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The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.

The Primado2 consists of the Control Unit, the Foot Control (optional) and various handpieces for use with specific motors. Available Motors include Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has handpieces or attachments specific to that series. Burs, drills, blades (saws), and rasps are available for use with specific handpieces / attachments. Handpieces and attachments are available for cranial surgery, trephination, oral surgery, and craniotomy. Sagittal, reciprocating, and oscillation saw blades are available, including for intra oral use.

The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.

The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.

The provided text describes a surgical system, the "Primado2 Total Surgical System," and its performance testing. However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The document is a 510(k) summary for a medical device submission to the FDA, focusing on substantial equivalence to predicate devices and compliance with safety and electrical standards.

Here's an analysis based on the information provided and what is missing:

The device is the Primado2 Total Surgical System. Its intended use is "for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures."

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria (Stated/Implied)	Reported Device Performance
   Compliance to internal functional specifications (including software)	Demonstrated that the device is safe and effective.
   Compliance to FDA Guidance for Software Contained in Medical Devices (verification/validation, traceability to software requirements and risk hazards)	Documentation provided; testing confirmed compliance.
   Compliance to relevant voluntary safety standards (IEC 60601-1, IEC 60601-1-2) for Electrical safety and Electromagnetic Compatibility	Testing confirmed compliance.
   Compliance to applicable standards for biocompatibility and sterilization	Evaluations and validations performed to demonstrate compliance.
   Substantial equivalence to predicate devices (K083112, K040369, K040300, K081475, K053526)	Stated that the device is substantially equivalent based on similarities in primary intended use, principles of operation, functional design, and established medical use.

   Note: The document does not report specific quantitative performance metrics for the device's surgical capabilities beyond general statements of "safe and effective" and compliance with standards. There are no sensitivity, specificity, or accuracy figures typical of diagnostic or AI-driven devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   This information is not provided in the document. The testing described is verification/validation to internal specifications, software requirements, and safety standards, rather than a clinical trial with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   This information is not provided. The device is a surgical system, and the reported testing is about its functional, electrical, and safety performance, not about assessing clinical outcomes against expert-established ground truth in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here.

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

   This information is not provided. An MRMC study is not relevant for this type of device (a surgical tool) and the type of performance testing described. The device is not an AI-driven assistive tool for readers.

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

   This information is not provided and is not applicable. This device is a surgical system, requiring human operation, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   This information is not provided and largely not applicable in the context of the reported performance testing. The "ground truth" for the device's performance appears to be its ability to meet engineering specifications, safety standards, and functional requirements. For example, for "electrical safety," the ground truth would be conformance to IEC 60601-1.

8. The sample size for the training set

   This information is not provided. The device is not described as involving machine learning or AI that would require a "training set."

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

   This information is not provided and is not applicable, as there is no mention of a "training set" or AI/machine learning components in the device description.

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