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IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

The IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. There are HCT-1208/HCT-1208B/HCT-1208L 3 models in this application. Their work principle, intended use, structure, appearance，size，and operation are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

This document is an FDA 510(k) clearance letter for an IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L). The request asks to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance beyond basic safety and electrical testing.

However, the provided 510(k) clearance letter and summary primarily focus on establishing substantial equivalence to predicate devices through comparisons of technical specifications and robust safety testing (biocompatibility, electrical safety, eye safety, and software verification).

There is no detailed information provided in this document regarding a clinical performance study (e.g., patient trials, or studies that measure the actual effectiveness of hair removal) beyond the statement that "Performance data supports that the device is safe and as effective as the predicate device for its intended use." The "Performance Data" section specifically lists only safety and software V&V, not clinical efficacy.

Therefore, I cannot fully complete all sections of your request as the provided text does not contain the specific clinical performance study details you are asking for. The clearance is based on the device being "substantially equivalent" to predicate devices that are already cleared for the specified indications for use, and a demonstration that the new device meets relevant safety standards and its software functions as intended.

Here's what can be extracted and inferred based on the provided document:

Acceptance Criteria and Device Performance (Based on Provided Document)

While the document doesn't detail specific clinical efficacy acceptance criteria for the hair removal function, it does outline acceptance criteria for safety and technical performance, which are crucial for FDA clearance. The "study" proving these are met refers to the various engineering and safety tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Performance Test Set: Not applicable / Not specified in this document for a clinical efficacy study. The document focuses on bench testing and safety compliance.
• Safety Testing (Biocompatibility, Electrical, Eye): The "sample size" for these tests would typically refer to the number of devices or material samples tested. This information is not detailed in the provided 510(k) summary (e.g., how many units underwent electrical safety testing).
• Data Provenance: Implied to be from the manufacturer's own testing conducted in China (where the manufacturer is located). The nature of these tests (e.g., bench testing) makes the "retrospective or prospective" classification less applicable than for clinical data.

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

• Not applicable for this type of submission. This 510(k) relies on standardized engineering and safety tests, and establishing "ground truth" for these types of tests is typically based on adherence to the specified international standards (e.g., IEC, ISO) and laboratory procedures, rather than expert consensus on observational data.

4. Adjudication Method for the Test Set

• Not applicable for this type of submission. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert readers or evaluators independently assess data (e.g., medical images). The tests described here are compliance tests against predefined standards.

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

• No. An MRMC study is a specific type of clinical study used primarily for medical imaging devices to evaluate human reader performance with and without an AI algorithm. This document describes a physical hair removal device, not an imaging device, and does not mention any clinical comparative effectiveness study, especially not one involving human readers.

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

• Not applicable for this type of device. This device is a direct-use consumer product. While it has "Software Verification and Validation," this refers to the embedded software controlling the device's functions (e.g., light emission, skin sensor), not a standalone diagnostic algorithm whose performance would be measured independently.

7. The Type of Ground Truth Used

• For safety and electrical performance: Ground truth is established by the requirements and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety). The device's performance is measured against the specifications and limits defined by these standards.
• For substantial equivalence: The ground truth is the performance and safety data of the legally marketed predicate devices, against which the subject device is compared. The argument is that the subject device's technical characteristics and tested safety performance are "substantially equivalent" to these predicates.

8. The Sample Size for the Training Set

• Not applicable. This document describes the clearance of a physical medical device, not a machine learning or AI model that requires a "training set" of data. The software verification mentioned refers to traditional software testing methodologies.

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

• Not applicable. (See point 8).

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The R&G Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The R&G surgical mask is a single-use, three-layer, flat-pleated surgical mask with ear loops and nosepiece. The mask is made of three layers, the inner layer is made of white polypropylene nonwoven fabric, the outer layer is made of white polypropylene nonwoven fabrics, and the middle layer is made of meltblown fabrics. The mask is held in place over the wearer's mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are made of 80% polypropylene + 20% spandex. The nose piece on the mask is to allow the user to adjust the mask around their nose and is made of 75% plastic + 25% wire. The R&G surgical mask will be supplied in white. The mask is sold unsterilized and is intended to be a single-use disposable device.

This document is a 510(k) summary for the R&G Surgical Mask (K232112). This submission focuses on comparing the R&G Surgical Mask to a predicate device (K202745, Disposable medical face mask) to demonstrate substantial equivalence, rather than providing a detailed study of the R&G Surgical Mask's performance in isolation. Therefore, much of the requested information about device performance studies and ground truth establishment is not explicitly detailed in this document.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting Level 2 requirements of ASTM F2100-23, along with other specified standards.

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

The document does not specify the sample sizes used for each of the non-clinical tests. The tests are general performance and biocompatibility tests on the device material, not a clinical performance study with patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical sense; the data would originate from specialized testing laboratories conducting the specified ASTM, EN, and ISO tests on samples of the R&G Surgical Mask.

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

Not applicable. The "ground truth" for these tests is established by standardized testing protocols and measurements as per the listed ASTM, EN, and ISO standards, not by expert consensus on clinical cases. The tests measure objective physical and biological properties.

4. Adjudication method for the test set

Not applicable. As described above, the tests are objective measurements against established standard criteria, not interpretations 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

Not applicable. This is a submission for a surgical mask, not an AI-assisted diagnostic or therapeutic device. There is no MRMC study or AI component.

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

Not applicable. This is a submission for a surgical mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical testing comprises the defined pass/fail criteria established by the respective international and national standards (ASTM, EN, ISO, 16 CFR). These standards outline specific methods and thresholds for evaluating bacterial filtration, breathability, fluid resistance, flammability, cytotoxicity, sensitization, and irritation.

8. The sample size for the training set

Not applicable. There is no training set in the context of this surgical mask submission. The device is a physical product, not a machine learning model.

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

Not applicable. There is no training set.

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The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.

The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.

This FDA 510(k) summary does not contain information about the performance of an AI/ML device. Instead, it describes a "Facial Toning device" which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, specifically for cosmetic use involving facial stimulation.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective) for an AI/ML device.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI versus without AI assistance.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• The sample size for the training set of an AI/ML device.
• How the ground truth for the training set was established for an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (K181062 and K130065) through a comparison of technical specifications and compliance with electrical safety and biocompatibility standards for the TENS device.

Information available regarding the Facial Toning Device:

Acceptance Criteria and Reported Device Performance (Summary from Non-clinical Testing section):

The device "met all requirements" based on bench tests. The compliance standards serve as the acceptance criteria for various aspects of the device's safety and performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a "Non-clinical Testing Summary" which involved bench tests.

The document indicates these bench tests verified that the proposed device met all requirements as outlined by the listed international standards. No details on sample size for these bench tests, data provenance (beyond the fact they were "bench tests"), or expert involvement are provided. There is no mention of an AI component or associated studies like MRMC or standalone performance evaluations for an algorithm.

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Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for an Electronic Muscle Stimulator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details you've requested.

The document confirms that the device (Electronic Muscle Stimulator, Model: MP01) is substantially equivalent to legally marketed predicate devices for specific indications for use:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, toning, and firming of arms and legs.

It also notes that the device is intended for Over-The-Counter Use.

To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance against specific acceptance criteria.

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The Hygenix is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms. body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This device is disposable, non-sterile and for single use only.

The Hygenix is a 3 Ply flat- pleated and Disposable surgical mask. The inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The nose wire contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of PC coated Aluminium wire. The model ear loop is held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The ear loops are made of Polyester and Spandex. The dimensions of the Mask are: length- 175 ± 5 mm and width- 95 ± 5 mm. These masks are single-use, disposable devices, provided non-sterile.

Here's an analysis of the Hygenix device based on the provided FDA 510(k) summary, specifically focusing on its acceptance criteria and the study that proves it meets those criteria.

Acceptance Criteria and Device Performance for Hygenix (K232797)

The Hygenix device is a 3-ply disposable mask, and its performance is evaluated against established standards for surgical masks. The study proving its compliance is a non-clinical performance and biocompatibility testing regime.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is in black color, non-sterile and can be available in six specifications: XS, S, M, L, XL, XXL. It meets all of the requirements of ASTM standard D6319-19.

The provided document is a 510(k) Premarket Notification from the FDA for "Disposable Medical Examination Nitrile Gloves." It details the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical testing results.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.

This document describes the acceptance criteria and the study that proves the device, STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R), meets those criteria.

Key takeaway: This submission (K231489) is for a modification of an already cleared device (K181993). The primary modifications are a change in the pressure vessel supplier, some operational feature optimizations, and reduced air removal and dry times. The performance claims for sterilization and drying are maintained. Therefore, the acceptance criteria and study primarily focus on demonstrating that these modifications do not negatively impact the previously established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device, the acceptance criteria are generally that the modified device performs "as well as or better than" the predicate device and meets relevant industry standards. The performance data presented demonstrates this equivalence or improvement.

• No growth at half cycle with validation loads
• Includes textile PCD, wrapped instrument PCD, and dental handpieces
• Compliance with ANSI/AAMI ST55:2016 |
  | Moisture Retention | Meets moisture retention test criteria in ANSI/AAMI ST55:2016 for:
• Textile test packs
• Wrapped instrument test trays
• Paper-plastic peel pouches |
  | Empty Chamber Temperature Mapping | Capable of providing steady-state thermal conditions within the chamber consistent with the desired SAL in the load. (Compliance with ANSI/AAMI ST55:2016) |
  | Air Removal Performance (Bowie-Dick Test) | Verified air removal performance. (Compliance with ANSI/AAMI ST55:2016) |
  | Electrical Safety | Meets all applicable safety requirements for electrical equipment specified in UL 61010-1 3.1 Ed., and IEC 61010-2-040 3rd Ed. 2020-05. |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | Meets all applicable electromagnetic compatibility and electrical safety requirements for electrical equipment specified in EN IEC 61326-1:2021 and associated standards. |
  | Software Verification & Validation | Software meets safety and functional requirements and fulfills user needs. |
  | Cycle Times (Example: Drying Cycle) | Reduced Drying Times:
• Unwrapped instruments: 20 minutes (previously 30 min)
• Wrapped instruments (pouches): 20 minutes (previously 30 min)
• Handpieces: 20 minutes (previously 30 min)
  Note: Wrapped instruments (Packs) drying cycle remains 30 minutes. The drying performance has been successfully verified using the reduced dry time. |
  | Safety (Pressure Relief) Valve Setting | Equivalent to predicate: 40 psi (275.8 kPa) to 41 psi (282.7 kPa) Max. ASME approved. |
  | Sterilization Method | Equivalent to predicate: Dynamic-air-removal steam sterilizer with 2 steam-flush pressure-pulses (previously 4). |

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of sterilization cycles performed for biological performance, number of Bowie-Dick tests). It refers to compliance with standards like ANSI/AAMI ST55:2016, which would dictate appropriate sample sizes for validation.

The data provenance is not explicitly stated as "country of origin," but given the submitter's address (STURDY Industrial CO., LTD., New Taipei City, Taiwan), it's highly probable the testing was conducted in Taiwan or by a contracted lab following international standards. The studies were retrospective in the sense that they were performed to validate design changes on an existing device, rather than a de novo clinical trial.

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

This device, a steam sterilizer, does not involve diagnostic interpretation or human-in-the-loop performance. Therefore, "ground truth" is established through objective engineering and microbiology performance metrics (e.g., spore kill, temperature and pressure readings, moisture levels, electrical safety standards compliance). There are no "experts" in the sense of clinicians or radiologists adjudicating results, but rather qualified test engineers and microbiologists performing and analyzing the validation tests according to established international standards (e.g., ANSI/AAMI, IEC, UL). The document does not specify the exact number or individual qualifications of these testing personnel.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance is based on objective measurements against pre-defined engineering and microbiological standards, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was performed.

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

The entire performance evaluation for this device is effectively "standalone" in the sense of the sterilizer's function without continuous human intervention during a sterilization cycle. The device's performance (sterilization efficacy, drying, etc.) is objectively measured and validated against standards, independent of human operators' real-time judgment during the sterilizing process.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on:

• Microbiological Standards: Demonstrated sterility (SAL of 10^-6) through biological indicator challenges and growth/no-growth results, a fundamental requirement for sterilizers.
• Physical Parameters: Objective measurements of temperature, pressure, and time profiles within the sterilization chamber during cycles, ensuring they meet the required conditions for sterilization.
• Engineering Standards: Compliance with relevant safety (electrical, pressure vessel), electromagnetic compatibility, and performance standards (e.g., ANSI/AAMI ST55:2016 for sterilizer performance, IEC and UL for electrical safety).
• Performance Metrics: Measurements of residual moisture content and verification of clean air removal (Bowie-Dick test).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for such a device would be its historical design and manufacturing processes, which are validated through adherence to quality systems and standards, not a specific data training set in the AI sense.

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

Not applicable, as this is not an AI/machine learning device requiring a discrete training data set with established ground truth. The "ground truth" for the predicate device's design (K181993) and the modifications in K231489 are established through adherence to recognized consensus standards for medical device design, manufacturing, and performance.

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The Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles.

• The big belt is intended for use on the muscles in abdomen.
• The small belt is intended for use on the muscles in arms and thighs areas.
  Contraindicated use on injured or otherwise impaired muscles.
  Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Fitness Belt (Model: KLT-07)

The provided text is a 510(k) clearance letter from the FDA for a device called "Fitness Belt (Model: KLT-07)". This letter confirms the device's substantial equivalence to legally marketed predicate devices.

However, the letter does not contain any information regarding the acceptance criteria or a study that proves the device meets those criteria, specifically concerning performance metrics like clinical accuracy, sensitivity, specificity, or any evaluation of an AI-powered component. The Fitness Belt is described as a "Powered Muscle Stimulator" and its indications for use are "improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles." This type of device typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical stimulation output (e.g., waveform, intensity, frequency), rather than a clinical study involving ground truth or expert consensus in the way an AI-driven diagnostic device would.

Therefore, I cannot provide the requested information from the given text. The details you're asking for (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size and ground truth establishment) are typical for AI/ML-based medical devices, especially those involved in diagnostic imaging or analysis. This document is for a physical stimulator device, which has very different regulatory and testing requirements.

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The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination.

The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.

The provided document is an FDA 510(k) clearance letter for Electric Breast Pumps. It details the device description, indications for use, comparison to a predicate device, and a summary of non-clinical performance testing.

However, the document does not contain information related to acceptance criteria or a study proving that the device meets those criteria, specifically concerning AI device performance. The sections discussed are typical for a breast pump's safety and performance (electrical safety, EMC, software validation, biocompatibility, vacuum/cycle performance, backflow protection, use life, battery performance) rather than AI-related metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot answer the requested questions using the provided text as it does not describe an AI medical device or its performance criteria and study. The prompt asks for information pertaining to AI model validation, such as:

1. A table of acceptance criteria and reported device performance: Not present in the document for AI performance.
2. Sample size and data provenance for test set: Not present for AI device testing.
3. Number of experts and qualifications for ground truth: Not present.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study and effect size: Not present.
6. Standalone AI performance: Not present.
7. Type of ground truth used: Not present for AI evaluation.
8. Sample size for training set (AI): Not present.
9. How ground truth for training set was established (AI): Not present.

The document focuses on the hardware and basic functional performance of an electric breast pump, not an AI component.

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The Medical Infrared Thermometer is a non-sterile. reusable clinical thermometer intended for the intermittent determination of human body temperature in no touch mode on the center of the forehead as the measurement site on people of one month and above.

The Medical Infrared Thermometer is a non-contact, hand-held, battery powered device designed to measure human body temperature, which has the feature of simple and easy use, rapid measurement and accurate temperature feedback. The Medical Infrared Thermometer is an infrared thermometer to measure human body temperature using the infrared energy emitted in the area around the subject's forehead. The reference body site of the temperature measurement is axillary. The temperature measurement distance is 1-5 cm. The product is composed of enclosure, control panel, LCD screen, infrared sensor, PCB board, battery pack and USB charging inlet. The thermometer has three functions of digital LCD display, buzzer indication for measurement results and three color back light indication for temperature (32.0℃ to 37.3℃ with green back light; 37.4℃ to 38.0℃ with yellow back light; 38.1℃ to 43.0℃ with red back light). The device is powered by Li-ion Battery (3.7VDC; 30mAh), which can be recharged through a computer with USB port or by switching power supply (100-240V, 50/60Hz) connected with a USB charging cable. The switching power supply is not provided with the subject device and the USB charging cable will be provided with the subject device as an accessory. There are two models RST-TC59-1001 and RST-TC60-1001 included in this document. Both models share the same construction except differences on product structure including appearance of enclosure, PCB design, sensor, MCU and working condition (ambient temperature). There are three buttons on control panel of both models, the first button is for power on/off and temperature measurement function, the second button is for temperature unit shift (°C and °F) function, the third button is for memory function.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Device Name: Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)

Study Details for Clinical Accuracy Validation Test:

The provided document describes a clinical accuracy validation test for the device.

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

   • Sample Size: A total of 165 subjects were selected for temperature measurement.
   • Data Provenance: The study was conducted in a clinical setting, but no specific country of origin is mentioned. It is described as a "clinical trial." The nature of the study (retrospective or prospective) is not explicitly stated, but the description "clinical accuracy validation is designed and performed" and "total of 165 subjects are selected to temperature measurement" strongly suggests a prospective study.

2. 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):

   • The document does not specify the number of experts or their qualifications for establishing ground truth.
   • Instead, the ground truth was established by a reference clinical thermometer (RCT), specifically a "mercury axillary thermometer (Geratherm Medical AG)." The accuracy of this reference thermometer itself is assumed to be the "ground truth."

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

   • The document does not mention an adjudication method. The ground truth was established by a reference device, not by multiple human readers needing adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study was not done. This device is an infrared thermometer, which provides a direct temperature reading, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.

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

   • Yes, the clinical accuracy validation test described is effectively a standalone performance test of the thermometer. It compares the device's readings directly against a reference clinical thermometer. The device itself is an "algorithm only" in the sense that it processes infrared data to produce a temperature reading, without a human intermediary interpreting its output for diagnosis purposes.

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

   • The ground truth was established by comparison to a reference clinical thermometer (mercury axillary thermometer), which is a widely accepted standard for body temperature measurement.

7. The sample size for the training set:

   • The document does not provide information about a training set. This is a medical device that measures a physical parameter (temperature) using established principles of infrared thermometry, rather than an AI/Machine Learning model that typically requires a large training dataset. The "algorithm" mentioned refers to the internal calculations for converting infrared energy to a temperature reading, which is based on physics, not statistical learning from a training set in the modern AI sense.

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

   • As no training set is described in the context of typical AI/ML, this question is not applicable.

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