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Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

The design of the Rhythmlink Disposable Concentric EMG Needle is similar to existing stainless steel needles used to record muscle activity during electromyograph procedures. The device consists of a needle and a needle body. The inner sensor of the needle is made of stainless steel and is separated from the stainless steel outer cannula by a layer of biocompatible insulation. The needle is sharpened at a 15° angle, creating a recording surface area of 0.07mm² or 0.12mm², depending upon needle diameter. The needle body houses the component that connects the needle to the leadwire. Inside this body, a gold-plated brass inner sensor pin is crimped onto the end of the inner sensor of the needle and is isolated from the outer cannula of the needle. The needle and pin assembly is then cased in a gold-plated brass outer ring, which is crimped onto the outer cannula. Finally, the entire end of the needle assembly is covered with a polyethylene body that protects the needle and allows the clinician to accurately secure the needle into place. The assembly connects creates a unidirectional connection to the reusable cable, which connects the needle to electromyography recording equipment.

This K091055 submission describes the Rhythmlink Disposable Concentric EMG Needle. The provided document does not contain explicit acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical accuracy or a comparative effectiveness study with human readers.

The submission focuses on establishing substantial equivalence to predicate devices (Ambu Neuroline Concentric Needle K973529 and K071186) based on similar design, indications for use, and materials. The testing mentioned in such submissions typically relates to biocompatibility, sterility, electrical safety, and performance characteristics like impedance and signal quality, rather than clinical efficacy studies.

Therefore, the specific information requested cannot be fully extracted from the provided text for items 1-6 and 8-9.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., signal-to-noise ratio requirements, impedance ranges) within the provided text. Substantial equivalence is the primary acceptance criterion for 510(k) devices.
• Reported Device Performance: The document states the device "is similar to existing stainless steel needles used to record muscle activity during electromyograph procedures." This implies that its performance is expected to be comparable to the predicate devices. The listed physical specifications (e.g., 0.07mm² or 0.12mm² recording surface area, 15° sharpening angle) are design specifications, not performance outcomes from an efficacy study.

2. Sample sized used for the test set and the data provenance

• Not specified in the provided text. The submission is a 510(k) for substantial equivalence, which primarily relies on technological comparison and bench testing rather than large-scale clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is an EMG needle, a measurement tool. Ground truth in the context of clinical interpretation by experts is not directly relevant to this type of device's 510(k) submission for substantial equivalence.

4. Adjudication method for the test set

• Not applicable for a device of this nature in a 510(k) submission.

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

• No. This device is an EMG needle and does not involve AI or "human readers" in the context of diagnostic interpretation that would warrant an MRMC study.

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

• No. This device is a physical medical instrument, not an algorithm, so a standalone performance study in this context is not applicable.

7. The type of ground truth used

• As a diagnostic EMG needle, its "ground truth" performance would typically be assessed by its ability to accurately detect and transmit electrical signals from muscle activity, verified against established physiologcal principles and comparison to predicate devices, rather than an expert consensus on a diagnosis. The submission focuses on substantial equivalence to legally marketed predicate devices, meaning its performance characteristics (e.g., electrical properties, biocompatibility) are expected to be similar enough that it can be used for the same intended purpose.

8. The sample size for the training set

• Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of its 510(k) submission.

9. How the ground truth for the training set was established

• Not applicable.

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