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The H-Wave® H4 is indicated for the treatment of chronic pain, acute pain, postsurgical pain, and temporary pain.

The H-Wave® model H4 consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic stimulation at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

Here's an analysis of the provided text regarding the H-Wave® Electrical Stimulator (model H4) and its acceptance criteria, structured according to your request:

Acceptance Criteria and Device Performance Study for the H-Wave® H4 Electrical Stimulator

Based on the provided 510(k) summary (K112485), the acceptance criteria for the H-Wave® H4 device are primarily demonstrated through compliance with recognized consensus standards and by establishing substantial equivalence to previously cleared predicate devices. The study proving the device meets these criteria is a bench testing/technical comparison study, not a clinical trial with human subjects.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical test set with patient data. The "test set" here refers to the device itself being tested against standards and compared to predicate devices in a bench environment.
• Data Provenance: The data comes from the technical specifications and testing of the H-Wave® H4 device itself, and comparison against the technical specifications of three predicate devices as documented in their 510(k) clearances. This is primarily retrospective in terms of referencing predicate devices and their cleared specifications, combined with prospective bench testing of the new device against recognized standards. The country of origin for the H-Wave® H4 device is implied to be the USA (Electronic Waveform Lab, Inc. of Huntington Beach, CA).

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

• Number of Experts: Not explicitly stated as part of the submission documentation.
• Qualifications of Experts: The ground truth for compliance with recognized standards (IEC 60601 series) would be established by experts in electrical safety, electromagnetic compatibility, and medical device performance testing, typically within a certified testing laboratory. For the substantial equivalence comparison, the "experts" were the reviewers at the FDA's Office of Device Evaluation (Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices), who are physicians and scientific reviewers responsible for assessing medical device safety and effectiveness.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This submission relies on compliance with objective performance standards and direct comparison of technical specifications against predicate devices, rather than subjective interpretation by multiple human readers that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No.
• Effect Size of Human Readers: Not applicable, as this is a physical electrical stimulator and the submission focuses on its technical characteristics and safety, not on diagnostic performance or human-in-the-loop clinical interpretation tasks.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study Done: Yes, in a sense. The "standalone" performance is assessed through the device's compliance with the cited IEC standards (IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2) which are objective tests of the device's electrical safety and performance parameters without human intervention or interpretation during the testing. The comparison table also provides standalone technical characteristics of the device.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • Recognized Consensus Standards: For electrical safety and electromagnetic compatibility (IEC 60601 series).
  • Predicate Device Specifications: The technical specifications (e.g., frequency, power source, channels, features) of legally marketed, cleared predicate devices (K813601, K103738, K021496).
  • Device Technical Specifications: The measured or designed technical specifications of the H-Wave® H4 device itself.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI-based device that requires a training set of data. The "training" for this device would be its engineering and design process, ensuring it meets technical specifications.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no "training set" in the context of this device's submission. The closest analogy would be the engineering design requirements and regulatory standards that guide the device's development to ensure it meets its intended function and safety profiles.

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The H-Wave® is indicated for the following conditions:

1. Relaxation of muscle spasms;
2. Prevention or retardation of disuse atrophy;
3. Increasing local blood circulation;
4. Muscle re-education;
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion.

The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.

This 510(k) submission describes the H-Wave® Electrical Stimulator (model H4). The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, the H-Wave (model P-4). Therefore, the study presented focuses on verification and validation testing of changes to the device and its compliance with recognized standards, rather than a clinical trial demonstrating specific clinical performance metrics against predefined acceptance criteria for indications for use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are primarily defined by compliance with specific electrical medical equipment safety and performance standards, and comparison with the predicate device's features. The "reported device performance" refers to the H-Wave H4's demonstrated adherence to these standards and its characteristics.

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

• Sample Size: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for clinical performance. The testing described is primarily bench testing and software verification/validation on the device itself and its components.
• Data Provenance: Not applicable, as this is not a study involving patient data. The testing is internal to the manufacturer, verifying the device's adherence to engineering specifications and regulatory standards.

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

• Number of Experts: Not applicable. Ground truth, in the context of this submission, refers to the established technical specifications and recognized consensus standards (e.g., IEC standards). The "truth" is dictated by these objective, pre-defined technical benchmarks.
• Qualifications of Experts: N/A for establishing "ground truth" as it would apply to a clinical study. Technical experts within the manufacturer and potentially third-party testing labs would have been involved to ensure compliance with the specified engineering and safety standards.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study that requires adjudication of findings, as it focuses on technical compliance and equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for a medical device that relies on established physiological principles of electrical stimulation and seeks substantial equivalence to a predicate device based primarily on technical specifications and safety standards, not a comparative clinical performance trial involving multiple readers or human-AI interaction.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The H-Wave is an electrical stimulator, not an AI/algorithm-driven diagnostic or therapeutic system that would have a "standalone" performance in the context of an algorithm. While it contains software, its function is to deliver electrical impulses, and its performance is evaluated by its adherence to specified electrical output parameters and safety.

7. The Type of Ground Truth Used

• The "ground truth" for the verification and validation testing is defined by:
  • Recognized Consensus Standards: IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2.
  • Regulatory Requirements: 21 CFR Part 898 and general controls provisions of the Act.
  • Engineering Specifications: Internal design specifications for the device's electrical output, safety features, and mechanical performance.
  • Predicate Device Specifications: The technical parameters and performance characteristics of the H-Wave (model P-4) served as a benchmark for equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The "training" in the device's development refers to its design and engineering process to meet specified technical parameters.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set was used for an AI/ML algorithm. The "truth" for the device's design and manufacturing is established by engineering principles, regulatory compliance, and a detailed understanding of the intended physiological effects of electrical stimulation.

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The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.

The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.

The provided text describes a 510(k) submission for the H-Wave® Sport, a powered muscle stimulator. The regulatory pathway for this device is based on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria and performance metrics typically associated with AI/ML-based devices or therapies requiring more rigorous clinical evidence.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this specific 510(k) summary. The "study" referenced is largely laboratory bench testing to ensure the device functions as intended and supports the use of low-frequency stimulation for endurance and active recovery, rather than a clinical trial proving specific performance metrics against a defined ground truth.

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

1. A table of acceptance criteria and the reported device performance

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: Not explicitly stated. The text refers to "laboratory bench testing" without specifying the number of devices tested or the specific test parameters.
• Data Provenance: The testing was "laboratory bench testing," implying an engineered environment rather than a human subject study. The country of origin for the data is not specified, but the applicant (Electronic Waveform Lab, Inc.) is based in Huntington Beach, CA, USA.
• Retrospective or Prospective: Not applicable as it was bench testing, not a human study.

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)

• Number of Experts: Not applicable. Ground truth in this context refers to engineering specifications and functional performance metrics, not clinical interpretation by experts.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. Adjudication is typically used for resolving discrepancies in expert interpretations in clinical studies.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This device is not AI-driven and does not involve human readers interpreting cases.

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

• Standalone Performance: Not applicable. This is a physical medical device (muscle stimulator), not an algorithm or AI. The "performance" refers to the device's electrical and mechanical functioning.

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

• Type of Ground Truth: The "ground truth" for the bench testing would be the device's design specifications and established engineering principles for powered muscle stimulators. Functional performance was assessed against these expected outcomes.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in the AI/ML sense.

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

• Ground Truth Establishment for Training Set: Not applicable.

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