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To be used 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.

The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.

This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, which does not involve AI or complex diagnostic interpretations. Therefore, many of the requested categories concerning AI performance, expert consensus, and ground truth establishment are not applicable.

Here's the analysis based on the provided text:

Device: Santamedical Pulse Stimulator (Transcutaneous Electrical Nerve Stimulator - TENS)

1. Table of Acceptance Criteria and Reported Device Performance

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

This is an OTC TENS device. The performance and safety testing described are primarily non-clinical bench testing to confirm compliance with electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and electrode safety. Software verification was also performed.

• Test Set Sample Size: Not applicable in the context of patient data. The "test set" would refer to the physical device units undergoing non-clinical testing. The document does not specify the number of devices tested, which is typical for such non-clinical regulatory submissions.
• Data Provenance: Not applicable in the context of patient data. The data provenance refers to laboratory testing results, not patient or clinical data.

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

Not applicable. Ground truth, in the context of this device, refers to the established standards and safety requirements (e.g., electrical parameters, EMC limits). Compliance with these standards is assessed by testing laboratories and engineers, not by clinical experts establishing a "ground truth" for diagnostic or AI performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for clinical studies involving multiple reviewers for diagnostic agreement or outcome assessment. This submission demonstrates compliance with engineering and safety standards.

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 pain relief stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is a physical stimulator, not an algorithm, and does not have standalone AI performance in the way a diagnostic AI would.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" implicitly used for this device is compliance with established electrical safety and electromagnetic compatibility (EMC) standards (IEC 60601-1, IEC 60601-1-2) and FDA's guidance for software in medical devices. The device's technological characteristics were also compared directly to a legally marketed predicate device (K122744).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set for model development.

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

Not applicable. This is not an AI/ML device.

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Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.
Prescription Use

The Electronic Pulse Massager, which includes Models PL009, PL009A, and PL029, is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. TENS can help to relieve the pain caused by trauma or continual strain, and is suitable to be used on the user's back, neck, shoulders, legs, arms, and feet. The proposed Electronic Pulse Massager, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users. According to the need of users, the pulse intensity can be adjustable on the front control panel of the massager. Both Models PL009 and PL009A have five automatic stimulation programs and three manual programs, while Massager PL029 contains five automatic stimulation programs and eight selectable programs. The only difference between Models PL009 and PL009A is the former has a "REPEAT" program function and the latter does not. All these programs as well as the pulse intensity and time remaining can be displayed on the liquid crystal display screen of both massagers.

The provided K113544 510(k) Summary for the Electronic Pulse Massager, Models PL009, PL009A, and PL029, does not describe the use of a study with acceptance criteria and reported device performance in the typical sense of a clinical trial or algorithm performance evaluation.

This submission is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, which is a medical device and not an AI/ML algorithm. Therefore, the questions related to AI/ML specific aspects like training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable.

Instead, the submission demonstrates substantial equivalence to a predicate device (TENS 3000 Stimulator, K102014) through a comparison of technological characteristics and compliance with a set of voluntary non-clinical design standards.

Here's an breakdown based on the information provided and addressing the nature of the device:

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

For this type of device (TENS), "acceptance criteria" and "reported device performance" are primarily demonstrated through compliance with recognized standards and comparison to a predicate device. The submission does not provide explicit numerical "performance" metrics/acceptance criteria like sensitivity/specificity for disease detection, but rather shows that its properties and functionalities meet expected standards for safety and effectiveness for a TENS device.

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

Not applicable. This device is cleared through substantial equivalence based on non-clinical testing and comparison to a predicate, not clinical data or performance on a test set of patient data.

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. Ground truth for a test set is not established for this type of device clearance.

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

Not applicable.

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 is not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This is not an algorithm.

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

Not applicable. For this device, "ground truth" is conceptually represented by the established safety and performance standards for TENS devices and the characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for this device.

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