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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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