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A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the symptomatic relief and management of chronic intractable pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. , and

A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.

The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.

CUR is a high-quality wearable medical device that provides professional-grade TENS therapy along with an easy-to-use interface and compact aesthetic design. It is comprised of the main CUR device, a disposable gel pad, and a charging cable with AC adapter for recharging the device.

A use session typically begins with the user placing the Gel Pad on the skin near the location of pain, attaching the CUR Device to the Gel Pad using the magnetic attachment points on the bottom surface of the Device and on the plastic connector of the Gel Pad. The user then presses the power "start/stop" button on the Device to begin treatment. The user may use buttons on the Device labeled with standard ISO "+" and "-" symbols to control the intensity of treatment. They also may connect the Device to a compatible Mobile Device via Bluetooth and control treatment through the CUR Mobile App. After treatment is finished, the user may leave the Device attached to the Gel Pad until the next treatment session, or may remove the Device from the Gel Pad and attach the Device to the Charging Base using the magnetic attachment points on the Device and Charging Base to store and re-charge the Device.

CUR Model 1 may be used for pain relief on most parts of the body. Intended placements include:

• Shoulder ●
• Waist ●
• Back
• Neck
• Upper extremities (arm) ●
• Lower extremities (leg)

Do not place CUR Model 1 on the throat, chest, or head.

The disposable Gel Pad utilizes a high-quality polyacrylate hydrogel material that provides excellent patient comfort, biocompatibility, and adherence to a wide range of skin types. Pads typically last about 6-10 days with regular daily use and storage before needing to be replaced. And since the Device uses an internal rechargeable battery for power, no other batteries or consumables are needed offering increased convenience and positive benefit to the environment.

The Mobile App provides access to treatment controls and usage instructions for the device from a compatible mobile device. This is an added convenience for cases where the user would rather adjust the treatment from their mobile devices rather than directly from the app and also a means of providing detailed warnings and usage instructions information in a portable way that the user can access at any time.

The provided text describes the Thimble Bioelectronics CUR Model 1, a transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulation (PMS) device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a standalone study for the device against specific acceptance criteria.

However, based on the non-clinical testing section and the comparison tables, we can infer the acceptance criteria are largely related to meeting established electrical performance specifications and international safety/performance standards.

Here's an analysis of the requested information:

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

Since specific acceptance criteria are not explicitly listed in a direct "acceptance criteria table" in the document, these are inferred from the technological characteristics comparison with predicate devices and the non-clinical testing performed against recognized standards. The "reported device performance" refers to the CUR Model 1's measured electrical specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "Thimble determined that bench and non-clinical testing were sufficient to demonstrate that the CUR Model 1 device is as safe and effective as the predicate devices." (Page 10)

• Sample Size: Not specified for non-clinical testing, but typically refers to a statistically significant number of test units or components tested according to engineering and quality assurance protocols for device performance, and materials tested for biocompatibility. No human subject data (test set) is mentioned for clinical performance.
• Data Provenance: The tests are described as "bench and non-clinical testing" conducted by Thimble Bioelectronics (a US company, based on the address). This indicates laboratory or bench-top testing rather than clinical data from patients. The document does not specify the country of origin of the data or if it was retrospective or prospective in a clinical sense, as it was non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document states that no clinical testing was performed to establish ground truth from human experts. The assessment was based on non-clinical engineering and performance testing against established standards and comparison to predicate devices, not on expert interpretations of medical results.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As no clinical test set with human data or expert review was conducted, no adjudication method was used.

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

Not applicable. This device is a TENS/PMS stimulator, not an AI-assisted diagnostic or interpretive device. No MRMC study was performed, nor would it be relevant for this type of medical device which directly delivers electrical stimulation.

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

Not applicable. This device does not involve an "algorithm only" component in the sense of AI or diagnostic interpretation. Its "performance" is its ability to generate electrical signals according to specifications. The device operates either directly through physical buttons or via a mobile app interface.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's acceptable performance is defined by compliance with recognized international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, FCC Part 15) and by meeting its own design specifications as verified through electrical, mechanical, and software testing. It also uses the performance characteristics of legally marketed predicate devices (NeuroMetrix ASCEND and Philips Consumer Lifestyle PulseRelief) as a basis for demonstrating substantial equivalence. No clinical "ground truth" (e.g., pain relief scores, muscle performance measurements) from patient outcomes was used in this submission.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable, as no training set was used.

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