(448 days)
KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
The KLS Martin Neuro Rongeurs are manual, reusable, stainless-steel instruments. They are provided non-sterile and must be cleaned and sterilized by the end user before use. Validated methods are provided in the instructions for use that accompany each device. The instruments are available coated or uncoated in a variety of styles, with options for a range of cutting angles, shaft lengths and profiles, jaw widths, and handle designs. Additionally, the KLS Martin Neuro Rongeurs can have a push button opening mechanism to allow separation of the long shafts allowing for improved cleaning and sterilization.
This document is a 510(k) Summary for the KLS Martin Neuro Rongeurs, a manual surgical instrument. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in the conventional sense for medical device performance. Instead, the performance testing section describes the types of tests conducted and uses phrases like "No corrosion detected," "Smooth cuts achieved, pass," and "Comparable to reference device" as outcomes.
Based on the "Performance Testing - Non-clinical" section, here's a table summarizing the tests and results, which serve as the implicit acceptance criteria and reported performance:
| Test Name | Test Description | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Testing | |||
| Autoclave Test | Test to verify corrosion resistance during autoclaving. | No corrosion detected after autoclaving. | No corrosion detected |
| Boiling Test | Test to verify corrosion resistance of instruments. | No corrosion detected after boiling. | No corrosion detected |
| Copper Sulfate Test | Test to verify corrosion resistance of instruments. | No corrosion detected after Copper Sulfate test. | No corrosion detected |
| Thermal Test | Test to verify thermal resistance of instruments. | No corrosion detected after thermal testing. | No corrosion detected |
| Cut Quality | Compare cut quality. | Achieve smooth cuts comparable to the reference device. | Smooth cuts achieved, pass |
| Comparative Functional Testing | |||
| Spring Force | Compare spring force. | Spring force comparable to the reference device. | Comparable to reference device |
| Cut Force | Compare cut force. | Cut force comparable to the reference device. | Comparable to reference device |
| Push Button Force | Compare push button force. | Push button force comparable to the reference device. | Comparable to reference device |
| Biocompatibility Testing | |||
| Biocompatibility | Evaluated in accordance with ISO 10993. | Meet biocompatibility endpoints (chemical characterization, cytotoxicity, sensitization, etc.). | KLS Martin Neuro Rongeurs are biocompatible. |
| Sterilization Testing | |||
| Steam Sterilization | Validations based on AAMI ANSI ISO 17665-1. | Achieve a sterility assurance level (SAL) of 10⁻⁶ using biological indicator overkill method. | All test method acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of KLS Martin Neuro Rongeurs or individual components tested for the non-clinical performance and functional tests. It mentions "Comparative testing was completed versus the reference device," implying a sample of both the subject device and the reference device was used, but quantities are not provided.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission for a new device, the performance testing would typically be prospective, conducted by the manufacturer (KLS-Martin L.P. is based in Jacksonville, Florida, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this device's performance testing. The KLS Martin Neuro Rongeurs are mechanical surgical instruments. "Ground truth" established by experts (like radiologists reading images) is relevant for diagnostic AI/software devices. For mechanical devices, performance is assessed through objective physical and chemical tests rather than expert interpretation.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple readers or experts to resolve discrepancies, particularly in diagnostic contexts. Since the performance testing for these rongeurs involved objective physical and chemical tests, an adjudication method for a "test set" is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating diagnostic performance, often with AI assistance compared to human-only performance. This device is a manual surgical instrument, not an AI or diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No, a standalone study was not done. This question is also typically relevant for AI/software devices that can operate without human intervention. The KLS Martin Neuro Rongeurs are manually operated instruments; they do not have an algorithm or standalone operating mode.
7. The Type of Ground Truth Used
As elaborated in point 3, the concept of "ground truth" as derived from expert consensus, pathology, or outcomes data is not applicable here. The performance data is the ground truth based on objective measurements and observations from the physical and chemical tests (e.g., presence/absence of corrosion, measurement of force, observation of cut quality).
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical instrument, not an AI/software device that requires a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated in point 8, there is no training set for this type of device.
§ 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).