(37 days)
The CONTACT™ EMG Rotatable Endotracheal Tube is intended for use as a means of providing both an open airway for patient ventilation and for intraoperative monitoring of EMG activity of the intrinsic laryngeal musculature when connected to an appropriate EMG monitor.
The EMG Tube is indicated for use where continuous monitoring of the integrity of the nerves supplying the laryngeal musculature is required during surgical procedures.
The CONTACT™ EMG Rotatable Endotracheal Tube is a flexible, cuffed, Endotracheal tube manufactured from silicone elastomer, reinforced with an embedded stainless steel spiral. Four stainless steel wires are longitudinally embedded in the tube and serve, over an exposed length, as a pair of sensing/recording electrodes designed to interface with an electromyographic monitor.
The provided text describes a 510(k) submission for the Medtronic XOMED CONTACT™ EMG Rotatable Endotracheal Tube. It does not present a detailed study with acceptance criteria and reported device performance in the format requested.
Instead, it's a regulatory document demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a legally marketed device, rather than providing new clinical study data with specific performance metrics and acceptance criteria.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and how established) cannot be extracted from this document, as they pertain to detailed performance validation studies which are not characteristic of a standard 510(k) submission focused on substantial equivalence.
Based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria in a new study.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document states that "In-house laboratories conducted studies verifying the design of this device; all followed scientific protocols." However, it does not specify the nature, sample size, or provenance of any test sets used in these "in-house" studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. As no specific test set data is presented for performance evaluation, there is no mention of expert involvement in establishing ground truth.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, a MRMC comparative effectiveness study is not mentioned or described in the provided document. The submission is for a medical device (endotracheal tube with EMG detection), not an AI-assisted diagnostic tool that would typically involve a reader study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This device is a component for use with an electromyographic monitor and directly interfaces with human physiology. It's not an algorithm operating in a standalone capacity.
7. The Type of Ground Truth Used:
This information is not provided. The document mentions "in-house laboratories conducted studies verifying the design," but it does not detail how ground truth was established for any specific performance evaluations.
8. The Sample Size for the Training Set:
This information is not provided. The concept of a "training set" typically applies to AI/ML models, which is not the focus of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established:
This information is not provided.
Summary of Conclusions from the Submission:
The document states:
- "In-house laboratories conducted studies verifying the design of this device; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7." - This indicates internal testing was performed, but details are not published here.
- "The data presented in this Premarket Notification support that the subject device is safe and effective and performs in the same manner as the predicate devices when used in accordance with the labeled directions for use and for the specified indication(s)." - This is the core claim of substantial equivalence.
- "The risks of the subject device, as well as the benefits to the patient, are the same as those attributed to the use of the predicate devices." - Further reinforcing substantial equivalence.
The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence to a previously cleared predicate device, rather than meeting specific novel performance benchmarks. The "study" here is the entire 510(k) submission, comparing the new device's design, materials, and intended use to existing devices. The key comparison is provided in the table on page 2, highlighting similarities and differences with the predicate devices (K003745 and K925640).
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.