(209 days)
Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting 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 ejector tips; 4.75 - 15" shaft lengths; and various handle and shaft styles, including Detach®. Integra™ Kerrison Rongeurs are distributed under the following brand names: Jaril®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHamd®.
This document is a 510(k) summary for the Integra™ Kerrison Rongeurs. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, clinical studies, or performance data.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
This document focuses on regulatory approval based on substantial equivalence, not on specific performance studies or clinical trial data.
§ 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).