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510(k) Data Aggregation
(84 days)
emField
The emField is indicated to be used for:
*Relaxation of muscle spasms;
*Prevention or retardation of disuse atrophy;
*Increasing local blood circulation;
*Muscle re-education;
*Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
*Maintaining or increasing range of motion.
emField is a non-invasive therapeutic device. The device produces a magnetic field that interacts with the tissues of the human body. By muscle stimulation, the emField is indicated for bulk muscle excitation in the legs or arms for rehabilitative purposes.
The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emField is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.
The provided document is a 510(k) Pre-market Notification from the FDA regarding the Zimmer MedizinSysteme GmbH emField device. It outlines the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.
However, the document does not contain information about acceptance criteria for a study proving device performance in the context of an AI/ML medical device. The emField device is a "Powered Muscle Stimulator" that generates a magnetic field for therapeutic purposes, which falls under conventional medical devices, not AI/ML-driven devices.
Therefore, I cannot provide the requested information about acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) for an AI/ML device, because this document is not about such a device.
The "Performance data" section (starting on page 7) refers to the device's compliance with voluntary standards (like IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and IEC 60601-2-10 for nerve and muscle stimulators) and preclinical testing for magnetic field output and tissue heating. These are standard performance tests for electromechanical medical devices, not AI/ML performance metrics.
In summary, the provided document does not contain the information needed to answer the prompt, as it concerns a non-AI/ML medical device.
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(239 days)
emFieldPro
emFieldPro is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen.
- Strengthening, toning and firming of buttocks and thighs.
emFieldPro is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the emFieldPro helps to strengthen, tone and firm the abdomen, buttocks and thighs.
The device housing protects the patient from electrical shock and mechanical injuries. The device is mobile standalone equipment with four wheels. Two applicators are available for therapy: a large and a small one. The main body of emFieldPro is used to control function of magnetic stimulation. It is operated with parameters such as Frequency, Time and Intensity. These parameters can be controlled by the user on LCD and with the help of a rotary knob at the user control panel.
The provided document (K182963) is a 510(k) premarket notification for the emFieldPro device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (BTL 799-2 - K180813), rather than presenting a performance study with detailed acceptance criteria and clinical outcome data in the manner typically seen for more complex diagnostic AI/ML devices.
Therefore, much of the requested information regarding acceptance criteria for a study proving the device meets those criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document. The document primarily describes the device, its indications for use, and a comparison of its technological characteristics and compliance with general safety and performance standards against a predicate device.
Here's a breakdown of the information that is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or improvement in specific clinical endpoints) or a study proving the device meets these. Instead, the "acceptance criteria" for this 510(k) revolve around technical specifications and compliance with recognized standards to demonstrate substantial equivalence to a predicate device.
The table below summarizes the comparison of technological characteristics, which serves as the "performance" data for substantial equivalence in this context. The "acceptance" is that these differences do not raise new questions of safety or effectiveness.
| Technological Characteristic | Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (emFieldPro) | Discussion on Equivalence (Justification for "Acceptance") |
|---|---|---|---|
| Indications for Use | Must be substantially equivalent to predicate. | Improvement of abdominal tone, strengthening of abdominal muscles, development for firmer abdomen. Strengthening, toning, and firming of buttocks and thighs. | Identical to predicate device. |
| Primary Function | Muscle stimulation. | Muscle stimulation. | Identical to predicate device. |
| Principle of Action | Initiating action potential of nerves resulting in muscle contraction. | Initiating action potential of nerves resulting in muscle contraction. | Identical to predicate device. |
| Electrical Protection | Electrical safety must be covered. | Class I, BF | Electrical safety is covered, with Class I device considered equal to a Class II device for safety purposes. |
| Touch Screen Size | Usability maintained despite size difference. | 7" | Smaller than predicate (15.6"), but "all icons and data are displayed clearly and usability is passed successfully." |
| Magnetic Field Intensity | Differences within acceptable variability (e.g., 20%); no new safety/effectiveness concerns. | Large applicator: 0.5 - 1.5T +/- 20% Small applicator: 0.5 - 2T | The maximum field intensity for the small applicator (2.0T) is slightly higher than the predicate (1.8T), but this difference "is within 20% of the acceptable variability in field intensity" and does not raise new safety/effectiveness questions. |
| Total Induced Current in Tissue | Differences do not result in different clinical effect. | 251 mA | Less than predicate (285 mA), and therefore "safer with the same effect." The difference (just over 10%) is "not great enough of a variation to produce a different clinical effect." |
| Pulse Duration | Within typical clinical range (50-500 µs). | Large applicator: 400 µs +/- 20% Small applicator: 250 µs +/- 20% | Differences from predicate (280 +/- 20% µs) are within the typical clinical range of 50 to 500 µs, referencing a paper on nerve fiber size recruitment patterns to support this. |
| System Dimensions | No influence on safety or effectiveness. | 542x501x993mm | Different from predicate (500×1380×580 mm), but "no influence on the safety or effectiveness of the device. The usability is passed successfully." |
| Operating Ambient Temperature Range | Labeling reflects typical environment. | 10°C to 30°C | The allowed operating temperature range is narrower than the predicate (-10°C to +55°C), but the "emFieldPro labeling allows for device usage in an environment that is more typical than the environment stated in the predicate labeling." This implies the device is suitable for its intended use environment, meeting the practical "acceptance" for operational range. |
| Compliance with Voluntary Standards | Device complies with relevant standards. | IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-10, 62366-1, 62304, 14971. | All listed "required performance tests" were conducted and show "substantial equivalence with the predicate devices." |
| Magnetic Field Testing | Operate within specifications. | Each applicator operates within specifications. | Confirmed that large and small applicators "operate within the magnetic field intensity specifications." |
| Tissue Heating Study | No appreciable rise in temperature at max intensity risking the patient. | No appreciable rise in temperature. | Confirmed that "tissue being treated by the device does not present an appreciable rise in temperature at maximum intensity to cause a risk to the patient." |
The following information is NOT available in the provided document:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes laboratory and engineering tests (e.g., electrical safety, EMC, usability testing, magnetic field measurements, tissue heating studies) to verify technical specifications and compliance with standards. It does not mention a clinical performance "test set" with patient data in the typical sense for AI/ML device validation.
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)
- Not applicable / Not provided. Ground truth, in the context of diagnostic AI/ML, refers to a definitive correct answer for a given case. This device is not a diagnostic AI/ML tool. Its "truth" is established by physical measurements and compliance with engineering standards. For usability, implicit "experts" (or trained users) would have assessed the interface, but this is not detailed as "ground truth establishment."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No such adjudication method is mentioned, as there is no specific "test set" requiring expert consensus for clinical labeling.
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 / Not provided. This is not an AI/ML device that assists human readers. It's a non-invasive therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an AI algorithm. Its "performance" is its ability to generate an electromagnetic field according to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. As a therapeutic device, its "ground truth" relates to its physical performance and safety (e.g., measured magnetic field intensity, temperature rise, electrical safety testing results) rather than diagnostic accuracy against a clinical reference standard.
8. The sample size for the training set
- Not applicable / Not provided. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.
In summary, this 510(k) focuses on demonstrating substantial equivalence through comparison of technical specifications and compliance with performance standards, rather than clinical trial data with defined acceptance criteria for AI/ML performance. The "study" referenced in the document primarily consists of various engineering and safety tests outlined in the standards listed, such as IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-10 (particular requirements for nerve and muscle stimulators), and ISO 14971 (risk management).
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