(37 days)
The NAI Tech Products Medical Digital Recorder is intended for use in Radiology applications to capture and digitize images and record them to single or multiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).
Medical Digital Video Recorder
The provided text is a 510(k) clearance letter from the FDA for a "Medical Digital Video Recorder." It does not contain the specific technical details about acceptance criteria or a study proving those criteria are met for the device itself.
The document states that the device is "intended for use in Radiology applications of capture and digitize video images and record them to single or multiple media in the form of CD (Compact Disc) or DVD (Digital Video Disc)." This describes the function, but not performance metrics or how performance was validated.
Therefore, I cannot provide the requested information based solely on the text provided. The acceptance criteria and the study results would typically be contained within the 510(k) submission document itself, which is not fully included here.
However, I can deduce what types of information would typically be present in such a study for this kind of device, if it were available:
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Acceptance Criteria: For a medical digital video recorder, common acceptance criteria would likely revolve around image quality, recording accuracy, data integrity, and compliance with relevant standards. Examples might include:
- Resolution preservation (e.g., recorded image resolution matches input resolution).
- Frame rate integrity (e.g., no dropped frames during recording).
- Color accuracy (e.g., recorded colors are perceptually similar to input).
- Absence of artifacts (e.g., compression artifacts, noise introduction).
- Successful recording and playback rate (e.g., 99.9% successful recordings).
- Data permanence on recorded media (e.g., ability to reliably retrieve data after X years).
- Compliance with DICOM or other relevant medical imaging standards for interoperability.
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Study Design (Hypothetical, based on device type):
- Device Performance: Assessment would involve recording various medical video sources (e.g., fluoroscopy, endoscopy, ultrasound, etc.) and evaluating the output against the input.
- Ground Truth: For a device that digitizes and records, the "ground truth" would likely be the original analog or digital video signal itself, as observed on a calibrated monitor or measured electronically.
- "Experts": For image quality assessment, radiologists, clinicians, or imaging scientists might subjectively evaluate recorded media, or objective metrics could be used. For data integrity, technical experts would verify bit-for-bit accuracy.
- Sample Size: This would depend on the statistical power needed to demonstrate compliance with the acceptance criteria. For a variety of medical video types and recording durations.
- Data Provenance: Could be a mix of synthetic data, clinical data from various institutions (potentially retrospective), and test patterns.
- Adjudication Method: If subjective image quality assessment was used, a consensus method (e.g., 2+1 or 3+1) among experts would be common.
- MRMC Comparative Effectiveness: Highly unlikely for this type of device. An MRMC study assesses the impact of a diagnostic tool on human reader performance. A video recorder's primary function is data capture and storage, not diagnostic interpretation. It doesn't "improve" human readers in the same way an AI diagnostic algorithm might.
- Standalone Performance: Yes, the performance would be standalone – the algorithm / device would be judged on its ability to accurately capture and store the video, without direct human-in-the-loop interpretation being part of its primary function.
- Training Set: For a digital video recorder, extensive "training" in the AI sense is unlikely. The device likely relies on established digital signal processing, compression algorithms, and hardware. If there were any adaptive components, the "training data" would be technical specifications and various video inputs used for calibration and testing during development.
- How Ground Truth for Training Set was Established: Again, not applicable in the AI sense. Ground truth for calibration and testing would be established by comparing processed video to known input video signals, using objective metrics.
In summary, the provided document is a regulatory clearance letter, not a technical report detailing the performance study. To get the specific information requested, one would need access to the actual 510(k) submission and its supporting technical documentation.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
NAI Technology Products % Mr. Robert E. Johnson President Diagnostic Data, Inc. 1342-D North Benson Avenue UPLAND CA 91786
Re: K042484
Trade/Device Name: Medical Digital Video Recorder Regulation Number: 21 CFR 892.2030 Regulation Name: Medical imager digitizer Regulatory Class: II Product Code: 90 LMA Dated: September 13, 2004 Received: September 13, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave icenced your becaller been) processor (is) problem (for the indications for use stated in above and nave determined with the devices marketed in interstate commerce prior to the enclosure) to tegary markedd production Device Amendments, or to devices that have been May 20, 1770, the chactinent acto of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordantee with the proval application (PMA). You may, therefore, market the do for require approval or a premants approvisions of the Act. The general controls provisions of the Act device, subject to the general ventual 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 If your device is classilled (200 additional controls. Existing major regulations affecting your Apploval), it the 70 Subject to activederal 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 FIEast oc advised mart 1271 5 issualled by device complies with other requirements of the Act or any FDA has made a determination and Joan and Jose Federal agencies. You must comply with all the I cacal statues and regulations and limited to registration and listing (21 CFR Part 807); labeling Act S requirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and by the FDA finding of substantial equivalence of your device to a legally premaince notification - ensults 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 rr you declie 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 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/dsmaldsmamain.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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Indications for Use Statement Original 510(k) Submission Indications for OSE Oxatoristration Number 2938727 NAT Tech Products, Registration Name
Device Name/Model: Medical Digital Recorder, Video
NAI Tech Products Applicant: 12919 Earhart Avenue Auburn CA 95602 Adban Number: 2938727
to be assigned by FDA 510(k) Number:
Medical Digital Recorder, Video Device Name:
The NAI Tech Products Medical Digital Recorder is Indications for use: The NAT Foor Productions of capture and digitize intended for ass in Reo images and record them to single of makiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Boydon
Division Sign Off
(Division Sian-Off Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
Prescription use
Per 21 CFR 801.109
N/A