The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

Device Description

The Aloka DAS-RS1 system is a software based medical image system. This system receives, reviews and store patient exam images and data, prepare/print reports and communicates with Aloka Ultrasound systems. This system has a PC workstation that can be used to analyze the data for report generation. The software allows for the download of DICOM files to a single PC from a single Aloka Ultrasound system located within the same facility.

AI/ML Overview

Acceptance Criteria and Study for Aloka DAS-RS1

Based on the provided 510(k) summary for the Aloka DAS-RS1, the device did not undergo a clinical study with specific acceptance criteria that translate to performance metrics (e.g., sensitivity, specificity). The submission explicitly states:

"Clinical Tests: None Required to confirm safety and effectiveness. However, evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment."

This indicates that the Aloka DAS-RS1, as a Picture Archiving and Communication System (PACS) device, was cleared based on its substantial equivalence to a predicate device (Philips Medical Systems QLAB Software, K021966) and adherence to general safety and effectiveness standards, rather than specific performance benchmarks derived from a clinical trial.

Therefore, many of the requested details regarding acceptance criteria and a study proving their attainment cannot be provided as they were not part of this clearance process.

Here's an analysis of the provided information concerning the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission ("None Required to confirm safety and effectiveness" in a clinical context), there are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a study proving clinical efficacy (e.g., sensitivity, specificity, accuracy). The acceptance was based on:

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Functional Equivalence to Predicate Device	"functionally comparable and substantially equivalent to the Philips Medical Systems QLAB Software (K021966)"
Similar Technological Characteristics to Predicate Device	"similar technological characteristics"
Similar Key Safety and Effectiveness Features to Predicate Device	"key safety and effectiveness features"
Essentially Same Intended Use as Predicate Device	"essentially the same intended use"
Conformance to Design Specifications	"evaluated for conformance to its design specifications"
Conformance to Applicable Industry Standards for Software Development	"evaluated for conformance to... applicable industry standards for software development"
Risk Management/Hazard Control	"Risk management is ensured via risk analysis which is used to identify potential hazards. The potential hazards are controlled via software development, verification and validation."
System Compatibility	"verified for system compatibility with the Aloka Ultrasound device that it communicates to."
Compliance with Safety Standards for Hardware	"Computer hardware is certified to applicable safety standards."
Usability, Reliability, Compatibility in Clinical Setting	"evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment."
Conformance to Quality Systems	"conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485: 2003 quality systems."
DICOM Compliance	"The device is DICOM compliant"
Conformance to Medical Safety Standards	"conforms to applicable medical safety standards"

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

Sample Size: Not applicable. No specific test set for clinical performance evaluation (e.g., disease detection) was described. The "evaluation in a clinical setting" was for usability, reliability, and compatibility, but no details on sample size for this were provided.
Data Provenance: Not applicable, as no data for clinical performance metrics were presented or required for this 510(k). The "evaluation in a clinical setting" would likely have involved internal testing or limited pilot use, but specific origins (e.g., country) are not mentioned.

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

Number of Experts: Not applicable. No ground truth for clinical performance was established as part of this 510(k) for the reasons stated above.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No specific test set requiring adjudication of clinical outcomes was part of this submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

Was it done?: No. An MRMC study was not conducted or required for this submission. The device is a PACS system, not an AI diagnostic tool intended to improve human reader performance in a comparative study setup.
Effect size of improvement: Not applicable.

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

Was it done?: Not applicable in the context of an AI algorithm's performance. The DAS-RS1 is a software system for image handling and analysis, not an AI algorithm performing a diagnostic task independently. Its "standalone" function refers to its ability to process and store images, which was verified through non-clinical tests and compatibility assessments.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for this device's clearance was its ability to perform its intended functions (acquire, read, display, store, review DICOM data, analyze, print reports) reliably and safely, and its substantial equivalence to a predicate device. This was verified through design specifications, software development standards, risk analysis, and compatibility testing.

8. The Sample Size for the Training Set

Sample Size: Not applicable. The Aloka DAS-RS1 is a data analysis and archiving system, not a machine learning model that requires a training set in the conventional sense for a diagnostic algorithm. Its development involved traditional software engineering and testing, not AI model training.

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

How Established: Not applicable, as there was no training set for an AI model.

In summary, the Aloka DAS-RS1 received 510(k) clearance as a "Picture Archiving and Communication System" based on substantial equivalence to a predicate device and adherence to software development, quality system, and safety standards. It was not cleared as an AI-powered diagnostic tool, and therefore, the type of performance data typically associated with such tools (e.g., sensitivity, specificity, MRMC studies) was neither required nor provided.

Summary

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Model DAS-RS1

510(K)

JUL 1 5 2008

510(k) Summary

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

Date Prepared: 05/27/2008

Section a):

1. Submitter:	Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492
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Contact Person:	Richard J. Cehovsky, RA/QA Coordinator,Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075
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2. Device Name:

Trade Name- DAS-RS1 (Ultrasound Data Analysis System), ◆
. Classification Name: Picture Archiving and Communication System.
. Classification Panel: Radiology,
. CFR Section: 21 CFR 892.2050,
Device Class: II, �
Product Code: LLZ ●

3. Intended Use:

The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

4. Device Description:

5. Substantial Equivalence:

The Aloka DAS-RS1 is functionally comparable and substantially equivalent to the Philips Medical Systems QLAB Software (K021966). The DAS-RS1 has similar technological characteristics, key safety and effectiveness features and essentially the same intended use as the predicate device.

6. General Safety and Effectiveness

Section b):

1. Non-Clinical Tests:
  The DAS-RSI has been evaluated for conformance to its design specifications and applicable industry standards for software development. Risk management is ensured via risk analysis which is used to identify potential hazards. The potential hazards are controlled via software development, verification and validation. It is further verified for system compatibility with the Aloka Ultrasound device that it communicates to. Computer hardware is certified to applicable safety standards.

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510(k) Summary

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

Date Prepared: 05/27/2008

2. Clinical Tests:

None Required to confirm safety and effectiveness. However, evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment.

7. Summary Conclusion:

The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485: 2003 quality systems. The device is DICOM compliant and conforms to applicable medical safety standards and compliance is verified through internal and independent quality system and test verification. Intended uses and other key features of the device are consistent with traditional clinical practice, FDA guidelines and established methods of handling patient examination images and data. PACS devices and medical information systems in general have demonstrated a history of effective performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka DAS-RS1 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared market.

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Image /page/2/Picture/0 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 a stylized symbol that resembles an abstract caduceus, featuring three diagonal lines that curve and converge at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2008

Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K081843

Trade/Device Name: Aloka DAS-RS1 (Ultrasound Data Analysis System) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2008 Received: June 30, 2008

Dear Mr. Borsai:

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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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 (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known):

Device Name:

Indications For Use:

Aloka DAS-RS1 (Ultrasound Data Analysis System)

The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arqui M. Khan

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

Page 1 of 1

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).