(56 days)
Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Integra® Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles: regular and thin/low profile footplates: standard and eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.
The provided text describes a 510(k) submission for Kerrison Rongeurs, focusing on a labeling change regarding sterilization instructions. It is not an AI/ML device, therefore, many of the requested categories related to AI performance, ground truth, and reader studies are not applicable.
Here's the breakdown based on the provided information:
Acceptance Criteria and Device Performance (Not applicable for AI/ML device)
This section would typically detail the specific performance metrics (e.g., sensitivity, specificity, AUC) the AI device needs to meet. Since this is a manual surgical instrument, these metrics are not relevant.
The acceptance criteria for this device, as indicated by the 510(k) submission, revolve around its substantial equivalence to a predicate device, particularly concerning its design, materials, intended use, and the safety and effectiveness of its sterilization methods.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | Demonstrated: The device is substantially equivalent to the predicate device K092227. |
| Materials | Identical (420 Stainless steel, same surface coatings as predicate) |
| Intended Use | Identical (cutting or biting bone during surgery involving the skull or spinal column) |
| Technological Characteristics | Identical (manual, non-electrical, non-sterile, reusable, non-malleable, sterilizable) |
| Sterilization Validation | Passed: Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 20 minutes for both Assembled and Open Configuration. |
| Biocompatibility | Not applicable (no change in materials) |
Study Information
1. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML device. The submission references sterilization validation testing, but it's not a "test set" in the context of AI/ML evaluation. The sterilization validation would have involved a specific number of test cycles and biological or chemical indicators, but the specific quantity is not detailed beyond "successful sterilization validation."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for an AI/ML device. Ground truth, in this context, would be external validation against disease or condition. For a medical device like a Kerrison Rongeur, safety and effectiveness are established through physical and mechanical testing, biocompatibility, and sterilization validation; not by expert consensus on diagnostic interpretations.
3. Adjudication method for the test set:
- Not applicable for an AI/ML device. Adjudication methods are used in AI/ML studies to resolve discrepancies in expert ground truth labels. This submission doesn't involve such a process.
4. 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 manual surgical instrument and does not involve AI assistance or human readers in the diagnostic sense.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical instrument, not an algorithm.
6. The type of ground truth used:
- Not applicable in the AI/ML sense. For this device, the "ground truth" for its safety and effectiveness is established through:
- Predicate device comparison: demonstrating that its design, materials, and intended use are substantially equivalent to a device already legally marketed.
- Sterilization validation: adherence to recognized standards (ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009). This is a technical validation against established protocols.
7. The sample size for the training set:
- Not applicable. This device does not use machine learning or require a training set.
8. How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or require a training set.
§ 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).