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The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.

The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each.

Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results.

EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin.

The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically.

The EM25 - glute toning device is a powered muscle stimulator intended to improve muscle tone of the buttocks muscles in healthy persons through transcutaneous electrical muscle stimulation (EMS).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., a specific percentage improvement in muscle tone measured by a defined metric). Instead, the acceptance criteria are implicitly defined by compliance with a series of recognized safety and performance standards. The "reported device performance" is essentially that the device met these standards, and is deemed substantially equivalent to a predicate device.

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

No test set related to clinical performance or human efficacy is mentioned. The primary "test set" for this submission refers to the physical device itself and its components undergoing engineering and biocompatibility testing. The data provenance for these tests is implicitly from the manufacturer's testing (Hivox Biotek, Inc., Taiwan). The document confirms that no clinical test data was used to support the decision of safety and effectiveness (Section 5.9).

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

Not applicable. No clinical test set with human data and expert ground truth was established for this submission. The "ground truth" for the non-clinical tests was adherence to the specified international standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was used, as no clinical studies were performed.

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

Not applicable. This device is a muscle stimulator, not an AI-assisted diagnostic or imaging device, and does not involve "human readers" or AI assistance in that context.

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

Not applicable. See point 5. This device is a physical therapeutic device, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to recognized international technical standards for safety, biocompatibility, software lifecycle, and electrical safety (e.g., ISO 10993 series, IEC 62304, IEC 60601 series, ISO 14971). The claim of "effectiveness" is supported by substantial equivalence to an existing predicate device, rather than direct clinical evidence for efficacy.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm was used, as this is not an AI/software device that requires machine learning.

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

Not applicable. See point 8.

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These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.

The provided document is a 510(k) summary for the HIVOX Spopad EMS SP-910, SP-920, and SP-620, which are powered muscle stimulators. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the way a clinical trial might.

Therefore, the information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (as typically found in AI/ML device evaluations) is not present in this 510(k) summary. These devices are much simpler than AI-powered diagnostic tools and rely on established electrical safety and performance standards for their regulatory clearance.

However, I can extract the relevant comparison information that serves as the basis for the declaration of substantial equivalence, which implicitly acts as the "criteria" for approval in this context.

Here's a summary based on the provided text, aligning with your request where possible, and noting when information is unavailable:

Acceptance Criteria and Device Performance (Implicit from Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The following table summarizes the comparison made by the manufacturer. The reported device performance is presented in comparison to the predicate, with the conclusion that differences are minor and do not raise new safety or effectiveness concerns.

Detailed information based on your numbered points:

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant industry standards. The reported performance of the HIVOX devices is compared against these implicit criteria.

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

   • Not Applicable. This 510(k) summary does not describe a clinical study or a test set in the conventional sense for evaluating a diagnostic or AI device. The comparison is based on the technical specifications of the device and its predicate, and compliance with performance and safety standards.
   • The document implies that the devices meet IEC electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which involve specific tests, but the sample sizes for these standard compliance tests are not specified in this summary.

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

   • Not Applicable. No ground truth in the context of expert review for medical imaging or AI performance is mentioned. This device is a muscle stimulator, not an AI diagnostic tool.

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

   • Not Applicable. No such adjudication method is mentioned or relevant for this type of device submission.

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 device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • Not Applicable. This is not an algorithm-only or AI device. The "standalone" performance refers to the device's electrical output characteristics and its compliance with safety standards, which are evaluated without human intervention in the loop of its function (though a human operates the device).

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

   • Not Applicable. For a powered muscle stimulator, "ground truth" is typically defined by adherence to engineering specifications and electrical safety standards (e.g., measured current, voltage, frequency must be within specified ranges and below safety limits). The document states that the devices (both predicate and subject) "pass medical device electric safety standard, IEC 60601-1 and standard for Nerve and Muscle Stimulator, IEC 60601-2-10 and electromagnetic compatibility standard IEC 60601-1-2." This compliance with standards serves as the "ground truth" for safety and basic performance.

8. The sample size for the training set:

   • Not Applicable. This product is a physical electrical muscle stimulator, not an AI/ML product that undergoes training.

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

   • Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

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HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.

HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.

The provided text describes HIVOX self-adhesive electrode gel pads and their substantial equivalence to predicate devices, rather than an AI/algorithm-based device. Therefore, many of the requested categories (e.g., test set sample size, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable or cannot be extracted from this document, as they pertain to algorithm performance evaluation.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's the available information presented in the requested format, with "N/A" for criteria not applicable to this type of device or not found in the documentation:

Acceptance Criteria and Device Performance

Study Details:

• Sample size used for the test set and the data provenance: N/A (This is a medical device, not an algorithm, and its performance is established through non-clinical testing and comparison to predicates, not a clinical "test set" in the AI sense).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external "ground truth" or expert consensus dataset for evaluating an algorithm; safety and performance are evaluated against established medical device standards and predicate devices).
• Adjudication method for the test set: N/A
• 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: N/A (Not an AI device).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device's safety and effectiveness is established by compliance with ISO 10993 standards for biocompatibility and comparison to the established performance and materials of legally marketed predicate devices.
• The sample size for the training set: N/A (Not an AI device).
• How the ground truth for the training set was established: N/A (Not an AI device).

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The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, is indicated for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg), and lower back due to strain from exercise or normal household and work activities.

The HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904, can generate small pulses of electrical current and delivered these pulses pass through the skin and activated underlying nerves.

The provided text describes the 510(k) summary for the HIVOX Electric Stimulator OTC TENS, Rapid ReliefTM Pennypad PP-904. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and performance metrics in the way one might expect for a novel AI/medical imaging device.

Therefore, many of the requested sections (sample size, experts, ground truth, MRMC study, training set) are not applicable or cannot be extracted from this type of regulatory submission. The information provided is about an electrical stimulator, not an AI software/imaging device.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical performance study. Instead, it demonstrates performance by comparing its specifications to a predicate device and adhering to recognized electrical safety and performance standards.

Performance Tests Submitted (Compliance with Standards):

• IEC/EN 60601-1: Medical electrical equipment Part 1. General requirements for safety, 1996.
• IEC/EN 60601-1-2: Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007.
• IEC/EN 60601-2-10: Medical electrical equipment, Part 2-10: Particular requirements for safety of nerve and muscle stimulators, 2001.

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

Not applicable. This is a 510(k) summary for an electrical stimulator, not an AI/software device that would typically involve a specific "test set" of data or cases for performance evaluation. The substantial equivalence relies on device specifications and compliance with standards.

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

Not applicable, for the same reasons as above.

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 device is an electrical stimulator, not an AI-assisted diagnostic tool.

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

Not applicable.

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

Not applicable. The "ground truth" here is compliance with electrical safety and performance standards for TENS devices, and the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. There is no AI algorithm being trained.

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

Not applicable.

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The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.

HIVOX BIOTEK INC. submitted a 510(k) premarket notification (K112392) for their HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) on July 13, 2011. The submission aimed to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K060846 and K040512). The FDA cleared the device on March 19, 2012.

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

The acceptance criteria for this device are implicitly that the performance of the HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) must be substantially equivalent to the predicate devices in terms of electrical safety, electromagnetic compatibility, and specific output parameters. The reported performance is a comparison table against two predicate devices. The "reported device performance" is the measured electrical output characteristics of the HIVOX devices.

Study to prove device meets acceptance criteria:

The study proving the device meets the acceptance criteria is a non-clinical performance testing and substantial equivalence comparison against legally marketed predicate devices.

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

• Sample size for the test set: Not applicable in the context of this 510(k) submission. The testing conducted was electrical safety and performance testing on the device itself, rather than a clinical study with a patient test set.
• Data provenance: The testing was performed in accordance with international standards, implying compliance with established methodologies for medical device electrical safety and electromagnetic compatibility. The submitter, HIVOX BIOTEK INC., is based in New Taipei City, Taiwan, R.O.C., which is the country of origin of the device and likely where the non-clinical testing was conducted. The data is prospective, in that it was generated for the purpose of this submission.
• Retrospective or prospective: Prospective (tests were specifically conducted for the purpose of this 510(k) submission).

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)

• Number of experts: Not applicable. This was a non-clinical device performance and safety testing submission, not a study requiring expert readers to establish ground truth for a test set of medical cases.
• Qualifications of those experts: Not applicable.

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

• Adjudication method: Not applicable. There was no clinical test set 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

• MRMC study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a TENS unit, not an AI-assisted diagnostic or therapeutic tool.

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

• Standalone study: Not applicable. This is a physical medical device (TENS unit), not an algorithm.

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

• Type of ground truth: The "ground truth" in this context refers to established international consensus standards for electrical safety (IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-2-10) and the electrical output specifications of the predicate devices. The HIVOX devices' measured electrical parameters were compared against these standards and the predicate device specifications to demonstrate substantial equivalence.

8. The sample size for the training set

• Sample size for the training set: Not applicable. There is no AI component or machine learning involved that would require a training set.

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

• How ground truth for training set was established: Not applicable, as there was no training set.

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The TENS programs of HIVOX Electric Stimulator TENS & EMS, HD2:

The device is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for (1) Symptomatic relief of chronic (long term) intractable pain, and (2) adjunctive treatment in the management of post-surgical and post-traumatic pain problems.

The EMS programs of HIVOX Electric Stimulator TENS & EMS, HD2:

The device is an electrical powered muscle stimulator indicated for medical purpose to repeatedly contract muscles by passing electrical currents through electrodes contacting the affected body area. In particular, this device is indicated for use for (1) Relaxing muscle spasms, (2) Increasing local blood circulation, (3) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, (4) Muscle re-education, (5) Maintaining or increasing range of motion, and (6) Preventing or retarding disuse atrophy.

The HIVOX Electric Stimulator TENS & EMS, HD2 generates small pulses of electrical current. Delivered along lead cables to electrodes placed on your skin, these pulses pass through the skin and activated underlying nerves. The relief from chronic and acute pain that the HD2 can provide results from this electrical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HIVOX Electric Stimulator TENS & EMS, HD2:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are implied by substantial equivalence to a predicate device. The performance is assessed against recognized medical device standards and compared to the predicate device's specifications.

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

• Sample Size: Not applicable in the context of this 510(k) submission. This is a premarket notification primarily based on non-clinical performance testing and comparison to a predicate device, rather than a clinical trial with a specific test set of patients.
• Data Provenance: The performance data primarily comes from non-clinical tests conducted by HIVOX Biotek Inc. related to the specified IEC/EN standards. The data is retrospective in the sense that it's based on tests performed on the device itself, but it does not involve human subject data or a specific "test set" of patient cases. The country of origin of the device manufacturer and the testing company (implied) is Taiwan.

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

• Number of Experts/Qualifications: Not applicable. There was no "test set" requiring expert ground truth in the traditional sense of clinical opinion or diagnosis. The ground truth for electrical and performance characteristics is established by the relevant engineering and medical device standards (IEC/EN). Regulatory bodies (like the FDA) review compliance with these standards and the comparison data.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring human 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

• MRMC Study: No. This device is an electrical stimulator (TENS & EMS), not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study with human readers assisting AI or vice-versa is entirely irrelevant to this submission.

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

• Standalone Performance: Not applicable. This is not an algorithm or AI device. Its performance is inherent in its physical and electrical characteristics as measured against standards.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device's performance and safety is derived from:
  • International/National Standards: Compliance with IEC/EN 60601-1, IEC/EN 60601-1-2, and IEC/EN 60601-2-10.
  • Predicate Device Specifications: The established safety and effectiveness profile of the legally marketed predicate device (MEDIHIGHTEC TENS/EMS Combo, K082514). The comparison aims to demonstrate that the new device meets or exceeds the critical performance aspects and safety features of the predicate.
  • Engineering and Electrical Measurements: Verifiable data from tests on the device's electrical output, waveforms, and physical construction.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI, so there is no concept of a "training set" for an algorithm.

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

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

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used to apply a minor electrical current to electrodes on patient's wrist skin to function as:

• Helping relieve nausea and vomiting due to motion sickness.

Not Found

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "HIVOX DM-800."

This document does not contain information about:

1. Specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy).
2. Details of any study that proves the device meets acceptance criteria.
3. Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, or training set information.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (helping relieve nausea and vomiting due to motion sickness) and outlines regulatory compliance requirements. It is a regulatory clearance, not a scientific publication detailing performance studies.

Therefore, I cannot provide the requested table and study details based on the input text.

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The device is an electronic clinical thermometer using an infrared thermopile sensor to detect body temperature of the radiation from the tympanic part of the human of all ages at home.

AVITA TS0/TS1 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature by radiation emitted via the human ear (Tympanic Temperature).

Here's the analysis of the provided text regarding the AVITA TS0/TS1 Infrared Ear Thermometer (referred to as HIVOX Cover-Free Ear Thermometer TS-510 in the FDA letter, though the 510(k) summary lists AVITA as the submitter and manufacturer, suggesting a potential rebranding or distribution relationship).

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the AVITA TS0/TS1 Infrared Ear Thermometer (K020471) is very sparse on specific performance data and acceptance criteria for temperature accuracy. It primarily states compliance with general standards.

Study Proving Device Meets Acceptance Criteria:

The document states: "Moreover, bench technological characteristics do not raise and new questions of safety or effectiveness." This implies that bench testing was performed to demonstrate conformity. However, no detailed information about this bench study (e.g., specific protocols, results, sample sizes for the "test set" in this context) is provided in the summary. For a thermometer, "bench technological characteristics" would typically refer to tests for accuracy against a reference temperature source in a controlled environment. The primary evidence presented for substantial equivalence is conformity to recognized standards (ASTM E1965-98, IEC 60601-1, IEC 60601-1-2).

Missing Information (Not Available in the Provided Text):

The provided documents are a 510(k) summary and the FDA's clearance letter. These types of documents typically summarize the manufacturer's findings rather than providing exhaustive detail on the underlying studies. Therefore, many of the specific questions you asked are not answered by this limited information.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The manufacturer is based in Taiwan (AVITA International Corp).

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 question is more relevant for diagnostic AI/imaging devices. For an infrared ear thermometer, the "ground truth" for temperature measurement would typically be established by a calibrated reference thermometer in a controlled laboratory setting, not by human experts. No information on human experts is provided, nor would it be expected for this type of device.

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

• Not applicable. Adjudication methods are typically used when there are multiple human readers or interpretations of diagnostic data. For a thermometer's performance testing, measurement against a standard reference would be the method.

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

• Not applicable. This is not an AI-assisted diagnostic device, but a standalone measurement device.

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

• Yes, implicitly. The device is an infrared ear thermometer, designed to provide a temperature reading directly. Its performance would be evaluated as a standalone device, with its readings compared to a known reference (ground truth). The document states "bench technological characteristics," which points to standalone testing.

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

• For an infrared ear thermometer, the ground truth would be established by a calibrated reference thermometer in a controlled environment, likely using a black body or other stable heat source, as per the ASTM E1965-98 standard it claims to conform to.

8. The sample size for the training set

• Not applicable. Infrared ear thermometers are typically hardware devices with firmware, not machine learning algorithms that require "training sets" in the conventional sense. The "training" in this context would be the calibration process during manufacturing.

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

• Not applicable for the reason stated in point 8.

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