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510(k) Data Aggregation
(100 days)
ProMedTek Model C1400 Shortwave Diathermy Device
The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
- Relieving pain
- Reducing muscle spasm
- Increasing range of motion of contracted joints using heat and stretch techniques
- Increasing blood flow to tissues in the treatment area.
The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.
The provided document is a 510(k) summary for the ProMedTek Model C1400 Shortwave Diathermy Device. This type of document focuses on establishing substantial equivalence to a predicate device, primarily through technological comparison and compliance with relevant standards, rather than extensive clinical studies or AI-driven performance evaluations.
Given the nature of this submission for a shortwave diathermy device, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically understood for AI/ML-driven diagnostic devices (e.g., sensitivity, specificity, clinical endpoints) are not directly applicable in the same way. Instead, "acceptance criteria" here refer to meeting regulatory standards and demonstrating comparable performance to the predicate device through technical and safety testing.
Therefore, many of the requested numbered items for AI/ML device studies will not be present or directly relevant to this document. I will extract what information is available and indicate when a specific point is not applicable.
Acceptance Criteria and Study for ProMedTek Model C1400 Shortwave Diathermy Device
This device is a shortwave diathermy device, which primarily relies on established physical principles for deep tissue heating, rather than diagnostic algorithms or AI/ML. The "acceptance criteria" for this type of device in a 510(k) submission generally revolve around safety, electrical performance, and functional equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured by Compliance to Standards & Predicate Equivalence) | Reported Device Performance (ProMedTek Model C1400) |
|---|---|
| Safety & Electrical Performance: | |
| IEC 60601-1 (General Requirements for Basic Safety and Essential Performance) | Complies with IEC 60601-1 |
| IEC 60601-1-2 (Electromagnetic Compatibility) | Complies with IEC 60601-1-2 |
| IEC 60601-2-3 (Particular Requirements for the Basic Safety and Essential Performance of Short-wave Therapy Equipment) | Complies with IEC 60601-2-3 |
| Functional Equivalence to Predicate Device (Auto Therm 390, Model ME 390 K042554): | |
| Intended Use / Indications for Use Statement | "Almost identical" to predicate. New device statement: "...relieving pain, reducing muscle spasm, increasing range of motion of contracted joints using heat and stretch techniques, increasing blood flow to tissues in the treatment area." |
| Technology (System Components, Applicator Components, Accessories) | Same as predicate (Unit with Cart and Arm for Inductive Drum Applicator, Inductive Drum Applicator, Soft-Rubber Applicators (2), Felt spacers, Cloth cover, Velcro Receptive Elastic Straps). |
| Input (100-240 VAC, 50-60 Hz) | Same as predicate |
| Frequency (27.12 MHz) | Same as predicate |
| Output Types (Continuous, Pulsed) | Same as predicate |
| HF Output Continuous (100 W Average Power) | Same as predicate |
| HF Output Pulsed (200 W Peak Power) | Same as predicate |
| Pulse Rate Settings (10Hz, 20 Hz, 50 Hz, 100 Hz, 400 Hz) | Same as predicate |
| Pulse Width Settings (65 μs, 100 μs, 200 μs, 300 μs, 400 μs) | Same as predicate |
| Modes (Inductive, Capacitive) | Same as predicate |
| Treatment Time (1-30 minutes) | Same as predicate |
| Software controlled | Yes (Same as predicate, which is also software controlled according to comparison table) |
| User Display and Interface | LCD Touch Screen displays interactive instructions and indicators. (Predicate: "Similar User interface has tactile selection buttons and LED indicators." This is noted as a difference, but not one that raises new questions of safety or effectiveness according to the summary.) |
| Software Verification & Validation | Conducted as recommended by FDA guidance. Software level of concern: "moderate." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this device is a physical therapy device (shortwave diathermy) and not an AI/ML diagnostic or predictive device that would typically involve a "test set" of patient data in this context. The "testing" referred to is primarily electrical, safety, and functional conformance to standards and predicate device specifications.
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)
This information is not applicable. Ground truth experts are typically required for interpreting complex diagnostic images or patient data to validate AI/ML algorithms. This device's function is therapeutic deep heating, and its safety and efficacy are evaluated through engineering tests and comparison to predicate devices, not by expert interpretation of patient outcomes in a diagnostic "test set" validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are specific to conflict resolution in expert ground truth establishment for diagnostic or predictive tasks, not for the type of device being reviewed here.
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
This information is not applicable. MRMC studies are used to assess the impact of AI on human reader performance for diagnostic tasks. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is not an algorithm-only diagnostic or predictive tool. It is a physical therapy device operated by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable in the context of typical AI/ML device validation. The "ground truth" for this device's performance is established by:
- Compliance with recognized electrical safety and EMC standards (IEC 60601-1, -1-2, -2-3).
- Demonstrating functional equivalence to a legally marketed predicate device (Auto Therm 390), meaning it operates in the same way and produces the same therapeutic effects, which have been previously deemed safe and effective.
- Software verification and validation ensuring the control systems function as intended.
8. The sample size for the training set
This information is not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable. This device does not involve a training set or associated ground truth.
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