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510(k) Data Aggregation
(22 days)
Proposed Device Indications For Use (same as those for predicate device):
Therapeutic Ultrasound
- Pain relief
- Reduction of muscle spasm
- Localized increase in blood flow
- Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
- Temporary relaxation of muscle spasm (all waveforms)
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
- Increase of blood flow in the treatment area (all waveforms)
- Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
- Muscle re-education (all waveforms)
- Maintaining or increasing range of motion (all waveforms)
The Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle stimulation. The microprocessor controlled Sonicator Plus 930 provides pre-modulated medium frequency and symmetrical biphasic waveforms with enhanced reliability and ease of use. In addition the Sonicator Plus 930 offers 1 and 3 MHz ultrasound using a variety of interchangeable applicators.
The two-channel Sonicator Plus 930 allows the clinician to utilize up to two different waveforms using two channels simultaneously. The clinician can choose between several different amplitude modulation options such as the surge, reciprocation and amplitude modulation (interferential only, vector rotation). The interferential and pre-modulated modes offer frequency modulation as well as a static frequency option.
The membrane panel provides both tactile and audio feedback when buttons are pressed. Blinking LED's guide the operator through the easy setup routine. The new Treatment Status Indicator shows the operator which stimulation waveform has been chosen for treatment. The status display moves when treatment output is active.
Large, soft-touch control knobs make adjusting power for ultrasound and stimulation easy to accomplish with no guesswork involved. Two LED output displays allow the clinician to monitor two channels simultaneously for two channel combination treatment protocols. These also allow the operator to adjust both channels of an interferential protocol simultaneously while monitoring the current.
The Sonicator Plus 930 can provide electrical stimulation only, ultrasound only and combination therapy with the pre-modulated, biphasic and medium frequency waveforms
The provided text is a 510(k) premarket notification for a medical device, the Sonicator® Plus 930. This document focuses on demonstrating substantial equivalence to a predicate device (Sonicator® Plus 992) rather than presenting a study with acceptance criteria and device performance metrics in the way a clinical trial or AI/software validation study would.
Therefore, the requested information components related to an AI/software study (sample sizes, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this document. This document details technical specifications and indications for use to show equivalence, not performance against specific clinical endpoints or diagnostic accuracy.
However, I can extract the "acceptance criteria" in the context of device specifications and the "reported device performance" as presented in the comparison tables. It's important to understand that these are design specifications and measured characteristics rather than statistical performance metrics from a user study.
Here's an interpretation based on the provided text, focusing on the nearest equivalents for "acceptance criteria" and "reported device performance":
Acceptance Criteria and Reported Device Performance for Sonicator® Plus 930
The "acceptance criteria" for the Sonicator® Plus 930, as presented in this 510(k) submission, are primarily defined by its technical specifications and performance characteristics being substantially equivalent to the predicate device, Sonicator® Plus 992. The "reported device performance" are the stated specifications and measured values for the Sonicator® Plus 930.
1. Table of Acceptance Criteria and Reported Device Performance
As this document is a comparison for substantial equivalence, the "acceptance criteria" are implicitly that the proposed device's specifications meet or are comparable to those of the predicate device for safe and effective use. The "reported device performance" for the proposed device (Sonicator® Plus 930) is directly stated in the tables.
Below are selected examples of technical characteristics from the provided comparison tables, representing key "acceptance criteria" (predicate values) and "reported device performance" (proposed device values). A comprehensive table would include all parameters listed in documents {2}, {6}, {7}, {12}, {13}, {14}, and {15}.
| Characteristic / Acceptance Criteria (Predicate Device K984142) | Reported Device Performance (Proposed Device K013192) |
|---|---|
| Neuromuscular Stimulation | |
| Max output current (Interferential mode): 0-65 ±10% mA RMS, max., 1 Kohm load | 0-65 ±10% mA RMS, max., 1 Kohm load, Interferential mode |
| Max output current (Premodulated mode): 0-50 ±10% mA RMS, max., 1 Kohm load | 0-50 ±10% mA RMS, max., 1 Kohm load, premodulated and medium frequency modes |
| Max output voltage (Interferential mode): 0-65 ±10% volts RMS, 1 Kohm load | 0-65 ±10% volts RMS, 1 Kohm load, Interferential mode |
| Max output voltage (Premodulated mode): 0-50 ±10% volts RMS | 0-50 ±10% volts RMS premodulated mode and medium frequency modes |
| Frequency range (Interferential & Premodulated modes): 4000-4250 Hz ±1% | 4000-4250 Hz ±1%, (Interferential and Premodulated modes) |
| Beat Frequency (pps): 1-250 ±2 Hz or 10%, whichever is greater | 1-250 ±2 Hz or 10%, whichever is greater |
| Timer Settings: 1-60 minutes ±5% | 1-60 minutes ±5% |
| Maximum Leakage Current (Chassis): <100 µA | <100 µA |
| Maximum Leakage Current (Electrodes): <100 µA | <100 µA |
| Compliance with UL 2601-1-UL, CSA C22.2 NO 601.1-M90, IEC60601-2-10, EN-55011 (CISPR-11), MDD 93/42/EEC, Annex II | Yes (for all listed standards) |
| Therapeutic Ultrasound | |
| Frequency: 1.0 MHz ±5% | 1.0 MHz ±5% |
| Frequency: 3.2 MHz ±5% (Predicate has 3.3 MHz ±5%) | 3.2 MHz ±5% (Note: Slight difference from predicate's 3.3 MHz) |
| Modes: Continuous, Pulsed-20% duty cycle | Continuous, Pulsed-20% duty cycle |
| Pulse Repetition Rate: 100 Hz ±20% | 100 Hz ±20% |
| Pulse Duration (20% duty cycle): 2 msec ±20% | 2 msec ±20%, 20% duty cycle |
| Temporal Peak/average intensity ratio (20% duty cycle): 5:1 ±20% | 5:1 ±20%, 20% duty cycle |
| Maximum intensity: 2.2 W/cm² with all applicators | 2.2 W/cm² |
| Indication accuracy: ±20% (for any level above 10% of maximum) | ±20% (for any level above 10% of maximum) |
| Timer Accuracy: ±0.5 minutes for times less than 5 minutes; ±10% for times from 5 to 10 minutes; ±1.0 minute for times greater than 10 minutes | ±0.5 minutes for times less than 5 minutes; ±10% for times from 5 to 10 minutes; ±1.0 minute for times greater than 10 minutes |
| Compliance with IEC60601-2-5, FCC Part 15-B, FDA 21 CFR 1050.10, UL 2601-1-UL, CSA C22.2 NO 601.1-M90, EN-55011 (CISPR-11), MDD 93/42/EEC, Annex II | Yes (for all listed standards) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document is a 510(k) premarket notification demonstrating substantial equivalence based on technical specifications, design, and indications for use. It does not describe a "test set" in the context of a clinical performance study with patient data. The "test set" here would refer to the physical device prototypes and their components undergoing engineering verification. Data provenance is internal engineering measurements and compliance testing, not clinical data from countries of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the sense of clinical diagnoses or outcomes, is not relevant to this type of submission which relies on comparing technical specifications and intended use against a legally marketed predicate device. The "experts" involved would be the manufacturer's engineers and quality assurance personnel performing the measurements and verifying compliance with standards and internal specifications to demonstrate equivalence.
4. Adjudication method for the test set:
- Not Applicable. There is no "adjudication method" in the context of resolving discrepancies in expert interpretations of clinical data. Testing typically involves objective measurements against predefined engineering tolerances and regulatory standards.
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 document pre-dates and is unrelated to AI/ML device submissions, and therefore no MRMC studies or AI assistance effect sizes are discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (ultrasound and muscle stimulator). There is no "algorithm only" component in the context of an AI/software device. Its performance is the direct output of its physical and electrical functions.
7. The type of ground truth used:
- The "ground truth" for this submission is implicitly the technical specifications and performance characteristics of the predicate device (Sonicator® Plus 992) and relevant industry standards (e.g., UL, CSA, IEC, FDA regulations). The proposed device (Sonicator® Plus 930) is compared against these established benchmarks to demonstrate substantial equivalence. This is not clinical pathology, expert consensus on patient data, or outcomes data.
8. The sample size for the training set:
- Not Applicable. This device is hardware with firmware, not an AI/ML system that utilizes a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no "training set" for an AI/ML algorithm, this question is not relevant.
Summary of the Study (510(k) Premarket Notification):
The "study" presented here is a premarket notification (510(k)) submission to the FDA. The purpose of this submission is not to conduct a clinical trial or a performance study in the traditional sense, but rather to demonstrate substantial equivalence of the proposed device (Sonicator® Plus 930, Model ME 930) to a legally marketed predicate device (Sonicator® Plus 992, Model ME 992) under the provisions of the Federal Food, Drug, and Cosmetic Act.
The proof that the device meets "acceptance criteria" (defined by predicate device specifications and regulatory standards) is established through detailed technical comparison tables (Documents {2}, {6}, {7}, {12}, {13}, {14}, {15}) listing various physical, electrical, and performance characteristics. The manufacturer attests that the proposed device's specifications fall within acceptable ranges or are identical to the predicate device, thereby supporting its safety and effectiveness for the stated indications for use (Documents {1} and {18}). The FDA's review and resulting letter (Documents {16} and {17}) acknowledge this demonstration of substantial equivalence.
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