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The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

The Myoject™ Luer Lock Needle Electrode is a Disposable Hypodermic Needle Electrode

Here's a breakdown of the acceptance criteria and the study information for the Natus Manufacturing Limited Myoject™ Luer Lock Needle Electrode, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Teca Myoject Disposable Needle Electrode K973444) through a comparison of characteristics and performance testing. There isn't a direct "acceptance criteria" table with specific pass/fail metrics explicitly stated alongside the new device's performance in a quantitative manner for most characteristics. Instead, the "Discussion of Differences" column in Table 5A (starting on page 5) serves as the primary mechanism for demonstrating equivalence and addressing performance.

However, for Biocompatibility and Bench Testing, the performance is reported against established ISO and ASTM standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not explicitly state specific sample sizes for each of the performance tests (tensile, coating thickness, leak, tip geometry, penetration, Luer Lock verification). It refers to "Performance Testing" and "Bench Testing" being performed. For biocompatibility tests, details are provided on the methods (e.g., L929 cells for cytotoxicity, rabbit for intracutaneous reactivity, mouse for local lymph node assay), but the exact number of test items or animals used is not specified in this summary.
• Data Provenance: The studies were conducted by Natus Manufacturing Limited, which is based in Ireland. The nature of these tests (biocompatibility, bench testing) usually implies controlled laboratory settings rather than patient data. Therefore, the data Provenance is the manufacturer's internal testing. Not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• This is not applicable as the studies described are non-clinical performance tests (biocompatibility and bench testing) and technical comparisons to a predicate device. The "ground truth" is established by adherence to recognized international standards (ISO, ASTM) for materials, design, and manufacturing quality, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable, as this refers to non-clinical performance and design verification tests, not clinical studies with human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic electromyograph needle electrode, not an image-based diagnostic AI device that would typically involve an MRMC study. The comparison is primarily against a predicate device's design specifications and performance standards through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a medical instrument (needle electrode), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating the device's acceptable performance and substantial equivalence is based on:
  • Adherence to International Standards: ISO 10993 series (Biocompatibility), ISO 2859-1 (Sampling), ASTM F 1980 (Sterile Barrier).
  • Predicate Device Specifications: The Teca Myoject Disposable Needle Electrode (K973444) serves as the primary benchmark for comparison of design and technological characteristics.
  • Design and Performance Specifications: The device's own predetermined specifications for physical characteristics and functional performance (e.g., tensile strength, leak integrity, penetration force).

8. The Sample Size for the Training Set:

• Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI or machine learning model.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set.

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The subject monitor detects bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified. Although the monitor is indicated for guidance of any muscle-specific injection, it is typically used for injections into muscles of the head and neck. This includes botulinum toxin injections of facial and laryngeal muscles.

The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.

The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.

The provided text is a 510(k) summary for the XOMED® AccuGuide Muscle Injection Monitor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute performance against predefined acceptance criteria from novel studies. Therefore, the information provided focuses on comparing the new device to existing, legally marketed devices.

Based on the document, here's a breakdown of the requested information, with specific answers where available and explanations where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission does not present specific quantitative acceptance criteria or a dedicated performance study with a table of results. Instead, it relies on demonstrating that the proposed device, the AccuGuide, is substantially equivalent to a predicate device (Allergan BOTOX® Injection Amplifier) in terms of intended use, technology, and safety/effectiveness. This means it's assumed to meet the same unstated performance benchmarks as the predicate.

For the purpose of this request, we can infer the "acceptance criteria" and "reported performance" are met if the device is deemed substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

The provided 510(k) summary does not describe a specific "test set" or a performance study with a defined sample size for the AccuGuide device. The submission relies on a comparison to a predicate device and existing knowledge of EMG technology. Therefore:

• Sample Size for Test Set: Not applicable / Not provided.
• Data Provenance: Not applicable, as no specific test data set is described for the new device. The comparison is based on the known performance and characteristics of the predicate device (Allergan BOTOX® Injection Amplifier), which is a "currently marketed" device. This implies its performance is established from its prior marketing and regulatory clearance, which would have involved some form of testing, but details are not provided here for the predicate either.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the 510(k) summary. Given that no specific test set or performance study is detailed for the AccuGuide, there is no mention of experts establishing a ground truth for such a study. The substantial equivalence argument relies on the established use and safety/effectiveness of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As there's no described test set or performance study, there's no mention of an adjudication method.

5. 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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) submission.
• AI Assistance: The device described is an EMG monitor, a hardware medical device that provides bioelectrical signal detection. It does not incorporate Artificial Intelligence (AI) for interpretation or assistance in the way current AI-driven diagnostic tools do. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. The AccuGuide is a hardware device (EMG monitor) designed to provide real-time feedback (audible and visible through LCD bargraph) to a human user (clinician) to guide injections. It does not operate as a standalone "algorithm" generating diagnoses or interpretations without human involvement in the clinical context. Its function is to assist in real-time muscle localization during a procedure.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no specific performance study is detailed, the type of ground truth for the AccuGuide's performance is not explicitly stated. However, the basis for its perceived "truth" or effectiveness stems from the functionality of its predicate device, the Allergan BOTOX® Injection Amplifier. The fundamental "ground truth" for these types of EMG monitors is the accurate detection of muscle electrical activity (bioelectrical signals) in the target muscle, confirmed by clinical observation (e.g., specific muscle movement in conjunction with the EMG response) and the subsequent successful and safe injection into that muscle, leading to the desired therapeutic outcome. This is a clinically established method for guiding precise injections.

8. The Sample Size for the Training Set

The provided 510(k) summary does not describe a "training set" for the AccuGuide. This device is a traditional hardware medical device, not a machine learning model that requires a training set in the conventional sense. The design and validation would have followed standard engineering and quality system processes, rather than machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is described for this device.

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