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The DYMEDIX Incorporated Reusable Airflow/Snore Scnsor is used with existing recording devices in support of diagnostic recording of nasal, oral airflow and breath sounds (snore). The sensors are used with patients who require a sleep study.

During evaluation of sleep disorders and other clinical applications for airflow recording, an airflow sensor is applied to the patient, typically under the nasal passages, to support recording of airflow signals. During the evaluation of sleep disorders and other clinical applications for breath sounds (snore) recording, a snore sensor is applied to the patient to support recording of snore signals. These recorded signals are analyzed by a qualified physician, clinician or licensed medical practitioner in support of diagnosis of sleep and airflow disorders.

The Reusable Airflow/Snore Sensor is a pyroelectricity (pyro) and piezoelectric (piezo) sensor. The temperature difference between patient exhaled air and ambient air generates a small voltage signal, which can be recorded as airflow by diagnostic recording equipment. The vibration from breath sounds (snoring) produce a small voltage signal, which can be recorded as snoring by diagnostic recording equipment. The user's recording device displays the resulting signal for interpretation by a trained physician or clinician.

Polarized Polyvinylidene Fluoride Film (PVDF) is the temperature sensing matcrial. The polarized PVDF material has pyro (temperature) signal generation capability. Polarized PVDF material self generates a small electrical charge in the presence of temperature. The predicate Disposable Airflow/Snore Sensor (K990321) applied the same PVDF Film airflow and breath sound (snore) sensing technology.

The DYMEDIX Airflow/Snore Sensor consists of a temperature sensitive material (PVDF) molded into a reusable housing. The molding material is PVC. This same PVC material is used in the lead wires from the sensor. This same PVC material is used with the predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires, reference K990321.

The DYMEDIX Reusable Airflow/Snore Sensor is intended for diagnostic recording of nasal, oral airflow, and breathing sounds (snore) in patients requiring a sleep study, used in conjunction with existing recording devices.

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

   The provided document does not explicitly define acceptance criteria as quantitative thresholds for performance metrics. Instead, it relies on demonstrating "equivalent performance" to a predicate device through laboratory data.

   Performance Metric/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
   Airflow Sensing Capability	Equivalent to predicate (DYMEDIX Gemini Sensor K990321)	Demonstrated through laboratory data using polarized PVDF film
   Snore Sensing Capability	Equivalent to predicate (DYMEDIX Gemini Sensor K990321)	Demonstrated through laboratory data using polarized PVDF film
   Material (temperature sensing)	Polarized Polyvinylidene Fluoride Film (PVDF)	Uses Polarized Polyvinylidene Fluoride Film (PVDF)
   Material (housing/lead wires)	PVC material used in predicate (K990321)	Uses PVC material, same as predicate DYMEDIX Disposable Airflow/Snore Sensor lead wires
   Biosafety/Biocompatibility	Not explicitly stated, but implied by "standards certifications"	"standards certifications" support safety

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

   The document states that "Representative laboratory data are presented to demonstrate equivalent performance." However, it does not specify the sample size used for this testing or the provenance of the data (e.g., number of subjects, country of origin, retrospective or prospective nature).

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 document. The study relies on laboratory data for "equivalent performance" rather than expert clinical assessment as ground truth for a test set.

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

   This information is not provided in the document. The study focuses on laboratory data demonstrating equivalence, not human-in-the-loop diagnostic accuracy with adjudication.

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 performed. This device is a sensor, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

   The document describes the device as a "sensor" that generates voltage signals for interpretation by a "trained physician or clinician." It does not mention an algorithm or standalone performance without human interpretation. The study focused on demonstrating the sensor's ability to produce signals equivalent to a predicate device in a laboratory setting.

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

   The "ground truth" implicitly used for this device is the performance of the predicate device, the DYMEDIX Gemini Sensor (Disposable) (K990321), and the Pro-Tech Services Inc. Cannula-Style Thermocouple Airflow Sensor (K913396). The study aimed to show equivalent performance to these legally marketed devices based on "representative laboratory data." There is no mention of expert consensus, pathology, or outcomes data as ground truth for this particular submission.

8. The sample size for the training set:

   This information is not applicable and is not provided. The DYMEDIX Reusable Airflow/Snore Sensor is a physical sensor, not a machine learning model that requires a training set.

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

   This information is not applicable and is not provided, as the device is not a machine learning model.

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The DYMEDIX, Inc. Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor are used with existing sleep study recording devices in support of diagnostic recording of respiratory effort and limb movement. The sensors are used with patients who require a sleep study recording.

The Respiratory Effort Belt Sensor and Limb Movement Sensor are reusable devices. The sensors use a self-generating, piezo material technology. The piezo material generates a small voltage in response to stretch, compression and vibration due to motion. The sensors contain no active electronics or software.

The Respiratory Effort Belt Sensor attaches to the patient with a Velcro belt and a cloth strap. The Limb Movement Sensor is applied to the patient with a Velcro belt.

The Respiratory Effort Belt Sensor is applied to the upper chest and/or abdomen. Respiration effort results in stretch of the sensor with chest and/or abdomen circumference change indicative of respiration effort. The sensor transfers this change to a small voltage signal which can be recorded.

The Limb Movement Sensor is applied to the arm, hand, leg or foot of the patient. The sensor translates limb movement into a small voltage signal which can be recorded.

The sensors connect to the user's sleep study recording equipment. The sleep study recording equipment amplifies and conditions the sensor signal to the user's preferences. The sleep study recording device provides electrical isolation for the applied sensors.

Here's a breakdown of the requested information based on the provided text, along with a note on the limitations of the document for this specific request:

The provided text is a 510(k) Summary of Safety and Effectiveness for the Dymedix Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor. It aims to demonstrate substantial equivalence to previously marketed devices rather than presenting a detailed study proving the device meets acceptance criteria in the way a clinical trial for a novel device would. Therefore, much of the requested information about clinical studies, ground truth, and acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, is not present in this type of document.

This document focuses on:

• Device Description: What the device is and how it works.
• Intended Use: The purpose of the device.
• Technological Characteristics: The materials and basic setup.
• Comparison to Predicate Devices: Establishing that it's similar to already approved devices.
• Safety Information: Biocompatibility and lead wire compliance.

Analysis of Provided Information Against Request:

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

• Acceptance Criteria: Not explicitly stated as performance metrics (e.g., sensitivity, specificity, accuracy thresholds). The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. This means showing that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as a legally marketed device.
• Reported Device Performance: No quantitative performance data or metrics (like accuracy, sensitivity, or specificity) are reported for the new device or against specific acceptance criteria. The document only generally states: "Laboratory data are presented to establish the performance of the Reusable Respiratory Effort Belt Sensor and Reusable Limb Movement Sensor in comparison to predicate sensors." However, the details of this "laboratory data" are not provided in this summary.

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 for Test Set: Not specified.
• Data Provenance: Not specified. The document only mentions "Laboratory data." It does not indicate if this data came from human subjects, animal models, or purely bench testing, nor does it specify if it was retrospective or prospective.

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)

• Number of Experts: Not applicable/not specified. The nature of the "laboratory data" is not detailed, so there's no mention of experts establishing a ground truth in a clinical context.

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

• Adjudication Method: Not applicable/not specified.

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

• MRMC Study: No. This device is a sensor, not an AI-powered diagnostic system, so an MRMC study with human readers and AI assistance is not relevant to its type. The document makes no mention of AI.

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

• Standalone Performance: Not applicable. The device contains "no active electronics or software." It generates a raw voltage signal that connects to existing sleep study recording equipment, which then requires interpretation by "Professionals (physicians, clinicians)." It is not an algorithm performing a standalone task.

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

• Type of Ground Truth: Not explicitly stated. Given the comparison to "predicate sensors," the "ground truth" for performance may have been implied as the known and accepted performance of those predicate devices, but the specific methodologies are not described. The document states "Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis."

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a passive sensor without software or active electronics, so there is no "training set" in the context of machine learning or algorithms.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding "studies":

The document primarily relies on:

• Comparison to Predicate Devices: This is the core "study" or justification for a 510(k). The regulatory review determined the new device is "substantially equivalent" to predicate devices (K001030, K923402, K940014) from Dymedix Inc. and Pro-Tech, Inc.
• Laboratory Data: Mentioned generally to establish performance "in comparison to predicate sensors." No details are provided on what this data entails.
• Biocompatibility Testing: Patient contact material biocompatibility is mentioned as provided.
• Regulatory Compliance Certification: Certification of Conformance to FDA Performance Standard for Lead Wires and Patient Cables (21 CFR Part 898) is provided.

Conclusion:

This 510(k) Summary of Safety and Effectiveness document is primarily a regulatory filing to demonstrate substantial equivalence for a non-AI, passive medical device. It does not contain the detailed performance study results, acceptance criteria, or ground truth methodologies typically found in clinical trial reports for novel or software-driven devices. The "study" here is largely a demonstration of similarity to existing, approved devices and adherence to basic safety standards.

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The DYmedix Inc. Chin Electrode is a cutaneous electromyography (EMG) electrode. The Chin Electrode supports EMG monitoring of muscles in the chin and other surface EMG monitoring locations as directed by a physician during sleep studies.

The Chin Electrode is provided as a convenience to the sleep clinician. The Chin Electrode consists of three cutaneous electrodes within one assembly. In clinical application, the Chin Electrode is placed on the subject's chin. The lead wires are connected to the user's sleep recording instrumentation. The user's sleep recording instrument provides the electrical isolation for patient safety.

The provided text describes a 510(k) submission for the DYmedix, Inc. Chin Electrode. It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific performance metrics against defined acceptance criteria from a study. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be provided based on the given text:

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

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio) for the Chin Electrode. Instead, it focuses on demonstrating technological equivalence and compliance with safety standards.

Therefore, a table of acceptance criteria and reported device performance cannot be created from this text. The "Data Summary" section vaguely mentions "Laboratory data are presented to demonstrate performance," but no specific performance results are provided.

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

The document does not mention any formal clinical study or test set with a specified sample size. The "Laboratory data" mentioned are likely related to engineering testing for compliance with standards rather than clinical performance evaluation on patient data.

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)

Not applicable, as no clinical test set or ground truth establishment is described.

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

Not applicable, as no clinical test set or adjudication process is 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. The Chin Electrode is a physical medical device (electrode) for EMG monitoring, not an AI or software-as-a-medical-device (SaMD) product. Therefore, an MRMC study or AI-assistance evaluation is not relevant.

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

Not applicable, as this is a physical device, not an algorithm.

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

Not applicable, as no clinical ground truth establishment is described. The "ground truth" in this context would likely be the accurate measurement of EMG signals, which would be assessed through electrical performance testing, not clinical consensus or pathology.

8. The sample size for the training set

Not applicable, as this is a physical device, not an algorithm that requires a training set.

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

Not applicable, as this is a physical device, not an algorithm that requires a training set.

Summary of Information from the Document:

While the document doesn't provide the requested AI/algorithm-specific details, it does state the following relevant information regarding the device's acceptance and supporting data:

• Acceptance Criteria (Implied / Compliance-based):

  • Technological Equivalence: The Chin Electrode must be technologically equivalent to existing cutaneous electrodes.
  • Biocompatibility: Skin contact materials must be qualified by ISO 10993 or have a history of safe use.
  • Lead Wire Safety: Lead wires must comply with FDA requirement 21 CFR Part 898.
  • Functional Performance: Must be able to conduct EMG signals. (No specific performance metrics are given, but "Laboratory data are presented to demonstrate performance.")
  • Safety and Effectiveness: The overall conclusion of the submission is to support the safety and effectiveness.

• Study That Proves the Device Meets Acceptance Criteria (as described):

  • Type of Study: The submission primarily relies on "Laboratory data" and "Certification of Conformance" to relevant standards. This indicates engineering testing and compliance documentation rather than a clinical trial.
  • Specific Tests/Certifications Mentioned:
    • Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
    • Compliance with ISO 10993 for biocompatibility.
  • Nature of "Data Summary": The document states that "Laboratory data are presented to demonstrate performance," but does not elaborate on the specific tests conducted or their results in a quantitative manner. The FDA's decision is based on a review of the provided 510(k) submission, confirming "substantial equivalence" to the predicate device.

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