(90 days)
The Handmaster is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.
The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable. A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle. The electrode locations allow the Handmaster to give finger and thumb extension and flexion. The user can select from five stimulation programs by pressing the mode button on the control unit. The active mode is displayed by a light glowing next to the labeled mode. When the device is stimulating, the light flashes. The stimulation programs are supplied as microprocessor firmware. They comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment display. During the initial system set-up, the clinician opens a clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the with a giobal villing offectively speeding or slowing the cyclic hand motion. The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device. The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the comfortable oncerce and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony with bols poly arounded are made from metal foil coated with carbon-impregnated polymer. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A over and crood bottle is provided to facilitate wetting of the electrode pads. Rechargeable nickel-cadmium batteries power the device. Battery status can be displayed both during device operation and while recharging butteries. Both visual and audio battery-low warnings are provided. It is necessary to disconnect splint/electrodes in order to recharge the batteries, as the same socket is used for both.
This 510(k) summary does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Instead, the document focuses on:
- Device identification: Trade name, common/usual name, classification name, predicate devices.
- Intended use: Specific medical conditions and therapeutic goals.
- Device description: Physical characteristics, functionality, user interface, power source.
- Performance data & substantial equivalence: A statement that the device is identical to a previously cleared version and that clinical data supports the expanded indication for hemiplegic patients, but no details of that clinical data or any specific study results are provided.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states that the device is "exactly the same device in all aspects to the market-cleared Handmaster" with the only difference being an "expansion of the indication." This expansion is "supported by clinical data that demonstrates that the Handmaster can be safely and effectively used for this indication," but the details of this supporting clinical data are not included in this summary.
Summary of missing information based on your request:
- Table of acceptance criteria and reported device performance: Not provided.
- Sample size used for the test set and data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not provided.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not applicable, no AI/algorithm training set mentioned.
- How the ground truth for the training set was established: Not applicable, no AI/algorithm training set mentioned.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).