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Pure Impact is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
• The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.

Pure Impact device provides both training and physical therapy using Electrical Muscle Stimulation (EMS). The EMS is provided through electrodes that are controlled by the Touch Control Module.

The system includes:

• Touch Control Module
• Pure Impact™ Wireless Stimulation Modules
• Pure Impact™ Electrode Pads
• Pure Impact™ Charging Station

The Touch Control Module runs the Pure Impact™ program and displays the user interface, which provides the full range of controls to identify the patient and the required treatment. The Pure Impact™ Wireless Stimulation Modules provide EMS to selected body locations on the patient and communicate to the Touch Control Module through Bluetooth Low Energy (BLE). Each Stimulation Module contains a main stimulation unit and several stimulation subunits, each of which is attached to a Pure Impact™ Electrode Pad placed on the patient. The Pure Impact™ Electrode Pads are disposable and intended for single patient, single use only. They contain a hydrogel adhesive to attach to the selected body locations on the patient and magnetic connectors to attach to the Stimulation Modules. The Pure Impact™ Charging Station charges the Stimulation Modules.

This FDA 510(k) clearance letter pertains to the Pure Impact device, a powered muscle stimulator. The clearance is based on demonstrating substantial equivalence to a predicate device, the Pure Impact Module of the SofWave System (K250146).

The document states that the Pure Impact device is a modification of the predicate, with the only changes being related to the standalone PC, GUI, and software updates. It explicitly states that no changes were made to the Pure Impact Charging Station Unit, Pure Impact Wireless Stimulation Modules, or Pure Impact Electrode Pads. Furthermore, the change does not affect the treatment protocols, stimulation parameters, or energy delivery.

Therefore, the performance data and acceptance criteria for electrical muscle stimulators (EMS) typically revolve around safety and technical specifications, rather than clinical efficacy or diagnostic accuracy, which would involve more complex studies like MRMC or ground truth assessment from expert consensus or pathology. This is because EMS devices, particularly those for muscle conditioning, are often cleared based on demonstrating that their technical characteristics (e.g., waveform, output, safety features) are equivalent to a legally marketed predicate device, and that these characteristics do not raise new questions of safety or effectiveness.

Given the information provided, which heavily emphasizes direct technical comparison and safety testing (electrical safety, EMC, software V&V), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily framed around these technical and safety aspects, and the device's functional equivalence to its predicate. There is no mention of a clinical study assessing improvement in muscle tone or firmness with quantified metrics from human subjects, or any study involving human readers/experts for performance evaluation, as would be common for diagnostic AI/ML devices.

Here's a breakdown of the requested information based solely on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are predominantly framed as mirroring the technical specifications and safety standards met by the predicate device, and ensuring the modified device continues to meet these.

Study Proving Acceptance: The document states "Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device. In all instances, the subject Pure Impact device performed as intended." Specific tests mentioned for verification include:

• Software verification and validation
• Cybersecurity testing
• Electrical Safety (IEC 60601-1)
• Electromagnetic Compatibility (IEC 60601-1-2)
• Specific medical electrical equipment standards (IEC 60601-1-6, IEC 60601-2-10)
• Risk analysis (ISO 14971)

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

The document does not detail a specific "test set" in terms of patient data or clinical images, as this is a modification of an existing EMS device primarily cleared based on technical and safety equivalence. The testing described is primarily engineering verification testing of the device's hardware and software components.

• Sample Size for Test Set: Not applicable in the context of patient data or clinical performance. The "test set" refers to the specific Pure Impact device and its components undergoing engineering and software verification.
• Data Provenance: Not applicable in the context of patient data. The "data" pertains to the results of internal engineering and software validation tests.

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

Not applicable. This device is an electrical muscle stimulator, and its clearance is based on technical equivalence and safety testing, not on the interpretation of medical images or other diagnostic data where expert ground truth would be established. The "ground truth" for this device's performance would be against its own design specifications and relevant safety standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers or expert panels to resolve discrepancies in diagnoses or assessments. This type of study was not conducted for this 510(k) clearance.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of AI assistance on human reader performance. This device is an electrical muscle stimulator where the primary demonstration of effectiveness for this submission is substantial equivalence to a predicate's technical and safety characteristics.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

While the device itself is a "standalone" product (meaning it's not a module of the SofWave system anymore), the clearance does not describe an "algorithm only" performance study in the context of diagnostic AI/ML. The "standalone" aspect refers to its physical change from a module to an independent device with its own PC and GUI. The performance evaluation focuses on the engineering and software functionality of the device itself.

7. The Type of Ground Truth Used

The ground truth used for this submission is primarily:

• Predicate Device Specifications: The technical and safety characteristics of the predicate device (Pure Impact Module of the SofWave System K250146) served as the "ground truth" for the subject device to demonstrate substantial equivalence.
• Regulatory Standards: Compliance with electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), specific EMS standards (IEC 60601-2-10), and risk management (ISO 14971) constitutes another form of "ground truth" for safety and performance.
• Design Specifications: The internal design specifications for the device, confirmed through verification testing, served as the "ground truth" for its functional performance.

8. The Sample Size for the Training Set

Not applicable. This is not a submission for an AI/ML device that requires a training set of data. The "training" here refers to manufacturing the physical device to specifications and programming the software.

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

Not applicable. As this is not an AI/ML device requiring a training set, the concept of establishing ground truth for a training set does not apply. The "ground truth" for the device's development involves adherence to engineering design specifications, safety standards, and functional equivalence to the predicate.

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