(196 days)
The HPM-6000 device is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
The HPM-6000 device is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
Indications for Use for Muscle Stimulators:
- 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
- Maintaining or increasing range of motion
The HPM-6000 is a non-invasive therapeutic device produces electromagnetic field that interacts with the tissues of the human body, while mainly affected structures are muscular, collagenous, and neuronal tissue. The electromagnetic field is delivered in the subdermal, muscular or collagenous tissue area triggering the stimulation and relaxation. The subject device does not use electroconductive media.
The HPM-6000 is equipped with a color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen, buttons and knob on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided text is a 510(k) Summary for the HPM-6000 device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to a predicate device (Neotonus MS-101 Magnetic Muscle Stimulator System) rather than providing detailed acceptance criteria and a study proving those criteria are met for the HPM-6000 itself.
Specifically, the document states:
"The substantial equivalence determination for the HPM-6000 is not based on clinical testing. The device safety and efficacy was demonstrated by performance data and comparison of technical characteristics between the HPM-6000 and the predicate device."
Therefore, most of the requested information cannot be extracted directly from this document, as it describes a comparison study, not a study specifically designed to prove acceptance criteria for the HPM-6000 as a standalone device.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria for the HPM-6000's performance in a standalone study. Instead, it compares the HPM-6000's characteristics to a predicate device to establish substantial equivalence.
| Characteristic | HPM-6000 Performance (Reported for comparison) | Predicate Device (Neotonus MS-101) | Acceptance Criteria (Not explicitly stated for HPM-6000 performance) |
|---|---|---|---|
| Primary Classification Name | Stimulator, Muscle, Powered | Stimulator, Muscle, Powered | Same as predicate |
| Classification Regulation | 21 CFR 890.5850, Class II | 21 CFR 890.5850, Class II | Same as predicate |
| Intended Use | As described in document | As described in document | Same as predicate |
| Electrical Protection | Class II, BF | Class II | Similar to predicate |
| Interface | Touch-screen | Graphical Display | Similar, not significantly different |
| Type of Energy | Magnetic field | Magnetic field | Same as predicate |
| Type of Applicator | Single magnetic coil | Single magnetic coil | Same as predicate |
| Number of Magnetic Coils | 1 | 1 | Same as predicate |
| Number of Applicators | 2 | 1 | No new safety/effectiveness concerns |
| Color Touch Screen | 8.4 in, 21.3 cm, 800x400 pixel | Unknown | N/A (not a direct comparison point) |
| Type of Operation | Continuous | Continuous | Same as predicate |
| Pulse Repetition Rate | 1 – 150 Hz | 1 – 55 Hz | Similar, demonstrated by comparison to another predicate (K952089) with 2-200 Hz range. |
| Magnetic Field Intensity | 299-1: 0.5 - 1.8 T; 299-2: 0.7 - 2.5 T | Up to 2.2 T | Similar, not significantly different |
| Pulse Duration (±20 %) | 280 µs | 275 µs | Same as predicate |
| Pulse Amplitude | 0 – 100 % | 0 - 100 % | Same as predicate |
| Therapy Time | Up to 60 min | 30, 60 min | Similar |
| Operating Temperature | 10-30 °C | 5-30 °C | Similar, not significantly different |
| Operating Humidity | 30-75 % | 20-75 % | Similar, not significantly different |
| Shape of Stimulation Pulse | Sine, biphasic | Sine, biphasic | Same as predicate |
| Energy Source | 100 - 240 V AC, 50 - 60 Hz, max 14 A | 110 V AC, 50-60 Hz, 12 A | Similar |
| External Exchangeable Fuse | Yes | Yes | Same as predicate |
| System Dimensions | 500×970×580 mm (20×38×23 in) | 500×580×230 mm (20×23×9 in) | Similar, not important for safety/effectiveness |
| System Weight | 33 kg (73 lb) | 28 kg (61 lb) | Similar, not important for safety/effectiveness |
| Position | Vertical - On castors | Horizontal | Similar, not important for safety/effectiveness |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The substantial equivalence determination for the HPM-6000 is not based on clinical testing."
Therefore, there is no human test set described in this document. The "test" here refers to non-clinical testing and comparison of technical characteristics.
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, as no human test set or clinical study to establish "ground truth" for diagnostic performance was conducted. The ground truth for device safety and performance is based on engineering testing and comparison to established standards and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human test set with expert adjudication was conducted.
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. The HPM-6000 is a physical medical device (muscle stimulator), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A true "standalone" clinical performance study for the HPM-6000, as an algorithm, was not done. The document states "The substantial equivalence determination for the HPM-6000 is not based on clinical testing." Instead, the device's technical specifications and non-clinical performance (e.g., electrical safety, electromagnetic compatibility, usability, biological evaluation) were evaluated as a standalone product relative to established standards and then compared to a predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing performed, the "ground truth" would be engineering specifications, adherence to international standards (e.g., ISO, IEC), and measurements of physical parameters. For the substantial equivalence claim, the ground truth is the performance and characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device that requires a training set.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).