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The ShockPhysio Mobile (model SW3200 Basic) is indicated for:

• Relief of minor muscle aches and pains
• Temporary increase in local blood circulation
• Activation of connective tissue

Not Found

This document is a 510(k) clearance letter from the FDA for a therapeutic massager, the "ShockPhysio Mobile (model SW3200 Basic)".

It does not contain any information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or specific study details like those expected for AI/software-based medical devices.

The letter explicitly 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 indicates a substantial equivalence (SE) determination, which often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and study information based on the provided text. The document is for a Class I Therapeutic Massager (a device with lower regulatory controls), and the FDA clearance process for such devices often focuses more on substantial equivalence to existing devices and adherence to general controls, rather than complex performance studies.

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NMES Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle Re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion

EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)

TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

EMG Biofeedback, relaxation muscle training and muscle re-education

Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers.

The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable).

For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.

For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining.

For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.

For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception.

LE9011 consists of the following elements:

• Main device
• Pedestal
• Lead wire
• Electrode pad
• Vaginal probe
• Rectal probe (optional)
• PC Software(optional)
• USB Cable(optional)

The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device's clinical performance.

Instead, this document is a 510(k) Summary for a medical device (Levator Elite Model LE9011), which aims to demonstrate substantial equivalence to previously cleared predicate devices. The focus is on comparing the proposed device's technical characteristics, indications for use, and performance data (primarily non-clinical) to those of the predicate devices.

Here's a breakdown of what is and isn't present, based on your request:

What's missing that you asked for:

• Acceptance Criteria for clinical performance: The document does not specify quantitative clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific thresholds for clinical improvement).
• Study Proving Device Meets Acceptance Criteria: There is no clinical study described that directly evaluates the device's performance against predefined clinical acceptance criteria.
• Reported Device Performance (against clinical criteria): Because there are no clinical acceptance criteria or clinical studies described, there's no reported device performance in those terms.
• Sample size for test set: No test set of patients/cases is described for clinical evaluation.
• Data provenance (country, retrospective/prospective): Not applicable as no clinical study is presented.
• Number of experts for ground truth & qualifications: Not applicable.
• Adjudication method for test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
• Effect size of human readers with/without AI assistance: Not applicable as it's not an AI-assisted diagnostic device and no MRMC study was done.
• Standalone (algorithm-only) performance: Not applicable as it's a physical electrical stimulator, not an algorithm-based diagnostic tool.
• Type of ground truth used: Not applicable as no clinical study is presented.
• Sample size for training set: Not applicable as it's not an AI/ML device that requires a training set in that context.
• How ground truth for training set was established: Not applicable.

What is provided regarding "Performance Data" in the 510(k) Summary (Section 6):

The "Performance Data" section focuses on non-clinical testing to ensure the device is safe and performs as intended, and that any technological differences from predicates do not raise new questions of safety or effectiveness.

1. Biocompatibility testing:

   • Acceptance Criteria (implicit): Compliance with ISO 10993-1.
   • Reported Performance: "The biocompatibility evaluation for the accessories (Electrode pad, Vaginal probe and Rectal probe) was conducted in accordance with the International Standard ISO 10993-1..."
   • Tests Conducted: Cytotoxicity, Sensitization, Irritation.
   • This is not a "study that proves" clinical effectiveness, but rather a demonstration of material safety.

2. Electrical safety and electromagnetic compatibility (EMC):

   • Acceptance Criteria (implicit): Compliance with relevant IEC standards.
   • Reported Performance: "The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC."
   • This is technical performance testing, not clinical.

3. Software Verification and Validation Testing:

   • Acceptance Criteria (implicit): Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
   • Reported Performance: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." "The software for this device was considered as a 'Moderate' level of concern."
   • This ensures the software functions correctly and safely, not clinical effectiveness.

4. Output waveform Testing:

   • Acceptance Criteria (implicit): Verification of output specifications according to IEC 60601-2-10.
   • Reported Performance: "oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10."
   • This confirms the device delivers the specified electrical output, which is a technical performance aspect.

Conclusion from the document:

The document concludes that the device is substantially equivalent to the predicate devices and that any technological differences do not raise new questions regarding safety and effectiveness. This is the premise of a 510(k) submission – to demonstrate equivalence to an already cleared device, often without new clinical studies if non-clinical data suffice.

In summary, based only on the provided text, a comprehensive response to your structured request for acceptance criteria and clinical study details is not possible because the document focuses on non-clinical performance and substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria.

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Migraine TENS Digital Pain Reliever LT1103

• The acute treatment of migraine with or without aura in patients 18 years of age or older.
• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Migraine TENS Digital Pain Reliever LT1103-P

• The prophylactic treatment of episodic migraine in patients 18 years of age or older.

The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.

The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.

The Migraine TENS Digital Pain Reliever consists of the following elements:

• Main Device
• Charging Station
• Electrode Pads
• USB cable

This document is a 510(k) summary for the Migraine TENS Digital Pain Reliever. It describes the device and compares it to a predicate device (Cefaly® Dual) to demonstrate substantial equivalence.

Based on the provided text, here's what can be extracted regarding acceptance criteria and the study proving the device meets them:

This device is a TENS unit for migraine relief, not an AI/imaging diagnostic device. Therefore, many of the requested criteria (like ground truth, expert consensus, MRMC studies, effect size of human improvement with AI, standalone AI performance, training set details) are not applicable to this type of medical device submission.

The acceptance criteria here pertain to safety and performance equivalence with a legally marketed predicate device, rather than diagnostic accuracy or human-AI reader performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal "acceptance criteria" table in the typical sense for AI/diagnostic devices. Instead, it demonstrates equivalence by comparing the technical specifications of the new device (Migraine TENS Digital Pain Reliever LT1103, LT1103-P) against the predicate device (Cefaly® Dual, K201895).

The "S.E. Discussion" column in the table below effectively serves as the "reported device performance" against the implicitly accepted predicate's performance.

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

This is not applicable as this is a TENS device, not an AI/imaging device that would use a test set of patient images or data in that context. The "testing" here refers to engineering and safety performance testing.

• Test Set Sample Size: Not applicable.
• Data Provenance: Not applicable. The "data" comes from engineering tests, not patient studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of diagnostic accuracy is not relevant for this device. Safety and performance are established through objective engineering tests against international standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no concept of "adjudication" in the context of engineering and safety testing for a TENS device in this 510(k) summary.

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 treatment device, not a diagnostic AI device. Human "readers" are not involved in its primary function, nor is AI assistance relevant to its therapeutic mechanism.

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. Its performance is inherent to its physical and electrical characteristics.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable in the AI/diagnostic sense. The reference standard or "ground truth" for this submission are:

• International safety and performance standards (e.g., ISO 10993-1, IEC 60601 series).
• The established safe and effective performance of the predicate device (K201895 Cefaly® Dual).

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or require a "training set."

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

Not applicable. There is no training set for this device.

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Combo Stimulator MT9000
For TENS/IF/MIC mode

1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
   For EMS mode
4. Relaxation of muscle spasm.
5. Increase of local blood flow circulation
6. Prevention or retardation of disuse atrophy
7. Muscle re-education
8. Maintaining or increasing range of motion.
9. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Combo Stimulator LT7102
For TENS/IF/MIC mode

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

TENS Stimulator Intensity 10

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

MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode 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 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. 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 provided document is a 510(k) Summary for medical devices (stimulators) and does not contain information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven diagnostic devices.

The document details the substantial equivalence of new stimulator models (Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10) to previously marketed predicate devices. The "performance data" section covers biocompatibility, electrical safety, EMC, and software verification/validation, which are typical for this type of medical device submission, but do not involve acceptance criteria or studies related to AI/ML diagnostic performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and reported device performance (for AI/ML diagnostic context)
2. Sample size for the test set and data provenance
3. Number of experts and qualifications for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size)
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. Ground truth establishment for the training set

The document is primarily focused on demonstrating that the new devices have the "same intended use and technological characteristics" as existing devices, and that changes do not affect safety or effectiveness, as confirmed by regulatory compliance testing (e.g., IEC standards).

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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. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

LT5019 is designed to be used at home, by adults of all genders. The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).

The provided text describes the 510(k) summary for the "Smart Pain Reliever, Model LT5019," a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS). This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria related to its clinical effectiveness with an AI component or analysis of diagnostic performance.

Therefore, many of the requested details about acceptance criteria for AI/diagnostic performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/diagnostic device studies proving clinical utility) are not present in this regulatory submission document.

This document focuses on:

• Technological equivalence: Comparing the technical specifications (e.g., waveform, pulse duration, frequency, power source) of the new device to predicate devices.
• Compliance with safety standards: Demonstrating that the device meets relevant electrical safety, electromagnetic compatibility (EMC), biocompatibility, software verification/validation, and usability standards.

Here's what can be extracted from the provided text regarding device performance and criteria based on the regulatory context:

Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) for a TENS/EMS device)

For this type of device, "acceptance criteria" are primarily related to meeting established electrical and safety performance specifications and demonstrating that these specifications are either equivalent to predicate devices or fall within accepted physiological/safety limits. The performance "reported" is primarily in the form of meeting these technical specifications rather than clinical diagnostic metrics.

Table of Acceptance Criteria and Reported Device Performance (as relevant for a TENS/EMS device):

Regarding the other specific questions about AI/diagnostic studies, the provided text does not contain this information:

2. Sample sizes used for the test set and the data provenance: Not applicable/not provided for this type of submission. The performance data described is bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this device is based on technical specifications rather than interpretations by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is its electrical output and safety characteristics as measured by technical instruments and adherence to international standards.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a TENS/EMS device, demonstrating substantial equivalence through technical specifications and compliance with safety standards. It does not involve AI or diagnostic performance studies, hence the absence of information related to expert review, test/training datasets, or MRMC studies.

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The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.

The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.

The Non-contact Forehead Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.

The provided document is a 510(k) Summary for a Non-contact Forehead Thermometer (Model TH1009N). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the information provided:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not explicitly stated for the clinical evaluation. The document mentions a "clinical evaluation..." conducted in compliance with ASTM E1965-98. ASTM E1965-98 specifies the clinical accuracy requirements for infrared thermometers (e.g., in Section 8), which typically involves a minimum number of subjects (e.g., 50 subjects for clinical accuracy studies, as per older versions of similar standards, but the exact number isn't in this document).
• Data Provenance: The "Clinical evaluation of Non-contact Forehead Thermometer was conducted by Shenzhen Dongdixin Technology Co., Ltd". This implies the study was conducted by the manufacturer, likely in China. The document does not specify if the data was retrospective or prospective, but clinical evaluations are typically prospective.

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

• This information is not provided in the document. For thermometer accuracy, "ground truth" is typically established by comparing the device reading against a highly accurate reference thermometer (e.g., an oral or rectal thermometer with known accuracy, or a blackbody simulator), rather than expert interpretation.

4. Adjudication method for the test set

• This information is not applicable and therefore not provided, as the ground truth for thermometer accuracy is typically a direct measurement from a reference device, not an interpretation requiring adjudication.

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

• This is not applicable. This device is a non-contact forehead thermometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

• This is not applicable in the context of "algorithm only" performance as commonly discussed for AI/ML devices. The device itself is standalone in that it provides a temperature reading without human interpretation for the result. Its "performance" is its accuracy.

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

• For the clinical evaluation, the ground truth would be established by measurements from a highly accurate reference clinical thermometer (e.g., an oral or rectal thermometer) as specified by the ASTM E1965-98 standard. The document states the clinical evaluation was in compliance with this standard.

8. The sample size for the training set

• This information is not applicable and therefore not provided. The device described does not appear to involve machine learning or AI that would require a "training set" in the conventional sense. Its function is based on infrared sensing and internal algorithms, not on learning from a large dataset.

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

• This information is not applicable as there is no mention of a training set for machine learning or AI algorithms within the provided documentation.

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.

The device is an electronic clinical thermometer using an infrared sensor.

The provided text is a 510(k) clearance letter from the FDA for an Infrared Ear Thermometer. It does not contain the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details.

The letter explicitly 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..." This indicates that the clearance is based on substantial equivalence to an existing device, not necessarily on a detailed study proving performance against specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided document.

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