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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K040605" written in a handwritten style. The text is oriented diagonally, running from the bottom left to the upper right corner of the image. The characters are bold and slightly distorted, giving them a casual, informal appearance.

Summary of Safety and Effectiveness

APR 2 6 2004

Company Name:	DYMEDIX, Inc.3989 Central Ave. NE, Suite 116Minneapolis, MN 55421
Contact:	Bill Ham, President, COO
Phone:	(763) 789-8280
Fax:	(763) 781-4120
Summary Date:	April 12, 2004
Trade Name:	Reusable Respiratory Effort Belt SensorReusable Limb Movement Sensor
Common Name:	Respiration Effort Sensor, Limb Movement Sensor
Classification Name:	Predicate devices have been found substantially equivalent to21 CFR 868.2375, Breathing Frequency Monitor, Class II, BZQ.
Predicate Device(s):
	510(k) Number:	K001030
	Manufacture:	DYMEDIX Inc.
	Trade Name:	Respiratory Effort Belt Sensor, Periodic Limb MovementSensor
	510(k) Number:	K923402
	Manufacture:	Pro-Tech, Inc.
	Trade Name:	Crystal Trace Piezo Respiratory Effort Sensor
	510(k) Number:	K940014
	Manufacture:	Pro-Tech, Inc.
	Trade Name:	PLM Sensor, Model PLM1 (Periodic Limb Movement)

1.0 Description of Sensors

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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 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.

2.0 Intended Use of Sensors

The sensors arc applied to the patient prior to a sleep study evaluation. The Respiratory Effort Belt Sensor provides a signal that is recorded as respiration effort, chest/abdomen movement. The Limb Movement Sensor provides a signal that is recorded as arm, hand, leg, foot movement. Professionals (physicians, clinicians) interpret the recorded signals in support of sleep study diagnosis. The sensors are contraindicated for use as apnea monitoring sensors.

The sensors indication for use is:

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3.0 Technological Characteristics

The sensors consist of a piezo material, polarized Polyvinylidene Fluoride Film (PVDF) sensor assembly. The sensor assembly has lead wires attached. The lead wires comply with 21 CFR Part 898 Performance Standards for Sensor Lead Wires and Patient Cables. The sensor lead wires interface to the user's existing sleep recording device.

4.0 Data Summary

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. Patient contact material biocompatibility is provided.

A Certification of Conformance to the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898 is provided.

5.0 Conclusions

The laboratory data, skin contact material information and certification presented support the conclusion of the safety and effectiveness the Respiratory Effort Belt Sensor and Limb Movement Sensor.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2004

Dymedix, Inc. C/O Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger LN. Stoughton, WI 53589

Re: K040605

Trade/Device Name: Dymedix Reusable Respiratory Effort Belt Sensor, Model 601 Regulation Number: 868.2375 Regulation Name: Respiratory Belt Sensor and Limb Movement Sensor Regulatory Class: II Product Code: BZQ Dated: March 02, 2004 Received: March 08, 2004

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Acti: 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K040605

Device Name: Reusable Respiratory Effort Belt Sensor and a Reusable Limb Movement Sensor Indications for Use:

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.

Prescription Use X Over-The-Counter Usc AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

cotuh

v. General Hospital.

510(k) Number:

Page 1 of 1

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).