(131 days)
Noodle is intended to reduce the pain of hypodermic injections into the upper extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.
The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers.
Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such as the upper and lower extremities (arms and legs), buttocks, abdomen, and deltoid and is not intended to be used on smaller body parts such as the hands, feet, head (including ears, nose and around the eyes), the neck, and the abdominal area in pregnant women.
Noodle is a battery-operated handheld device that includes a TENS unit and a motor operated by a 9V commercial battery. The classification product code for Noodle is a Class II Device: § 882.5890 - Transcutaneous electrical nerve stimulator for pain relief. Once it is activated, it operates for 25 seconds and shuts off automatically.
Noodle consists of a TENS unit and a small motor that causes a polyurethane sponge stick to rotate and tap the skin. The combination of the TENS application and tapping on the skin for 25 seconds numbs the skin temporarily for a subsequent injection. The sponge stick is impregnated in 70% isopropanol and disinfects the injection site at the same time it taps it.
The device body has 5 pieces, the enclosure, the bottom, the battery door, and the receptacle. Noodle further includes a PCB that is controlled by a firmware. The PCB supplies TENS stimulation that is transferred to the skin by a pair of hydrogels that come in electrical contact with the skin around the injection site.
Here's a summary of the acceptance criteria and study findings for the Noodle device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative manner as is typical for AI/ML performance. Instead, it describes clinical benefit based on pain reduction. I will interpret the reported clinical results as the "reported device performance."
| Acceptance Criteria (Inferred from Clinical Study Goal) | Reported Device Performance |
|---|---|
| Reduction in pain scores (VAS scale) for hypodermic injections | - 77% of subjects (14 of 18) reported a reduction in pain scores of at least 3 or greater on the VAS scale when preconditioned with Noodle. |
- This is approximately a 30% pain reduction.
- Average VAS was lower with Noodle than with the sham device by 35%.
- The difference seen was considered to provide clinical benefit to patients. |
| No significant adverse effects or safety risks | - No adverse events were reported in the 18 subjects. |
| Compliance with non-clinical test standards (electrical safety, EMC, nerve stimulation) | - Noodle passed all non-clinical tests (ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 18 patients.
- Data Provenance: The study was a multi-site causal-comparative trial conducted at 3 sites (one doctor's office and two pharmacies). It was a prospective clinical study designed to test the device's efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The concept of "ground truth" as typically defined for AI/ML (e.g., expert consensus on image labels) is not directly applicable here. The study measures a subjective patient outcome (pain perception via VAS scale) during a medical procedure.
- Ground Truth Establishment: The ground truth for pain reduction was established by the patients themselves using the VAS pain scale. Healthcare professionals administered the injections and collected the VAS scores. The document does not specify the qualifications of the healthcare providers who administered the injections or collected the data, beyond stating the study took place in a "doctor's office" and "pharmacies."
4. Adjudication Method for the Test Set
Not applicable in the AI/ML sense. Patient-reported outcomes (VAS scores) were directly collected. The study was described as "sham-controlled double-blind," meaning neither the patient nor the person administering the treatment (presumably the healthcare provider) knew whether the active Noodle device or a sham device was used. This blinding helps minimize bias in outcome reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?
Not applicable. This device is a transcutaneous electrical nerve stimulator for pain relief, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study comparing human performance with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
Not applicable. This is a medical device, not an algorithm. The device provides the therapy (electrical and mechanical stimulation) directly to the patient. It requires human-in-the-loop for application and administration of the injection. The study evaluates the device's effect on patient pain, not the performance of an algorithm.
7. The Type of Ground Truth Used
The ground truth used was patient-reported outcomes (pain perception), measured using the Visual Analog Scale (VAS).
8. The Sample Size for the Training Set
Not applicable. This document is a 510(k) summary for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of device development described here. The clinical study described served as a clinical validation (test set) to demonstrate safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).