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Prescription Use:
The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

Over the Counter Use:
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain associated with arthritis.

The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate.

The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.

This document is a 510(k) summary for the Strive™ Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" paired with "reported device performance" in a single table format. Instead, it presents performance testing results against recognized standards and claims substantial equivalence to predicate devices. The comparisons provided in Tables 1a, 1b, 2, 3, and 4 effectively serve as the device's reported performance against established benchmarks (predicate devices' specifications and general standards for TENS devices).

Here's a synthesized table based on the information provided, focusing on the Strive device's performance against relevant standards and the finding of substantial equivalence:

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

The document does not specify the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests (Electrical Safety and EMC, Software Verification, Usability/Human Factors, Coexistence Testing). These types of tests typically involve testing the device itself or a representative number of devices, rather than a clinical dataset of patients.

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)

The document does not mention the use of experts to establish a "ground truth" for any test sets in the way that would apply to diagnostic imaging or clinical trials. The tests performed are primarily engineering and simulated user environment tests.

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

No adjudication method is mentioned or implied, as the nature of the tests (electrical safety, software verification, usability, coexistence) does not typically involve human adjudication of results in the way a clinical study or expert review of images would.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a TENS unit for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers."

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

This question is not applicable. The Strive™ device is a medical device (TENS unit) that delivers electrical stimulation. It does not employ an "algorithm" in a diagnostic or interpretive sense that would operate "standalone" versus "human-in-the-loop." Its performance is about its physical outputs and safety, not an interpretive algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The "truth" for the performance tests mentioned (electrical safety, software, usability, coexistence) is conformance to the specified standards or design requirements.

8. The sample size for the training set

This question is not applicable. The Strive™ device is a TENS unit, not an AI/machine learning model that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

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The Strive™ Dual Zone PFM is a monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation maneuver. The device will monitor the PEF of patients whose doses of medication are dependent upon a measured obstruction in PEF.

The Strive™ Peak Flow Meter is designed for children five years or older and adults. The intended environments for use include home, hospitals and clinics.

The Strive™ Dual Zone Peak Flow Meter (PFM) is a hand-held monitoring device that measures Peak Expiratory Flow (PEF) generated by the patient during a forced exhalation mancuver. It can be used to objectively measure PEF by tracking day-to-day changes in breathing patterns.

The Strive™ PFM meets the Standards of Spirometry, 2005 revision, for portable peak flow meters as established by the American Thoracic Society and also meets ISO23747, First edition 2007-07-15, for Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans. The Strive™ PFM and product insert meets the educational guidelines recommended by the National Asthma Educational Prevention Program (NAEPP) of the National Institutes of Health.

The Strive™ PFM has two scale ranges to make the device suitable for both pediatric (+5 yrs) and adult patients who use a peak flow meter as part of their treatment program for respiratory conditions. A range selector is used to select the scale that best fits the patient's needs as determined by a healthcare provider. The device incorporates the NAEPP three zone color codes. The color-coded zone indicators on the side of the device adjust to define the patient's red, yellow and green zones. They can be readjusted as recommended by a healthcare provider.

The provided text describes a 510(k) summary for the Strive™ Dual Zone Peak Flow Meter (PFM). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance and AI-specific metrics is not available in the provided document.

However, based on the non-clinical testing sections, we can infer the acceptance criteria for performance and the type of evaluation conducted.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance and functional testing against established standards (ATS, ISO 23747). It does not mention a "test set" in the context of clinical data or patient samples. The testing would have involved physical units of the Strive™ Dual Zone PFM and potentially simulated exhalation profiles, as per the standards. Specific sample sizes of devices or simulated breath cycles for these non-clinical tests are not provided in this summary. There is no data provenance in terms of country of origin or retrospective/prospective for clinical data, as no clinical study was performed.

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

Not applicable. No clinical expert-based ground truth was established for a "test set" as no clinical study was conducted. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the ATS and ISO standards.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 physical medical device (peak flow meter) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement analysis was conducted.

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

Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation in the context of AI. Its "standalone performance" is its accuracy and reliability in measuring PEF, which was evaluated against the ATS and ISO standards.

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

For the non-clinical and functional testing, the "ground truth" was established by recognized industry and medical standards: the American Thoracic Society (ATS) Standard of Spirometry: 2005 and ISO 23747 International Standard. These standards define the acceptable range of accuracy and performance for peak flow meters.

8. The sample size for the training set

Not applicable. This device is a physical medical device and does not involve machine learning or AI models, so there is no training set in that context.

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

Not applicable. As there is no training set for AI/machine learning, this question is not relevant.

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