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The Heat StimPlus, Model FDES115 is intended

TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.

EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation.

It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.

FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

Stimulation from FDES115 is intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.

The accessories include:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage.

The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.

The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.

The FDES115 is considered - OTC devices.

This device, "Heat StimPlus (Model FDES115)", is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) intended for temporary pain relief and muscle performance improvement, respectively. It does not rely on AI, machine learning, or complex algorithms that would require the typical acceptance criteria and study designs found in AI/ML medical device submissions. Therefore, the questions related to ground truth, number of experts, adjudication methods, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this device.

The provided document, an FDA 510(k) Premarket Notification summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device (HIVOX OTC Electrical Stimulator EM59-2, K203574) through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance:

Since the device is not an AI/ML device, the acceptance criteria are not in the form of diagnostic performance metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are adherence to established medical device standards and acceptable ranges for electrical stimulation parameters. The "reported device performance" is demonstrated through compliance with these standards and comparison of its technical specifications to the predicate device.

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FDES106 (ED406) Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
FDES106A (ED406A) Multi-function Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance.
FDES105 (ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
FDES107 (ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.

The FDES106(ED406) Series Stimulator, which includes models FDES106(ED406), FDES106A(ED406A), FDES105(ED405) and FDES107(ED407), 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 device unit of FDES106(ED406) and FDES106A(ED406A) are same, only the applied part are different: the applied part of FDES106(ED406) is electrode pad; the applied part of FDES106A(ED406A) is electrode belt. They are portable device, battery powered (3.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The FDES106 (ED406) includes FDE$105 (ED405). FDES106 (ED406) has TENS and EMS two treatment mode 5 programs (N, B, H, E1, E2), FDES105 (ED405) only has TENS mode 5 treatment programs (N1, N2, B, H, F).Their appearance, structure, circuit, software operation is exactly the same, only different output treatment procedure.
FDES107 (ED407) has 10 EMS treatment process, whose intended use, waveform characteristics and is basically the same as FDES106 (ED406) EMS model, The difference is from only operation mode and structure appearance.
Independent channel (by electrode pad or electrode belt) that effectively transfers your desired choice of pre-programmed electrical pulses directly through electrode pad or electrode belt) to suggested area of the body where the electrode are placed, causing minimal muscle contractions. The FDES106 (ED406 ) and FDES106A (ED406A ) have 3 TENS programs and 2 EMS programs; FDES105 (ED405) have 5 TENS programs; FDES107 (ED107) have 10 EMS programs.

The provided document is a 510(k) premarket notification for the Famidoc FDES106 Series Electro-Stimulator devices (including models FDES106, FDES106A, FDES105, and FDES107). It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Critical Note: This document explicitly states: "The FDES106(ED406) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there are no acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy), nor is there any study related to device performance in a clinical context reported within this document. The "acceptance criteria" and "device performance" in this context refer to adherence to established electrical, mechanical, and biocompatibility safety standards.

Below is an analysis based on the information provided regarding the non-clinical tests and comparisons.

Acceptance Criteria and Study to Demonstrate Device Meets Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for an electro-stimulator, the acceptance criteria are generally based on compliance with recognized safety and performance standards for such devices, and substantial equivalence to predicate devices. The "reported device performance" refers to the device's adherence to these standards and its characteristics as compared to the predicates.

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

• Test Set Description: The "test set" in this context refers to the Famidoc FDES106 Series devices themselves, which underwent non-clinical (bench) testing.
• Sample Size: The document does not specify a quantitative sample size for the bench testing (e.g., "N units were tested"). It describes the tests generally applied to the device series. It is implied that representative units of each model (FDES106, FDES106A, FDES105, FDES107) were tested to demonstrate compliance.
• Data Provenance:
  • Country of Origin: The test results are presumably from China, where the manufacturer (Famidoc Technology Co., Ltd.) is located.
  • Retrospective or Prospective: The testing described is prospective, in the sense that the devices were tested against established standards to support the premarket notification.

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)

• Ground Truth Establishment: For non-clinical device safety and performance testing, "ground truth" is established by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FDA software guidance). These standards represent a consensus among experts (engineers, medical professionals, regulatory bodies) over years of development and revision.
• Number of Experts: Not applicable in the sense of individual expert review for each test outcome. Compliance is assessed against the defined requirements of the standards.
• Qualifications of Experts: The experts involved are those who developed and maintain the relevant IEC and ISO standards, and FDA guidance documents. Their qualifications would typically include extensive experience in electrical engineering, biomedical engineering, materials science, toxicology, and regulatory affairs pertaining to medical devices.

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

• Adjudication Method: Not applicable. The "adjudication" for non-clinical testing refers to the objective measurement of device parameters against the defined limits or requirements of the standard. There is no human subjective adjudication of the test results themselves, beyond internal quality control and regulatory review for compliance.

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

• MRMC Study: No. This is not an imaging or diagnostic device that relies on human readers interpreting results, nor does it incorporate AI. The device is an electro-stimulator for pain relief and muscle conditioning.
• Effect Size of AI: Not applicable, as there is no AI component or MRMC study.

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

• Standalone Performance Study: No. This is a physical medical device (electro-stimulator), not a software-only algorithm. The "software verification" mentioned confirms the software functions as designed and complies with FDA guidance, but it's not a standalone performance study in the sense of an algorithm.

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

• Type of Ground Truth: The ground truth for this submission is compliance with international safety and performance standards (IEC, ISO) and FDA software guidance. This reflects an expert consensus on what constitutes a safe and acceptably performing electro-stimulator. The claims of "substantial equivalence" are based on comparing the device's characteristics to those of legally marketed predicate devices, which themselves have met these regulatory standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set.

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FDES101(ED401) TENS and EMS Stimulator
For TENS 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
   FDES102(ED402) TENS Stimulator
10. Symptomatic relief of chronic intractable pain
11. Post traumatic pain
12. Post surgical pain
    FDES103(ED403) EMS Stimulator
13. Relaxation of muscle spasm.
14. Increase of blood flow circulation
15. Prevention or retardation of disuse atrophy
16. Muscle re-education
17. Maintaining or increasing range of motion.
18. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

The FDES101(ED401) Series Stimulator, which includes models FDES101(ED401), FDES102(ED402) and FDES103(ED403), 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 three models FDES101(ED401), FDES102(ED402) and FDES103(ED403) 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 FDES101(ED401) TENS and EMS Stimulator is the combination unit with the TENS. EMS functions, the function can be selected by press buttons. The range of settings is identical to those of FDES102(ED402) and FDES103(ED403). The difference on the five units can be identified by the LCD display.

The provided document is a 510(k) Summary for FAMIDOC TECHNOLOGY CO., LTD.'s FDES101 (ED401) Series Electro-Stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the results of a de novo study with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the information relevant to non-clinical testing for substantial equivalence and general device specifications.

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

For a 510(k) submission, the "acceptance criteria" for performance are typically substantial equivalence to a predicate device and compliance with relevant safety and performance standards. The "reported device performance" is demonstrated through these comparisons and adherence to standards.

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

This document describes a 510(k) submission for an electro-stimulator, which is a hardware device. It demonstrates substantial equivalence through comparisons to a predicate device and adherence to international safety and performance standards.

• No "test set" in the context of AI/ML performance evaluation (e.g., retrospective vs. prospective data, country of origin) is mentioned or applicable here.
• The comparison is based on the technical specifications and safety testing of the device itself and its components, against those of a predicate device and industry standards.

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. This is a hardware device submission, not specifically an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set.

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

Not applicable, as there is no "test set" or human expert review process described for performance evaluation in the context of an AI/ML device.

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 a hardware device submission, not an AI/ML device intended to assist human readers. The document explicitly states: "The FDES101(ED401) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence."

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

Not applicable. The device is a physical electro-stimulator, not an algorithm.

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

Not applicable. For this type of device, "ground truth" relates to compliance with engineering and safety standards, and functional equivalence to an already legally marketed device, rather than diagnostic accuracy against a clinical reference standard. The "proof" is through non-clinical bench testing and comparative analysis of specifications against predicate devices.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

Not applicable. As above, this is a hardware device, and the concept of a training set and its ground truth is not relevant to this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this 510(k) context is primarily substantial equivalence to a predicate device and compliance with recognized safety standards) is a non-clinical bench testing and comparative analysis study.

• The document explicitly states: "The FDES101(ED401) 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:"

  • 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 basic safety and essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests, Interpretation Sheet."
  • IEC 60601-1-4 "Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems"
  • IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"

• Evidence of Compliance: The submission includes bench testing results, safety reports, and a Risk Analysis Report to demonstrate that any engineering differences from the predicate device "do not affect the intended use or alter the fundamental scientific technology of the device," thus maintaining "the same safety and effectiveness as that of predicate device." Specific comparisons like power source, patient leakage current, electrical/mechanical safety classifications, and material properties are presented.

• Data Provenance: The comparative data is derived from the technical specifications and test results of the new device manufactured by Famidoc Technology Co., Ltd. (China) and the predicate device (MT9000 Series Electro-Stimulator, K093138, manufactured by Shenzhen Dongdixin Technology Co., Ltd.). This is a retrospective comparison based on existing device specifications and non-clinical test data.

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Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.

Famidoc Infrared FDIR series Thermometers are hand-held, reusable, battery operated devices, which can measure human body temperature in two ways.

• On forehead, the skin temperature on one's forehead.
• In ear, the tympanic temperature in one's ear.
  The operation principle is based on Infrared Sensor technology. The IR sensor can output different signal when measuring different object temperature or in different ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.
  The subject devices (Models: FDIR-V2, FDIR-V4, FDIR-V6, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15) are the same series in Famidoc. Their design principle, intended use, indications for use, material, control keys, software and the applicable standards are the same. The differences between them are appearance, some parameters (e.g. LCD size), and some minor functions (e.g. Voice function).

The provided document is a 510(k) summary for an Infrared Thermometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/device.

Therefore, the requested information cannot be fully extracted as it pertains to a different type of device evaluation (e.g., for an AI/ML medical device).

However, I can provide what information is available in the document regarding performance and equivalence:

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the thermometer's accuracy against a ground truth. Instead, it relies on conformance to standards.

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

The document does not provide details on a specific "test set" in the context of clinical data for performance evaluation. The "tests in this submission" likely refer to bench testing for compliance with the mentioned standards (ASTM, IEC). No information on sample size, country of origin, or retrospective/prospective nature of data is provided.

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 and not provided. The evaluation is based on technical standards conformance and substantial equivalence, not a clinical study requiring expert ground truth assessment.

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

This information is not applicable and 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

This information is not applicable and not provided. This is an infrared thermometer, not an AI-assisted diagnostic device.

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

This information is not applicable and not provided. This is a standalone medical device, but not one that employs an algorithm in the AI/ML sense where "standalone performance" against a human baseline would be relevant.

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

The "ground truth" used for this type of device is typically established against calibrated reference thermometers and environmental conditions during testing for compliance with standards like ASTM E1965-98. The document does not specify the exact methods or type of ground truth beyond conformance to these standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" in the context of machine learning, as this is a traditional medical device.

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

This information is not applicable and not provided.

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Famidoc Digital Clinical Thermometers are intended for the measurement and monitoring of human body temperature, by doctor or consumers in the hospital or home. It is used alone for human beings at all ages.

Famidoc Digital Clinical Thermometer (model FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4) are hand-held, reusable, battery operated, maximum device that can measures human body temperature. Models FDTH-V0-1, FDTH-V0-2, FDTH-V0-3, FDTH-V0-4 have the same indication for use. the difference points are their shapes、waterproof function and measurement speed. The operation principle is based on thermistor and ASIC technology, a thermistor using as temperature sensor, the sensor's signal is then calculated and displayed by an ASIC. The digital thermometer comprises a thermistor for temperature sensing, a reference resistor for comparing the resistance of the thermistor, a buzzer for sounding effect, an ASIC and a LCD for calculating and displaying the target temperature digitally which the thermistor is immersed.

The document provided describes the Famidoc Digital Clinical Thermometer and its FDA 510(k) summary. Here's a breakdown of the requested information based on the provided text:

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

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

The document mentions "clinical tests" for repeatability and standard deviation based on EN 12470-3:2000. However, it does not specify the sample size used for these tests. The country of origin and whether the data was retrospective or prospective are not mentioned.

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)

This information is not provided in the document. The nature of the device (a thermometer) suggests that ground truth would likely be established by a reference temperature standard rather than expert consensus on interpretation.

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

This information is not provided in the document. Given the type of device, an adjudication method as typically described for image analysis or diagnostic interpretation by experts would not be 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This type of study is typically relevant for AI-powered diagnostic tools that assist human readers, which is not the function of a digital clinical thermometer.

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

The device itself is a standalone electronic thermometer. The "bench testing" mentioned for accuracy, precision, and repeatability, as well as the "clinical tests" for repeatability and standard deviation, effectively constitute standalone performance assessments. The performance reported in the table (meeting ASTM and IEC standards) is the standalone performance of the device.

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

For the bench testing and clinical tests, the ground truth would inherently be a highly accurate reference temperature (e.g., from a calibrated standard thermometer or controlled thermal environment). The document doesn't explicitly state "reference temperature" as the ground truth but refers to meeting standards like ASTM Ell12-00, which govern the accuracy of thermometers against such reference standards.

8. The sample size for the training set

The device described is a digital clinical thermometer, which is a physical measurement device based on thermistor and ASIC technology. It does not involve a "training set" in the context of machine learning or AI algorithms. Therefore, this question is not applicable to the described device.

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

As there is no "training set" for this type of device, this question is not applicable.

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

Infrared Thermometer Model: FDIR-VI is a hand-held, reusable, battery operated, maximum device that can measures human body temperature by two ways.

1. on forehead, the skin temperature on one's forehead.
2. in ear, the tympanic temperature in one's ear.
   The operation principle is based on Infrared Sensor technology. IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature, an ASIC can turn the signal from IR Sensor to a digital value and display it by LCD.

The provided text does not contain detailed information about a specific study with acceptance criteria and reported device performance in the format requested.

The document is a 510(k) summary for an Infrared Thermometer. It states that "The device conforms to applicable standards included ASTM E1965-98, EN 12470-5: 2003, IEC 60601-1 and IEC 60601-1-2 requirements." and that "tests in this submission provide demonstrate these small difference do not raise and new questions of safety or effectiveness." This implies that the device was tested against these standards, and its performance met the requirements within them, leading to the conclusion of substantial equivalence to a predicate device.

However, the specific "acceptance criteria" (e.g., accuracy +/- 0.X degrees C), the numerically "reported device performance," and other details like sample sizes, ground truth establishment, or expert involvement are not explicitly provided in this 510(k) summary. These details would typically be found in the full test reports referenced by the submission to FDA.

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