ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I

• K Number: K094021
• Device Name: ACCULIS ACCU2I PMTA APPLICATOR MODEL ACCU2I
• Manufacturer: MICROSULIS MEDICAL LIMITED
• Date Cleared: 2010-08-06 ( 219 days)
• Product Code: NEY
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.

Device Description

Acculis Accu2i pMTA Microwave Tissue Ablation Applicator

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Acculis Accu2i pMTA Microwave Tissue Ablation Applicator) and focuses on establishing substantial equivalence to a predicate device. It does not contain information about a study that proves the device meets specific performance acceptance criteria as would typically be found in a clinical trial report or a comprehensive validation study.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance because it is not present in the provided text.

The document primarily states:

• The device's name and regulation information.
• Its intended use: "intraoperative coagulation of soft tissue."
• That it is substantially equivalent to a legally marketed predicate device.

There is no mention of:

• Specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity, temperature ranges, ablation zone size).
• A study design (e.g., test set, training set, experts, ground truth, MRMC study).
• Any performance metrics or results.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.