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For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.

The provided text is a 510(k) summary for the ALEVE® Direct Therapy® medical device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Based on the provided document, the device is a TENS unit, and the acceptance criteria and study proving it meets these criteria are related to its safety and performance based on engineering and laboratory testing, rather than clinical efficacy studies for AI/ML performance.

Therefore, I cannot provide information on AI/ML specific criteria such as:

• A table of acceptance criteria and reported device performance related to AI/ML metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets in an AI/ML context.
• Number of experts and their qualifications for ground truth establishment for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• MRMC comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used in an AI/ML context.
• Sample size for a training set (AI/ML).
• How ground truth for a training set was established (AI/ML).

Here's a breakdown of what can be extracted from the document regarding the device's acceptance criteria and the study that proves it meets them, framed in the context of a medical device submission (Premarket Notification 510(k)) that relies on substantial equivalence to predicate devices:

Device: ALEVE® Direct Therapy® (Second Generation) - Transcutaneous Electrical Nerve Stimulator (TENS) for Pain Relief

1. Table of Acceptance Criteria and Reported Device Performance (Based on Substantial Equivalence and Non-Clinical Testing):

The document does not present a formal table of explicit acceptance criteria with numerical performance targets for a new device. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicates through a series of non-clinical tests and shows comparable technological characteristics.

• Unit level testing
• System testing
• Software verification and validation |
  | Usability Engineering | Testing performed and results contributed to meeting established specifications. |
  | Biocompatibility | Met requirements per ISO 10993-1. |
  | Electrical Safety | IEC 60601-1:2005 Ed. 3 + C1:2009 + A1:2012 (FDA Recognition Number 19-4) compliant. |
  | Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 Ed. 4 (FDA Recognition 19-8) compliant. |
  | Home Healthcare Environment | IEC 60601-1-11 Edition 2.0 2015-01 (FDA Recognition Number 19-14) compliant. |
  | TENS Specific Safety | IEC 60601-2-10 Edition 2.0 2012.06 (FDA Recognition Number 17-11) compliant. |
  | Risk Management | ISO 14971 Second edition 2007-03-01 (FDA Recognition Number 5-40) compliant. |
  | Software Life Cycle Processes | IEC 62304 Edition 1.1 2015-06 (FDA Recognition Number 13-79) compliant. |
  | Chemical Characterization (Materials) | AAMI/ANSI/ISO 10993-10:2010 (FDA Recognition Number 2-173) compliant (implied by biocompatibility). |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a "sample size" in the conventional sense of a clinical trial or a machine learning test set. The validation is based on non-clinical bench and safety testing of the device itself (e.g., electrical safety, software validation, biocompatibility), not a dataset of patient data or clinical images. Therefore, the "test set" would refer to the physical units of the device tested in the laboratory. The document does not specify how many units were tested.
• Data Provenance: Not applicable in the context of patient data. The data provenance is from laboratory testing performed by the manufacturer, Bayer HealthCare LLC. The document does not specify the country where these tests were conducted, but the company is based in Whippany, New Jersey, USA. The testing is retrospectively reported as part of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

• Not applicable. Ground truth for a TENS device's safety and performance in the context of a 510(k) is established through adherence to recognized international and national standards (e.g., IEC, ISO, ANSI/AAMI) verified by laboratory testing, not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set:

• Not applicable. There is no human adjudication process involved in verifying the compliance of a TENS device with electrical safety, EMC, or biocompatibility standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images. This device is a therapeutic TENS unit.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable in the context of an AI/ML algorithm. The "standalone" performance here refers to the device's ability to operate according to its specifications (e.g., output electrical pulses within specified parameters) without human intervention during its operational cycle, which is verified through bench testing. The mobile app controls the device, but the "performance" validated is of the TENS output, not the app's diagnostic or interpretive capabilities.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is its compliance with pre-defined technical specifications, safety standards, and performance characteristics as demonstrated through non-clinical bench testing, software verification/validation, and adherence to recognized standards (e.g., electrical safety, EMC, biocompatibility, risk management). It is essentially engineering and regulatory standard compliance.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, this is not an AI/ML device.

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Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The ALEVE Direct Therapy device is a battery powered transcutaneous electrical nerve stimulator (TENS) for applying an electrical current to electrodes on a patient's skin to relieve pain. The device reduces the perception of pain by electrically stimulating peripheral nerves across the skin. The design of the device limits the application for use to the anatomical site of the back.

The device is comprised of a TENS unit with integral electrodes, one pair of replaceable electroconductive hydrogel pads, batteries for the remote and TENS unit, and a remote control. The user can turn the device on/off by pressing a button on the TENS unit. The hydrogel pads are adhesive and gently adhere the TENS unit to the user's skin on the lower back. There is also a remote control for the device, which the user turns on/off, and by which the user adjusts the intensity of stimulation.

This document is a 510(k) summary for the ALEVE Direct Therapy TENS device, claiming substantial equivalence to a predicate device (Pain Pilot™ / WiTouch® K120500). As such, it focuses on demonstrating similarity rather than presenting a detailed de novo study with specific acceptance criteria and performance against those criteria in the way a novel device might.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal "acceptance criteria" table with specific quantitative thresholds for the device's clinical performance (e.g., pain reduction scores). Instead, it relies on demonstrating substantial equivalence to a predicate device, meaning its performance is expected to be similar or identical.

The performance data primarily focuses on engineering and safety standards, and a single usability study.

• ISO 14971:2007 (risk management)
• AAMI/ANSI ES60601-1:2005/(R)2012 (general basic safety and essential performance)
• IEC 60601-1-2 Ed 4.0 2014-02 (EMC)
• IEC 60601-1-11 Ed 1.0 2010-04 (home healthcare environment)
• IEC 60601-2-10 Ed 2.0 2012-06 (nerve and muscle stimulators) |
  | Biocompatibility Standards Compliance | Conformance with ISO standards:
• AAMI/ANSI/ISO 10993-1:2009/(R) 2013 (biological evaluation, risk management)
• AAMI/ANSI/ISO 10993-5:2009/(R) 2014 (in vitro cytotoxicity)
• AAMI/ANSI/ISO 10993-10:2010 (irritation and skin sensitization)
  (Note: The document states "The safety of this colorant has been demonstrated (Section 12, Biocompatibility).") |
  | Software Verification and Validation (Moderate Level Concern) | Software verification and validation testing conducted, documentation provided in accordance with FDA's guidance for "Moderate level concern device." |
  | Device Output Characteristics | Data in support of the device waveform and verification of output characteristics provided. (The specific characteristics are listed in the "Basic Unit Characteristics Comparison" table on page 5, which are all "IDENTICAL" or "Substantially Equivalent" to the predicate, implying conformity to the predicate's established performance). |
  | Usability | A 15-subject usability study was conducted for the predicate device (K120500) and reported to the FDA. The submitter (Bayer HealthCare, LLC) references this study due to the devices and labeling being "sufficiently similar." This implies the predicate device met usability criteria, and by extension, the new device is considered to meet them. |
  | Substantial Equivalence | The overall acceptance criterion is "substantial equivalence" to the predicate device (Pain Pilot™ / WiTouch® K120500). The document concludes: "The electrical safety, EMC, biocompatibility, software verification and validation, basic unit characteristics, and output specifications information provided in the 510(k) submission is sufficient to demonstrate substantial equivalence to the predicate device. As the ALEVE Direct Therapy TENS device is nearly identical to the predicate device, with identical indications for use and essentially identical technological characteristics, the ALEVE Direct Therapy TENS device is substantially equivalent to the predicate device." |

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

• Test Set Sample Size:
  • For the usability study (which is the only human-based performance data mentioned), the sample size was 15 subjects.
  • No other human clinical "test set" data is explicitly described for performance on the primary indication (pain relief). The submission relies on the predicate device's established effectiveness.
• Data Provenance: The usability study was conducted by Hollywog (the original manufacturer of the predicate device). The document doesn't specify the country of origin for this study, nor does it explicitly state if it was retrospective or prospective, though usability studies are typically prospective.

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. This device is a TENS unit for pain relief, not an AI/imaging diagnostic device. Ground truth, in the sense of expert annotation, is not relevant to the usability study or the engineering/safety tests described. Pain relief, if directly measured in a clinical trial, would typically rely on patient-reported outcomes, not expert-established ground truth.

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

Not applicable, as described in point 3.

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 is not an AI-assisted diagnostic or interpretation device that would involve human readers or MRMC studies.

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 unit), not a software algorithm or AI.

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

For the usability study, the "ground truth" would be the direct experience and feedback of the 15 subjects regarding the device's ease of use and functionality. For the safety and engineering tests, the "ground truth" is compliance with recognized standards or objective measurements of electrical characteristics. For the primary indication (pain relief), the justification relies on the predicate device's established clinical effectiveness, which would have been based on patient outcomes data (e.g., pain scores) in its original approval.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI that would require a "training set."

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

Not applicable, as described in point 8.

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