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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

Not Found

The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.

This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:

• The device name and models
• The applicant's information
• Regulation numbers and product codes
• Regulatory classification (Class II)
• The date of clearance
• General controls provisions (registration, listing, GMP, labeling)
• Information about when new 510(k) submissions might be needed for device changes
• Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
• Contact information for the FDA

Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)

It does not include:

• Details on performance studies.
• Specific acceptance criteria used for performance verification.
• Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS device (TENS and Muscle Stimulator). This type of letter does not contain the detailed information about the acceptance criteria and study data that would be submitted as part of the 510(k) premarket notification.

A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. While this process involves demonstrating safety and effectiveness, the FDA approval letter itself does not typically include the specific performance metrics, study designs, sample sizes, or ground truth methodologies that an AI/ML device submission would detail. Those technical details are part of the original submission package, not the clearance letter.

Therefore,Based on the provided FDA 510(k) Clearance Letter for the TENS AND EMS (TENS and Muscle Stimulator) device (K250053), there is no information available regarding the acceptance criteria or the specific study details that would prove the device meets these criteria. The letter is an official notification of clearance, stating that the device is substantially equivalent to a predicate device, and does not contain the detailed technical data typically found in a product's technical file or a clinical study report.

The following information cannot be extracted from the provided document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical device, not an AI/ML algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (not an AI/ML device, so no training set in the typical sense).
9. How ground truth for the training set was established: Not applicable.

The letter focuses on regulatory compliance, outlining the device's classification, applicable regulations (e.g., Quality System regulation, UDI Rule), and general controls. It refers to the device as a "TENS and Muscle Stimulator," which is a traditional physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML specific studies (like MRMC, training sets, ground truth establishment methods for algorithms) are not relevant to this type of device and would not be found in its 510(k) clearance.

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Transcutaneous Electrical Nerve Stimulation (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36): 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.

Electrical Muscle Stimulation (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS & EMS Stimulator(Model:MHD-1083) is portable and DC 3.7V battery powered device, offering both transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulation (EMS) qualities in one device.
TENS & EMS Stimulator has 36 operation programs, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. And the TENS (Program 3,4,6,7,8,9,16,17,19,20,21,22,23,24,28,29,34,36) 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.
Electrical Muscle Stimulation (EMS) (Program 1,2,5,10,11,12,13,14,15,18,25,26,27,30,31,32,33,35) to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
The electronic stimulatory module has the operating elements of Switch, LCD Display screen, Screen lock key, Intensity Modification keys, Timing key, Output sockets, and USB port for battery charging.
The LCD screen can display treatment remaining time, battery power, selected program, output port, current intensity, selected intensity and lock state.
The device is equipped with accessories of electrode pads, electrode cables, a battery charger and a USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the AC charger and the built-in lithium battery. All accessories, including the USB cable, electrode pads, electrode cables, and the charger can only be replaced by the specialized person. Please ask the retailer to replace it.
The electrodes are interchangeable. The application area of electrode pads must be larger than 10cm². The electrode pads are provided by Dong Guan Ou Kang Electronics CO., LTD. with 510(k) cleared Number K181234.

The provided text is a 510(k) Premarket Notification from the FDA for a TENS & EMS Stimulator (MHD-1083). This document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for a novel AI/ML-driven medical device and then proving it meets those criteria through a dedicated performance study.

Therefore, the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "ground truth establishment" cannot be found within this document.

This document details the following:

• Acceptance Criteria & Device Performance: The document does not describe acceptance criteria in the typical sense for a new AI/ML algorithm's performance. Instead, it compares the new device's specifications to those of its predicate devices to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it falls within similar ranges or uses similar technology to cleared predicates.

  • Table of Acceptance Criteria and Reported Device Performance: Not applicable in the context of an AI/ML algorithm's performance study. The table provided (on pages 6-7) is a comparison of the new device's technical specifications against two predicate devices (K190115 and K133929). It highlights similarities and differences in parameters like power source, output modes, channels, waveform, maximum output voltage/current, pulse width, frequency, and safety compliance. For example:
    • Parameter: Indications for Use
      • New Device: TENS for temporary pain relief; EMS to stimulate healthy muscles for performance.
      • Predicate K190115: TENS for temporary pain relief; PMS (Powered Muscle Stimulation) to stimulate healthy muscles for performance.
      • Predicate K133929: TENS for temporary pain relief; PMS to stimulate healthy muscles for performance.
      • Comparison: Same (in terms of general use).
    • Parameter: Number of Output Modes
      • New Device: 36
      • Predicate K190115: 12
      • Predicate K133929: 25
      • Comparison: Similar (Note 2 states this difference doesn't impact safety/effectiveness).
    • Parameter: Maximum Output Voltage
      • New Device: 82V±20% @ 500Ω; 158V±20% @ 2kΩ; 168V±20% @ 10kΩ
      • Predicate K190115: 78V±15% @ 500Ω; 153V±15% @ 2kΩ; 161V±15% @ 10kΩ
      • Predicate K133929: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
      • Comparison: Similar (Note 3 states differences don't exceed safety limits and meet IEC 60601-2-10 requirements).

• Sample sizes for test and training sets: Not applicable. This submission relies on technical specifications and adherence to recognized safety standards rather than a clinical performance study with test/training datasets for an AI algorithm.

• Data provenance: Not applicable. No clinical data or images are involved for AI training/testing.

• Number of experts and qualifications: Not applicable. Ground truth for an AI algorithm is not established here. The comparison is against established predicate device specifications and recognized safety standards.

• Adjudication method: Not applicable.

• MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted diagnostic or therapeutic device that involves human readers.

• Standalone performance: Not applicable. The device's operation is purely electrical stimulation, not an AI algorithm.

• Type of ground truth: Not applicable. The "ground truth" here is compliance with electrical safety standards (e.g., IEC 60601 series) and demonstrating that the device's functional parameters are within ranges considered safe and effective, similar to already-cleared devices.

• How ground truth for training set was established: Not applicable.

In summary, the provided document is a 510(k) submission for an electrical stimulator, not an AI/ML-driven device. Therefore, the specific criteria and study details relevant to AI/ML device acceptance (as outlined in your prompt) are not present. The "proof" of the device meeting "acceptance criteria" here is its demonstrated adherence to relevant electrical safety standards and substantial equivalence to predicate devices, focusing on hardware and electrical characteristics.

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The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "TENSWave," which is a Transcutaneous Electrical Nerve Stimulator for pain relief.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to predicate devices, its regulatory classification, and applicable general controls and regulations.

Therefore, an answer to the request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be generated from the given text.

The provided information only states:

• Trade/Device Name: TENSWave
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
• Regulatory Class: Class II
• Product Code: GZJ
• Indications for Use: The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

To answer the user's request, information regarding performance testing, clinical study results, and defined acceptance criteria would be necessary, which is absent in this FDA clearance letter.

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TENS (mode 1-3)

The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS (mode 4-6)

The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

The provided document is a 510(k) clearance letter from the FDA for TENS and EMS units (SM9109A, SM9109B). This type of document does not typically contain acceptance criteria or detailed study results for the device's performance.

510(k) clearances are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness from scratch. The letter confirms that the device is substantially equivalent for the stated indications for use, meaning its performance is considered comparable to existing devices on the market.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. This information would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated test reports and clinical data summaries provided by the manufacturer to the FDA.

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The TENSOR® Suture Button System is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the TENSOR® implants are intended to provide fixation during the healing process for the following indications:

Syndesmotic trauma, such as ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures; fixation of dorsal distal radioulnar ligament (DRUL) disruptions; Acromioclavicular separations due to coracoclavicular ligament disruptions; Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle; and, Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process.

The TENSOR® Suture Button System consists of metal buttons, a polymer suture, an optional washer, and instruments. The buttons are available in various sizes to accommodate varying patient anatomy and surgical needs. The buttons and washer are manufactured from titanium alloy or stainless steel, and the suture is manufactured from ultra high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET). The implants are sterile packaged with various instruments to aid in insertion.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the TENSOR® Suture Button System. It outlines the device's classification, indications for use, and the basis for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance. The "Performance Data" section specifically mentions "Mechanical testing (static and dynamic tension)" and "Bacterial endotoxin testing (BET)," which are standard tests for evaluating the mechanical properties and biocompatibility of implantable devices. There is no mention of clinical trials, AI/ML algorithm development, or human-in-the-loop performance studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML performance, as the provided document does not pertain to an AI/ML device.

To directly answer your questions based only on the provided text, a significant portion of the requested information is absent because the device is a mechanical implant, not an AI/ML-driven diagnostic or assistive system.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria Mentioned (Implicit/Explicit):
  • Mechanical Performance: Static and dynamic tension (implied to meet relevant standards for load-bearing and fatigue).
  • Biocompatibility/Sterility: Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011 (acceptance criteria would be below a certain endotoxin limit).
  • Substantial Equivalence: To predicate devices in terms of design, intended use, material composition, and range of sizes, and that differences "do not raise any different questions of safety or effectiveness."
• Reported Device Performance:
  • "Performance data demonstrates substantial equivalence to the predicate devices." (This is a summary statement, specific numerical results are not provided).

2. Sample size used for the test set and the data provenance

• Not applicable/Not provided. The testing mentioned (mechanical, endotoxin) uses material samples, not a "test set" in the sense of patient data for AI.

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

• Not applicable/Not provided. Ground truth, in the context of the requested AI/ML study, is not relevant for this device.

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

• Not applicable/Not provided.

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, not applicable/Not provided. This is a mechanical implant, not an AI-assisted diagnostic tool.

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

• No, not applicable/Not provided.

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

• Not applicable. For mechanical testing, the "ground truth" would be engineering specifications and validated test methods.

8. The sample size for the training set

• Not applicable/Not provided. No AI/ML training set is mentioned.

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

• Not applicable.

In summary: The provided document is a regulatory clearance for a traditional medical implant, not an AI/ML device. Therefore, the requested information pertaining to AI/ML development, testing, and clinical validation is not present.

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The TENS device-HeadaTerm 2 is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

TENS device-HeadaTerm 2 offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device- HeadaTerm 2 enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort. The device could adhere to patient's forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, the product provides the user with 9 gear options, and the user can control the stimulating intensity by selecting one of gear.

The provided text describes the regulatory clearance of a medical device (TENS device-HeadaTerm 2) and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on:

• Regulatory Clearance: FDA 510(k) clearance for the TENS device-HeadaTerm 2 (K230782).
• Device Description: What the device is and how it works.
• Indication for Use: Prophylactic treatment of episodic migraine in patients 18 years or older, for Over-The-Counter (OTC) use.
• Predicate Devices: Comparison to TENS device-HeadaTerm (K172450) and Cefaly® Dual (K201895).
• Technological Characteristics Comparison: A table detailing similarities and differences with predicate devices.
• Performance Data (Non-clinical): Lists standards the device was tested against (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, ISO 10993-23) for safety, EMC, and biocompatibility.
• Usability Verification: A brief mention of a usability study.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document confirms the device passed tests according to various standards but does not list specific numerical acceptance criteria (e.g., a minimum sensitivity or specificity) or the resulting performance values for these criteria.
2. Sample size used for the test set and the data provenance: Only a usability study is mentioned with a sample size of 24 participants. No test set for measuring specific performance metrics (like efficacy in migraine treatment) is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a performance test set with ground truth is not described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not indicated. The document explicitly states "Clinical testing is not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical TENS device, not an AI algorithm.
7. The type of ground truth used: Not applicable as no such performance study is described.
8. The sample size for the training set: Not applicable as no AI/machine learning algorithm training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The only "study" mentioned with concrete numbers is a usability study:

• Sample size: 24 participants.
• Goal: To prove the device is appropriate for OTC use.
• Outcome: All 24 subjects completed specified tasks correctly (equipment wearing, power-off, intensity adjustment, changing, storage). This implicitly serves as an "acceptance criterion" for usability in an OTC setting, and the reported performance (all 24 subjects successful) meets it.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location, likely China. It's a prospective study.
• Ground Truth: Established by observing correct completion of tasks by the participants and assessment by a "study team and the HCP" (Healthcare Professional), implying expert observation and judgment on task completion.

In summary, the provided document is a regulatory clearance letter and a 510(k) summary, not a detailed clinical or performance study report with specific acceptance criteria beyond adherence to recognized medical device standards and a basic usability verification.

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TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):

• To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
• To stimulate healthy muscles in order to improve and facilitate muscle performance .
• To temporarily increase local blood circulation in healthy muscles.

TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.

This document describes the premarket notification (510(k)) for the TENS & EMS Device (Models LY-ET-01, LY-ET-02, LY-ET-04). This filing primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and comparison, rather than clinical efficacy studies. Therefore, many of the requested elements for acceptance criteria and study proving device meets criteria (especially those related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment) are not applicable in this context.

However, based on the provided text, I can extract information related to the acceptance criteria and the non-clinical studies conducted to demonstrate the device's safety and performance in the context of electrical safety and general device functionality, as required for a TENS/EMS device.

Here's a breakdown of the available information:

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

The document provides a table summarizing non-clinical performance testing. The "Acceptance criteria" column states the general requirements for the tests, and the "Test results" column indicates "Pass" for all listed tests. There are no specific quantitative performance metrics provided as acceptance criteria for the TENS/EMS functionality itself (e.g., specific pain reduction percentages), as this is a non-clinical submission relying on equivalence to a predicate device.

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

• Sample Size for Non-Clinical Testing: "The test sample is the final, finished product." For each listed test (General requirements, Electromagnetic disturbances, Home Healthcare environment, Nerve and muscle stimulators), the sample size is specified as "Model: LY-ET-01, LY-ET-02, LY-ET-04." This implies a representative sample of each device model was used for testing, but specific numerical quantities (e.g., N=3 of each model) are not given.
• Data Provenance: The tests are laboratory "bench testing" conducted by the manufacturer, Jiangxi Royall Smart Technology Co., Ltd. (China). The document does not specify if these were retrospective or prospective tests, but they are typically prospective tests performed to verify compliance with standards for the specific device being submitted. All cited standards (IEC, ISO) are international.

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

This information is not applicable. The device is a TENS & EMS stimulator, and the testing documented is non-clinical (electrical safety, EMC, biocompatibility, usability, software V&V). There is no "ground truth" in the clinical sense (e.g., for disease diagnosis or treatment efficacy) established by experts for these types of tests. Compliance is against published international standards.

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

Not applicable, as this is related to clinical ground truth establishment or reader studies, which were not performed.

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-powered diagnostic or therapeutic device. The submission is for a TENS & EMS device, demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing.

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

Not applicable. This is not an algorithm-only device. It's a physical medical device.

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

For the non-clinical tests, the "ground truth" is compliance with the requirements and limits defined in the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-10, IEC 60601-1-11, IEC 62366-1, ISO 10993 series).

8. The sample size for the training set

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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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