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The neurotech BACKTENS device is intended to provide to pain associated with sore and The neurotech BACKTENS device is intentiou to provins time sump and the program and in activities

The NeuroTech BackTENS device is a self-contained battery operated transcutaneous electrical muscle stimulator. The adhesive electrodes are mounted on a belt offering lumbar support to the user during therapy delivery. The device is intended to provide a non-invasive therapy for over the counter sale.

The provided text describes a 510(k) summary for the NeuroTech® BackTENS & Lumbar support Type 294 device. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets specific performance metrics for clinical efficacy or accuracy in the way described in the prompt.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of this 510(k) submission is to demonstrate that the NeuroTech BackTENS device is substantially equivalent to a legally marketed predicate device (NeuroTech© Smart-TENS, Type 456, K961376).
• Safety and Performance to Standards: The device's safety and performance are assessed against existing, recognized electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 601-1-1, IEC 601-1-2, IEC 61000-4-2, IEC 61000-4-3, DD ENV 50204, EN 55011). It also mentions hazard, risk, and failure mode effects analyses.
• Electrical Output Comparison: Non-clinical tests involved comparing the electrical outputs of the new device to the predicate device, showing similar results.
• Intended Use: The device is indicated for transcutaneous electrical nerve stimulation (TENS) for symptomatic relief and management of chronic lower back pain, and for lumbar support.

Therefore, I cannot populate the table or answer most of the questions as the required information (acceptance criteria, performance data, clinical study details, ground truth, expert opinions, sample sizes for testing/training sets, MRMC study, standalone performance) is not present in the provided text.

The document details the regulatory process (510(k) submission, FDA review, substantial equivalence determination) rather than the results of an empirical study with performance metrics.

Here's an attempt to address the prompt based only on the available information, with the understanding that most sections will be marked as "Not Provided" or "Not Applicable" for a traditional device performance study.

1. Table of acceptance criteria and the reported device performance

• IEC 60601-1:1990
• IEC 60601-2-10
• IEC 601-1-1 (A1:1991, A2:1995) |
  | Compliance with EMC Standards | Designed and independently tested to:
• IEC 601-1-2
• IEC 61000-4-2:1995
• IEC 61000-4-3:1997
• DD ENV 50204:1996
• EN 55011:1998 |
  | Hazard, Risk, FMEA | Hazard analysis, risk analysis, and failure mode effects analysis have been carried out. |
  | Final Performance Testing | All devices are subject to final performance testing (industry practice). |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not provided. The document describes "non-clinical tests" comparing electrical outputs, but no specific sample size for device units tested or patients is mentioned.
• Data Provenance: Not provided, beyond the manufacturer being Bio-Medical Research Ltd in Galway, Republic of Ireland. The tests mentioned are likely in-house or by independent testing labs for electrical/EMC compliance, not clinical data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Provided: The document does not describe a clinical test set requiring expert-established ground truth. The "tests" mentioned are primarily electrical and safety compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable/Not Provided: There is no clinical test set described that would require adjudication.

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 a TENS device, not an AI or diagnostic imaging device. An MRMC study is not relevant to the information provided.

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

• Not Applicable: This is a physical medical device (TENS stimulator), not an algorithm or AI. Standalone algorithmic performance is not relevant.

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

• Not Applicable/Not Provided: For the electrical and safety tests, the "ground truth" would be the specified parameters in the standards and the electrical output of the predicate device. No clinical ground truth method is discussed.

8. The sample size for the training set

• Not Applicable: This is a physical medical device; there is no "training set" in the context of machine learning or algorithms.

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

• Not Applicable: As above, there is no training set mentioned or implied.

Summary of what the document does convey regarding device acceptance:

The NeuroTech BackTENS device was accepted by the FDA based on the demonstration of substantial equivalence to an existing predicate device (NeuroTech© Smart-TENS). This equivalence was supported by:

• Similar intended use.
• Comparable technological characteristics (e.g., delivery of stimulation signal, parameter settings, LCD screen, user compliance logging).
• Non-clinical tests showing similar electrical outputs between the two devices.
• Compliance with recognized national and international electrical safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, IEC 601-1-2).
• Completion of risk management activities (hazard analysis, risk analysis, FMEA).

The acceptance criteria were therefore focused on meeting the requirements for substantial equivalence and demonstrating adherence to established safety and performance standards for transcutaneous electrical nerve stimulators, rather than an independent clinical efficacy study with specific performance metrics.

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