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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.

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