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The PROSTIM 1000/2000 is used for the symptomatic relief and management of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.

The PROSTIM 1000/2000 are battery operated TENS units for pain control. User driven the units feature a wide array of output combinations. The user may set the timer for 15 minutes to 30 minutes or a continuous mode. They also feature three modes: B (Burst), N (Normal), and M (Modulation). The pulse rate, pulse width, and amplitude are adjustable.

The devices are supplied with electrodes and electrode leads(K 042301) and electrode leads, battery case and 9V battery, Instruction manual and carrying case.

This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called PROSTIM 1000/2000. For such devices, acceptance criteria and detailed performance studies are typically focused on electrical safety, electromagnetic compatibility (EMC), and functional performance specifications rather than clinical efficacy studies with human subjects or AI performance metrics.

Based on the provided text, the device's acceptance criteria are primarily met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. There is no clinical study involving human patients or AI performance metrics within this submission.

Here's a breakdown of the requested information based on the document:

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

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

• Sample Size: Not applicable. This submission does not describe a test set or clinical study involving human data. The assessment is based on comparison to predicate devices and adherence to safety standards.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable. No ground truth for a test set was established as no clinical study or human data evaluation is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring adjudication is 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

• MRMC Study: No. This is a TENS device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or presented in this document.

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

• Standalone Performance: No. This is not an AI algorithm.

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

• Type of Ground Truth: Not applicable. The "ground truth" in this context refers to the established safety requirements and the functional parameters of the predicate devices. There is no clinical ground truth established from patient outcomes, pathology, or expert consensus described for a study.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI device.

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

• Ground Truth for Training Set: Not applicable. This is not an AI device.

In summary: The PROSTIM 1000/2000 received 510(k) clearance by demonstrating substantial equivalence to previously legally marketed predicate TENS devices in terms of intended use, technology, operating principles, and by complying with recognized electrical safety and EMC standards. This type of submission does not typically involve clinical performance studies with human subjects or AI performance evaluations as described in your prompt.

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