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510(k) Data Aggregation
(204 days)
TENS(1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9126
TENS(3,4,5,6,11,12,16): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9186
TENS(3,4,7,8,11): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS(1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Model: SM9196
TENS(1015): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.9): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
PMS(1
TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
The provided text describes a 510(k) premarket notification for a TENS & PMS device. This submission aims to demonstrate substantial equivalence to an already legally marketed predicate device (K121719). The document focuses on comparing the technical characteristics and performance of the new device models (SM9079, SM9126, SM9186, SM9196) against the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the safety and performance parameters of the legally marketed predicate device (K121719) and compliance with various recognized standards. The reported device performance is demonstrated through the comparative tables (Table 1, 2, 3, 4) where the new device's parameters are listed alongside the predicate device's, and through the statement of compliance with specific IEC and ANSI/AAMI standards.
Since the tables in the document are already in a comparative format, I will summarize the key parameters and their reported performance for one of the new models (SM9079) against the predicate. The "Remark" column in the original tables already serves as a concise statement of whether the new device meets or is similar to the predicate.
Table: Acceptance Criteria and Reported Device Performance (Example: Model SM9079 vs. Predicate K121719)
| Parameter / Acceptance Criteria (Derived from Predicate) | Reported Device Performance (New Device SM9079) | Meets Criteria? | Notes |
|---|---|---|---|
| General Characteristics | |||
| Manufacturer | Hong Qiangxing (Shenzhen) Electronics Limited | Yes | Same |
| Intended Use (TENS) | Temporary relief of pain for specific body parts due to strain | Yes | Same (Expanded list of programs, but comparable) |
| Intended Use (PMS) | Stimulate healthy muscles to improve performance | Yes | Same (Expanded list of programs, but comparable) |
| Type of Use | OTC | Yes | Same |
| Power Source | DC 3.7V lithium battery | Yes | Same |
| Method of Line Current Isolation | Type BF | Yes | Same |
| Patient Leakage Current (Normal Condition) | < 10μA | Yes | Same |
| Patient Leakage Current (Single Fault Condition) | < 50μA | Yes | Same |
| Average DC current through electrodes | < 0.01μA | Yes | Same |
| Number of Output Modes | 24 | Similar | More treatment programs, all comparable to predicate's mode 3. No new safety/effectiveness issues. |
| Number of Output Channels | 2 | Yes | Same |
| Synchronous or Alternating Channel Output | Alternating | Similar | Different from predicate's synchronous, but same technology and treatment effect. No new safety/effectiveness issues. |
| Method of Channel Isolation | Voltage transformer Isolation | Yes | Same |
| Regulated Current or Voltage | Voltage control | Yes | Same |
| Software/Firmware/Microprocessor Control | Software | Yes | Same |
| Automatic Overload Trip? | No | Yes | Same |
| Automatic No-Load Trip? | No | Yes | Same |
| Automatic Shut Off? | Yes | Yes | Same |
| User Override Control? | Yes | Yes | Same |
| Indicator (On/Off Status) | Yes | Yes | Same |
| Indicator (Low Battery) | Yes | Yes | Same |
| Indicator (Voltage/Current Level) | Yes | Yes | Same |
| Timer Range | 10 ~ 60 minutes, 10 min/step | Yes | Same |
| Biocompatibility | All user directly contacting materials comply with ISO10993-5 and ISO10993-10 requirements. | Yes | Same |
| Accessories | Self-adhesive electrodes, electrode wires, Battery charger, USB cable | Yes | Same |
| Physical Characteristics | |||
| Weight | 102g±5g | Similar | Difference in weight and dimensions noted, but deemed not to raise safety/effectiveness issues. |
| Dimensions | 6012312mm | Similar | Difference in weight and dimensions noted, but deemed not to raise safety/effectiveness issues. |
| Housing Materials & Construction | ABS | Yes | Same |
| Output Specifications (Max Values from Table 5 for SM9079 vs. Predicate Mode 3/1/2) | |||
| Waveform | Pulsed, symmetric, biphasic | Yes | Same |
| Shape | Rectangular | Yes | Same |
| Max Output Voltage (@500Ω) | 42V±20% | Similar | Predicate 42V±10%. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Max Output Current (@500Ω) | 84mA±20% | Similar | Predicate 84mA±10%. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Pulse Width | 190µs (max) | Similar | Predicate 100µs. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Pulse Period | 40-1070ms (range) | Similar | Predicate 9.3~850ms. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Max Pulse Frequency | 0.935-25Hz±10% (range) | Similar | Predicate 110Hz. Differences in pulse width, frequency, period allowed as parameters don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Net Charge (per pulse) | 0µC @500Ω; Balanced waveform | Yes | Same |
| Max Phase Charge (@500Ω) | 13.30µC@500Ω | Similar | Predicate 16.8µC@500Ω. Differences in these parameters allowed as they don't exceed safety limits and passed IEC 60601-2-10 tests. |
| Max Current Density (@500Ω) | 0.065mA/cm² | Yes | Meets max current density <2mA/cm² (predicate value not given explicitly here, but stated in Note 4 for SM9126). |
| Max Average Power Density (@500Ω) | 2.64mW/cm² | Yes | Meets max average power density <0.25W/cm² (predicate value not given explicitly here, but stated in Note 4 for SM9126). |
| Compliance with Standards | |||
| ANSI AAMI ES60601-1 | Yes | Yes | Same |
| IEC 60601-2-10 | Yes | Yes | Same |
| ANSI AAMI IEC 60601-1-2 | Yes | Yes | Same |
| IEC 62133 | Yes | Yes | Same |
| ANSI AAMI HA60601-1-11 | Yes | Yes | Same |
| 21 CFR 898 (if applicable) | Yes | Yes | Same |
2. Sample size used for the test set and the data provenance
The document explicitly states that the new devices have "passed testings according to the following standards" and that the "conclusion drawn from the testings are that the new devices are substantially equivalent to the predicate device." These "testings" refer to compliance with various medical device standards (ANSI AAMI ES60601-1, IEC 60601-2-10, ANSI AAMI IEC 60601-1-2, IEC 62133, ANSI AAMI HA60601-1-11).
However, the document does not provide details about a clinical study or a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission is based on a comparison of technical specifications and performance against a predicate device and adherence to recognized standards, rather than a separate clinical trial with a defined sample size. The testing appears to be functional and electrical safety testing as per the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that a clinical study or human-in-the-loop performance evaluation with a test set requiring expert ground truth is not described in the provided text, information on the number and qualifications of experts for establishing ground truth is not available. The evaluation is based on technical specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no clinical test set requiring human adjudication is mentioned, there is no information provided on any adjudication method.
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
The device described is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). It is a physical therapy device and not an AI-assisted diagnostic or imaging interpretation device. Therefore, a Multi Reader Multi Case (MRMC) comparative effectiveness study focusing on human readers improving with AI assistance would be irrelevant and is not mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, this is a physical therapy device, not an algorithm, so no standalone algorithm performance evaluation is applicable or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:
- Compliance with recognized electrical safety and performance standards: This includes specific limits for voltage, current, pulse characteristics, leakage current, and electromagnetic compatibility.
- Comparison of technical specifications with a legally marketed predicate device: The predicate device itself has established safety and effectiveness. The "ground truth" is that the predicate device is safe and effective when used as intended, and the new device demonstrates similar performance and characteristics to be considered equivalent.
- Biocompatibility testing: Compliance with ISO10993-5 and ISO10993-10 for materials directly contacting the user.
There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for this specific submission. The "ground truth" is established by adherence to existing regulatory frameworks and engineering standards.
8. The sample size for the training set
As this is not an AI/machine learning device, the concept of a "training set" is not applicable and therefore, no sample size for a training set is provided.
9. How the ground truth for the training set was established
As the concept of a training set is not applicable, no information is provided on how its ground truth would be established.
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