(77 days)
The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIP AIR" can be also used in the ENT and Orthopaedics.
The Medicon VIPAIR pneumatic high speed system is specially designed for cutting and drilling of cranial and spinal bones. This system combines security and precision in an ergonomic design. The latest technology allows a reduction of the noise level to a minimum. The System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms , burs, drills and cutters. The system components connect to each other via a safety coupling mechanism.
The provided document is a 510(k) Summary for the Medicon VIPAIR Pneumatic High Speed System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those specific criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, human reader studies, and training data is not present.
However, I can extract information related to the comparison with predicate devices, which serves as a form of "acceptance criteria" in the context of 510(k) submissions, as the device must be shown to be substantially equivalent.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission, "acceptance criteria" are typically defined by demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics.
| Characteristic / "Acceptance Criteria" | Medicon VIPAIR System Performance / Comparison |
|---|---|
| Intended Use | YES (Used for same clinical applications as predicates in Neurology, ENT, Orthopaedics) |
| Methods of Sterilization / Sterility Status | YES (Steam Sterilization (DIN 58953-9); non-sterile upon delivery, requiring user reprocessing) |
| Material (Patient Contact) | YES (Surgical stainless steel, as per DIN ISO 7153-1) |
| Motor (Operation) | YES (Pneumatic power source, foot pedal control for speed) |
| Motor (Speed - RPM) | 100,000 RPM (Comparable to predicates ranging from 80,000 to 95,000 RPM) |
| Pressure (Operating PSI) | 90-120 PSI (Comparable to predicates ranging from ~20 to 150 PSI) |
| Handpieces and Accessories | YES (Includes straight and curved handpieces, craniotoms, burs, drills, and cutters, similar to predicates) |
| Industry Standards (MDD 93/42 EEC) | YES (Class IIA product, CE Certificate) |
| Company Certification (ISO 9001:2000 or EN ISO 13485-2003) | YES |
| German Medical Product Law (MPG) | YES |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A): This document describes a 510(k) submission focused on substantial equivalence to predicate devices, not a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm or diagnostic performance. Instead, it relies on comparative analysis of technical specifications and intended use against existing devices. There is no mention of a "test set" or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A): As explained above, there is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission. The evaluation is based on comparing device specifications and regulatory compliance.
4. Adjudication method for the test set:
- Not applicable (N/A): No test set or expert adjudication is described.
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, not done: This is a pneumatic surgical drill system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, not done: This is medical hardware (a pneumatic drill system), not a standalone algorithm.
7. The type of ground truth used:
- Not applicable (N/A): No "ground truth" as typically defined in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is used here. The "truth" for this 510(k) submission is the existence and regulatory status of predicate devices with similar characteristics and the device's conformance to established industry standards and its own specifications.
8. The sample size for the training set:
- Not applicable (N/A): This document does not describe the development or evaluation of an algorithm or AI model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable (N/A): As there is no training set, this information is not relevant or provided.
In summary: The provided document is a regulatory submission for a pneumatic surgical drill, demonstrating substantial equivalence to existing devices. It is not a study evaluating acceptance criteria for a novel diagnostic or AI-powered medical device. Therefore, many of the requested details about studies, sample sizes, ground truth establishment, and expert involvement are not pertinent to this specific document or type of device.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).