compatibility requirements and tests for medical electrical equipment.
  • UL2601-1: General safety requirements for medical electrical equipment.
  • CAN/CSA-C22.2 No. 601.1-M90: Canadian standard for general safety requirements for medical electrical equipment.

This approach, known as 510(k) premarket notification, relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, often by showing it meets the same functional and safety benchmarks as those predicates, or complies with relevant recognized standards. The FDA's letter (K053526) confirms that substantial equivalence was determined based on the information provided, allowing the device to be marketed.

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