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General Indications for Use :

• · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
• · Symptomatic relief of acute pain.
• · Symptomatic relief of post-operative pain.

The ST-5A is a patented non-invasive electro-analgesia device, with 5 chamels that deliver low-intensity stimuli (max. 5 mA) generated by a completely automated treatment program. Five artificial neurons create "packets" (strings) of information recognized as "non pain", the content of which is controlled by a proprietary algorithm. This various information of "no pain" produces an immediate analgesic effect, capable of completely eliminating pain in real time. Up to 5 pairs of independent electrodes can be placed on the patient's body based on the need of the treatment. Two microprocessors ensure the correct operation of the device by automatically establishing the optimal parameters of effectiveness and safety, which cannot be modified by the operator. In order to perform the treatment correctly, the operator only needs to position the electrodes and adjust the stimulation levels correctly. The placement of the electrodes requires scrupulous observance of the method of identifying the areas of pain treatment. If the treatment is performed correctly, normally the pain is zeroed (or reduced very close to zero) in real time regardless of the initial intensity and the pathology that generated it.

The provided text is a 510(k) summary for the Scrambler Therapy® Technology (Model ST-5A). It primarily focuses on demonstrating substantial equivalence to a predicate device (Scrambler Therapy® MC-5A) rather than presenting a standalone study with defined acceptance criteria and performance metrics.

Therefore, much of the requested information regarding a study proving acceptance criteria is not explicitly available in this document. The submission argues that since the new device is technologically identical to the predicate device, the prior scientific literature and clinical performance for the predicate device are directly applicable.

Here's an attempt to answer your questions based on the provided text, highlighting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in the form of a table with numerical targets (e.g., sensitivity, specificity, accuracy) and reported performance metrics are provided for the ST-5A device in this submission. The submission asserts that the ST-5A has "the same expected performance of efficacy, security, usability" as the predicate device (MC-5A) due to their technological identicality.

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

Not applicable/Not provided. The submission does not describe a new specific test set or a clinical study for the ST-5A device. It relies on the equivalence to the predicate device.

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

Not applicable/Not provided. As there is no new specific test set or clinical study described, there were no experts used to establish ground truth for such a study.

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

Not applicable/Not provided. As there is no new specific test set or clinical study described, there was no 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

No. This device is an electro-analgesia device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

The device is an electro-analgesia device and not an AI algorithm. Its performance is intrinsically linked to its use by a human operator (a physician or trained healthcare personnel) for electrode placement and stimulation level adjustment. The text explicitly states: "the proper use of Scrambler Therapy®, being operator-dependent, allows only for a partial double-blind or single-blind trial design." This suggests that a purely "standalone" (without human interaction) performance evaluation is not relevant or feasible for this type of medical device.

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

For the claimed efficacy (which is referenced from the predicate device through technological equivalence), the "ground truth" would implicitly be patient-reported outcomes of pain relief. The text states, "the result of this theoretical model applied in the Scrambler Therapy® medical device, is an immediate and complete analgesic effect in treatment." This indicates that pain reduction is the primary clinical endpoint.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/machine learning device that requires a training set in the conventional sense. The "proprietary algorithm" mentioned refers to the system's internal control over generating "non pain" information, which is described as being inherent to the device's design, not learned from a dataset.

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

Not applicable/Not provided. As stated above, this is not an AI/machine learning device requiring a training set with established ground truth. The "proprietary algorithm" within the device creates specific "information of 'no pain'" based on its inherent design and mechanism of action.

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The Scrambler Therapy MC-5A Device is indicated for:

• Symptomatic relief of chronic, intractable pain, post-surgical and posttraumatic acute pain.
• Symptomatic relief of acute pain.
• Symptomatic relief of post-operative pain.

The Scrambler Therapy MC-5A Device is a multi-channel device which allows simultaneous treatment of a number of pain sites. Stimulation impulses are generated and controlled according to a stored program to provide pain relief.

The provided text is a 510(k) premarket notification for a medical device called the "Scrambler Therapy MC-5A Device." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing specific acceptance criteria and the results of a primary clinical study for this device.

Therefore, many of the requested details about acceptance criteria, specific study design elements (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), and training set information are not present in this regulatory submission.

The document states: "Testing of the Scrambler Therapy MC-5A Device demonstrates that the device meets design and performance specifications." However, it does not provide the specifics of these specifications (acceptance criteria) or the detailed results of such testing. The core of this 510(k) is a comparison to a predicate device (SCRAMBLER MC-5A TENS DEVICE, K081255).

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical outcome (e.g., pain reduction percentage, adverse event rate threshold). The document implies that the device must meet "design and performance specifications," but these are not detailed.
• Reported Device Performance: Not explicitly stated as quantifiable outcomes from a primary clinical study on the device itself. The 510(k) aims to show that the new device is "substantially equivalent" to an existing one, implying similar performance.

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

• Sample Size: Not mentioned. The document references "testing" but does not specify a clinical study test set size.
• Data Provenance: Not mentioned. It's likely that the "testing" referred to might be bench testing or verification/validation, not necessarily a clinical trial with human subjects whose provenance would be relevant in this context.

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

• Not Applicable/Not Provided. As there's no detailed clinical study described with a "test set" requiring ground truth established by experts for classification or diagnosis (as would be common for AI/imaging devices), this information is absent.

4. Adjudication Method for the Test Set

• Not Applicable/Not Provided. For the same reasons as above, an adjudication method is not described.

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

• No. This type of study is not mentioned. MRMC studies are typically used for diagnostic devices (like imaging AI) to compare human performance with and without AI assistance. This device is a therapeutic electrical stimulator.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not Applicable/Not Provided. This device is a physical medical device (electrical stimulator), not an algorithm or AI software that would have a "standalone" performance. Its operation inherently involves a human user applying it.

7. The Type of Ground Truth Used

• Not Applicable/Not Provided. The concept of "ground truth" (e.g., pathology, outcomes data for diagnosis) is not applied in the context of this device's regulatory review in the provided document. The 510(k) process for this type of device typically relies on engineering and electrical safety testing, biocompatibility, and functional performance, compared to an already cleared predicate.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided. This device is hardware for electrical stimulation. There is no "training set" in the context of machine learning.

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

• Not Applicable/Not Provided. As above, there is no training set for this type of device.

Summary based on the provided document:

The 510(k) notification for the Scrambler Therapy MC-5A Device establishes substantial equivalence to a predicate device (SCRAMBLER MC-5A TENS DEVICE, K081255) based on intended use, fundamental technology, and operation characteristics. It generally states that "Testing... demonstrates that the device meets design and performance specifications." However, it does not provide the detailed acceptance criteria or the specific results of a clinical study in the format requested. The document does not describe a clinical study for performance evaluation that would necessitate the concepts of "test set," "training set," "ground truth experts," or "MRMC studies" as commonly understood in the context of AI/diagnostic device approvals.

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