Search Results

The SNAP Model 7™ device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.

The SNAP Model 7™ testing system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.

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

The SNAP Model 7™ system consists of several components, many of them essentially unchanged from the predicate devices. The major components of the system are the Model 7 Data Recorder, which is an updated design modification to the Model 6 predicate device. Other major elements of the system are the DLL (Dynamic Link Library) and GUI (Graphical User Interface) software which run on a PC in the physician's office, and the data analysis software located on computers at the SNAP laboratories central location. The DLL contains low-level routines for setup, control and data transfer, whereas the GUI is a high-level program which provides the interface between the user (doctor's office) and the DLL.

The SNAP Model 7™ Data Recorder is a small DC powered device designed to be simple and easy to use by a patient. It is self-contained, with integrated microcontroller and LCD display and all necessary interface electronics to perform all system recording functions. It does not require connection to a host computer in order to perform the recording functions. The data recorder consists of the physical hardware and firmware that interfaces to the patient to collect the physiological data. The recorder has sensors to collect sound, pulse oximetry, respiration effort (belt), and body position. The information is digitized and stored on a removable solid state memory card. The data on the removable data card is accessed through a USB port on the device, connecting to a PC running the DLL software.

The DLL software provides the interface for all communication between the recorder and the computer in the doctor's office. This DLL handles the low-level USB communications as well as parsing and storing intermediate files on the connecting computer. The DLL also interacts with a higher-level GUI client application. The GUI calls DLL functions to interact with the data recorder. The GUI also interacts through the Internet with the central website to transfer the patient data, and provides various data entry functions.

The data analysis software is essentially unchanged from that used with both predicate devices.

This 510(k) summary (K080321) for the SNAP Model 7™ device focuses on establishing substantial equivalence to predicate devices and describes the device's design, intended use, and safety features. It does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity for apnea/snoring detection).

The document primarily states that the SNAP Model 7™ is an evolutionary design modification to earlier versions (SNAP Model 5™ and SNAP Model 6™) and uses essentially the same core data analysis software as its predecessors. The "Performance Testing" row in the Substantial Equivalence Comparison Chart states "Extensive testing, as summarized in other sections of this document," but these other sections are not provided in the given input. Therefore, I cannot extract specific performance metrics, sample sizes, or details about ground truth establishment for a diagnostic accuracy study.

However, based on the provided text, I can infer some general "acceptance criteria" related to functionality, safety, and equivalence, and how the device is claimed to meet them.

Here's an attempt to structure the information based on your request, highlighting what's present and what's missing from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As the provided document focuses on substantial equivalence rather than a detailed performance study with quantitative diagnostic metrics, the "acceptance criteria" are implied by the claims of equivalence and compliance with standards.

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

• Test Set Sample Size: Not specified in the provided document. No clinical performance study data is included.
• Data Provenance: Not specified. There is no mention of the country of origin of any data, nor whether it was retrospective or prospective.

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

• Number of Experts: Not specified. No clinical performance study is detailed, thus no information on ground truth establishment by experts is present.
• Qualifications of Experts: Not specified.

4. Adjudication Method (for the test set)

• Adjudication Method: Not specified. Since no clinical performance study is detailed, no adjudication method is mentioned.

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

• MRMC Study: No. The document does not describe an MRMC comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is a "Snoring and Apnea Recording and Analysis Device," implying it provides data for clinicians rather than acting as an AI assistant to human readers in the sense of image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance)

• Standalone Performance Study: Not explicitly described with quantitative metrics. While the device performs analysis and generates reports based on its algorithm (the "data analysis software"), the document focuses on the hardware's equivalence and safety, stating the software itself is unchanged from predicate devices. There are no standalone performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard for apnea/snoring events) provided for the algorithm's output in this document. The "analysis is performed and reports are generated at the SNAP laboratories central site," which sounds like a standalone algorithmic analysis, but its performance is not detailed here.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. Without a detailed performance study, the type of ground truth (e.g., expert consensus, pathology, polysomnography, outcomes data) used for validating the device's diagnostic capabilities is not mentioned.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. The document states that the "data analysis software is essentially unchanged from that used with both predicate devices." This implies that the software's underlying algorithms and any "training" it might have undergone would have happened prior to the predicate devices or at least were not re-evaluated for a new training set specific to the Model 7. There is no mention of a newly trained algorithm or a training set for the Model 7.

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

• Training Set Ground Truth: Not applicable/Not specified. As there is no mention of a specific training set or new training for the Model 7's algorithms, there is no information on how ground truth would have been established for it.

Ask a specific question about this device

Ask a specific question about this device

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.

Ask a specific question about this device

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).

Ask a specific question about this device

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

The Oxi-SNAP testing system is only intended for short term monitoring such as to record the oximetry level continuously during the night.

The "Oxi-SNAP" 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.

This notification is for a modification to the existing device, the "Snap Testing Device" the modified device is called the "Oxi-Snap" The modification involves the addition of the ability to record and analyze, (along with snoring sounds) the oxygen saturation level of the patient being monitored. An FDA cleared oximeter (Palco Model K943842) is connected to the currently used DAT tape 305, recorder, and the oxygen saturation is recorded while the patient is under test. Later, during the analysis phase, O2 SAT levels appear on the playback analysis screen, thereby allowing an additional criterion of apnea to be used.

The provided text [K971184](https://510k.innolitics.com/search/K971184) is a 510(k) summary for the "Oxi-Snap" device, which is a modification of an existing device ("Snap Testing Device") to include oxygen saturation level recording and analysis. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove the device meets those criteria in a typical stand-alone performance study format.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring. Instead, it relies on demonstrating that the modified device ("Oxi-Snap") is as safe and effective as its predicate devices, primarily the "Snap Testing Device" (K944524), and incorporates an FDA-cleared oximeter (Palco Model 305, K943842).

The "Performance Testing" section in the Substantial Equivalence Chart for the "Oxi-SNAP" states "Summarized above," referring to the general conclusion of safety and effectiveness presented earlier. For the predicate "SNAP testing device," it refers to "Original submission," implying detailed performance data was provided in its initial filing.

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance metrics directly from this document. The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence and maintaining the safety and effectiveness of the predicate.

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

The document mentions "bench and user testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not mention using experts to establish ground truth for a test set. This type of study design for determining diagnostic accuracy with expert-derived ground truth is not described in this 510(k) submission, which focuses on substantial equivalence.

4. Adjudication Method for the Test Set

Since no expert-established ground truth study is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on the technical modification of the device and its claimed equivalence to existing devices. Its purpose is not to demonstrate improvement over human readers with or without AI assistance.

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

The "Oxi-Snap" system is described as an "analyser service center" where tapes are analyzed, implying a human-in-the-loop for interpreting the recorded data. However, the core of the submission is about the device's ability to record and present data, not a standalone AI algorithm producing diagnoses. The Palco Model 305 oximeter, which is incorporated, would have undergone standalone performance testing as a prerequisite for its own FDA clearance (K943842). The Oxi-Snap itself is an analysis system that presents data.

7. The Type of Ground Truth Used

The document does not explicitly describe a ground truth used for performance evaluation of "Oxi-Snap" similar to what would be found in a diagnostic accuracy study. The "effectiveness" is primarily assessed by its ability to record and provide additional information (oxygen saturation) in a manner comparable to its predicate and the incorporated cleared oximeter. Polysomnography (PSG) is often considered the gold standard for sleep apnea diagnosis, and the document states the Oxi-SNAP system is "not intended as a substitute for full polysomnography." This suggests that while it screens for apnea, its "ground truth" for screening performance is likely benchmarked against clinical utility as a screening tool, not necessarily against a definitive PSG diagnosis within this specific filing.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is not an AI/machine learning device in the contemporary sense, but rather a modification to a recording and analysis system.

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

Since there is no mention of a training set, no information is provided on how its ground truth would have been established.

Ask a specific question about this device