Search Results

The Ultraviolet Phototherapy Device is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI).

Ultraviolet Phototherapy Device

This FDA 510(k) clearance letter is for a physical device, an Ultraviolet Phototherapy Device, and not for an AI/software as a medical device (SaMD).

Therefore, the document does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Any study proving AI model performance.
• Data provenance, sample sizes, expert qualifications, or adjudication methods for an AI test set.
• Multi-Reader Multi-Case (MRMC) studies for AI.
• Standalone AI performance.
• Training set details for an AI model.

The clearance is based on substantial equivalence to existing predicate devices, which primarily relies on technological characteristics, indications for use, and safety/performance data typical for physical medical devices (e.g., electrical safety, EMC, photobiological safety, performance of the UV light output).

In summary, none of the requested information regarding acceptance criteria and studies for an AI/SaMD can be extracted from this document, as it pertains to a traditional physical medical device.

Ask a specific question about this device

The devices are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive oximeter equipment. The sensors are reusable depending on models, and are intended for adult, pediatric or infant, depending on models. They shall be used in healthcare settings.

The proposed device, SpO2 Sensors are accessories to the oximeters, which are intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in noninvasive U.S. legally marketed oximeters or patient monitors. The sensors are reusable or disposable depending on models, and are intended for adult, pediatric or infant, depending on models.

The proposed devices measure, along with the corresponding oximeters, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).

The patient contact components include cable and sensor. The contact level is surface device and contact duration is limited contact (less than 24h).

This document describes the validation of SpO2 Sensors. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." While the specific number of volunteers is not explicitly stated in this summary, it is implied that a sufficient number participated to "validate the accuracy."
• Data Provenance: The data was obtained from clinical hypoxia tests conducted in human adult volunteers. The document does not specify the country of origin, but the submitting company is based in China. The study appears to be prospective as it involves active testing on human subjects.

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

The document does not provide details on the number or qualifications of experts involved in establishing the ground truth. It states that "arterial oxygen saturation (SaO2) as determined by co-oximetry" was used as the ground truth. This suggests that the ground truth was established through a gold standard measurement technique rather than human expert interpretation of images or other data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by co-oximetry, which is a direct measurement, not an interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This study is for an SpO2 sensor, not an AI or imaging device where human readers would interpret results. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only) Performance

Yes, in a sense. The primary performance evaluation (SpO2 and Pulse Accuracy) is an assessment of the device's ability to measure these parameters against a known ground truth (arterial oxygen saturation by co-oximetry). While the sensor is an accessory to an oximeter, its accuracy is evaluated inherently as a standalone measurement component interacting with the human body to produce data.

7. Type of Ground Truth Used

The ground truth used was outcomes data/physiological measurement. Specifically, "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is a laboratory method considered a gold standard for measuring oxygen saturation in arterial blood.

8. Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (SpO2 sensor), not an AI algorithm that requires a separate training set. The device's underlying principles are based on established physics (red and infrared light absorption of hemoglobin), not machine learning from a large dataset.

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

Not applicable, as there is no training set mentioned or implied for this type of medical device.

Ask a specific question about this device

The ECG Disposable Lead Wires are intended to be used with ECG. The lead wire is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.

The ECG Disposable Lead Wires are comprised of patient end termination, leadwire and patient leadwire connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The lead wire connector plugs into one end of the external trunk cable which are plug into an ECG monitor.

The provided document is a 510(k) premarket notification for an ECG Disposable Lead Wires device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy testing.

Therefore, many of the requested details regarding acceptance criteria, study design for proving performance (e.g., sample size for test sets, expert involvement, MRMC studies, ground truth establishment), and specific performance metrics for an AI/ML device are not applicable to this type of submission.

The document states:

• "No clinical study is included in this submission." This explicitly means there isn't a study designed to prove clinical performance or diagnostic accuracy in the way described in your request.
• The "Non-Clinical Test Conclusion" section lists compliance with various electrical and biocompatibility standards, not performance against clinical acceptance criteria.
• The "Substantially Equivalent (SE) Comparison" table details similarities in product codes, regulations, classification, indications for use, anatomical sites, physical components, and compliance with general safety and performance standards for medical electrical equipment. It does not provide accuracy metrics or clinical performance data.

Given this, I can only extract information relevant to the device's characteristics and the basis for its marketing clearance, which is substantial equivalence to an existing legally marketed device, not a new performance claim based on a dedicated clinical study or AI algorithm validation.

Here's a breakdown based on the provided text, highlighting what is not available from this document:

Acceptance Criteria and Device Performance (as understood from a 510(k) for a conventional medical device)

The acceptance criteria for this device are largely implied by its substantial equivalence to the predicate device and compliance with recognized standards. The "performance" is demonstrated through meeting these standards and having similar characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Information NOT available from the document (as it pertains to AI/ML or diagnostic performance studies):

2. Sample size used for the test set and the data provenance: Not applicable. No test set for AI/ML performance is mentioned.
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 establishment for AI/ML performance is mentioned.
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.
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.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission for ECG Disposable Lead Wires is for a conventional medical device, not an AI/ML-driven diagnostic tool. Therefore, the "study" described is a series of non-clinical bench tests and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices, rather than a clinical trial proving specific diagnostic accuracy or AI performance metrics.

Ask a specific question about this device