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510(k) Data Aggregation
(218 days)
The PainKARE is indicatied for Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities.
PainKARE is an OTC medical device intended to temporarily relieve pain due to strain from exercise or normal household work or activities via electro-therapy. The Device consists two Stimulator pads connected by a USB cable for Electrotherapy. PainKARE's Stimulator pads operate in a programmable micro-current mode and deliver Biphasic waveforms which in turn provide electrical stimulation to the body that aids in relieving pain.
The provided document is a 510(k) premarket notification for a medical device called PainKARE, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document aims to demonstrate that PainKARE is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, quantitative manner typically seen for complex AI/diagnostic devices. Instead, it lists the standards the device was tested against and states that the test data showed safety and effectiveness for its intended use, implying compliance with those standards.
Below is a table summarizing the technological characteristics of the subject device (PainKARE) and its predicate devices, which can be interpreted as demonstrating how the device's technical specifications are comparable or superior to the predicates. While not "acceptance criteria" in a strict performance metric sense, these are the points of comparison used to establish substantial equivalence.
| Parameter | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (PainKARE) |
|---|---|---|
| Intended Use | Temporary relief of pain of sore and aching muscles, joints, and tissues | Temporary relief of pain of sore and aching muscles, joints, and tissues due to strain from exercise or normal household and work activities. |
| Operation Mode (Waveform) | Pulsed square wave, Amplitude: 50μA, Frequency: 0.5Hz, Polarity: Mono-phasic | Pulsed square wave, Amplitude: 50μA, Frequency: 0.3Hz, Polarity: Biphasic (Alternating Mono-phasic) |
| Power Source | Primary battery only, one-time use | Primary Battery only, Rechargeable |
| Micro-processor Control | Yes | Yes |
| Automatic Overload Protection | Yes (Predicate K090042, K130114), No (Predicate K090042, K130114 in second occurrence) | Yes |
| Automatic No Load Alarm | Yes | Yes |
| User Override Control | No | Yes |
| Operational Indicator | Yes | Yes |
| Time Range | Not adjustable, Up to 250 hours | 30 minutes to 4 hours, depending on pain |
| Housing Materials | Plastic (ABS) enclosure | Plastic (ABS) enclosure |
| Body Contact Material | Electrode, CE certified | Electrodes, FDA approved |
| Maximum Average Current | 50 μA | 50 μA |
| OTC Use | Yes | Yes |
| Dimensions (W x H x D) | 1.55 x 0.29 x 1 in. | 1.2 x 0.6 x 1.6 in. |
| Weight | 0.03 lb. | 0.1 lb. |
| Operating Temperature/Humidity | 10-45°C, 20%-90% | 10-45°C, 20%-90% |
| Method of Line-Current Isolation | N/A | N/A |
| Patient Leakage - Current | Type CF | Type BF (Normal: 0 μA, Single Fault: 50 μA) |
| Average DC current through electrodes when device is on but no pulses are being applied | 0 | N/A (Pulse always applied when on) |
| Number of output modes | 1 | 2 |
| Number of Output Channels | 1 channel, monophasic | 1 channel, biphasic (alternating monophasic) |
| Regulated Current/Voltage | Regulated Current | Regulated Current |
| Software/Firmware/Microprocessor Control? | Yes | Yes |
| Automatic Overload Trip? | No | Yes |
| Automatic No-Load Trip? | Yes | Yes |
| Automatic Shut Off? | Yes | Yes |
| Indicator Display: On/Off Status? | Yes | Yes |
| Indicator Display: Low Battery? | No | Yes |
| Indicator Display: Voltage/Current Level? | No | No |
| Compliance with Voluntary Standards | UL260, EN60601-2 Part1, A1 & A2, EN 60601-2-10, Part 2-10, EN 60601-1-2 EMI | AAMI ES 60601-1, AAMI HA60601-1-11, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10 |
2. Sample size used for the test set and the data provenance
The document states: "The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence."
- Sample Size for Test Set: The document does not specify a sample size for any clinical or performance test set involving human subjects or data. The testing mentioned appears to be related to engineering bench testing against standards.
- Data Provenance: The document does not specify country of origin or whether data was retrospective or prospective. Given the nature of a 510(k) submission focused on substantial equivalence through technical comparison and compliance with electrical safety standards, it is unlikely a clinical trial with human data was conducted. The performance data primarily refers to adherence to electrical and safety standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, AAMI HA60601-1-11, IEC 60601-2-10).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information would be relevant for devices involving image interpretation or diagnostic performance studies where expert consensus defines ground truth. The PainKARE device is a TENS unit for pain relief, and its "performance" is assessed by adherence to design specifications and safety/electrical standards, not through expert-adjudicated clinical outcomes in a test set.
4. Adjudication method for the test set
Not applicable. As noted above, the evaluation framework is not based on expert adjudication of a test set.
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 device is not an AI-based diagnostic tool, and therefore, MRMC studies are not relevant to its submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The PainKARE is a physical medical device, not a standalone algorithm. Its performance is assessed against technical specifications and safety standards, not algorithmic output accuracy.
7. The type of ground truth used
The "ground truth" for this submission is adherence to established electrical and safety performance standards (e.g., AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-1-6, AAMI HA60601-1-11, IEC 60601-2-10) and functional specifications. There is no biological "ground truth" (like pathology or clinical outcomes data) in the context of this 510(k) submission.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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