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510(k) Data Aggregation
(207 days)
MyHomeDoc
The MyHomeDoc device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
MyHomeDoc device is intended for use by adult lay users in a non-clinical environment. MyHomeDoc application enables counseling with the physician and transmission of the information over an IP network.
The MyHomeDoc device is a home use device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device.
The Device enables user's examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data.
Here's a breakdown of the acceptance criteria and study information for the MyHomeDoc device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides acceptance criteria implicitly through the successful completion of tests and explicit statements of meeting criteria in specific cases.
| Test Name | Acceptance Criteria (Implicit/Explicit from description) | Reported Device Performance |
|---|---|---|
| Thermometer Performance & Accuracy | Explicit: Difference between IR readings and Black body less than 0.3°C. Compliance with ASTM E1965-98. | The MyHomeDoc device met all acceptance criteria. The results demonstrate that the difference between the IR readings ("Direct mode") and the Black body is less than 0.3°C. The test tables demonstrate compliance of the MyHomeDoc Thermometer component with ASTM E1965-98. |
| MyHomeDoc Device vs. Braun Predicate for Oral Equivalence | Explicit: Difference between MyHomeDoc and Brown NTF3000 predicate device less than or equal to 0.4°C. | The difference between MyHomeDoc and the Brown NTF3000 predicate device was less than or equal to 0.4°C in 81 users. Therefore, the MyHomeDoc device met the acceptance criteria. |
| SpO2 Verification | Implicit: Met all acceptance criteria, including displayed SpO2 value for each simulator value, and MyHomeDoc measurements of monotonic increasing/decreasing values are monotonic and align within the 20% range. | The MyHomeDoc device met all acceptance criteria, including meeting specified criteria for displayed SpO2 values and monotonic behavior of measurements within a 20% range. |
| Pulse Rate Verification | Implicit: Met acceptance criteria, with measured pulse results between 30BPM to 250BPM. | MyHomeDoc device measured pulse results between 30BPM to 250BPM. MyHomeDoc device met the acceptance criteria. |
| Pulse Oximeter Hypoxia Protocol | Implicit: Met all acceptance criteria for validating SpO2 measurements. | The MyHomeDoc device met all acceptance criteria. |
| Stethoscope Test Report | Implicit: Met the acceptance criteria. (Specific criteria are not detailed in the provided text). | MyHomeDoc devices used in the test met the acceptance criteria. |
| Otoscope Test Report | Implicit: Met the acceptance criteria for line-pair separation, color differentiation, and illumination flux. | Line-pair separation test, Color differentiation and Illumination flux were evaluated. MyHomeDoc devices used in the test met the acceptance criteria. |
| Otoscope-Gold Standard vs. MyHomeDoc Ear Test Comparison | Implicit: MyHomeDoc images were clear, allowing clinical evaluation; landmarks of the ear were easily identified; physician subjective assessment was positive; images equivalent to those of the gold standard. | MyHomeDoc images were cleared allowing clinical evaluation, Landmarks of the ear were easily identified and the physician subjective assessment was positive. Therefore, the MyHomeDoc device met the acceptance criteria and MyHomeDoc images are equivalent to those of the gold standard. |
| Biocompatibility Evaluation | Implicit: Compliance with ISO 10993-1. | In compliance with ISO 10993-1. |
| Cleaning, Packaging | Implicit: Compliance with relevant standards for cleaning validation, transportation, and use life calculation. | All tests were successfully completed. |
| Software Validation | Implicit: As recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Software verification and validation testing were conducted and documentation was provided as recommended. The software level of concern is moderate. |
| Electrical Safety and EMC | Implicit: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62471 First edition, ISO 80601-2-61 and IEC 60529, wireless coexistence testing. | Conducted on the MyHomeDoc device. In addition, the system complies with the listed standards. |
| Usability Testing | Implicit: Demonstrate that MyHomeDoc device can be used by the intended users for the intended uses and under the expected use conditions without serious use errors or problems. | A usability study was conducted to evaluate the use-related safety and effectiveness of the MyHomeDoc when used by lay-user via observational data, knowledge task data, and interview data, and demonstrated the device can be used without serious use errors or problems. |
2. Sample Sizes and Data Provenance
- Thermometer Oral Equivalence Test: 81 users.
- Hypoxia Protocol (Pulse Oximeter): The sample size is not explicitly stated in the provided text, but it was a "hypoxia test" performed for validation.
- Other Performance Tests (Stethoscope, Otoscope, SpO2 verification, Pulse Rate verification): The specific sample sizes for these tests are not provided in the document.
- Usability Study: The sample size is not explicitly stated, but it involved "lay-users" via observational data, knowledge task data, and interview data.
- Data Provenance: The document does not explicitly state the country of origin for the clinical or performance data. It is a submission by "MyHomeDoc Ltd." which has an address in Ra'anana, Israel. The study type is not explicitly labeled as retrospective or prospective, but the description of "testing performed" and "study conducted" implies prospective data collection for the performance and usability evaluations.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Thermometer Oral Equivalence Test: Not applicable, as ground truth was established by comparison to a predicate device (Brown NTF3000 thermometer) and a quantitative difference threshold.
- SpO2 Verification / Hypoxia Protocol: Not applicable, as these tests are based on device measurements against a simulator or established physiological conditions rather than expert interpretation.
- Stethoscope Test Report: Not explicitly stated how ground truth was established or if experts were involved in a comparative clinical sense. It was evaluated against a predicate stethoscope (Littman).
- Otoscope-Gold Standard vs. MyHomeDoc Ear Test Comparison Report:
- Number of Experts: Not explicitly stated. The text mentions "the physician subjective assessment was positive," implying at least one physician.
- Qualifications of Experts: Mentioned as "physician," but no specific details on experience or specialty (e.g., ENT, general practitioner) are provided.
- Type of Ground Truth: "Gold standard" (implicitly, in comparison to other otoscope images) and "physician subjective assessment."
4. Adjudication Method
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth from multiple experts for any of the performance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers with vs. without AI assistance is described. The usability study evaluates lay-user interaction, but not the comparative diagnostic effectiveness of humans aided by the MyHomeDoc device.
6. Standalone Performance Study (Algorithm Only)
The performance data presented primarily focuses on the standalone performance of the device's sensors (thermometer, pulse oximeter, stethoscope, otoscope) against established standards, predicate devices, or physical measurements. For example, the thermometer's accuracy against a black body, SpO2 against a simulator or hypoxia protocol, and otoscope image clarity. This aligns with the "algorithm only" aspect for each specific measurement component. The overall device is a multi-sensor device, where each sensor's performance is independently evaluated.
7. Type of Ground Truth Used
- Thermometer (Performance & Accuracy): Black body (physical standard) and comparison to a legally marketed predicate device (Brown NTF3000).
- Pulse Oximeter (SpO2, Pulse Rate, Hypoxia): Simulator values, established physiological conditions (hypoxia protocol), and performance within specified ranges (30-250 BPM).
- Stethoscope: Comparison to a legally marketed predicate stethoscope (Littman).
- Otoscope (Images): "Gold standard" (implicitly, other high-quality otoscope images) and "physician subjective assessment" (expert opinion on clarity and identification of landmarks).
- Biocompatibility, Cleaning, Packaging, Electrical Safety, EMC: Compliance with international standards (ISO, IEC).
- Software Validation: Compliance with FDA guidance.
- Usability Testing: Observational data, knowledge task data, and interview data from lay users against the criterion of "no serious use errors or problems."
8. Sample Size for the Training Set
The document does not provide information about a training set or its sample size. This is a 510(k) submission for a device that primarily measures and transmits data, not a device with a complex machine learning algorithm that requires a separate training set for development. The "software" validation mentioned refers to the general software engineering practices rather than AI/ML model training.
9. How Ground Truth for the Training Set Was Established
As no training set is described for a complex AI/ML algorithm, this question is not applicable based on the provided text. The device's functionality leans more towards traditional instrumentation and data acquisition rather than advanced AI-driven diagnostics requiring extensive training data.
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