(144 days)
extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
extra oral source X-ray system for dental radiographic examination of the teeth
The provided text is a 510(k) summary for a medical device called ENDOS DC, which is an extraoral source X-ray system for dental radiographic examination. It compares the ENDOS DC to a predicate device, the GENDEX DENTSPLY model 765DC.
Based on the information provided, here's an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a typical quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) for a medical imaging device's diagnostic capability. Instead, it focuses on technical specifications and safety features to demonstrate substantial equivalence to a predicate device.
The premise of this 510(k) is that if ENDOS DC meets or performs comparably to the predicate device in these technical areas, it is considered safe and effective for its intended use. Therefore, the "acceptance criteria" are implied to be the specifications of the predicate device.
| Acceptance Criteria (Predicate Device K992610: GENDEX 765 DC) | Reported Device Performance (ENDOS DC) |
|---|---|
| Intended use: extra oral source X-ray system for dental radiographic examination | Intended use: extra oral source X-raysystem for dentalradiographic examinationof the teeth |
| High Voltage value: 65 kVp +/- 3kV | High Voltage value: 65 kVp+/-5% |
| Tube current: 7 mA +/- 5% | Tube current: 4-5 mA +/-5% |
| Focal spot size: 0.4 mm (IEC 336) | Focal spot size: 0.7 mm (IEC 336) |
| Anode inclination: 12.5° | Anode inclination: 19° |
| Total filtration: 2.0 mm Al | Total filtration: > 2.0 mm Al |
| HVL: 2.0 mm Al | HVL: > 1.5 mm Al |
| H.V. generator: High frequency | H.V. generator: High frequency |
| X-Ray exposure time control: Automatic - pre-programmed Microprocessor Controlled | X-Ray exposure time control: Automatic - pre-programmedMicroprocessorControlled |
| X-Ray exposure timing: 0.020 sec to 2 sec | X-Ray exposure timing: 0.010 sec to 2 sec |
| Electrical characteristics: 120 V, 5 impulsive A max | Electrical characteristics: 120 V,4.5 impulsive A max |
| Focus film distance: > 20 cm or > 30cm | Focus film distance: > 20 cmor > 30cm |
| Leakage radiation: < 28 mR/h at 1 meter from focus | Leakage radiation: < 25 mR/h at 1 meter fromfocus |
| X-ray beam dimension at 20cm: < 6cm | X-ray beam dimension at 20cm: < 6cm |
| Safety features: Dead man command | Safety features: Dead man command |
| Signaling devices: Acoustic and visual signal | Signaling devices: Acoustic and visual signal |
Note on Differences: While many specifications are comparable, there are a few differences (e.g., tube current, focal spot size, anode inclination, X-ray exposure timing). The FDA's substantial equivalence determination implies these differences do not raise new questions of safety or effectiveness. For example, a larger focal spot size (0.7mm vs 0.4mm) generally results in slightly less sharp images but is still within acceptable limits for dental radiography, and the lower tube current (4-5 mA vs 7 mA) means potentially longer exposure times or lower quality images (if not compensated by other factors), but the FDA still found it substantially equivalent.
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study with a "test set" in the context of diagnostic image analysis. This 510(k) submission is for a conventional X-ray generator, not an AI or image analysis device that would be evaluated for diagnostic accuracy on a dataset of images. Therefore, the concepts of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable to the type of information presented. The "test" here refers to engineering and performance testing against its own specifications and comparison to a predicate device's specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no diagnostic "test set" or "ground truth" derived from expert interpretation described in this submission. The device is an X-ray generator, and its performance is evaluated based on physical measurements of its output (e.g., kVp, mA, leakage radiation) and adherence to engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason mentioned in point 3. There is no diagnostic test set requiring adjudication of expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or new imaging techniques on human reader diagnostic performance. The ENDOS DC is an X-ray generator, not an AI or image analysis system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This concept applies to AI algorithms whose performance can be measured independently of human interpretation. The ENDOS DC is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No "ground truth" in the diagnostic sense is described or used. The "proof" for this device's performance primarily relies on:
- Engineering specifications and measurements: Demonstrating the device outputs X-rays within specified parameters (e.g., kVp, mA, filtration, leakage).
- Compliance with recognized standards: The document mentions IEC 336 for focal spot size, implying adherence to international standards for X-ray equipment.
- Substantial equivalence to a predicate device: The fundamental "proof" is that the device's technical specifications and intended use are similar enough to a legally marketed predicate device such that it raises no new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This device is an X-ray generator and does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
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Appendix 1 - 510 (k) SUMMARY
510(k) summary for STRATO X
Identification
| Applicant | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 BUCCINASCO - Milan- ItalyRegistration Number: 8021091 |
|---|---|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agentin the US | Andrew HryndzaDel Medical11550 West King StreetFranklin ParkIllinois 60131Tel. 847-288-7000 FAX. 847-288-7911 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.Via delle Azalee 3,20090 BUCCINASCO - Milan - Italy |
Trade name: ENDOS DC
Common name: ENDOS DC
Classification name: according to 21 CFR 872-1800, ENDOS DC is in Class II.
Substantial equivalent device: the ENDOS DC is defined as Substantially Equivalent (SE) to the GENDEX DENTSPLY model 765DC. The predicate device has been approved by FDA and has 510(k) approval number K992610
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| ENDOS DC | GENDEX 765 DC | |
|---|---|---|
| Intended use | extra oral source X-raysystem for dentalradiographic examinationof the teeth | extra oral source X-raysystem for dentalradiographic examination |
| High Voltage value | 65 kVp+/-5% | 65 kVp +/- 3kV |
| Tube current | 4-5 mA +/-5% | 7 mA +/- 5% |
| Focal spot size | 0.7 mm (IEC 336) | 0.4 mm (IEC 336) |
| Anode inclination | 19° | 12.5° |
| Total filtration | > 2.0 mm Al | 2.0 mm Al |
| HVL | > 1.5 mm Al | 2.0 mm Al |
| H.V. generator: | High frequency | High frequency |
| X-Ray exposuretime control | Automatic - pre-programmedMicroprocessorControlled | Automatic - pre-programmedMicroprocessorControlled |
| X-Ray exposuretiming | 0.010 sec to 2 sec | 0.020 sec to 2 sec |
| Electricalcharacteristics | 120 V4.5 impulsive A max | 120 V5 impulsive A max |
| Focus film distance | > 20 cmor > 30cm | > 20 cmor > 30cm |
| Leakage radiation | < 25 mR/h at 1 meter fromfocus | < 28 mR/h at 1 meter fromfocus |
| X-ray beamdimension at 20cm | < 6cm | < 6cm |
| Safety features | Dead man command | Dead man command |
| Signaling devices | Acustic and visual signal | Acustic and visual signal |
The following table compares the ENDOS DC V with the predicate device
Indication for use.
The indication for use of the ENDOS DC is: : extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
510(k) ENDOS DC
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a caduceus, a traditional symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Mr. Roberto Daglio QA Director Villa Sistemi Medicali via Azalee 3 20090 Buccinasco, Milan ITALY
Re: K030634
Trade/Device Name: ENDOS DC Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: May 7, 2003 Received: May 9, 2003
Dear Mr. Daglio:
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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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 one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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
Nancv 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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Indication for use Statement 4.1.
510(k) Number: 长 030634
Device Name: ENDOS DC
The indication for use of the ENDOS DC is: : extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
used as:
prescription only: $\checkmark$__
David A. Seppanen
IVISION Sion-
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.