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TENS: 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. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Heating: It is intended for temporary relief of minor aches and pains.

The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain. The Low-frequency stimulator has 7 buttons on the main unit: Press Power button to turn on/off the device. Press "Mode+" and "Mode-" buttons to select 9 stimulation modes; Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from; Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that can be adjusted. Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on. The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode. All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

This document (K212989) is a 510(k) Premarket Notification for a Low-frequency Stimulator. The document details the product description, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than providing details of a clinical study assessing the device's performance against specific acceptance criteria.

Therefore, most of the information requested in your prompt related to clinical study design, performance metrics, ground truth establishment, and expert involvement is not available within the provided text. The document explicitly states: "No clinical study is included in this submission."

However, I can extract the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study demonstrating performance against specific numerical acceptance criteria for clinical effectiveness (e.g., pain reduction percentage, muscle performance improvement metrics) was conducted or reported, such a table cannot be provided from this text. The acceptance criteria described are largely related to non-clinical testing and safety standards.

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not applicable as no clinical test set was used. The evaluation was based on non-clinical (bench) testing.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, the tests were conducted by the manufacturer, Shenzhen OSTO Technology Company Limited, in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as no clinical test set requiring expert-established ground truth was reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as no clinical test set was reported.

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 a stimulator, not an AI-assisted diagnostic tool for image interpretation. No human reader study of this type was performed or is relevant.

6. 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 a software algorithm for diagnostic interpretation. Its "performance" is measured by its physical output and adherence to safety standards. The software aspect mentioned is for verification and validation of the device's internal software control, not for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical testing, the "ground truth" or reference points were established by international and FDA-recognized standards (e.g., IEC 60601-1, ISO 10993-5, FDA Guidance documents for TENS and PMS devices). Device specifications and safety limits are derived from these standards.

8. The sample size for the training set:

• Not applicable as no machine learning model requiring a training set was used for the device's clearance.

9. How the ground truth for the training set was established:

• Not applicable as no machine learning model was used.

In summary, this 510(k) submission relies on non-clinical bench testing and comparison to legally marketed predicate devices to demonstrate safety and effectiveness for substantial equivalence, rather than de novo clinical study data.

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Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs. The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device. There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment. The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

This document is a 510(k) summary for the Intelligent Wireless Fitness Apparatus (Models: AST-301, AST-302, AST-303). It is a submission to the FDA demonstrating substantial equivalence to previously cleared predicate devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or human perception improvement (e.g., MRMC studies). This document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with general safety and performance standards, rather than a clinical performance study with specific acceptance criteria as you've described.

The "Test Summary" section (page 4, Section 6) outlines bench testing to ensure safety and functionality, but these are not performance studies in the context of diagnostic accuracy or human performance with AI assistance.

Therefore, I cannot provide the information requested in your bullet points regarding acceptance criteria, performance data, sample sizes, expert involvement, or MRMC studies, as this type of information is not present in the provided 510(k) summary for this particular device.

Here's an explanation for each of your points based on the absence of this information in the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Not provided. This document details technical characteristics and compliance with safety standards (e.g., electrical safety, EMC, usability), not performance against clinical acceptance criteria (e.g., accuracy for a diagnostic task).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable for performance test sets as described. The "tests" here are bench tests for electrical safety, electromagnetic compatibility, usability, and software verification/validation, not clinical performance studies involving patient data. Therefore, there's no "test set" in the sense of patient data for clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. No ground truth establishment for a clinical test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set requiring adjudication is described.

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:

   • No, an MRMC comparative effectiveness study was not done or reported. This device is a muscle stimulator, not an AI-assisted diagnostic device, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI algorithm. Its performance is evaluated through physical and electrical bench testing, not algorithmic accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable. No clinical ground truth is established or used for performance evaluation in this 510(k) summary. The "truth" here relates to compliance with engineering and safety standards.

8. The sample size for the training set:

   • Not applicable. This device does not use a training set as it's not a machine learning/AI device.

9. How the ground truth for the training set was established:

   • Not applicable. No training set ground truth to establish.

In summary, the provided document is a 510(k) Premarket Notification for a Powered Muscle Stimulator. The focus is on demonstrating substantial equivalence to existing predicate devices based on technological characteristics, intended use, and compliance with recognized safety and performance standards through bench testing. It explicitly states, "The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness." This type of submission does not typically include the kind of clinical performance study details (like sensitivity, specificity, or MRMC studies) that would be found for a diagnostic device or an AI-powered medical device.

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

• Neck Pad is used in back of neck.
• Meridian Pad is used in shoulder, waist, back, and arm.

This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage.

The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button.

The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time.

The remote control is the only controller to select the pulse intensity and adjust the treatment time.

The provided text is a 510(k) Summary for a medical device (Neck Care Therapy, Model: SYK-509B) and does not contain a study that proves the device meets acceptance criteria in the manner described by your request (e.g., a clinical trial with a test set, ground truth established by experts, MRMC studies, or standalone performance evaluation).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Health Expert Electronic Stimulator, K133929) primarily through bench testing for safety and performance specifications, and a comparison of technical characteristics and intended use.

Here's an analysis based on the information provided, highlighting what is and is not present:

Key Takeaways from the document:

• This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, intended for Over-The-Counter Use.
• The primary method of demonstrating equivalence is through engineering bench tests of electrical safety, EMC, biocompatibility, usability, software verification, and waveform output.
• There is no mention of a clinical study involving human subjects or expert readers to evaluate the device's therapeutic effectiveness for pain relief, nor is there a direct assessment of its performance against a predefined "acceptance criteria" for clinical outcomes. The "acceptance criteria" in this context are primarily related to meeting safety standards and having comparable technical specifications to the predicate device.

Detailed Breakdown based on your Request (with notations on missing information):

1. Table of Acceptance Criteria and Reported Device Performance

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PMS (Mode 1)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 2)

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.

Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin.

The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy.

The device is equipped with accessories of electrode pads, electrode wire, adapter.

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 provided document is a 510(k) summary for a Low-frequency Multi-function physiotherapy instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new AI/ML-driven medical device.

Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth establishment for the training set) is not present in this document.

This document describes a traditional medical device (Physiotherapy instrument) and its submission for FDA clearance via a 510(k) pathway. The test summary mentions "lab bench testing" for electrical safety, electromagnetic compatibility, biocompatibility, usability, software verification and validation, and waveform testing, all according to established IEC and ISO standards and FDA guidance documents. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through engineering and bench testing, rather than extensive clinical studies or performance against specific AI/ML-related metrics.

In summary, this document does not contain the information required to answer the prompt, as it pertains to the clearance of a non-AI/ML medical device through predicate equivalence, not a performance study of an AI/ML device against predefined acceptance criteria.

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PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) 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.

Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection 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 provided document is a 510(k) summary for a Low Frequency Multi-Function Physiotherapy Instrument. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with an AI device. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, and MRMC studies) is not applicable or not detailed in this document.

However, I can extract information regarding the device's technical specifications and how its performance was evaluated against standards for safety and effectiveness.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a clinical performance study with thresholds for metrics like sensitivity or specificity. Instead, it demonstrates compliance with recognized medical device standards and compares the technical specifications of the new device (Subject Device) with a legally marketed predicate device. The "Verdict" column in the comparison table essentially serves as the "reported device performance" against the implicitly accepted performance of the predicate and compliance with standards.

                                          | Type BF Applied Part                                                                                                                                                                                                    | SE           |

| Patient Leakage Current | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | NC: AC: 54.5µA, DC: 0.5µA; SFC: AC:120.0µA, DC: 0.6µA | SE |
| Main Unit Weight | 115 g | 2 kg | SE (Note 1) |
| Main Unit Dimension | 128.6 x 69.8 x 25 mm | 428 x 428.8 x 185mm | SE (Note 1) |
| Number of Output Channels | 2 | 2 | SE |
| Number of Output Modes | 2 | 25 | SE (Note 2) |
| Output Intensity Level | 99 | 99 | SE |
| Synchronous or Alternating? | Synchronous | Synchronous | SE |
| Regulated Current or Regulated Voltage? | Yes | Yes | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | SE |
| Automatic Shut Off | Yes | Yes | SE |
| Indicator Display | On/Off Status, Voltage/Current Level | Yes (On/Off Status, Voltage/Current Level) | SE |
| Indicator Display (Low Battery) | Yes | No | SE |
| Timer Range | 5-60 min | 25 min | SE (Note 2) |
| Waveform | Pulsed, symmetric, biphasic | Pulsed, symmetric, biphasic | SE |
| Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | SE |
| Maximum Output Voltage | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ | SE |
| Maximum Output Current | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ | SE |
| Pulse Duration | 120μs | 120μs | SE |
| Pulse frequency | 77.3Hz | 77.3Hz | SE |
| Charge density | 0.21µC/ cm² @ 500Ω | 0.21µC/ cm² @ 500Ω | SE |
| Power density | 16.37μW/cm² @ 500Ω | 16.37μW/cm² @ 500Ω | SE |
| Active surface area | 50.04cm² | 50.04cm² | SE |
| Environment for operation | Temperature: 5 ~ 45°C; Humidity: 15% - 90%; Atmospheric pressure range of 700 hPa to 1 060 hPa | Temperature: 5 ~ 45° C; Humidity: 20 ~ 65% RH | SE |
| Environment for storage | Device: -25 - +70°C, up to 90% humidity, 700-1060 hPa; Pads: 10-20°C, up to 90% humidity, 700-1060 hPa | Device: 0 ~ 45° C, 10 ~ 90% RH; Electrode Pad: 10~20° C | SE |

Note 1 (Weight, Dimension): The differences in weight and dimensions are deemed substantially equivalent as they "won't affect the safety and effectiveness of the device."
Note 2 (Number of Output Modes, Time Range): The differences are justified as the design meets requirements in the energy aspect due to adjustable levels and default treatment time.

The study that proves the device meets the acceptance criteria:

The "study" here refers to a series of laboratory bench tests and comparisons against a predicate device, rather than a clinical trial for an AI algorithm. The device demonstrated substantial equivalence through:

• Electrical safety test: According to IEC 60601-1-11 and IEC 60601-2-10 standards.
• Electromagnetic compatibility test: According to IEC 60601-1-2 standard.
• Biocompatibility test: According to ISO 10993-5 and ISO 10993-10.
• Usability test: According to IEC 62366 standard.
• Software verification and validation test: According to the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Waveform test: Conducted to verify output specifications according to "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over The Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning."
• Comparison to a predicate device (K133929): The detailed comparison table shows that the subject device shares technological characteristics, features, specifications, materials, mode of operation, and intended use with the predicate, with differences not raising new questions of safety or effectiveness.

Regarding the specific questions about AI/Software-as-a-Medical-Device (SaMD) studies:

This device is a physical medical instrument (Transcutaneous Electrical Nerve Stimulator/Powered Muscle Stimulator) and not an AI/SaMD. Therefore, many of the questions related to AI device evaluation are not applicable.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A): This is a hardware device, and the evaluation involved bench testing and comparison to technical specifications, not a clinical test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A: No expert-established ground truth for a test set in the context of diagnostic or interpretive AI performance was required or provided. The "ground truth" for this device's evaluation was based on engineering standards and the established performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A: No adjudication method was used as there was no test set requiring interpretation by multiple experts.

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

• N/A: Not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, in concept: The "standalone" performance of the device was evaluated through the bench tests mentioned above (electrical safety, EMC, biocompatibility, usability, software verification, waveform tests) and direct comparison of its technical specifications to the predicate device. This is the device's inherent performance without human interpretation "in-the-loop" in a diagnostic sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Technical Specifications and Regulatory Standards: The "ground truth" for this submission refers to the established safety limits and performance parameters defined by international medical device standards (e.g., IEC 60601 series, ISO 10993) and the documented performance of the legally marketed predicate device (K133929).

8. The sample size for the training set

• N/A: Not an AI device; no training set in the context of machine learning.

9. How the ground truth for the training set was established

• N/A: Not an AI device; no training set.

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