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The BC1® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

The BCI model WW1030 is a handheld pulse oximeter intended for continuous monitoring. The WW1030 monitors and displays patient functional oxygen saturation %SpO2, pulse rate, perfusion index, and pulse signal strength information. It is equipped with audible and visual patient alarms. The user interface includes a blue LED display, speaker, a 5-button keypad control, and an ON/OFF button. The WW1030 comes with disposable batteries, a reusable pulse oximetry sensor with extension cable and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, nurse call cables, universal mounting bracket and protective glove. The WW1030 is compatible with BCI oximetry sensors, Nellcor DS100A oximetry sensor and extension cables.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the SpO2 accuracy tests. However, it implicitly suggests that the device passed these tests. For pulse oximeters, the FDA typically requires accuracy within a certain range (e.g., ±2-3% SpO2) compared to a co-oximeter. Given that the device received 510(k) clearance, it implies that the device met the established accuracy requirements, even if the specific numerical criteria for passing are not detailed in this summary.

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

The exact sample sizes for the "Desat 37, Desat 38, and Desat 39" studies are not explicitly stated in the provided text.
The data provenance is clinical testing, presumably conducted in a controlled environment as indicated by "desaturation clinical studies." The country of origin is not specified but it relates to FDA submission, so likely US or through an international standard applicable to FDA. The studies appear to be prospective as they were designed specifically to determine the SpO2 accuracy of the device.

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

The text states that the SpO2 accuracy was determined "as determined by the reference CO-oximeter." This implies that the ground truth for oxygen saturation levels was established by a co-oximeter, which is a laboratory device, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth in this context is not applicable as scientific instrumentation provided the reference.

4. Adjudication Method for the Test Set

Since the ground truth was established by a reference co-oximeter, there was no human adjudication method required for the primary physiological parameter (SpO2). The co-oximeter directly provided the reference values for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is a primary component. The device in question is a pulse oximeter, and its performance is evaluated against a gold standard (co-oximeter), not against human readers. Therefore, there's no mention of how much human readers improve with or without AI assistance.

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

Yes, the performance studies described are essentially standalone (algorithm only) performance assessments. The device (specifically, its internal Digital Micro Power OEM oximeter board) was directly evaluated against a reference co-oximeter to determine its SpO2 accuracy. The accuracy determined was of the device itself, providing objective measurements, not an assessment of human-in-the-loop performance.

7. The Type of Ground Truth Used

The type of ground truth used for SpO2 accuracy was established by a reference CO-oximeter. This is akin to a "laboratory gold standard" or "scientific instrumentation gold standard" rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is common for devices that are not "AI" in the modern sense of machine learning algorithms requiring explicit training data. The BCI model WW1030 pulse oximeter relies on established physiological principles and signal processing, and while its internal algorithms are likely sophisticated, they are not described as being "trained" in the typical machine learning paradigm. The studies aim to validate the device's accuracy after its design and development are complete.

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

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. The WW1021 may be used in the hospital or clinical environment.

The BCI® WW1021 is intended for use with any device which supports the BCI® Communication Protocol (BCICP), if the device is connected to the PC through the USB port. It can be used to configure the device; view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data; view event logs and self diagnostic information from the device and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It cannot be used to configure or download data to the PC from devices that are wirelessly connected. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians and other qualified health care providers. BCI® WW1021 may be used in the hospital or clinical environment. Communication between the device and BCI® WW1021 is possible using any standard USB cable.

Here's an analysis of the acceptance criteria and the study conducted for the BCI® WW1021 PC Application Software, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

• Test Set Sample Size: 4 subjects (one subject was studied twice, making it 5 "sessions" of data for analysis).
• Data Provenance: Retrospective – the study re-analyzed clinical data previously gathered for the investigation of the BCI® 1621 Software. The country of origin of the data is not specified.

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

• The document states "comparison to clinician scoring of desaturation events." It does not specify the number of clinicians/experts, nor their specific qualifications (e.g., years of experience, specialty).

4. Adjudication method for the test set:

• The document implies that the ground truth was established by "clinician scoring," but it does not describe an adjudication method (e.g., 2+1, 3+1) if multiple clinicians were involved. It simply refers to "clinician scoring" as if it were a singular, definitive assessment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the performance of the software's desaturation detection algorithm against clinician scoring, not on human reader improvement with AI assistance.

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

• Yes, a standalone study was performed. The "Clinical Testing" section describes an investigation to determine the clinical accuracy and functionality of the BCI® WW1021 software's desaturation detection algorithm by comparing its output directly to clinician scoring. The reported false negative and false positive rates are for the algorithm's performance.

7. The type of ground truth used:

• Expert consensus (single clinician or unspecified number of clinicians) based on "clinician scoring of desaturation events." The definition of a desaturation event used by the BCI® WW1021 Software was also used by the clinicians for scoring.

8. The sample size for the training set:

• The document does not specify a sample size for a training set. The study described is a clinical validation with a test set. There is no mention of a separate training phase or an independent dataset used for training the algorithm. Given the nature of a "PC Application Software," it's possible the "algorithm" refers to predefined thresholds or rules rather than a machine learning model that requires a dedicated training set.

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

• This information is not provided. As noted above, a separate training set is not mentioned in the documentation provided.

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The BCI® model WW1000 handheld pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians, and home users. The intended patient population ranges from infant to adult. It can be used on patients with low perfusion. The WW1000 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

The BCI® model WW1000 handheld pulse oximeter is intended for spot-check applications. The WW1000 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a red LED display and an ON/OFF button. The WW1000 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective

The provided text describes the BCI® model WW1000 Pulse Oximeter, its intended use, and the performance testing conducted to support its substantial equivalence. However, it does not explicitly state specific, quantifiable acceptance criteria in the form of a table for device performance (e.g., accuracy +/- X% with Y% confidence). Instead, it refers to general performance expectations and the results of clinical desaturation studies.

Thus, I will synthesize the information provided to construct a response that best addresses your request, highlighting what is available and what is not.

Here's an analysis of the acceptance criteria and study information for the BCI® model WW1000 Pulse Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state a table of quantifiable acceptance criteria with specific thresholds for accuracy, precision, or other performance metrics. Instead, it broadly states that "Results of the three individual clinical desaturation trials indicate that the WW1000 pulse oximeter performs as intended and is safe and effective for use." and that "The Micro-power OEM board produced the same readings (within ±1 digit) in all three host devices" during comparison testing.

Without explicit acceptance criteria, it's impossible to create a direct comparison table. However, the document does imply that the device performance was deemed acceptable based on the clinical desaturation studies (Desat 24, 27, and 40) and comparison testing, which confirmed the expected functionality and consistency across different host devices.

Implied Acceptance Criterion (based on comparison testing):

• Deviation between Micro-power OEM board and host devices:

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The BCI® model WW1020 pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.

The BC10 model WW1020 pulse oximeter is intended for spot-check applications. The WW1020 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a blue LED display and an ON/OFF button. The WW1020 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective glove. The WW1020 is compatible with BCT® oximetry sensors, Nellcor DS100A oximetry sensor, and extension cables.

Here's a breakdown of the acceptance criteria and the study information for the BCI® Model WW1020 Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria for SpO2 accuracy that the device needed to meet. Instead, it refers to "Accuracy Testing (Section 11)" as a mitigation measure for "Inadequate Device Performance" and describes the purpose of the clinical studies. However, the standard expectation for pulse oximeter accuracy (often RMS difference) in such submissions for the 70-100% SpO2 range is typically around 2-3% or less. Without specific numerical acceptance criteria, we can only infer the performance based on the general description of the studies.

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

• Sample Size for Clinical Studies (Test Set): Not explicitly stated in terms of number of patients or readings. The document mentions "three separate desaturation clinical studies: Desat 37, Desat 38, and Desat 39."
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective clinical studies ("undergone three separate desaturation clinical studies").

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

Not explicitly stated. For pulse oximeter studies, ground truth for SpO2 is typically established by a reference instrument (CO-Oximeter) during induced hypoxemia in human subjects, not by human experts.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 is established by a reference instrument (CO-oximeter), not through expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is common for image-based diagnostic devices where multiple human readers interpret cases. For a pulse oximeter, the primary performance measure is the accuracy of the device's numerical readings against a reference standard.

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

Yes, the clinical studies (Desat 37, 38, 39) evaluated the standalone performance of the pulse oximeter board (Digital Micro Power OEM oximeter board (31402B2)), which is the core component of the BCI WW1020. The studies aimed to determine the SpO2 accuracy of the device itself against a reference standard.

7. The Type of Ground Truth Used

The ground truth used was reference CO-oximeter measurements ("reference CO-oximeter") for arterial oxygen saturation (SaO2), obtained from human subjects during induced desaturation.

8. The Sample Size for the Training Set

No training set information is provided in this document. Algorithms in pulse oximeters are typically designed based on physiological principles and calibrated using known signals, rather than being "trained" on a large, labeled dataset in the same way modern machine learning models are. The clinical studies described are for validation/testing the device's accuracy.

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

Not applicable, as no training set is described for this device in the provided text.

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The 3304 provides fast, reliable SpO2, pulse rate and pulse strength measurements. It may be used in the hospital or clinical environment, during emergency air or land transport and in the home. The oximeter will operate accurately over an ambient temperature range of 32 to 104°F (0 to 40°C). The oximeter works with all BCI oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The oximeter permits patient monitoring with adjustable alarms limits as well as visible and audible alarm signals.

The subject device is the same as the legally marketed predicate device BCl 3304 Autocorr M Digital Pulse Oximeter (K962156) with one minor change to the labeling that does not raise new questions of safety and efficacy. This pulse oximeter was originally cleared with the current algorithms. However, it was not clinically validated under motion conditions and no motion claims were made. The aim of this premarket submission is to obtain clearance for an additional motion claim.

The 3304 Autocorrille pulse oximeter is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top oximeter with a wall mount charger. The system features an SpO2 probe interface, display of patient data via an LED display (SpO2, Pulse Rate, Pulse Strength), system status LEDs (Probe, Lo Batt, Silence, Alarm, Artifiact, Search), and the function keypad area consisting of eight keys (O/I, ID/Clear, Up and Down Arrows, Alarm Select, Alarm Silence. Alarm Volume, Pulse Volume). The oximeter has a printer/pc port that is used for data communication, an optional analog output and an optional digital alarm adapter for a remote location.

This Special 510(k) covers the labeling modification of BCI® Autocorr™ 3304 Digital Pulse Oximeter that was cleared under 510(k) K962156. The modification involves revising the 3304 labeling to add pulse oximetry performance specifications with motion. Results from clinical evaluation are provided to support the labeling change. No significant device modifications have been made to the 3304. The labeling change does not affect the intended use or alter the fundamental scientific technology of the device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BCI® Autocorr™ 3304 Digital Pulse Oximeter:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 10 paid, adult, volunteer subjects.
• Data Provenance: The study was a descriptive, cross-sectional investigation conducted within a controlled clinical setting, comparing measured SpO2 values to a reference CO-oximeter. This is considered prospective data, specifically designed for this study. The country of origin is not explicitly stated, but based on the manufacturer's address (Waukesha, WI, USA) and the FDA submission, it can be inferred that the study was conducted in the USA.

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

There were no experts used to establish the ground truth in the traditional sense of medical image interpretation or clinical diagnosis. The ground truth for oxygen saturation (SaO2) was established by a CO-oximeter, which is a highly accurate laboratory device used to measure actual arterial oxygen saturation. This is a direct physical measurement, not an expert interpretation.

4. Adjudication Method for the Test Set

There was no adjudication method described for the test set regarding expert consensus. The study compared the device's SpO2 readings directly against the objective measurements from a CO-oximeter (reference condition).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on the device's standalone performance under motion, not on its impact on human reader performance.

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

Yes, a standalone performance study was done. The entire study evaluated the accuracy of the BCI® Autocorr™ 3304 Digital Pulse Oximeter's algorithm (which provides the SpO2 measurement) in a motion condition, directly comparing its output to a reference standard (CO-oximeter). There was no human interpretation or intervention in the measurement process itself, only the application and reading of the device.

7. The Type of Ground Truth Used

The type of ground truth used was objective measurement by a CO-oximeter (co-oximeter determined functional oxygen saturation, SaO2). This is a highly accurate and direct physiological measurement often considered the gold standard for arterial oxygen saturation.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set. The device (BCI® Autocorr™ 3304 Digital Pulse Oximeter) was already cleared with its current algorithms (K962156). The current submission is for an additional motion claim and involves clinical validation of the existing algorithms under motion conditions, not the development or retraining of new algorithms. Therefore, a "training set" in the context of machine learning model development is not applicable here.

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

As no training set (in the context of algorithm development for this submission) is mentioned, the method for establishing its ground truth is not applicable/not provided. The existing algorithms were presumably developed and validated prior to the original K962156 clearance, but details of that process are not included in this document.

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