(270 days)
Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
The Vitalitec Medizintechnik GmbH Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: 1-6 mm bite sizes; 14 mm - 16 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin footplates; various handle and shaft styles; sliding shaft; detachable.
A rongeur is a robust constructed reusable surgical instrument with sharp, spoon shaped working ends, which used for cutting or biting bone during surgery involving the skull or spinal column.In Neurosurgery a rongeur is used for grasping and dissecting of bone and tissue during neurosurgical and orthopedic procedures.
This document is a 510(k) summary for the Vitalitec Kerrison Rongeurs, a manual surgical instrument. It compares the device to a predicate device (Integra Kerrison Rongeurs, K092227) to demonstrate substantial equivalence, rather than describing a study to prove acceptance criteria for an AI-powered device. Therefore, most of the requested information regarding AI device evaluation is not applicable here.
However, I can extract the information relevant to this specific device (a manual surgical instrument) as best as possible.
Device Overview:
- Device Name: Vitalitec Kerrison Rongeurs
- Regulation Number: 21 CFR 882.4840
- Regulation Name: Manual Rongeur
- Regulatory Class: Class II
- Product Code: HAE
- Indications for Use: Manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
- Predicate Device: Integra LifeSciences Corporation device, Integra™ Kerrison Rongeurs, cleared under 510(k) K092227.
1. Table of Acceptance Criteria and Reported Device Performance
For this manual surgical instrument, "acceptance criteria" are implied by the performance standards it needs to meet to be considered substantially equivalent to the predicate device and to ensure safe and effective use. These are primarily mechanical performance and compliance with relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of results) |
|---|---|
| Mechanical Performance (Cutting/Bite Force): Equivalent or better than predicate device. | Mechanical testing was performed. 100% inspection of samples of both the predicate and proposed Kerrison Rongeurs met the requirements of DIN 58298. Test showed the measured functional specifications of the Vitalitec Kerrison rongeurs were equivalent or better than comparable specifications of the predicate device. |
| Sterility: Information for reprocessing (sterilization) provided. | Tested in accordance with AAMI / ANSI ST81:2004/(R)2010 (Sterility) and ISO 17665-1 First edition 2006-08-15 (Sterilization of health care products - moist heat). Reprocessing cleaning and disinfection validation studies performed in accordance with FDA Draft Guidance: Processing/Reprocessing Medical Devices in Health Care Settings. |
| Biocompatibility: Meets relevant standards for patient contact materials. | Tested in accordance with AAMI / ANSI / ISO 10993-1:2009/(R) 2013 (Biocompatibility). |
| Material Composition: Complies with surgical instrument material standards. | Tested in accordance with ISO 7153-1 Second edition 1991-04-01 (Surgical instruments - metallic materials -- part 1: stainless steel). Materials are 1.4021 (420 SS) composition X20Cr13 according to DIN EN ISO 7153-1. |
| Risk Management: Application of risk management to medical devices. | Tested in accordance with ISO 14971 Second edition 2007-03-01 (Medical devices - application of risk management). |
| Labeling/Symbols: Use of standard symbols for medical device labels and information. | Tested in accordance with ISO 15223-1 Second Edition 2012-07-01 (Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied). |
| Functional Equivalence: Performs cutting/biting bone as intended without new safety issues. | "The design, operational principle and technology of cutting bone are identical to Integra predicate Rongeurs. The material is captured and removed the same as the predicate device. The mechanical cut... is identical to the predicate." |
2. Sample size used for the test set and the data provenance
- Sample Size: For the mechanical testing, it states "100% Inspection resulted in all samples of both the predicate and the proposed Kerrison Rongeur meeting the requirements of DIN 58298." This implies that all units (or a representative batch) used for the mechanical comparison were inspected. The exact number of units is not specified, but the "100% inspection" suggests a complete evaluation of the test batch.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory-based, non-clinical performance test conducted by the manufacturer to compare their device against a predicate, following international standards. It is a prospective test in the sense that the new device was subjected to defined tests under controlled conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI device or a diagnostic device requiring expert interpretation of results. The "ground truth" for this manual surgical instrument is established by objective mechanical performance tests (e.g., cutting a specific material) and compliance with recognized standards for materials, biocompatibility, and sterilization, rather than expert annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per the answer to question 3, there's no diagnostic output or subjective assessment that would require an adjudication method. The testing results are objective measurements against defined standards.
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 is not an AI device, therefore no MRMC study involving human readers and AI assistance was conducted or is relevant. This is a manual surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by objective technical and mechanical testing standards and compliance with recognized international standards (e.g., DIN 58298 for cutting, ISO 10993 for biocompatibility, AAMI ST81 for sterilization). Equivalence to the predicate device's performance also serves as a benchmark.
8. The sample size for the training set
- Not Applicable. This is not an AI device; therefore, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI device, there is no training set and no ground truth established for it.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).