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OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.

The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.

The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.

The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

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

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

• Expected data values/formats: Verifying that captured oximetry data matches the source.
• Report accuracy: Confirming that generated reports correctly reflect the stored data.
• System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
• Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

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

As no training set is mentioned or applicable to this type of software, this information is not provided.

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The intended use of the "Snap Model 5™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.

The "Snap Model 5™" testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.

The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.

CAUTION: US Federal law restricts this device to sale by or on the order of a physician. Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the "Snap Model 5TM" device.

This notification is for a modification to the existing device, the "Digi-Snap™" Testing Device. The modified device is called the "Snap Model 5™4" The modification involves the use of a personal computer with certain options installed instead of the specialized microcomputer and Zip drive system. The oximeter is connected to the unit along with the usual microphone/cannula apparatus and the oximeter sensor is slipped over the patient's finger in the usual manner. The patient turns on the unit, then goes to sleep. Apnea and snoring events are then recorded. After awakening, the patient returns the disk and the equipment to the analysis service center, where the disk is analyzed. If the patient's own personal computer was used, only a disk is returned to the analysis center for evaluation.

The provided text describes a 510(k) premarket notification for the "Snap Model 5TM" device, which is a modification of an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone performance study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring, nor does it present a table of such performance. Instead, it relies on demonstrating substantial equivalence to an existing predicate device ("Digi-Snap™ Testing Device," K984169).

The "Performance testing" section in the Substantial Equivalence Chart simply states "Summarized above," but no performance data or acceptance criteria are actually summarized above or elsewhere in the provided document. The conclusion states: "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device."

2. Sample Size for Test Set and Data Provenance

The document does not specify any sample size for a test set (e.g., number of patients or recordings used for evaluation). It mentions "user testing data" but provides no details on its composition or origin.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth or their qualifications. The evaluation appears to be based on the device's functional equivalence to a previously cleared device.

4. Adjudication Method for Test Set

The document does not describe any adjudication method, as it doesn't detail a study involving expert review or grading of cases.

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

No MRMC comparative effectiveness study is mentioned. The submission is focused on device modification and substantial equivalence, not on comparing reader performance with and without AI assistance.

6. Standalone Performance Study

A standalone performance study (algorithm only performance without human-in-the-loop) is not described. The submission focuses on the modified device's functionality and its equivalence to the predicate device, stating that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." However, no numerical results from such testing are provided.

7. Type of Ground Truth Used

Given the absence of a detailed performance study, the document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The implicit "ground truth" for the modified device's performance appears to be the established performance of the predicate device.

8. Sample Size for Training Set

The document does not mention a training set or its sample size. This is consistent with the nature of the submission, which is for a modification to an existing device rather than a de novo submission for a new AI algorithm requiring extensive training data.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, there is no information on how its ground truth would have been established.

Summary of what is indicated:

The submission for the "Snap Model 5TM" is a 510(k) for a modification to an already cleared device ("Digi-Snap™"). The core argument for clearance is substantial equivalence to the predicate device, focusing on changes in hardware (personal computer instead of specialized microcomputer, floppy disk instead of Zip drive) and updates to labeling and instructions. The performance claim is that the modified device is "as safe and effective as the predicate device," based on unspecified "bench and user testing data," but no quantitative performance metrics, test set details, or ground truth methodologies are provided in this document.

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The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required. The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested. CAUTION: US Federal law restricts this device to sale by or on the order of a physician, Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the "Digi-Snap™" device.

This notification is for a modification to the existing device, the "Oxi-Snap™" Testing Device. The modified device is called the "Digi-Snap. TM" The modification involves the use of a 100 MB "Zip" drive in place of the DAT tape recorder. This eliminates one A/D-D/A conversion because the snoring sounds are digitized at the first opportunity, in the unit at the patient's bedside.

The provided text does not contain any specific acceptance criteria or performance metrics for the "Digi-Snap TM" device. The submission is for a modification to an existing device, focusing on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed performance outcomes against predefined criteria.

The document primarily describes:

• Device Identification: The "Digi-Snap TM" device, its classification, and common name.
• Predicate Device: "Oxi-Snap TM" Testing Device (K971184).
• Intended Use: Screening patients for apnea and snoring, providing quantitative and qualitative analysis, short-term monitoring, not a substitute for full polysomnography.
• Description of Modification: Replacement of a DAT tape recorder with a 100 MB "Zip" drive for digital recording.
• Substantial Equivalence Chart: Compares characteristics of the modified device to the predicate device, highlighting changes in recording device, channels acquired, user equipment, and energy source.
• Conclusion: The device is deemed as safe and effective as the predicate device based on "bench and user testing data," achieving substantial equivalence.
• FDA Clearance Letter: Confirms substantial equivalence finding.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here's an attempt to answer based on the available information, explicitly stating when data is not provided:

Acceptance Criteria and Device Performance Study Information for "Digi-Snap TM"

The provided 510(k) submission for the "Digi-Snap TM" device focuses on demonstrating substantial equivalence to a predicate device ("Oxi-Snap TM," K971184) due to a modification (replacing a DAT tape recorder with a Zip drive). It emphasizes that the modified device is "as safe and effective" as the predicate based on "bench and user testing." However, no specific quantitative acceptance criteria or detailed performance results from a clinical study are provided in this document to directly populate the requested table or answer most detailed questions about device performance against such criteria.

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or corresponding reported device performance metrics are provided in the document. The submission states that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." This is a qualitative statement of equivalence rather than a report on specific performance metrics against defined criteria.

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

• Test Set Sample Size: Not provided. The document mentions "bench and user testing" but gives no details on the number of subjects or cases included in these tests.
• Data Provenance: Not specified, but given the context of US regulatory submission by a US company (Glenview, IL), it can be inferred that testing would likely have taken place in the US. The document does not specify if the data was retrospective or prospective.

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

Not provided. Details about how "user testing" was conducted, who assessed the results, or the qualifications of any involved experts are absent.

4. Adjudication Method for the Test Set

Not provided.

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

Not indicated. The document focuses on device modification and equivalence, without suggesting a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone Performance Study

The submission indicates "bench and user testing," but no specific standalone performance study report with detailed metrics (e.g., sensitivity, specificity for apnea detection) is included in the provided text. The focus is on demonstrating that the modified component (Zip drive for recording) does not compromise the overall safety and effectiveness established by the predicate device.

7. Type of Ground Truth Used

Not explicitly stated. Given the device's purpose (screening for apnea and snoring), the "user testing" likely involved comparisons to established methods of diagnosing these conditions (e.g., polysomnography or other clinical assessments), but this is not detailed in the document.

8. Sample Size for the Training Set

Not applicable. This device is a recording and analysis system, not an AI/machine learning algorithm that typically requires a training set. The modification described is a hardware change (recording medium).

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

Not applicable (as it's not an AI/ML device with a training set).

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This device is viewed as a component of a system. The APEX Oximeter adds modularity to Marquette's CD Telemetry System product line. The Apex Oximeter is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. This device is intended to be used by personnel trained in the use of the equipment. It is intended to be used within the hospital/facility environment.

This device is viewed as a component of a system. The APEX OXIMETER adds modularity to Marquette's telemetry product line. It is intended for portable patient monitoring of an ambulating patient's oxygen saturation and pulse rate. The oxygen saturation calculations for the Apex Oximeter is performed identically to the method used in the Nonin 8500 series hand held pulse oximeter. The oximeter generates serial communications with a custom protocol to communicate with the CD Telemetry System.

Here's a breakdown of the acceptance criteria and study information for the KC180299 APEX OXIMETER, based on the provided text:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. As such, it does not contain the granular level of detail typically found in a comprehensive clinical or performance study. The information below is extracted directly from the text; many common elements of a detailed study will be marked as "Not provided" because the document does not include them.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on substantial equivalence to predicate devices (Nonin Model 8500 and 9500 pulse oximeters) and general statements about meeting requirements. The "reported device performance" is a high-level conclusion rather than specific metrics.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not provided. The document mentions "Various reliability and software testing" but does not specify sample sizes for these tests or for any patient data.
   • Data Provenance: Not provided. Country of origin or whether the data was retrospective or prospective is not mentioned.

2. 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)

   • Not provided. The document does not describe the establishment of a ground truth in the context of expert review for a test set. The primary method of demonstrating performance is substantial equivalence to predicate devices.

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

   • Not applicable/Not provided. No expert-based adjudication method is described.

4. 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. This is a pulse oximeter, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • Yes, implicitly. The "various reliability and software testing" would assess the device's (algorithm's) performance in a standalone context to ensure it met its functional requirements and performed identically to the predicate device in its oxygen saturation calculations. The device itself is a standalone measurement tool, although it communicates with a telemetry system.

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

   • The "ground truth" for the oxygen saturation calculation is based on the identical method used by the predicate device, the Nonin 8500 series pulse oximeter. For other functional aspects (reliability, software performance), the ground truth would be defined by the technical specifications and requirements the device was designed to meet. No independent expert consensus, pathology, or outcomes data is explicitly mentioned as being used to establish ground truth for this device's performance validation beyond its equivalence to the predicate.

7. The sample size for the training set

   • Not applicable/Not provided. This device is a pulse oximeter, and its core function is based on established biophysical principles and algorithms, not machine learning that requires a "training set" in the modern sense of AI/ML development.

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

   • Not applicable/Not provided, as there is no "training set" in the context of AI/ML. The device's foundational "ground truth" for oxygen saturation measurement is essentially derived from the established and validated performance of its predicate devices, whose methods it duplicates.

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