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For Russian, and High Volt:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For interferential and premodulated interferential:

• Symptomatic relief of chronic, intractable pain
• Management of pain associated with post-traumatic or post-operative conditions

For Ultrasound:
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

• Pain Relief
• Reduction of muscle spasms
• Joint contractures

For TENS and EMS:

• Symptomatic relief and management of chronic intractable pain
• Adjunctive treatment in the management of post surgical and post traumatic acute pain condition

Ultrasound and Muscle Stimulator. Transcutaneous electrical nerve stimulator for pain relief, Powered muscle stimulator. Available as 2 channel stimulator, 4 channel stimulator, ultrasound, 2 channel stimulator with ultrasound, and 4 channel stimulator with ultrasound. Units are supplied with electrodes listed in 510(K) K050469, typically 2 x 2 inch. Units are supplied with a bottle of ultrasound coupling gel listed in 510(K) K012522, or similar gels already in the market.

Here's an analysis of the provided information regarding the acceptance criteria and study for the Sonic-Stim device:

Important Note: The provided document is a 510(k) summary and FDA clearance letter. These documents explicitly state "Non-clinical Testing: Not Applicable" and "Clinical Testing: Not Applicable." This means no specific clinical study was performed or required to demonstrate the device meets acceptance criteria in the traditional sense of a performance study with numerical endpoints. Instead, clearance was granted based on substantial equivalence to predicate devices.

Summary based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance	Comments
   Not specified in terms of numerical performance metrics.	Not specified in terms of numerical performance metrics.	The device was cleared based on substantial equivalence, implying its performance is considered comparable to existing legally marketed predicate devices (K031077 and K010749) for the stated indications for use. No specific quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic device) or corresponding performance data are presented.

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

   • Sample Size: Not applicable. No clinical test set was used for performance evaluation in this 510(k) submission.
   • Data Provenance: Not applicable.

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

   • Not applicable. No ground truth establishment by experts for a test set was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set:

   • Not applicable. No test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was one done? No.
   • Effect size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study:

   • Was one done? No. This device is a physical therapy device (ultrasound and stimulator), not an AI algorithm.

7. Type of Ground Truth Used:

   • Not applicable. For a device like this, the "ground truth" for its function would typically be its ability to generate specific electrical stimulation waveforms and ultrasound frequencies/intensities, for which non-clinical engineering tests would be done. However, based on the document's explicit statement, these were also deemed "Not Applicable" for this 510(k) and likely covered by the predicate device's existing clearance or general safety and performance standards.

8. Sample Size for the Training Set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

Explanation of the 510(k) Context:

This 510(k) submission for the Sonic-Stim device achieved clearance by demonstrating substantial equivalence to existing predicate devices (Chattanooga Group Vectra GENiSYS and Biomedical Life Science, QUADSTAR II). This means the FDA determined that the Sonic-Stim device has the same intended use and the same technological characteristics as the predicate devices, or if it has different technological characteristics, that the different characteristics do not raise different questions of safety and effectiveness, and that the device is as safe and effective as the predicate device.

Therefore, the "acceptance criteria" were met by showing:

• The same intended use as the predicates (e.g., relaxation of muscle spasms, pain relief, increased local blood circulation, etc.).
• Similar technological characteristics (Ultrasound and Muscle Stimulator).
• Compliance with general controls (e.g., manufacturing practices, labeling).

No de novo clinical or non-clinical performance studies were required for this specific 510(k) submission because the device was deemed to be substantially equivalent to devices already on the market with a long history of safe and effective use.

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The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Electrodes, Cutaneous

The provided document is a 510(k) summary for the Naimco EZ-stik Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it asserts substantial equivalence based on component usage and physical testing.

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. No separate "test set" in the context of AI/machine learning or clinical performance evaluation is mentioned. The submission relies on "non-clinical testing" which refers to comparing the components of the proposed device to those of predicate devices.

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. There is no mention of experts establishing ground truth for a test set.

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

Not applicable. No adjudication method is mentioned as there is no test set or expert review process described.

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/machine learning device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. "Ground truth" in the context of device performance is not explicitly discussed. The comparison is based on the characteristics of the device's components and physical testing, with the implicit "ground truth" being the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set is mentioned.

Summary of available information from the K050469 510(k) submission:

• Acceptance Criteria/Performance: The device (EZ-stik Electrodes) is deemed to meet acceptance criteria by demonstrating substantial equivalence to legally marketed predicate devices (K945676, K970426, K012463).
• Study Proving Acceptance: The study provided is a non-clinical testing comparison.
  • Method: The submission states that the "critical components used in NAImco, Inc. EZ-stik electrodes (Amgel 703 or Amgel 702 and Conductive Plastic Film) are the same as used in the predicate device." Physical testing was also conducted, but no details are provided about the specifics of this testing or its results beyond the general statement of "technological characteristics that are substantially equivalent."
  • Conclusion: "Therefore there is no reason to believe that the NAlmco, Inc. EZ-stik electrodes will perform any different than the predicate device."
• Clinical Testing: The document explicitly states "Clinical Testing: Not Applicable."

In essence, this 510(k) submission relies on the established safety and effectiveness of predicate devices and demonstrates that the new device is fundamentally the same in its critical components, thus inferring equivalent performance without requiring a new clinical study.

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NAImco, Inc. Iontophoresis Drug Delivery Electrodes are indicated to introduce ions of soluble salts or other drugs into the body.

The Naimco, Inc. Iontophoresis Drug Delivery Electrode System consists of an active drug delivery electrode and a passive return electrode. These electrodes are designed for one use by a single patient for the local administration of ionic drug solutions into the body for medical purposes. There are multiple sizes and shapes of drug delivery electrodes to accommodate placement various sites on the body. The size of the return electrode is the same for all drug delivery electrode sizes. The Naimco, Inc. Iontophoresis Drug Delivery Electrodes have technological characteristics equivalent to those of the predicate devices, including comparable performance specifications, comparable materials including the same buffering agent (Ag/AgCI) and fiberous polyester reservoir materials on the active drug delivery electrodes and the same buffering, self-adhering polymer on the return electrode, multiple shapes and sizes of active the drug delivery electrodes, and equivalent packaging and labeling.

The provided text is a 510(k) summary for Naimco, Inc. Iontophoresis Drug Delivery Electrodes, which is a regulatory submission to the FDA. This type of document is concerned with demonstrating substantial equivalence to predicate devices for market approval rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel medical device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it relates to performance endpoints derived from clinical or technical studies. The document only states that the Naimco electrodes have "technological characteristics equivalent to those of the predicate devices, including comparable performance specifications."

Here's why the requested information cannot be extracted:

• Acceptance Criteria and Device Performance: The document lists predicate devices and claims "comparable performance specifications" but does not define these specifications or provide quantitative data on how the Naimco device performs against them. This type of information would typically be detailed in a separate test report or clinical study summary, not necessarily in the 510(k) summary itself, which focuses on equivalence.
• Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, training set): None of these details are present because the submission hinges on demonstrating equivalence to existing devices rather than presenting a novel study to establish new performance benchmarks. The "study" here is essentially the comparison to predicate devices, and the "proof" is the FDA's determination of substantial equivalence.

In summary, this document is a regulatory filing for an iontophoresis electrode product, focusing on its equivalence to previously approved devices. It does not contain the detailed clinical or technical study data (performance metrics, study design, ground truth establishment, sample sizes, etc.) that would typically be associated with a description of acceptance criteria and the evidence proving a device meets them for a novel or significantly modified device.

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