ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.

Device Description

The ApLab is a re-usable, respiratory pressure sensor system intended to provide a recording of respiratory pressure during sleep. This physician prescribed device will provide a screening index for and aid in the diagnosis of obstructive sleep apnea syndrome. The device is about the size of a common beeper that contains proprietary electronic circuitry and embedded software. The ApLab utilizes a disposable, lightweight plastic nasal cannula that can be conveniently worn while sleeping at home. At completion of a sleep study the device is returned for data analysis and report generation.

AI/ML Overview

ApLab™ Ventilatory Effort Recorder - Acceptance Criteria and Study Details

Here's a breakdown of the acceptance criteria and study information for the ApLab™ device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined "acceptance criteria" in the traditional sense before the study was conducted. Instead, it presents the results of clinical tests and compares them to a manually scored Polysomnography (PSG) and an auto-scored PSG. The "acceptance" can be inferred by the FDA's substantial equivalence determination, which implicitly accepts the reported performance as sufficient compared to predicate devices.

Metric (Criterion)	Reported ApLab™ Performance	Comparison to Predicate/Manual PSG
Accuracy (Mean AHI)	The ApLab™ and PSG were equivalent in mean AHI.	Equivalent to manually scored PSG (SomnoStar α).
Sensitivity (Apnea & Hypopnea Event Count vs. Manual PSG)	69%	Auto-scored PSG sensitivity was 21% (ApLab™ statistically superior).
Positive Predictive Value (PPV) (Apnea & Hypopnea Event Count vs. Manual PSG)	65%	ApLab™ and auto-scored PSG statistically equivalent on PPV (auto-scored PSG PPV was 58%).
Sensitivity (Detection of OSAS - AHI >= 10 vs. Manual PSG)	89%	When compared to an industry standard AHI of 10.
Positive Predictive Value (PPV) (Detection of OSAS - AHI >= 10 vs. Manual PSG)	100%	When compared to an industry standard AHI of 10.
Breath-by-breath accuracy	Equivalent on a breath-by-breath basis at all three time intervals.	Equivalent to PSG.
Completeness of breathing record	Provides a complete record of breathing to confirm the AHI scoring.	Implied to be sufficient for AHI scoring.

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

Sample Size: Not explicitly stated as a single number for the "test set" or clinical study. The document mentions "Nine patients wore the ApLab for an average of 4.46 hours" in the safety results section, which likely refers to the clinical study population. It's unclear if this is the entire "test set" used for efficacy analysis, or if efficacy analyses were conducted on a larger, unspecified dataset.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective or a single prospectively collected small cohort, given the limited patient count mentioned. However, the document does not specify whether the data was collected retrospectively or prospectively.

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

Number of Experts: Not explicitly stated. The ground truth was established by a "manually scored SomnoStar α PSG" which implies interpretation by a trained professional.
Qualifications of Experts: Not explicitly stated (e.g., "radiologist with 10 years of experience"). However, manual scoring of PSG is typically performed by trained polysomnographic technologists or sleep physicians.

4. Adjudication Method for the Test Set

The document states that "Breath by breath accuracy was verified manually on both systems." This suggests a direct comparison, but no explicit adjudication method (like 2+1 or 3+1 consensus) is described for reconciling discrepancies or establishing the definitive ground truth where opinions might differ. The "manually scored SomnoStar α PSG" serves as the reference, implying a single authoritative scoring.

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 conducted. The study compares the ApLab™ (and auto-scored PSG) to a single manual PSG score. There is no mention of multiple human readers or an analysis of how AI assistance impacts human reader performance.

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

Yes: The reported "ApLab™ sensitivity" and "ApLab™ PPV" are measures of the device's standalone algorithm performance when compared to a manually scored PSG. The focus is on the device's ability to automatically detect apnea and hypopnea events and identify OSAS.

7. The Type of Ground Truth Used

Expert Consensus (implied single expert): The primary ground truth used was a "manually scored SomnoStar α PSG." This represents expert interpretation of polysomnographic data, likely by a trained polysomnographic technologist or sleep physician. It is not pathology or direct outcomes data.

8. The Sample Size for the Training Set

Not Provided: The document does not specify any information regarding a training set or its sample size. This suggests the device's algorithms were either developed using proprietary data not disclosed in this summary, or it relies on principles and technologies that do not require a separate, extensive, and explicitly documented training phase in the context of this 510(k) submission. Given the 2003 date, deep learning techniques with large training sets may not have been as prevalent.

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

Not Applicable / Not Provided: Since no information about a training set is given, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Sector Medical Corp, along with the date AUG 2 9 2003. The logo consists of a stylized "S" shape on the left, followed by the word "SECTOR" in bold, uppercase letters. Below "SECTOR" is the text "Medical Corp" in a smaller font size. The date is positioned above the logo.

320 Northpoint Parkway Suite P Acworth, Georgia 30102

Phone: 770.975.1384 Fax: 770.975.1385

510(k) SUMMARY

The assigned510(k) number is:	K030379
Prepared By:	Sector Medical Corp.320 Northpoint Parkway, Suite PAcworth, GA 30102
Telephone:Fax:	770.975.1384770.975.1385
Contact:	Bradley Jeffries, MD, MS
Date prepared:	August 28, 2003
Proprietary name:Classification name:Common name:	ApLab™Ventilatory Effort RecorderAirflow Pressure Sensor
Classification:Regulation number:Product code:	Class II868.2375MNR
Predicate device(s):	SensorMedics SomnoStar α Series Sleep System510(k) Number: K012085Biomec SleepFlow510(k) Number: K020607

Description of device:

Intended use:

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Technological Characteristics:

The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. This is to demonstrate that ApLab has no significant differences from the predicate device that would adversely affect product safety and effectiveness.

ComparisonParameter	SensorMedicsSomnoStar α SeriesSleep System K012085	Biomec SleepFlowK020607	Sector MedicalCorpApLab
Intended Use	Recording physiologicalparameters during sleep,including respiratory flowand effort, EEG,electroculogram,electromyogram, ECG,oxygen saturation, etc.	Recording airflow,snore, body position,thoracic effort,abdominal effort andbody position duringsleep.	Recordingrespiratory nasalpressure duringsleep.
Population	Not specified	2 yrs or older	2 yrs or older
Power Source	115 VAC	3-Volt (2AA in series)	3-Volt Lithium battery
Number ofChannels	Variable with a nominalchannel count of 14	Four channels	Single channel
Method ofConnection tothe Patient	Plastic tubing andcannula for pressuresensing; elastic clothmaterial for effort belts;insulated electricalsensors.	Plastic tubing andcannula for pressuresensing; elastic clothmaterial for effortbelts	Plastic tubing andcannula for pressuresensing; elastic clothmaterial belt tosupport unit.
SafetyCharacteristics	Uses non-conducting,disposable, plasticcannula containing ahydrophobic 0.2 micronfilter; insulated electricalconnections to ensurepatient isolation.	Use non-conducting,disposable, plasticcannula containing ahydrophobic 0.2micron filter.	Use non-conducting,disposable, plasticcannula containing ahydrophobic 0.2micron filter.
Re-use	Plastic cannula & filterare single usedisposable. Remainingportions requirecleaning.	Plastic cannula &filter are single usedisposable.Remaining portionsrequire cleaning.	Plastic cannula &filter are single usedisposable.Remaining portionsrequire cleaning.
SensorTechnology	Utilizes various sensortechnologies includingsolid-state pressuresensor, Gold cupelectrodes, thermistors,strain gauges, andoximetry.	Utilizes solid-statepressure sensor thatconverts pressurechanges to electricalsignal levels.	Utilizes solid-statepressure sensor thatconverts pressurechanges to electricalsignal levels.

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Performance Data:

Clinical tests:

In Clinical tests, ApLab automatic scoring and SomnoStar a autoscore PSG were compared to a manually scored SomnoStar α PSG. Breath by breath accuracy was verified manually on both systems.

The efficacy results are:

The ApLab and PSG were equivalent in mean AHI. .
The ApLab sensitivity was 69% with a PPV of 65% on an apnea and ● hypopnea event count when compared to a manually scored PSG.
The autoscored PSG sensitivity was 21% with a PPV of 58% on an apnea . and hypopnea event count when compared to a manually scored PSG.
The ApLab and autoscored PSG were statistically equivalent on PPV and . the ApLab was statistically superior on sensitivity.
When compared to an industry standard AHI of 10, the ApLab produced a . sensitivity of 89% with a PPV of 100% when compared to a manually scored PSG to determine if a patient has OSAS.
The ApLab and PSG are equivalent on a breath-by-breath basis at all three . time intervals.
The ApLab provides a complete record of breathing to confirm the AHI . scoring.

The safety results are:

Nine patients wore the ApLab for an average of 4.46 hours with no device . related adverse effects. There were no abnormal vital signs related to the ApLab. There were no early terminations.

Conclusion:

The performance tests and clinical trials completed on the ApLab demonstrate substantial equivalence to the predicate devices. The safety and effectiveness is demonstrated by the tests confirming accuracy of the recorded data to the product specifications and comparison to the predicate device clinical trial results.

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Bradley Jeffries MD, MS Vice President Sector Medical Corporation 320 Northpoint Parkway, Suite P Acworth, Georgia 30102

Re: K030379

Trade/Device Name: ApLab Ventilatory Effort Recorder, Model 801D0030 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 13, 2003 Received: June 18, 2003

Dear Dr. Jeffries:

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 - Dr. Jeffries

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 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) 594-4646. 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 yours.

Susan Punner

Susan Runner, DDS, MA Interim 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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510(K) NUMBER: K030379

Indications For Use Statement

Signature

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number:

/ Prescription Use

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).