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Therapeutic Ultrasound

• Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
• 1. Pain relief, muscle spasms and joint contractures.
• 2. Relief of pain, muscle spasms and joint contractures that may be associated with:
• · Adhesive capsulitis
• Bursitis with slight calcification
• · Myositis
• · Soft tissue injuries
• · Shortened tendons due to past injuries and scar tissues
• 3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
• · Capsular tightness
• · Capsular scarring

For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:

• 1. Symptomatic relief of chronic intractable pain
• 2. Post-traumatic acute pain
• 3. Post-surgical acute pain

Additionally for NMS. NMS Burst, Hi-Volt and Russian:

• 1. Relaxation of Muscle spasms
• 2. Prevention or retardation of disuse atrophy
• 3. Increasing local blood circulation
• 4. Muscle re-education
• 5. Maintaining or increasing range of motion
• 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For EMG

• To determine the activation timing of muscles for:
• 1. Retaining of muscle activation
• 2. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

• 1. Relaxation muscle training
• 2. Muscle re-education

For EMG triggered Stim

• 1. Stroke rehab by muscle re-education
• 2. Relaxation of muscle spasms
• 3. Prevention or retardation of disuse atrophy
• 4. Increase local blood circulation
• 5. Muscle re-education
• 6. Maintaining or increasing range of motion

For DC Continuous Mode

• Relaxation of muscle spasm 1)

ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package.

A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly.

In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current.

The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.

The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education.

The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.

I am sorry, but without specific test data or performance metrics for the ComboRehab device, I cannot fill in the table for acceptance criteria and reported device performance. The provided text outlines the device's indications for use and lists the non-clinical tests performed, along with the standards it conforms to, but it does not contain quantifiable performance data or specific acceptance criteria for those performances.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies that would typically include acceptance criteria and their fulfillment.

However, I can provide the other requested information based on the text:

1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document states that "Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards." However, the specific reported device performance against numerical acceptance criteria is not detailed. The non-clinical tests focused on safety and electromagnetic compatibility per international standards.

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/Not provided. The document explicitly states "ComboRehab did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there was no "test set" in the context of clinical data for performance evaluation as typically understood for AI/medical device assessment. The non-clinical tests performed were likely on device prototypes or production units, not on human subjects or clinical data sets.

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. As no clinical tests were performed, there was no ground truth to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical tests were performed, there was no need for an adjudication method.

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. No multi-reader, multi-case clinical studies were conducted, as explicitly stated in the document. The device is a physical therapy device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapy unit that provides various modalities (ultrasound, muscle stimulation, biofeedback). It is not an algorithm-only device or an AI system that would have "standalone" performance in the sense of a diagnostic or interpretive algorithm. Its performance is inherent to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests performed, "ground truth" would refer to the adherence of the device's output to engineering specifications and international safety standards (e.g., electrical safety, electromagnetic compatibility, output intensity measurements). This is established through laboratory measurements and calibration against known standards, not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set
Not applicable. No training set was used, as the device is not an AI/machine learning system that requires data training.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

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The Cutaneous Electrodes including Garment electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

Not Found

This is a 510(k) premarket notification for "Cutaneous Electrodes." This document does not describe a study that uses AI or machine learning models. Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device.

The document discusses the regulatory approval for medical electrodes and their intended use, but it does not involve any performance evaluation of an intelligent algorithm.

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The OTC EMS stimulator MT1001 is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided text is a 510(k) summary for the Shenzhen Dongdixin Technology Co., Ltd. OTC EMS Stimulator MT1001. This document primarily focuses on FDA clearance for market entry based on substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the given text.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This statement confirms that the device was cleared based on substantial equivalence, rather than a detailed performance study proving specific acceptance criteria.

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The SW-Therm, Model ST 1001, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeatic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:

I ) Relieving pain;

2. Reducing muscle spasm;

3. Increasing range of motion of contracted joints using heat and stretch techniques; and

4. Increasing blood flow to tissues in the treatment area.

Not Found

This document is an FDA 510(k) clearance letter for a medical device (SW-Therm, Model ST1001), not a study report. It does not contain information about the acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document primarily focuses on the regulatory clearance process and confirms that the device is substantially equivalent to legally marketed predicate devices, subject to general controls. It does not detail specific performance studies, acceptance criteria, or methodological aspects like sample sizes, ground truth establishment, or expert qualifications.

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The Laser-Stim, Model LS2001, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "Laser - Stim LS2001" infrared lamp. This type of device does not typically undergo studies to demonstrate performance against specific, quantifiable acceptance criteria in the same way a diagnostic or AI-driven device would.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate. Clinical studies, especially those with acceptance criteria and ground truth, are generally not required for these types of devices unless there are significant differences in technological characteristics or intended use that raise new questions of safety and effectiveness.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not typically found in a 510(k) clearance document for an infrared lamp like the "Laser - Stim LS2001."

The document states:

• Regulation Name: Infrared Lamp
• Regulatory Class: Class II
• Product Code: ILY
• Indications For Use: The Laser-Stim, Model LS2001, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.

This device is cleared based on its equivalence to other infrared lamps already on the market, implying that the general safety and effectiveness of infrared lamps for these indications are already well-established. The submission likely focused on engineering specifications, electrical safety, biocompatibility (if applicable), and comparison to a predicate device rather than a prospective clinical study with performance-based acceptance criteria against a ground truth.

In summary, based on the provided document, I cannot fulfill the request for information regarding acceptance criteria and study details because the nature of this device and its 510(k) clearance process do not typically involve such studies.

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MT9001 OTC TENS/EMS stimulator
TENS: 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), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
LT3060 OTC TENS stimulator
TENS: 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), and lower extremities (leg) due to strain from exercise or normal household work activities.

Not Found

This document is an FDA 510(k) clearance letter for two OTC Electrical stimulator models (MT9001, LT3060). It acknowledges that the devices are substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria for a study, nor does it present the results of a study to prove a device meets those criteria.

The letter is a regulatory approval, not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, muscle spasms and joint contractures. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. Relief of sub-chronic, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: Relaxation of Muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

This is a 510(k) premarket notification for a medical device (CT 1000 SonicStimu Combo) and not a study proving the device meets specific acceptance criteria based on performance data.

Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval.

Here's what can be extracted and what cannot:

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

• Cannot be provided. This document is a 510(k) clearance letter, not a performance study. It does not contain acceptance criteria for specific performance metrics or reported device performance data in that context. The clearance is based on substantial equivalence to a predicate device, implying similar safety and effectiveness without necessarily requiring new, detailed performance studies against defined acceptance criteria.

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

• Cannot be provided. This information is not part of a 510(k) clearance letter for this type of device. There's no "test set" of patient data described for performance 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)

• Cannot be provided. No such clinical study or expert-adjudicated test set is described.

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

• Cannot be provided. Not applicable as no test set requiring ground truth adjudication is mentioned.

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

• Cannot be provided. This device is an Ultrasound and Muscle Stimulator, not an AI-powered diagnostic imaging tool that would typically involve MRMC studies for reader performance improvement.

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

• Cannot be provided. Not applicable as this is a physical therapy device, not an algorithm.

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

• Cannot be provided. No ground truth definition is relevant for this type of 510(k) clearance.

8. The sample size for the training set

• Cannot be provided. This device is not an AI/machine learning model, so there is no "training set."

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

• Cannot be provided. Not applicable.

What is provided in the document:

• Device Name: CT 1000 SonicStimu Combo
• Regulation Number: 21 CFR 890.5860
• Regulation Name: Ultrasound and muscle stimulator
• Regulatory Class: Class II
• Product Code: IMG, GZJ, LIH
• Manufacturer: Shenzhen Dongdixin Technology Company, Limited
• Indications for Use:
  • Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as pain relief, muscle spasms, joint contractures, adhesive capsulitis, bursitis with slight calcification, myositis, soft tissue injuries, shortened tendons, capsular tightness, and capsular scarring.
  • For TENS, Interferential, premodulated (IFC), NMS, and Microcurrent: Symptomatic relief of chronic intractable pain, post-traumatic acute pain, post-surgical acute pain.
  • Additionally for EMS, NMS, Hi-Volt, and Russian: Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
• Regulatory Basis: Substantial equivalence to legally marketed predicate devices, implying that the device has the same intended use as legally marketed predicate devices, and the same or similar technological characteristics. The safety and effectiveness are considered to be equivalent to that of the predicate device.

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The device is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

IR Ear/Forehead thermometer, which includes models DX6635, DX6637, TH1081 and TH1091, are a hand-held, reusable, battery operated device that can measures human body temperature by two ways:

• On forehead, the skin temperature on people's forehead
• In ear, the tymperature in people's ear
  The working principle based on infrared sensor technology. It utilizes infrared technology to receive infrared energy emitted from the eardrum or the surface of the object and convert to a voltage. The voltage value is responsible with the different temperature between the target object and infrared sensor. Then MCU will convert this value to digital data by an analog to digital (A/D) circuit. This data will be changed to the finalized temperature data by algorithms and displayed on LCD.

Here's a breakdown of the acceptance criteria and study information for the IR Ear/Forehead thermometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and conformance to standards rather than detailing a specific clinical study with granular raw performance data. The "Reported Device Performance" in the table reflects the specified accuracy and operational ranges claimed for the device, which are presented as being equivalent to the predicate device and in conformance with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for clinical performance. The focus of this 510(k) summary is on substantial equivalence to a predicate device through technological characteristics and adherence to recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts to establish a ground truth for a test set. This type of information would typically be found in a detailed clinical study report, which is not provided in this 510(k) summary.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for a test set. This suggests that a multi-reader or expert-adjudicated test set in the traditional sense was not performed or at least not detailed in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission relies on demonstrating substantial equivalence to a predicate device and conformance to standards, rather than proving improved human reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The document describes the device as a "hand-held, reusable, battery operated device that can measures human body temperature" and the working principle is "based on infrared sensor technology." This is a hardware device with an embedded algorithm for temperature conversion. The performance evaluation presented is intrinsically standalone in the sense that the device itself, functioning autonomously to measure temperature, is the subject of conformity to standards. There's no explicit mention of a separate "algorithm-only" performance study distinct from the device's overall operation. The device is the algorithm in this context.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is implicitly based on established metrological standards and physical measurements rather than clinical outcomes or expert consensus on interpretations. The reliance on standards like ASTM E1965-98 (2003) for "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature" implies that the device's accuracy claims are benchmarked against reference thermometers or controlled temperature environments as defined by these standards.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is a medical device that measures temperature using infrared technology, not a machine learning or AI algorithm that typically requires a large training dataset for model development in the way one might think of image recognition or diagnostic AI. The "algorithms" mentioned are for converting voltage to digital temperature data, likely based on known physics and calibration data, not iterative machine learning from a vast dataset.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for such a set was established. The device relies on established physical principles and calibration against known temperature references (as per standards like ASTM E1965-98) during its manufacturing and design, rather than learning from labeled training data.

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MT9000 Combo TENS/EMS/IF/MIC Stimulator:
For TENS mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
For EMS mode: 1. Relaxation of muscle spasm 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
For IF mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
For MIC mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain

MT9001 TENS Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain

MT9002 EMS Stimulator: 1. Relaxation of muscle spasm 2. Increase of local blood flow circulation 3. Prevention or retardation of disuse atrophy 4. Muscle re-education 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis

MT9003 IF Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain

MT9004 MICROCURRENT Stimulator: 1. Symptomatic relief of chronic intractable pain. 2. Post traumatic pain 3. Post surgical pain

The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003, MT9004, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients. The five models MT9000, MT9001, MT9002, MT9003 and MT9004 have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The MT9000 Combo TEN/EMS/IF/MIC Stimulator is the combination unit with the TENS, EMS. IF and MICROCURRENT functions, the function can be selected by press buttons. The range of settings is identical to those of MT9001, MT9002, MT9003 and MT9004. The difference on the five units can be identified by the LCD display.

The provided 510(k) summary for the MT9000 Series Electro-Stimulator (K093138) does not include acceptance criteria or a study demonstrating that the device meets such criteria.

Instead, this submission is a premarket notification (510(k)) that establishes substantial equivalence to a predicate device, the Sonicator Plus 940, ME940 Stimulator (K071137). The 510(k) process typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study.

Here's a breakdown based on the information provided, highlighting what's present and what's explicitly absent:

1. Table of acceptance criteria and reported device performance:

• Not Applicable. The document explicitly states: "The MT9000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." (Section 7)
• The comparison focuses on technological characteristics and intended use to demonstrate substantial equivalence, rather than quantitative performance metrics against acceptance criteria.

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

• Not Applicable. No clinical test set or data provenance is mentioned as no clinical studies were performed.

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

• Not Applicable. No clinical test set and therefore no ground truth established by experts is mentioned.

4. Adjudication method for the test set:

• Not Applicable. No clinical test set and therefore no adjudication method is mentioned.

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 an electrical stimulator, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

• Not Applicable. This is an electrical stimulator, not an algorithm.

7. The type of ground truth used:

• Not Applicable. No clinical studies were performed to establish ground truth. Substantial equivalence was based on non-clinical testing against voluntary design standards and comparison with a predicate device.

8. The sample size for the training set:

• Not Applicable. No machine learning or AI component, thus no training set.

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

• Not Applicable. No machine learning or AI component, thus no ground truth for a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the document):

The document explicitly states: "The MT9000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:" (Section 7)

The "study" or evidence provided to support the device's safety and effectiveness (and thus, its "acceptance" for market clearance via 510(k)) is based on:

• Non-clinical testing to validate design requirements.
• Conformance with voluntary design standards:
  • IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for safety".
  • IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard".
  • IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators".
• Bench testing, safety report, and Risk Analysis Report documentation (Section 8).
• Biocompatibility testing for the ABS material of the device shell and reliance on the predicate's electrodes (K070612) (Section 5).
• A "side-by-side comparison" between the MT9000 Series Electro-Stimulator and the predicate device (Sonicator Plus 940, ME940 Stimulator, K071137) to establish substantial equivalence in intended use, fundamental technology, and operational characteristics (Section 6).

In essence, the device's "acceptance" is based on demonstrating it is sufficiently similar to an already cleared device and meets relevant electrical safety and performance standards, rather than proving novel clinical efficacy against specific, pre-defined quantitative acceptance criteria through a dedicated performance study.

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LT3000 Combo Stimulator

• Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
• Increase of blood flow in the treatment area
• Relaxation of muscle spasm
• Immediate post-surgical stimulation of muscles to prevent venous thrombosis
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Maintaining or increasing range of motion.

LT3001 TENS Stimulator

• Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain

LT3002 EMS Stimulator

• Relaxation of muscle spasm.
• Increase of blood flow in the treatment area
• Immediate post-surgical stimulation of muscles to prevent venous thrombosis
• Muscle re-education
• Prevention or retardation of disuse atrophy
• Maintaining or increasing range of motion.

The LT3000 Series Stimulator, which includes models LT3000, LT3001 and LT3002, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.

The three models LT3000, LT3001 and LT3002 have the same housing in a molded portable plastic case, an accessible buttons、 switch, and accessible battery storage compartment. The case shape is rectangular. The process to set the parameter and attach lead wires to the three models is also the same except the Housing printing artwork, Mode No & destination.

The LT3000 Combo Stimulator is the combination unit with both TENS and EMS functions, the function can be selected by switch. The range of settings is identical to those of LT3001 and LT3002. The difference on the three units can be identified by printing artwork, Mode No.

The acceptance criteria and study information for the LT3000 Series Electro-Stimulator are outlined below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

For the LT3000 Series Electro-Stimulator (K100117), the acceptance criteria for substantial equivalence were primarily based on technological characteristics and safety standards adherence. Since this is a 510(k) submission for a medical device that did not involve clinical trials for its substantial equivalence determination, the "reported device performance" is not in terms of clinical outcomes but rather conformance to established safety and performance benchmarks relative to a predicate device.

The presented information focuses on demonstrating that the new device meets the same safety and performance profiles as its predicate device through non-clinical testing and comparison of technical specifications.

2. Sample Size Used for the Test Set and Data Provenance

The submission explicitly states: "The LT3000 Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards".

Therefore, there are no "test set" or "training set" in the context of patient data or clinical trials. The "test set" here refers to the actual devices being tested in a laboratory setting. There is no specific sample size mentioned for the number of devices tested, but it's implied that the non-clinical tests were conducted on representative samples of the LT3000 Series Electro-Stimulators.

The data provenance is from non-clinical bench testing conducted by the manufacturer (Shenzhen Dongdixin Technology Co., Ltd.) and relevant testing laboratories (e.g., Jiangsu TUV Product Service Ltd. Shanghai Branch for biocompatibility). This is considered retrospective in the sense that it's a report on tests already performed. The country of origin of the manufacturer is China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. As no clinical studies were performed, there was no test set requiring expert ground truth establishment in a clinical context. The "ground truth" for non-clinical tests is based on adherence to engineering and safety standards, and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was used.

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 an electro-stimulator, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation.

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

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was adherence to:

• Voluntary design standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 for medical electrical equipment safety.
• Manufacturer's specified design requirements.
• Biocompatibility test results for materials used.

Essentially, the ground truth was conformance to established engineering, safety, and material standards for medical devices of this type.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this was not a machine learning or AI device, nor did it involve clinical data for performance validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

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