(202 days)
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.
PL009 and PL009A are electrically powered devices intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides three selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows graphic information about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 6V power supplied by 4 AAA batteries. It is approximately 0.5lbs with dimensions 8" x 2" x 1" plus attachment pads. The only difference between PL009 and PL009A is the former has a button of "Repeat" representative of the function of repeat.
PL029 is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. It provides eight selectable massage pulse styles with five auto operational modes through two channels with four attachment pads and shows textual message about massage style, intensity and time remaining on a LCD based display which is incorporated with the device body. The device uses DC 3V power supplied by 2 AAA batteries. It is approximately 0.5lb with dimensions 8" x 2" x 1" plus attachment pads.
The differences between PL009 and PL029 include:
(1) PL009's work voltage is 6V supplied by 4 AAA batteries, while PL029's work voltage is 3V supplied by 2 AAA batteries.
(2) PL009 provides three operational modes, i.e., massage, beat and knead, which can be combined into six stimulation programs for WAIST, SHOULDER, JOINT, HAND-FOOT, REPEAT and SOLE, while PL029 provides eight operational, i.e., massage, beat, knead, slim, acupuncture, scraping, cupping and immune.
(3) PL009 uses mechanical potentiometer to control power and intensity, while PL029 uses electronic switches to control power and intensity.
(4) PL009's LCD display shows body parts in graphics when the device is in operation, while PL029's LCD display shows working modes in text only when the device is in operation.
Here's an analysis of the provided 510(k) summary for the Prospera OTC TENS Electronic Pulse Massager, structured to address your specific questions.
Important Note: The provided document is a 510(k) Summary, which is designed to demonstrate substantial equivalence to previously marketed devices, not necessarily to provide full clinical study reports with acceptance criteria and detailed performance metrics as one might find for a novel or high-risk device. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing performed to show compliance with electrical safety and electromagnetic compatibility standards, and comparison to predicate devices, rather than a clinical trial evaluating pain relief efficacy with specific performance targets.
1. Table of Acceptance Criteria and Reported Device Performance
For this device (a TENS unit), "acceptance criteria" are primarily established by compliance with recognized medical device standards for electrical safety, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators. The "reported device performance" refers to the measurements taken during these non-clinical tests and the comparison of key technical characteristics with predicate devices.
| Parameter/Acceptance Criteria | Reported Device Performance (Prospera OTC TENS) | Basis for Acceptance (Standard/Predicate Comparison) |
|---|---|---|
| Electrical Safety (IEC 60601-1) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-1. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-1-2. |
| Safety of Nerve & Muscle Stimulators (IEC 60601-2-10) | Compliance confirmed. | Demonstrated by non-clinical testing against IEC 60601-2-10. |
| Patient Leakage Current (Normal Condition) | PL009: 1.8 µA; PL029: 2.0 µA | Within limits of recognized standards and comparable to predicate devices (K102598: 2.0 µA). |
| Patient Leakage Current (Single Fault Condition) | PL009: 3.3 µA; PL029: 3.0 µA | Within limits of recognized standards and comparable to predicate devices (K102598: 4.2 µA). |
| Average DC Current through Electrodes (device on but no pulses) | 0 µA for all models. | Meets expectation for TENS devices to prevent continuous DC current. Comparable to predicate devices (0 µA). |
| General Construction and Materials | Enclosure: ABS | Comparable to predicate devices (ABS, silicone). |
| Software Verification | Carried out according to FDA guidance. | Compliance with FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. |
| Electrodes Safety Requirements | Meet safety requirements. | Mentioned as compliant, specific standard not detailed in summary. |
| Intended Use & Operational Principle | "Temporary relief of pain associated with sore and aching muscles..." | Substantially equivalent to predicate devices with similar indications and operational principles (generating electrical pulses through electrodes to activate nerves for pain relief). |
| Technical Characteristics (e.g., Output Voltage, Current, Pulse Duration, Frequency) | Values presented in Tables B and C (e.g., Max Output Voltage at 500Ω: PL009: 12.8V, PL029: 49.6V; Pulse Duration: PL009: 120-6800 µSec, PL029: 100-200 µSec) | These values are compared to predicate devices (e.g., K102598: Max Output Voltage at 500Ω 62.4V, Pulse Duration 16.3-781mS). The argument is for substantial equivalence despite numerical differences, based on the overall effect and safety profile being similar. The summary states "The design differences... are insignificant and do neither affect the intended use, nor alter the operational principle." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data. For non-clinical (engineering/bench) testing, the sample size typically involves a small number of devices (often 1-3 units) tested against standards. The document does not specify the number of devices tested for compliance with the enumerated standards.
- Data Provenance: The data is generated from non-clinical tests performed on the subject device. This refers to bench testing in a laboratory setting to evaluate electrical safety, EMC, and performance characteristics. There is no mention of country of origin for the non-clinical test data, but it would typically be conducted by a certified testing lab. The study is not a retrospective or prospective clinical study but rather a technical verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this 510(k) submission.
- Nature of the Device: The Prospera OTC TENS Electronic Pulse Massager is a hardware device for pain relief, and its approval relies on demonstrating electrical safety, functional performance, and substantial equivalence to existing predicate devices, not on the output of an algorithm or diagnosis by experts.
- "Ground Truth": For this type of device, "ground truth" relates to the objective measurements of electrical parameters, safety compliance with standards, and functional specifications, not expert consensus on medical diagnoses or interpretations. These are typically established by objective physical measurements and adherence to engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical trials, especially when evaluating subjective endpoints or interpretations (e.g., radiological reads), to resolve discrepancies or ensure consistency in expert assessment. This submission relies on objective physical measurements and comparisons to predicate device specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary.
- Device Type: This is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a direct-to-patient therapy device. It does not involve human readers interpreting output or an AI component that assists human readers in diagnosis or treatment planning.
- Purpose of 510(k): The 510(k) pathway focuses on demonstrating substantial equivalence, primarily through non-clinical testing for devices like TENS units. Clinical studies of efficacy (e.g., "how much human readers improve with AI vs without AI assistance") are typically not required for such devices unless there are significant technological differences or new indications for use that cannot be supported by equivalence.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
No, a standalone "algorithm only" performance study was not done or reported in this 510(k) summary.
- Nature of the Device: The Prospera OTC TENS is a hardware device with embedded software for controlling its electrical pulses and modes. It is not an "algorithm" in the sense of a diagnostic or predictive AI tool, and its function is not meant to be separated from the human user's interaction (e.g., selecting modes and intensity) for pain relief. Software verification was indeed performed, but this is to ensure the control software functions correctly and safely, not to evaluate its performance as a standalone interpretative algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Compliance with recognized electrical safety and EMC standards: This involves objective measurements against established thresholds defined in standards like IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10.
- Comparison to predicate device specifications: The technical characteristics (e.g., voltage, current, frequency, pulse duration) of the subject device are measured and compared to those of legally marketed predicate devices to establish substantial equivalence.
- Functional verification: Ensuring that the device operates as described (e.g., selection of massage styles, intensity, timer function).
There is no mention of pathology, expert consensus, or outcomes data being used as ground truth for this particular 510(k) submission because it's a TENS device seeking approval via substantial equivalence based on technical and safety characteristics.
8. Sample Size for the Training Set
This information is not applicable to this 510(k) submission.
- No AI/Machine Learning Training: The device does not employ machine learning or AI models that require a "training set." The embedded software controls the device's pre-programmed electrical pulse patterns and operational modes.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for an AI/ML model for this device. The "ground truth" for the device's functionality is its design specifications and compliance with established engineering and medical device safety standards.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).