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• Symptomatic relief of chronic intractable pain
• Adjunctive treatment for the management of post-traumatic or post-surgical pain

The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.

Here's an analysis of the provided text regarding the Chronic Pain Suppressor CPS-2000's acceptance criteria and studies, based on the information available:

The provided document is a 510(k) summary for the Chronic Pain Suppressor CPS-2000. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/ML device submission would.

Therefore, many of the requested sections about specific performance metrics, sample sizes, expert involvement, and ground truth are not applicable to this type of traditional medical device submission. The device is an Interferential Current Therapy device, not an AI/ML diagnostic tool.

Analysis of Acceptance Criteria and Supporting Study for Chronic Pain Suppressor CPS-2000

The provided 510(k) summary (K033358) for the Chronic Pain Suppressor CPS-2000 focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantitative acceptance criteria for clinical efficacy. The "acceptance criteria" here are implicitly related to meeting the standards of general safety and effectiveness comparable to existing devices of its type, as established through compliance with voluntary standards and descriptive characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

• UL 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
• AAMI/ANSI NS4:1986/(R)2002 Transcutaneous Electrical Nerve Stimulators (specifically items 3.1-3.1.2.1, 3.1.3-3.2.5, 4.1-4.2.3.2) - Note: While the device is an Interferential Current Therapy device, certain aspects of TENS standards may be considered relevant for electrical stimulation safety and performance characteristics. |

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

• Not Applicable (N/A) for clinical test set: This 510(k) summary does not describe a clinical performance study with a "test set" of patients in the context of typical clinical trial data submission for an AI/ML device. The evidence for substantial equivalence relies on descriptive characteristics and conformance to voluntary standards rather than new clinical data from a specific patient cohort.
• Data Provenance: N/A.

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

• N/A: No clinical test set requiring expert-established ground truth is described in this 510(k) summary. The submission relies on regulatory and engineering specialists confirming compliance with standards and comparing technical specifications to predicate devices.

4. Adjudication Method for the Test Set

• N/A: No clinical test set requiring adjudication is described.

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

• No: An MRMC comparative effectiveness study was not performed or described in this 510(k) summary. Such studies are typically for diagnostic devices or AI/ML-assisted interpretation, which is not the nature of the Chronic Pain Suppressor.

6. If a Standalone Performance Study Was Done

• Standalone (Technical) Performance: Yes, in the sense that the device's technical specifications and safety characteristics were evaluated for conformance to voluntary standards (UL, IEC, AAMI/ANSI NS4). This demonstrates the device's ability to operate safely and within expected electrical parameters. However, this is not a "standalone clinical performance" study for diagnostic accuracy or clinical efficacy against a novel endpoint.
• Results: The device was found to conform to the specified voluntary standards, indicating its technical safety and performance meet recognized benchmarks.

7. The Type of Ground Truth Used

• N/A (for clinical ground truth): The "ground truth" here is conceptual, relating to the established technical requirements and safety parameters defined by the voluntary standards (e.g., electrical output specifications, electromagnetic compatibility limits, safety features). There is no "pathology" or "outcomes data" ground truth established for a clinical cohort.

8. The Sample Size for the Training Set

• N/A: There is no "training set" as this is not an AI/ML device.

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

• N/A: There is no "training set," so the concept of establishing ground truth for it is not applicable.

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The MEDSTAR 100 Interferential Stimulator should only be used under the supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:

• symptomatic relief and management of chronic pain and/or .
• an adjunctive treatment in the management of post surgical and posttraumatic acute . pain.

The MEDSTAR 100 is a DC battery powered device that generates small pulses of electric current. These small pulses of electrical current are delivered through leads cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study to prove the device meets such criteria in the context of clinical or diagnostic efficacy. Instead, the document is a 510(k) summary and FDA clearance letter for a medical device called the MEDSTAR 100 Interferential Stimulator.

The "study" mentioned relates to functional and safety testing to demonstrate substantial equivalence to a predicate device, not clinical performance or diagnostic accuracy.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not provide a table of acceptance criteria for clinical performance or diagnostic accuracy. It states:

• Functional & Safety Testing: "Was performed with a signal generator voltmeter, 420 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V1 was set at approximately 2 volts. The voltage drop across the electrodes (V7) was measured and the impedance of the electrodes calculation is as follows: Impedance (Z) = V7/V1 x R"
• Reported Performance: No specific numerical performance results from this testing are reported in the provided text. The document only describes the methodology.
• Conclusion regarding performance: "The MEDSTAR™ 100 Interferential Stimulator is substantially equivalent to the HMP 4000 Interferential Stimulator for intended use, design, and electrical performance." This is an overall conclusion based on the testing, but no specific performance values are listed against explicit acceptance criteria beyond the general statement of electrical performance equivalence.

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

• Sample size for test set: Not applicable in the context of a clinical or diagnostic test set. The functional and safety testing described would typically involve a small number of devices, often a single unit or a few units, to confirm manufacturing specifications and basic electrical safety. The text does not specify the number of devices tested.
• Data provenance: Not applicable. The testing is described as "performed" by the submitter, MedNet Services, Inc. It is functional and safety testing, not human subject data.

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

• Not applicable. The "ground truth" here is the expected electrical behavior of the device and its safety, which is assessed through engineering measurements against established standards or predicate device specifications, not by expert interpretation of clinical data.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication" in the clinical sense mentioned. The functional and safety testing relies on direct electrical measurements.

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 is not an AI device or a diagnostic device that would involve human readers interpreting cases. It is an Interferential Stimulator for pain relief.

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

• No. This is not an algorithm-based device. It's a physical medical device.

7. The type of ground truth used

• For the functional and safety testing, the "ground truth" would be the engineering specifications and established electrical safety standards for medical devices of this type, potentially derived from the predicate device's characteristics. There's no clinical ground truth (pathology, expert consensus, outcomes data) as this is not a diagnostic device.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. As above, no training set.

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