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For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain.

Delta Scanner devices are micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and as adjunctive treatment in the management of post-traumatic and post surgical pain. They are handheld, easy-to-use battery operated portable devices, for use in the home or clinic. The technological characteristics of these devices, including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM

The provided text is a 510(k) summary for the Med-Lectric Corporation's Delta Scanner devices. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting new clinical trials with acceptance criteria and performance metrics described in the way a de novo or PMA submission would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a specific study proving the device meets them, as it relates to performance benchmarks (e.g., sensitivity, specificity, accuracy).

Here's why the information is not present and what the document does state:

• Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in the context of a performance study for the Delta Scanner devices. The submission claims substantial equivalence based on technological characteristics and intended use matching predicate devices. The document implies that the "acceptance criteria" are met if the new device's characteristics are similar enough to existing cleared devices.
• Study That Proves the Device Meets Acceptance Criteria: There is no specific clinical study described that proves the Delta Scanner devices meet quantitative performance acceptance criteria in terms of efficacy or safety beyond demonstrating substantial equivalence to predicate devices. The submission mentions "verification and validation tests" but provides no details on their methodology, results, or how they relate to specific performance metrics.

Breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Inferred): Substantial equivalence to predicate devices (InterX5000™, K042912, K053626; Body-Stim™, Biomodulator™, Best-RSI™, Best Pro™, K062641). Specifically, "technological characteristics... including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM." Also, the "intended uses" are the same.
   • Reported Device Performance: Not mentioned in terms of quantitative clinical outcomes or performance metrics (e.g., pain reduction percentage, adverse events rate, etc.) for the Delta Scanner itself, beyond the claim of substantial equivalence to predicate devices which are presumed to be safe and effective.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is detailed for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.

4. Adjudication method for the test set: Not applicable.

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 device is a TENS device, not an AI-based imaging or diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. No training set is detailed.

9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The 510(k) summary for the Delta Scanner devices relies on demonstrating "substantial equivalence" to already cleared devices. The "verification and validation tests" mentioned are general statements regarding software compliance and overall device equivalence, rather than detailed clinical performance studies with specific acceptance criteria and results for the new device itself.

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