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The Dolphin 2000 Oximetry Sensors are indicated for use in continuous monitoring of arterial oxygen saturation and pulse rate.

The Dolphin 2000 Oximetry Sensors are fully compatible disposable and re-usable replacement sensors for use with Nellcor pulse oximeter monitors. They represent a design change to the Dolphin 2000 BCI Compatible Sensors.

The disposable Dolphin 2000 Oximetry Sensors are constructed in a similar manner to predicate devices. The emitter and detector diodes are embedded in a laminate of tapes that is connected to the cable assembly. The sensors have an adhesive bandage backing that allows the sensor to be applied to the patient by wrapping it around a finger or toe (measurement site). Four sizes of disposable Dolphin 2000 Oximetry Sensors are available, which are indicated for use for adult, pediatric, infant and neonatal application sites. The Dolphin 2000 disposable sensors are provided non-sterile for single patient use.

The re-usable Dolphin 2000 Finger Clip Oximetry Sensor is an adult-sized clothespinstyle clip that is placed on the end of a finger. The finger clip sensor consists of the emitter and detector components mounted in opposing clip halves, maintained in mild compression by a spring hinge. The molded outer components house the optoelectric components within contoured pads that maintain contact with the patient's finger. Clear windows within these pads permit the optical energy to pass through the finger for the measurements. The Dolphin 2000 re-usable sensors are provided non-sterile.

The Dolphin 2000 Oximetry Sensors were validated in clinical testing to demonstrate their accuracy in measuring arterial oxygen saturation (SpO2).

1. Table of Acceptance Criteria and Reported Device Performance:

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The Fukuda Denshi model HG-500 Pulse Oximeter Module is indicated in those situations where it is desirable to perform continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin(SpO2) and pulse rate for adult, pediatric and neonatal patients who are under the care of a physician, within the confines of a health care facility. It is is not intended for home use

The Fukuda Denshi model HG-500 Pulse Oximeter (SpO2) module is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when used as part of the DS-5300 Patient Monitoring System (K964187). The HG-500 is a module not a stand-alone device. As a module it will only operate when installed into a DS-5300 Patient Monitoring System. The Fukuda Denshi model HG-500 Pulse Oximetry module will function with all Nellcor reusable and disposable oximeter sensors.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:

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

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. However, it does describe the general performance and safety goals for the device. The reported device performance is largely qualitative, asserting substantial equivalence to predicate devices and compliance with relevant standards.

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: The document mentions a "non-invasive controlled hypoxia study was performed by Nellcor Inc., to validate the HG-500 compliance to sensor accuracy specification when used with all eighteen models of Nellcor oxygen transducers." It does not specify the number of human participants or data points in this study.
• Data Provenance: The study was performed by "Nellcor Inc." No explicit country of origin is mentioned, but Nellcor is a US-based company. The study is described as a "controlled hypoxia study," which implies a prospective, interventional design where oxygen levels are intentionally varied.

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 information is not provided in the summary. For a hypoxia study, ground truth for arterial oxygen saturation is typically established using a co-oximeter (a device that directly measures different hemoglobin species from an arterial blood sample). However, the number and qualifications of individuals interpreting these results or validating the setup are not mentioned.

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

This information is not provided in the summary. Given the nature of a pulse oximeter accuracy study, adjudication of readings is less common than for, say, image interpretation. The comparison would likely be directly against a gold standard (e.g., co-oximetry).

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

• No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where human interpretation is a key component, often with AI assistance. The HG-500 is a direct measurement device (pulse oximeter) that provides numerical output (SpO2, pulse rate).

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

• Yes, in essence, standalone performance was assessed. The "non-invasive controlled hypoxia study" directly tested the HG-500's accuracy (an algorithm-driven device) against a gold standard in a simulated physiological environment. The module itself operates without direct human interpretive input into its primary SpO2 and pulse rate measurements. The submission focuses on the device's ability to measure accurately, not on how humans interpret those measurements.

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

• The ground truth for the accuracy assessment (hypoxia study) would have been arterial blood gas analysis using a co-oximeter. This is the accepted gold standard for determining actual arterial oxygen saturation. The summary mentions "sensor accuracy specification," which implicitly refers to this type of comparison.

8. The sample size for the training set

• This information is not provided and is generally not applicable in the way it is for AI/machine learning models that learn from vast datasets. The HG-500 utilizes algorithms licensed from Nellcor and identical to those in the Nellcor N-395, which are based on established physiological principles of light absorption by hemoglobin. While these algorithms were developed and refined using empirical data, the "training set" in the context of modern machine learning is not explicitly detailed here. It's more about validated engineering and physiological modeling.

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

• As above, details about an explicit "training set" for the algorithms are not provided. The algorithms are described as licensed from Nellcor and identical to existing, validated devices. The development of such algorithms historically involved extensive physiological studies where arterial blood gas measurements (co-oximetry) served as the gold standard for correlating light absorption patterns with actual oxygen saturation. This would have been done during the original development of pulse oximetry technology and specific manufacturer algorithms, rather than being a specific "training set" for this particular 510(k) submission.

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The N-395 Pulse Oximeter is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with neonatal, pediatric and adult patients during both no motion conditions and for patients who are well or poorly perfused, in hospital-type facilities and intra-hospital transport environments. For prescription use only.

The N-395 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The N-395 displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation. The N-395 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 100V to 240V) or alternatively by an integral sealed 6V rechargeable lead-acid battery. The N-395 is intended for prescription use with adult, pediatric and neonatal patients in hospital-type facilities and intrahospital transport environments. Audible and visual alarms for high/low saturation, pulse search are provided. The N-395 also includes adjustable alarm silence duration and other configurable power-on settings. The N-395 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The N-395 Pulse Oximeter has visual indicators for pulse search, motion, power mode (i.e. battery or AC) and alarm silence in addition to alarm features. In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. A convenient carrying handle is incorporated into the case. There is also a serial port (EIA-232 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. There is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable. The N-395 Pulse Oximeter measures functional oxygen saturation by calculating the light absorption of tissue, bone and blood in the sampling light beam path during the pulsatile cycle. Red and infrared LED's are utilized as light sources. A photodiode acting as a photodetector senses the signal strengths of the two wavelengths of light, which vary inversely with the amount of light transmitted through the tissue. The N-395 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide real time values of SpO2, Pulse Rate and Pulse Amplitude. The N-395 uses a similar SpO2 and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K955642, In addition, the N-395 possesses motion-filtering software that reduces the effects of patient/sensor motion, enabling the N-395 to read through motion artifact to provide valid SpO2 and Pulse Rate readings for many types of motion. Also included is an alam management software technique, known as SatSeconds which allows the caregiver to set the N-395 to accept desaturations below a specified threshold without alarming if those desaturations are of short duration or small magnitude. This submission requests clearance for a labeling modification to the original N-395, cleared under K991823, to extend Motion Performance Claims to three additional oximetry sensors, as follows: N-395 Motion Performance Device Claims: The N-395 features OXISMART®XL advanced digital signal processing which 1. enables the N-395 to read through motion artifact to deliver accurate saturation and pulse rate values. The N-395 reads through challenging motion conditions giving valid SpO2 and 2. Pulse Rate readings for many types of motion.

The provided document is a 510(k) summary for a pulse oximeter, primarily focusing on extending motion performance claims to additional sensors. While it describes the device and its intended use, it does not contain a detailed study with acceptance criteria and device performance results in the format requested.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, number of experts, adjudication methods, or type of ground truth used for a test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with/without AI assistance.
• Ground truth details (expert consensus, pathology, outcome data) for the training set or its establishment.
• Sample size for the training set.

However, based on the information provided, we can infer some aspects related to the device's claims and the general nature of its verification.

Inferred Information from the Document:

1. Acceptance Criteria and Reported Device Performance (Inferred from Motion Performance Claims):

   Acceptance Criterion (Inferred from Note 2)	Reported Device Performance (Inferred from Note 2)
   20% improvement in motion performance compared to the N-3000.	The N-395 produces a 20% improvement in motion performance compared to the N-3000 under "challenging motion" conditions.
   Ability to read through motion artifact to deliver accurate saturation and pulse rate values.	The N-395 enables reading through motion artifact to deliver accurate saturation and pulse rate values.
   Ability to read through challenging motion conditions, giving valid SpO2 and Pulse Rate readings.	The N-395 reads through challenging motion conditions, giving valid SpO2 and Pulse Rate readings for many types of motion.
   "Challenging motion" defined as causing the N-3000 to be in Pulse Search at least 40% of the time.	Tested under conditions where the predicate device (N-3000) would be in Pulse Search at least 40% of the time.

2. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Adult and Neonatal patients" for verification of motion performance claims for specific sensors, but no sample size or specific data provenance (country, retrospective/prospective) is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a pulse oximeter, the ground truth for oxygen saturation would typically come from an invasive arterial blood gas analyzer, not expert consensus on images. The document does not describe such a ground truth establishment process.

4. Adjudication method for the test set: Not applicable based on the information provided, as the ground truth is not established by multiple human experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for a pulse oximeter's primary performance claims. The comparison is between devices (N-395 vs. N-3000), not human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. A pulse oximeter's performance, especially its algorithm for reading through motion, is assessed as a standalone device function. The claims refer to the N-395's ability to "read through motion artifact" and "deliver accurate saturation and pulse rate values" which is a device-only performance evaluation.

7. The type of ground truth used: Not explicitly stated, but for pulse oximeters, the gold standard for oxygen saturation (SaO2) in clinical studies is typically obtained via arterial blood gas analysis, against which the SpO2 readings are compared. The document does not specify how "accurate saturation and pulse rate values" were determined for the performance claims.

8. The sample size for the training set: Not applicable and not mentioned. Pulse oximeters typically use a fixed algorithm derived from physiological principles and extensive sensor calibration, rather than a machine learning model that requires a "training set" in the conventional sense. The N-395 uses a "similar SpO2 and Pulse Rate software algorithm" to its predicate device, N-3000, and includes "motion-filtering software".

9. How the ground truth for the training set was established: Not applicable, as there's no mention of a training set or its ground truth in the context of machine learning.

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