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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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The Primado is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear nose, and throat area. A wide range of attachments includes a perforator drive, craniotome, straight/angle/malleable drills, and microsaws.

The Primado Surgical System is an AC-electrically powered total surgical system that allows for the use of multiple attachments to perform delicate bone dissection in neurological procedures. The device consists of a control unit, foot controller, micromotor, motor cord, AC power cord, perforator drive, craniotome, straight/angle/malleable drills, and microsaws. The device does not come sterile and all parts that contact the patient as well as the AC power cord should be sterilized prior to the first use and after each use.

Here's the analysis of the provided text regarding the Nakanishi Inc. Primado Surgical System:

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested fields (e.g., sample size, expert ground truth, MRMC study, AI improvement effect size, standalone performance, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The "study" here is primarily a comparison to predicates and compliance with standards.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are defined by the characteristics of the predicate devices. The "reported device performance" is the characteristics of the new device, aiming to be substantially equivalent to the predicates. The comparison largely depends on claiming "identical" or "similar" specifications and compliance with relevant safety standards.

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

• Not Applicable. This document is a 510(k) summary for a surgical drill system, not a diagnostic or AI device. The "test set" in this context refers to the device's technical specifications and compliance with standards, not a dataset of patient images or clinical outcomes. The demonstration of substantial equivalence relies on comparing technical specifications and intended use with previously cleared devices.

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

• Not Applicable. This document does not pertain to establishing ground truth for a test set in the context of diagnostic performance. Technical specifications and safety compliance for a surgical drill system are typically evaluated against engineering standards and design requirements, not expert-established ground truths.

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

• Not Applicable. See point 3.

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

• Not Applicable. This device is a surgical drill system. It does not involve human readers, AI, or diagnostic interpretation.

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

• Not Applicable. This is a hardware surgical instrument, not an algorithm.

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

• Not Applicable / Based on Predicate Equivalence and Standards. The "ground truth" for this device's acceptance is its demonstrated equivalence in technical specifications, intended use, and adherence to recognized safety standards (like IEC 60601-1) compared to legally marketed predicate devices. There is no biological "ground truth" in the sense of pathology or outcomes data for the device itself in this submission.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. See point 8.

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The Primado is an electrically powered surgical system for delicate bone dissection in the ear, nose and throat areas. A wide range of attachments includes a In the car, dood and chrous, straight/angle/malleable drills, and microsaws.

The Primado is an electrically powered surgical system.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device conformance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the "Primado Surgical Drill," indicating that it has been found substantially equivalent to a legally marketed predicate device. It specifies the intended use of the device and regulatory information but does not contain any performance study details or acceptance criteria for demonstrating that performance.

Ask a specific question about this device