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NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.

The NeMa-st is a pain relief treatment console, which includes Screen, Mouse, Kevboard, Processor, embedded Software, Power Supplies and the stimulator circuitry and probes.

The provided text describes a 510(k) submission for the "NeMa-st" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for back pain relief. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The 510(k) submission primarily focuses on:

• Device Description: What the NeMa-st is (console, screen, mouse, keyboard, processor, embedded software, power supplies, stimulator circuitry and probes).
• Intended Use and Indications for Use: TENS for back pain relief (chronic, intractable, post-surgical, post-trauma back pain).
• Safety & Effectiveness Statement: The device was designed, verified, and validated according to 21CFR 820.30 and certified to IEC 60601-1, IEC 60601-1-2, & IEC 60601-2-10 safety standards. It states that "This certification and the results of performance bench and validation testing demonstrate the device safety and effectiveness." However, no specific performance data or acceptance criteria from these tests are provided.
• Substantial Equivalency: Comparison to predicate devices (K062354 Vectra Genisys, K060517 Pointer Excel). This is a regulatory pathway, not a performance study in itself.

Therefore, I cannot provide the requested table and study details because the information is not present in the given text.

Summary of missing information based on your request:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size used for the test set and data provenance: Not provided (no specific performance study details).
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no ground truth is established for device performance in this document.
4. Adjudication method for the test set: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. The device is a TENS unit, not an imaging or diagnostic AI.
6. Standalone performance study: Not detailed beyond a general statement of "performance bench and validation testing." Specific results are absent.
7. Type of ground truth used: Not applicable (no ground truth data discussed for performance).
8. Sample size for the training set: Not applicable (no AI training mentioned, device is a TENS unit).
9. How ground truth for the training set was established: Not applicable.

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