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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.

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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.

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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

• Indications for Use: "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." (Similar to predicate's broader use with ECG, EKG, SpO2, invasive BP monitoring devices)
• Anatomical sites: "Attached to electrodes placed at standard specified locations on chest wall or extremities." (Similar to predicate's "Attached to electrodes placed at standard specified locations on chest wall")
• Patient end termination: Clip, Snap (Same as predicate)
• Leadwire material: Polyvinyl chloride (PVC) (Similar to predicate's Shielded & Unshielded Copper with PVC or TPU Jacket)
• Sterile: Non sterile (Same as predicate) |

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.

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Blood Pressure Cuffs, include reusable and disposable, are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to determine blood parameters on neonate, pediatric and adult patients.

The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve. Some types are disposable without a bladder; some are reusable with a bladder or without a bladder. There is a single-tube or twin-tube connected to the bladder and the NIBP measurement device for inflating and deflating. It is available in various sizes for different arm range. It is provided non-sterile and each cuff. It is used in conjunction with NIBP Monitor System.

The provided text describes a 510(k) submission for a blood pressure cuff and references some testing, but does not contain the detailed study information typically required to directly answer all parts of your request.

Specifically, it lacks:

• Explicit "acceptance criteria" for performance that are separate from the testing standards.
• "Reported device performance" in terms of specific metrics like accuracy, bias, or precision of blood pressure measurement.
• Details about a "test set" in the context of AI/algorithm performance (which is not applicable here as this is a physical device).
• Information on "experts" or "ground truth" establishment, as this is a physical measurement device, not an image analysis or diagnostic algorithm.
• Any mention of "multi reader multi case (MRMC) comparative effectiveness study" or "standalone (algorithm only)" performance, as these are related to AI/software.
• Sample sizes for training sets (again, not applicable to this type of device).

The document focuses on substantial equivalence to predicate devices and adherence to recognized standards for physical devices.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with specific performance metrics (e.g., mean difference in mmHg). Instead, it states that the device was tested per AAMI SP10:2002+A1:2003+A2:2006. For blood pressure cuffs, AAMI SP10 is the recognized standard for performance requirements and testing. Compliance with this standard implies that the device meets the performance specifications outlined within it (e.g., accuracy, pressure stability, deflation rates, etc.).

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

Not applicable in the context of an AI/algorithm test set. For a physical blood pressure cuff, testing typically involves a number of samples of the cuff itself and a number of human subjects for clinical validation studies if required, but these details are not provided in this summary. The summary only states "The device was tested per... AAMI SP10." The data provenance is not mentioned.

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

Not applicable. This is a physical device intended for measurement, not an AI/algorithm requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable to this type of device or study described.

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 physical device, not an AI system assisting human readers.

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

Not applicable. This is a physical blood pressure cuff, not an algorithm.

7. The type of ground truth used

For a blood pressure cuff, "ground truth" for blood pressure accuracy is typically established by comparing the device's readings against a reference standard method (e.g., intra-arterial measurement, auscultatory method by trained observers with mercury sphygmomanometer) as specified by standards like AAMI SP10. The document does not specify the exact method used for establishing the ground truth beyond stating compliance with AAMI SP10.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The APK SpO2 Pulse Oximeter Sensor (Resuable) is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment, which are intended for adult or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.

The APK SpO2 Pulse Oximeter sensor (Disposable) is intended for single use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are adults or pediatric patients (more than 5kg) in hospital-type facilities, and home environments.

The applicant sensor APK SpO2 Pulse Oximeter Sensor (Reusable and Disposable) measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode. The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb]. Those sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value. The device is not software-driven. The applicant sensors are not for implant. Those sensors are not sterile and do not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological product.

Here's an analysis of the provided text regarding the acceptance criteria and study for the APK SpO2 Pulse Oximeter Sensor:

Unfortunately, the provided document is a 510(k) summary for a pulse oximeter sensor, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a comprehensive study report with all the requested information for a novel AI/software medical device.

Key Missing Information for AI/Software Devices:

• Quantitative Performance Metrics (Acceptance Criteria): The document states "All the information about the device performance were provided," but it does not list specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy mean absolute error (RMSE), etc.) or the device's reported performance against such criteria. The focus is on demonstrating equivalence to the predicate, not on setting and meeting new performance thresholds.
• Sample Size and Data Provenance for Test Set: While a "Clinical Test Report following ISO 9919:2005" is mentioned, the crucial details of the test set (number of cases, data origin, retrospective/prospective) are absent in the summary. ISO 9919:2005 outlines requirements for pulse oximeters, but the specifics of this particular study are not elaborated.
• Ground Truth Establishment, Experts, and Adjudication: These details are completely omitted. For a pulse oximeter, "ground truth" for SpO2 is typically established through co-oximetry, not human expert consensus like in image-based AI.
• MRMC Study and AI-Assisted Performance: This is not applicable as the device is a hardware sensor, not an AI or software device. The document explicitly states, "The device is not software-driven."
• Standalone Performance: While a clinical test report is mentioned, it's not described as a "standalone" performance evaluation in the context of an AI algorithm, but rather a performance test of a physical sensor.
• Training Set Details: As the device is not software/AI-driven, there is no "training set" in the context of machine learning. The device relies on a "validated calibration table."

Analysis Based Only on Provided Information:

Given the nature of the device (a physical pulse oximeter sensor) and the document (510(k) summary for substantial equivalence), the requested information pertaining to AI/software device evaluation is largely absent or not directly applicable.

Here's what can be extracted and inferred from the text, with an emphasis on what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified in the summary.
• Data Provenance: Not specified. The document indicates a "Clinical Test Report following ISO 9919:2005" was completed, which typically involves human subject testing, but details like location or whether it was retrospective/prospective are not provided.

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

• Number of Experts: Not applicable. For pulse oximetry, "ground truth" (reference SpO2) is typically established using a laboratory co-oximeter on arterial blood samples from human subjects undergoing controlled desaturation, not expert interpretation of outputs.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Ground truth for pulse oximetry is instrumental (co-oximetry) rather than based on expert consensus requiring adjudication.

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

• Was a MRMC study done? No.
• Effect size of human readers improval with AI vs. without AI assistance: Not applicable, as this is a hardware sensor, not an AI or software device. The device is explicitly stated as "not software-driven."

6. Standalone Performance Study

• Was a standalone performance study done? A "Clinical Test Report following ISO 9919:2005" was performed, which evaluates the sensor's performance. However, this is not a "standalone (algorithm only without human-in-the-loop performance)" study in the context of an AI algorithm, as the device is not an AI algorithm. It's a performance test of the physical sensor.

7. Type of Ground Truth Used

• Type of Ground Truth: Most likely co-oximetry (measurement of arterial blood gas samples by a laboratory co-oximeter) as per standard pulse oximetry testing guidelines (e.g., ISO 9919). This is inferred, not explicitly stated beyond "Clinical Test Report following ISO 9919:2005."

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. The device is not an AI/ML-driven device that requires a training set. It uses a "validated calibration table."

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

• How Ground Truth Was Established (Training Set): Not applicable, as there is no training set for this type of device. The "validated calibration table" would have been developed and validated through similar clinical testing methods using co-oximetry as ground truth.

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