The Stingray DR Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

Device Description

The Stingray DR system uses a flat panel x-ray detector that contains a CsI Scintillator and a Amorphous Si TFT array for conversion of X-rays into an electronic digital image. This system is to be used as a replacement for Screen film x-ray devices for X-ray images. The Stingray DR system has a Personal computer that is used for image storage and retrieval and image processing. The system allows for post processing of images. This allows for the potential to use images that might have been useless if taken on film due to, for example, incorrect technique since the Stingray DR system can post process the images, modify the output look up table and possibly bring out data that could not be seen under normal circumstances.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Stingray DR), which aims to demonstrate "substantial equivalence" to existing legally marketed predicate devices, rather than establishing de novo acceptance criteria and conducting a study to meet them in the same way a novel device might. The core of a 510(k) submission is to show that the new device performs "the same functions in the same environment" as its predicates and has "the same resolution".

Therefore, the analysis below is based on the information provided in the 510(k) summary, interpreting "acceptance criteria" as the performance metrics used for comparison to predicate devices, and "study" as the comparative analysis presented to justify substantial equivalence.

1. Table of "Acceptance Criteria" (Predicate Device Performance) and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices. The InfiMed Stingray DR system aims to meet or exceed these characteristics to demonstrate substantial equivalence.

Feature/Item	"Acceptance Criteria" (Predicate Device Performance)	InfiMed Stingray DR Reported Performance
Flat Panel Producer	Trixell (Philips, Siemens)	Trixell
Detector Material	a-Si sensor array with CsI scintillator	a-Si sensor array with CsI scintillator
Detector Dimensions	17" x 17"	17" x 17"
Pixel Size	143 x 143 microns	143 x 143 microns
Detector Element Matrix	2981 x 3021	2981 x 3021
Dynamic Range	14 bits	14 bits
Spatial Resolution	Up to 3.5 lp/mm (Philips), 3.5 lp/mm (Siemens)	3.5 lp/mm
External Connectivity	DICOM 3.0 compatible	DICOM 3.0 compatible
Operator Console	Graphical User Interface based	Graphical User Interface based
Image Processor	Sun Ultra SPARC (Philips) or Pentium based PC (Siemens)	Pentium based PC
Image Storage	Hard Drive	Hard Drive
Operating System	UNIX (Philips) or Windows NT (Siemens)	Windows NT
Total Image Processing time	Not Available (for Philips/Siemens), 30 seconds (Canon)	30 seconds per image

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

The document does not report specific sample sizes for a dedicated test set in the traditional sense of a clinical trial. The "study" here is a technical comparison against predicate devices. The performance data, specifically the spatial resolution, is demonstrated against the claimed specifications of existing, approved devices (Philips Digital Diagnost, Siemens THORAX FD and MULTIX FD, Canon Digital Radiography System).

Test Set Description: Not applicable in the context of human-read or image-based test sets with patient data. The "test set" effectively consists of the published specifications and performance claims of the predicate devices.
Data Provenance: The data provenance for the performance characteristics (e.g., spatial resolution) of the InfiMed Stingray DR would typically come from internal engineering and lab testing conducted by Trixell (the flat panel producer) and InfiMed. The document doesn't specify the country of origin of this test data, but given that InfiMed is located in Liverpool, NY, USA, it's likely testing was conducted there or by Trixell (a European company at the time) and validated by InfiMed. The data for predicate devices is based on their respective 510(k) submissions or publicly available specifications. Whether InfiMed performed prospective or retrospective comparisons against these specifications is not explicitly stated, but it would have involved prospective measurements on the Stingray DR system and retrospective comparison to predicate device specifications.

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

Not Applicable.
Since this is a technical comparison for substantial equivalence rather than a clinical performance study involving diagnostic accuracy, there were no human experts used to establish a "ground truth" for a patient-image test set. The ground truth for the device's technical specifications (like spatial resolution) is established through standardized physical measurements and engineering tests.

4. Adjudication Method for the Test Set

Not Applicable.
There was no adjudication method (e.g., 2+1, 3+1) because there was no human interpretation of images or establishment of ground truth by multiple experts in the reported comparison.

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

No.
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not mentioned in the provided text. This type of study would typically assess the impact of the device on human reader performance, which is not the focus of this 510(k) submission.

6. Standalone (Algorithm Only) Performance Study

The provided information focuses on the entire "Stingray DR system" which includes the detector, image processing, and a controlling PC. While the document mentions "defect compensation and image correction algorithms" as part of the system, it does not report a standalone performance study specifically for the algorithm without human-in-the-loop performance. The performance metric reported (spatial resolution) is a characteristic of the overall imaging chain.

7. Type of Ground Truth Used

The "ground truth" for the comparison is primarily based on technical specifications and physical performance measurements (e.g., spatial resolution measured in lp/mm). These are objective, quantifiable metrics derived from standard test patterns and methods, rather than clinical outcomes, pathology, or expert consensus on patient images.

8. Sample Size for the Training Set

Not Applicable.
The document does not refer to a "training set." As a 510(k) for a digital radiography system, it's not an AI/ML device in the modern sense that would require a distinct training set for algorithm development in this context. The "defect compensation and image correction algorithms" would have been developed and tuned using internal engineering data, but this is not disclosed as a "training set" with a specified sample size.

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

Not Applicable.
Since there is no mention of a "training set" in the context of an AI/ML algorithm requiring ground truth, this information is not provided. The performance (e.g., spatial resolution) of the system itself is validated through physical measurements and comparisons to predicate device specifications.

Summary

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NUV - 9 1999

510(k) Summary of Safety and Effectiveness

K992794

Date Prepared: August 16, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: (315)453-4545 x224 Fax: (315)453-4550

Device trade name: Stingray DR Common name: Digital Radiography System Classification Name: Solid State X-ray Imager (SSXI)

Device Description:

Intended Use:

Conclusions drawn from comparison:

The Stingray DR system performs the same functions in the same environment as the other 510(k) approved devices. The Stingray DR system uses the same sensor as the Philips Digital Diagnost and the Siemens THORAX FD and MULTIX FD. the Trixell Pixium 4600 Digital Detector for Radiography. And as shown in the performance data section the InfiMed Stingray DR system has demonstrated the same resolution, up to 3.5 lp/mm as that claimed by the Philips and Siemens systems and better spatial resolution than the Canon system. This would imply that the only part of the Stingray DR system that would be different from the Philips system and the Siemens system, the defect compensation and image correction algorithms, results in the same image resolutions as the predicate devices.

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Substantially equivalent devices and comparison:

Feature/Item	InfiMed StingrayDR	Phillips DigitalDiagnost	Siemens:THORAX FD andMULTIX FD	Canon DigitalRadiographySystem	GE RevolutionXQ/i
510(k) number	N/A	K982795	K983732	K981556	K982196
Flat PanelProducer	Trixell	Trixell	Trixell	Canon	GE
Detector Material	a-Si sensor arraywith CsIscintillator	a-Si sensor arraywith CsIscintillator	a-Si sensor arraywith CsIscintillator	Scintillator over aa-Si with a thin-film-transistorarray	a-Si sensor arraywith CsIscintillator
DetectorDimensions	17" x 17"	17" x 17"	17" x 17"	17" x 17"	Not Available
Pixel Size	143 x 143microns	143 x 143microns	143 x 143microns	160 × 160microns	Not Available
Detector ElementMatrix	2981 x 3021	2981 x 3021	2981 x 3021	2688 X 2688	Not Available
Dynamic Range	14 bits	14 bits	14 bits	14 bits	Not Available
Spatial Resolution	3.5 lp/mm	Up to 3.5 lp/mm	3.5 lp/mm	3.1 lp/mm	Not Available
ExternalConnectivity	DICOM 3.0compatible	DICOM 3.0compatible	DICOM 3.0compatible	DICOM 3.0compatible	Not Available
Operator Console	Graphical UserInterface based	Graphical UserInterface based	Graphical UserInterface based	Graphical UserInterface based	Graphical UserInterface based
Image Processor	Pentium based PC	Sun Ultra SPARC	Pentium based PC	Pentium based PC	Not Available
Image Storage	Hard Drive	Hard Drive	Hard Drive	Hard Drive	Not Available
Operating System	Windows NT	UNIX	Windows NT	Windows NT	Not Available
Total ImageProcessing time	30 seconds perimage	Not Available	Not available	30 seconds perimage	Not Available
ROI view	Yes	Unknown	Unknown	Yes	Unknown
PowerRequirements	110/120V.230/240V50/60Hz	230V 50/60Hz	Not Available	110/120V,230/240V50/60Hz	Not Available

Table of Comparison To 510(k) Approved SSXID

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 1999

Ralph J. Flatau Quality Assurance Manager InfiMed., Inc. 121 Metropolitan Drive Liverpool, NY 13088

Re:

K992794 Stingray DR, Model 1 (SSXI System) Dated: August 19, 1999 Received: August 19, 1999 Regulatory class: II 21 CFR 892.1650/Procode: 90 MOB

Dear Mr. Flatau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number

K992794

Unknown at this time

Device Name Stingray DR Solid State X-ray Imaging Device.

Indications for Use

The Stingray Solid State X-ray Imaging Device is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

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

Concurrence of CDRH, Office of Device Evaluation ( DOE)

Prescription Use

Per 21 CFR 801.109

Over the counter Use

( Optional format 1-2-96)

Daniel A. Levenson
(Division Sign-Off)

( Division of Reproductive, Abdominal, ENT, and Radiological Dev. 510(k) Number

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.