(190 days)
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
| Feature | Acceptance Criteria (Predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Delicate bone dissection in the ear, nose, and throat areas (K#080722 - Primado Neurological Drill); Cutting of soft tissue and bone in various surgical procedures (K#002523 - Advantage Drive System) | Delicate bone dissection in neurological, maxillofacial, craniotomy, and spinal procedures, and in the ear, nose, and throat areas. |
| Description | Electrically powered surgical instrument system and handpieces operated by foot controller | Electrically powered drill and surgical motor system and attachments operated by foot controller |
| Compliance with Standards | IEC 601-1, IEC 601-1-2, UL2601-1 (for K#002523) | IEC 60601-1, IEC 60601-1-2 |
| High Speed | Up to 100,000 rpm | Up to 100,000 rpm |
| Low Speed | Up to 30 rpm (for K#002523) | Up to 234 rpm |
| Oscillating Saw | Up to 20,000 cpm | Up to 20,000 cpm |
| Sagittal Saw | Up to 20,000 cpm | Up to 20,000 cpm |
| Reciprocating Saw | Up to 17,000 cpm (for K#002523) | Up to 19,300 cpm |
| Patient Contact Materials | Unknown (for K#002523) | Surgical stainless steel; diamond |
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.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).