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510(k) Data Aggregation
(175 days)
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
This submission is for an Electronic Stimulator with multiple models, intended for temporary relief of pain associated with sore and aching muscles and temporary relief of minor aches and pains through electrical stimulation and heating.
The acceptance criteria and device performance are described below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device but rather a Transcutaneous Electrical Nerve Stimulator (TENS), the "acceptance criteria" are compliance with established safety and performance standards for similar devices. The "reported device performance" refers to the successful completion or compliance with these standards and tests. No specific accuracy or diagnostic performance metrics typically associated with AI/ML devices are present.
| Acceptance Criteria (Standards & Tests Met) | Reported Device Performance |
|---|---|
| Biocompatibility Safety: | The materials of the patient-directly contacting components of the Electronic Stimulator were evaluated and passed biocompatibility testing. This included: |
| * ISO 10993-5 Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity | * Passed ISO 10993-5 (In Vitro Cytotoxicity) |
| * ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization | * Passed ISO 10993-10 (Irritation and Skin Sensitization) |
| EMC and Electrical Safety: | Electrical safety and Eye safety testing was performed to and passed the following standards: |
| * IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance –Collateral standard: electromagnetic compatibility | * Passed IEC 60601-1-2 (EMC) |
| * IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance | * Passed IEC 60601-1 (General Safety and Essential Performance) |
| * IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment | * Passed IEC 60601-1-11 (Home Healthcare Environment Safety) |
| * IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | * Passed IEC 60601-2-10 (Nerve and Muscle Stimulators Specific Requirements) |
| Software Verification and Validation: | Software documentation consistent with a moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Other Performance Verification: | |
| * Electrodes performance test to verify current dispersion and shelf-life according to FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard. | * Electrodes performance test was conducted to verify current dispersion and shelf-life, and it passed. |
| * Waveform and output test according to FDA Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning. | * Waveform and output test was conducted to verify output specifications, and it passed. The maximum output voltage, current, pulse duration, and frequency are within acceptable ranges for TENS devices, and the net charge per pulse is 0µC, achieved through a balanced waveform. Maximum temperature setting is 43°C, which is within the acceptable range for heating functions in similar devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical trials or AI/ML model evaluation with patient data. Instead, performance data is based on non-clinical testing of the device itself against established safety and performance standards. Therefore, information about sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, or adjudication methods is not applicable in the context of this 510(k) summary for a TENS device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is a traditional medical device submission based on non-clinical engineering and safety performance, not an AI/ML device relying on expert-annotated ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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 is not an AI-assisted device, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-based algorithm; it is a physical electrostimulation device with heating functions.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this traditional medical device, "ground truth" refers to compliance with recognized consensus standards and predetermined engineering specifications for safety and effectiveness. This is demonstrated through objective physical and electrical testing, biocompatibility assessment, and software verification, rather than clinical outcomes or expert consensus on diagnostic images.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or an AI algorithm, so 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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(137 days)
Electronic stimulator
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, lower extremities (leg) and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Not Found
This document is an FDA 510(k) clearance letter for an Electronic stimulator and does not contain information about the acceptance criteria, study details, or performance data of the device.
Therefore, I cannot provide the requested information.
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(353 days)
Health Expert Electronic Stimulator (model: AST-3000L)
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
- TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, remote control ON/OFF key, Display screen, Heating adjust key, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text is a 510(k) Summary for the Health Expert Electronic Stimulator (model: AST-300L). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.
However, it does not describe:
- Acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a software or AI/ML device.
- A study that proves the device meets such performance acceptance criteria through the analysis of a test set, expert adjudication, or reader studies.
- Information regarding training sets, ground truth establishment methods for AI/ML, or the number of expert readers for an MRMC study.
The "Test Summary" section (Page 6) indicates various bench tests and standards compliance for electrical safety, electromagnetic compatibility, biocompatibility, usability, and software verification/validation. It also mentions a waveform test report. These are engineering and regulatory compliance tests, not a clinical or performance study of an AI/ML algorithm that would involve a test set, ground truth, or expert readers.
The conclusion of the document is based on substantial equivalence to predicate devices through technological characteristics and safety standards adherence, rather than demonstrating clinical performance of an AI/ML system.
Therefore, based solely on the provided text, the requested information on acceptance criteria and a study proving performance for an AI/ML device cannot be extracted. The device in question appears to be a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), which is a hardware device for pain relief and muscle stimulation, not an AI/ML-driven diagnostic or therapeutic software device.
In summary, none of the specific points (1-9) related to AI/ML device acceptance criteria and performance study can be addressed from this document because it is for a physical medical device, not an AI/ML software.
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(272 days)
Health Expert Electronic Stimulator
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.
The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys.
The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.
The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text is a 510(k) Pre-Market Notification for a medical device, the "Health Expert Electronic Stimulator." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.
Therefore, the document does not contain the type of AI-specific acceptance criteria or detailed study information typically found for novel AI/ML medical devices. The device in question is an electronic stimulator, not an AI/ML-driven diagnostic or therapeutic device.
The "Test Summary" and "Comparison to predicate device" sections outline the types of testing and comparisons performed for this device. These are primarily engineering, electrical, and biocompatibility tests, alongside a comparison of technical specifications to a previously cleared device.
Specifically, the document does not provide information on:
- AI-specific Acceptance Criteria: The device is not an AI/ML product.
- Study Proving Device Meets Acceptance Criteria for AI: No AI-specific studies were conducted because the device is not AI.
- Sample size for test set (for AI): Not applicable.
- Data provenance (for AI): Not applicable.
- Number of experts for ground truth (for AI): Not applicable.
- Qualifications of experts (for AI): Not applicable.
- Adjudication method (for AI): Not applicable.
- MRMC comparative effectiveness study for AI: Not applicable.
- Standalone (algorithm-only) performance for AI: Not applicable.
- Type of ground truth used (for AI): Not applicable.
- Sample size for training set (for AI): Not applicable.
- How ground truth for training set was established (for AI): Not applicable.
The "acceptance criteria" for this device are implicitly derived from the general and special controls for Class II medical devices, and the demonstrated substantial equivalence to the predicate device (K133929). This equivalence is shown through comparison of intended use, technical specifications, and compliance with relevant electrical safety, EMC, biocompatibility, usability, and software verification/validation standards.
Here's what the document does describe in terms of performance and testing:
1. Table of Acceptance Criteria (Implied by Equivalence) and Reported Device Performance:
The "Comparison to predicate device and conclusion" section (Pages 5-6) serves as the primary "performance" and "acceptance" comparison. The acceptance is based on demonstrating that the subject device's characteristics and performance are substantially equivalent to the predicate, and that any differences do not raise new safety or effectiveness issues.
| Elements of Comparison (Implied Acceptance Criteria) | Subject Device Performance | Predicate Device Performance | Remark (Fulfillment of "Acceptance" - SE = Substantially Equivalent) |
|---|---|---|---|
| Intended Use (PMS & TENS) | PMS (Mode 1 | PMS (Mode 1 | SE |
| Power Source(s) | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A | SE |
| Method of Line Current Isolation | Type BF Applied Part | Type BF Applied Part | SE |
| Patient Leakage Current | NC (Not specified numerically, implying compliance) | AC: 54.5μA, DC: 0.5μA | SE (implies within acceptable limits vs predicate) |
| SFC (Single Fault Condition) Leakage Current | NC (Not specified numerically, implying compliance) | AC: 120.0μA, DC: 0.6μA | SE (implies within acceptable limits vs predicate) |
| Avg DC current (device on, no pulses) |
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