(41 days)
The LaserPro 16 is a desk top laser image digitizer intended to produce digital copies of radiological film in 10 bit gray scale. The digital copies are transmitted to a conventional based personal computer (PC) where they may be transmitted to a PACS (Picture Archiving and Communication System) or other networks to other medical facility sites.
The eRadLink LaserPro 16 is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed optic path. There are no internal lenses, mirrors, or electro-optic devices. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable. Film, from a minimum of 2 inches to a maximum of 14 inches in width and, from a minimum of 2 inches to a maximum of over 52 inches in length is driven passed the scanning laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the host computer in DICOM format.
Here's an analysis of the provided text regarding the Laser Film Digitizer (eRadLink LaserPro 16), focusing on acceptance criteria and the study that proves device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K020243) is a 510(k) Summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than explicitly defining and meeting specific, quantitative acceptance criteria for safety and effectiveness in the way a clinical trial might.
The "Effectiveness" section [4] states:
"Program testing and calibration using Stoeffer T4110 gray-scale strip, linearity test patterns and typical x-ray film samples has demonstrated the LaserPro's 16's conformance to its defined specifications."
This sentence implies that the "defined specifications" are the acceptance criteria, and the testing performed confirms conformance. However, the specific numerical values of these "defined specifications" are not explicitly listed in the document as measurable acceptance criteria with corresponding performance results.
Instead, the document primarily compares the device's features and characteristics to a predicate device. If we were to infer "acceptance criteria" from the comparison, they would generally relate to matching or exceeding the capabilities of the predicate device.
Inferred "Acceptance Criteria" from Predicate Comparison and Reported Performance:
| Feature (Acceptance Criteria - inferred comparison to predicate) | Predicate Device (Lumiscan 75) Performance | eRadLink LaserPro 16 Reported Device Performance | Comments/Rationale for Inferred Criteria |
|---|---|---|---|
| Scan Size (min) | 7" x 7" | 2" x 2" | The LaserPro 16 meets/exceeds the minimum scan size of the predicate. Inferring an acceptance criterion of "at least as good as predicate." |
| Scan Size (max) | 14" x 36" | 14" x 15' (14" x 180") | The LaserPro 16 significantly exceeds the maximum scan size of the predicate. Inferring an acceptance criterion of "at least as good as predicate." |
| Spot Size | 100 um | 116 um | The LaserPro 16 has a slightly larger spot size (lower resolution capability) than the predicate. Without explicit justification, this might be a point of concern for some, but in a 510(k), it's deemed "substantially equivalent." Acceptance criteria implicitly allow for minor differences if overall safety and effectiveness are maintained. |
| Dynamic Range | 0.5 - 3.8 OD | 0.0-4.1 OD | The LaserPro 16 meets/exceeds the dynamic range of the predicate, offering a wider range. Inferring an acceptance criterion of "at least as good as predicate." |
| Gray Scale | 12 bits | 8, 12, or 16 bits | The LaserPro 16 meets/exceeds the gray scale capability of the predicate, offering more options. Inferring an acceptance criterion of "at least as good as predicate." |
| Digitizing Rate | 115 lines/sec | 100 lines/sec (16 bit gray scale) | The LaserPro 16 has a slightly slower digitizing rate at 16-bit gray scale, but the predicate rate (115 lines/sec) might be at a lower bit depth (e.g., 12-bit). If the predicate's 115 lines/sec was also at 16-bit, then the LaserPro is slightly below. However, the FDA found it substantially equivalent. |
| Pixel/mm | 10.09 | 8.6 | The LaserPro 16 has fewer pixels/mm (lower resolution) than the predicate (8.6 vs 10.09). Again, this is a minor difference that was accepted as part of substantial equivalence. |
| Conformance to "Defined Specifications" | N/A (Predicate has its own specs) | Demonstrated by program testing & calibration | This is the most direct statement of meeting criteria, but the specifications themselves are not detailed. |
| Safety Compliance | N/A (Predicate has its own compliance) | UL260, CSA 22.2, TUV, IEC 601-1 approved | The device must meet recognized safety standards. |
| EMT Requirements | N/A (Predicate has its own compliance) | CISPR 11 Class B for EMT requirements | The device must meet recognized electromagnetic compatibility standards. |
Study That Proves the Device Meets Acceptance Criteria:
The document describes the study in section (8) EFFECTIVENESS:
"Program testing and calibration using Stoeffer T4110 gray-scale strip, linearity test patterns and typical x-ray film samples has demonstrated the LaserPro's 16's conformance to its defined specifications."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The description mentions "typical x-ray film samples" but does not quantify the number of samples used (e.g., number of films, number of images).
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the "typical x-ray film samples" or if they were retrospective or prospective. Given the context of a 510(k) submission for a digitizer, these would likely be existing, retrospective films.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
It's highly probable that for a device like a film digitizer, "ground truth" would be established by comparing the digitized output to the original film's properties (e.g., optical density, resolution, linearity) rather than relying on human interpretation of the digitized image for diagnostic accuracy comparisons at this stage of approval. Therefore, expert radiologists might not have been directly involved in establishing the "ground truth" for the technical performance of the digitizer itself.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned, as the study described is technical validation of digitization performance against physical standards (gray-scale strips, linearity patterns) and "typical x-ray film samples," not a diagnostic study requiring human interpretation and consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or described. The study focuses on the technical performance of the digitizer, not its impact on human reader performance or diagnostic accuracy. There is no mention of comparing human readers with AI assistance vs. without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
- Yes, a standalone study was done. The "Program testing and calibration" described in section (8) "EFFECTIVENESS" is a standalone evaluation of the device's technical specifications. The device, being a digitizer, is the algorithm/hardware combination that performs the digitization process. The study evaluates its output against known standards, independent of human interpretation or interaction beyond setting up the test.
7. The Type of Ground Truth Used
- The ground truth used appears to be based on technical standards and physical measurements.
- Stoeffer T4110 gray-scale strip: A standardized tool used to evaluate the gray-scale reproduction and dynamic range of imaging systems.
- Linearity test patterns: Used to assess the geometric accuracy and linearity of the digitization process.
- Typical x-ray film samples: These would have known optical densities, resolutions, and content, allowing for evaluation of how accurately the digitizer captures these features.
8. The Sample Size for the Training Set
- Not applicable. This device is a film digitizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its "training" is in its design, engineering, and factory calibration to meet physical specifications, not in learning from a dataset.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As explained above, there is no "training set" for a film digitizer in the context of the provided document. The ground truth for its calibration and validation relies on standardized physical references like the Stoeffer T4110 and linearity test patterns.
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KO20243
Appendix A. 510(k) Summary of Safety and Effectiveness (See next page)
MAR 5 2002
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Per Title 21 CFR 807 . 92, the following is the 510(k) Summary for the Laser Film Digitizer manufactured by Clinical Laser Systems and marketed by eRadLink Inc. under the trade-name eRadLink LaserPro 16:
| (1) | SUBMITTER: | eRadLink Inc.22750 Hawthorne Blvd.Torrance, California 90505-Phone: 310-373-5673Fax: 310-373-9763 |
|---|---|---|
| CONTACT: | Albert KoubaRegulatory Affairs |
19529 Chaparral Circle Penn Valley, California 95946 Phone: 530-432-3791 530-432-4046 Fax:
نور دارنانو،
18 DEC 2001 SUBMISSION DATE:
DEVICE NAME: (2)
TRADE NAME: eRadLink LaserPro 16
COMMON NAME: Laser Film Digitizer
CLASSIFICATION NAME: Digitizer, Image, Radiological (per regulation 21 CFR 892.2030) (Class II device)
PRODUCT CODE:
Lumiscan 75 (510(k) number Not Known) PREDICATE DEVICE: (3) DI-2000 (Software application - 510(k) Number K980213) Lumisys Inc. 225 Humboldt Court Sunnyvale, California 94089
LMA
DEVICE DESCRIPTION: (4)
The eRadLink LaserPro 16 is a digitizing scanner that converts radiographic film transparency images to digital format. This is accomplished by utilizing a laser beam light source and a proprietary sealed optic path. There are no internal lenses, mirrors, or electro-optic devices. The new technology provides superior image quality, requires no internal optics cleaning, no optical alignment and is inherently highly accurate and reliable.
Film, from a minimum of 2 inches to a maximum of 14 inches in width and, from a minimum of 2 inches to a maximum of over 52 inches in length is driven passed the scanning laser beam by a clocked, stepping motor. Scanned data is electronically converted from analog to 16 bit digital gray scale and transmitted to the host computer in DICOM format.
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INTENDED USE OF DEVICE (ર)
The LaserPro 16 Laser Film Digitizer is intended to be used in a Radiological Laboratory or Doctors office to read and digitize gray scale images from conventional x-rays for transmission to PC computer. The receiving computer allows the technician to add patient identification, review the x-ray at various rotations and options and compress the image using industry accepted techniques to an average file size of less than one megabyte. Compressed images are encapsulated in DICOM (Digital Imaging and Communications in Medicine) format, which then may be transmitted via various communication protocols to other sites or archived by a PACS host.
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE -(6) HARDWARE
Table - A illustrates the comparative equivalence of the LaserPro 16 to the Predicate device Hardware.
| Feature | eRadLink | Lumisys | |
|---|---|---|---|
| Product Name | LaserPro 16 | Lumiscan 75 | |
| 510(k) Number | Not Known | ||
| Dimensions | 12"(h) x 18"(w) x 12"(d) | 16"(h) x 21"(w) x 29"(d) | |
| Weight | 30 lbs. (13.6 kg) | 90 lbs. (40.9 kg) | |
| Power | 85-264vac 2.8A 47-63 Hz | 110-120vac 1A 50/60 Hz | |
| Scan Size | 2" x 2" (min), 14" x 15' (max) | 7" x 7" (min), 14" x 36" | |
| Spot Size | 116 um | 100 um | |
| Dynamic Range | 0.0-4.1 OD | 0.5 - 3.8 OD | |
| Gray Scale | 8, 12, or 16 bits | 12 bits | |
| Digitizing Rate | 100 lines/sec (16 bit gray scale) | 115 lines/sec | |
| Laser | 35 mw Solid State | He-Ne Laser | |
| Beam Scan | Fiber Optics | Galvanometer | |
| Pixel/mm | 8.6 | 10.09 | |
| Interface | USB or Ethernet | PCISA or SCSI |
Table A - Hardware Comparison of LaserPro 16 to Predicate Devices
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SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE -(7) SOFTWARE
Table B illustrates the comparative equivalence of the LaserPro 16 to the Predicate device Software.
| Features | eRadLink | Lumisys |
|---|---|---|
| Product Name | eRadLink MedicalInternet Image &ManagementSystem | DI-2000 |
| 510(k) Number | - | K980213 |
| Patient Information - Add/Modify/Delete | Y | Y |
| Fax Report | N1 | Y |
| Print Dicom Image | N1 | Y |
| Image Rotate and Flip | Y | Y |
| Black/White Inversion | Y | Y |
| Multiple Image Display | N2 | Y |
| Dicom Send/Receive/Echo | Y | Y |
| Dicom Query User/Provider | Y | Y |
| Dicom Retrieve User/Provider | Y | Y |
| Dicom Print | N3 | Y |
| JPEG Compression lossy/lossless | Y | Y |
| iJPEG Compression | Y | Y |
| Wavelet Compression | Y | Y |
| Industry Standard Digital CommunicationSupport | Y | Y |
| Color Images | N | Y |
| Cine Loop Viewing | N | Y |
| Dicom Removable Media Support | N | Y |
| Measurement Tools | N4 | Y |
| Communication protocols | Y5 | Y5 |
Table B - Software Comparison of LaserPro 16 to Predicate Devices
In progress
2 Dicom Viewer
3 Display only
4 Dicom Viewer
5 ADSL, Cable and Analog Modems and Phone Lines, ATM, ISDN, FDDL, Ethernet, Token Ring
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(8) EFFECTIVENESS
Program testing and calibration using Stoeffer T4110 gray-scale strip, linearity test patterns and typical x-ray film samples has demonstrated the LaserPro's 16's conformance to its defined specifications.
1 6 5 1 1 2
(9) SAFETY
The LaserPro 16 is powered by an external power supply, which is UL260, CSA 22.2, The LaserFro To is powered by an externa: power safety and Class B for EMT requirements.
TUV and IEC 601-1 approved for safety and CISPR 1 1 Class B for EMT requirements. TO V and IDC 001-1 approved for salesy anting range from 0 to 70° C, overvoltage and I catures mercure 4000 VIC ibelief, operating .5% maximum at full load.
The LaserPro 16 Scanner is currently under test for FCC Class A EMT, RFI and UL safety compliance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows a black and white logo. The logo consists of a circular border with text around the top half, and a symbol in the center. The symbol appears to be three stylized lines or curves, possibly representing a bird or a wave.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
Mr. Albert J. Kouba Regulatory Affairs eRadLink, Inc. 19529 Chaparral Circle PENN VALLEY CA 95946-9443 Re: K020243
Trade/Device Name: LaserPro 16 Laser Digitizing Scanner Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: 90 LMA Dated: January 22, 2002 Received: January 23, 2002
Dear Mr. Kouba:
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 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.
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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Nancy C Brogdon
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __eRadLink LaserPro 16
Indications for Use
The LaserPro 16 is a desk top laser image digitizer intended to produce digital The LaserFlo 10 Is a desk top lastr mage orgy scale. The digital copies are a copies of radiological min in 10 roversonal computer (PC) where they may be transmitted to a rentiall based porsonal verspace (0) = ) networks to other medical facility sites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
6
David G. Brown
Prescription Use (Per 21 CFR 901.109)
OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.