(208 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description focuses on a standard non-contact tonometer mechanism.
No
The device is used for measurement (diagnosis) and does not provide any treatment.
Yes
Explanation: The device measures intraocular pressure, which is a physiological parameter used to assess the health of the eye and diagnose conditions like glaucoma.
No
The device description explicitly states it is a "non-contact measurement system" using an "air puff" and an "autoalignment system," which are hardware components. The performance studies also compare it to another tonometer, implying a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The TX-10 tonometer directly measures intraocular pressure of the human eye using an air puff. It does not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states "measurement of intraocular pressure of the human eye," which is a direct measurement on the body, not an analysis of a sample.
Therefore, based on the provided information, the TX-10 tonometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The TX-10 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
Product codes
HKX
Device Description
The TX-10 is a tonometer designed using a non-contact measurement system. A ir puff gently measures the intraocular pressure with the help of an autoalignment system. Features quick and easy measurement that does not require any special skills.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparison in the measurement accuracy among Canon TX-10 and Canon T-2 was performed.
Key results are:
- Regression Slope: TX-10 (0.996) vs T-2 (0.907), ISO Specifications (0.95 to 1.05)
- Regression Y intercept: TX-10 (0.462mmHg) vs T-2 (1.08mmHg), ISO Specifications (-1.0 to +1.0)
- Standard Deviation of Difference, Sd: TX-10 (1.56mmHg) vs T-2 (2.12mmHg), ISO Specifications (2.5mmHg)
- Coefficient of Correlation: TX-10 (0.926) vs T-2 (0.858), ISO Specifications (Unspecified)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
8
Image /page/0/Picture/3 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '963079'. The handwriting style appears cursive and the numbers are written in a connected manner.
CANON U.S.A., INC. ONE CANON PLAZA LAKE SUCCESS, NY 11042-1198 TELEPHONE: (516) 328-5000 GENERAL FAX TELEPHONE (516) 328-5069
MAR - 3 1997
510(k) Summary
July 23, 1996 1. Date Prepared: 2. Applicant's Name: Canon USA, Inc. One Canon Plaza Lake Success, NY 11042 U.S.A. Mr. Glenn Impal / Mr. Ken Shadoff Phone: (516) 328-5600 (516) 328-2169 Fax: 3. Model Name: Canon TX-10 Tonometer 86HKX, Tonometer, AC Powered Document Control Number: ? Canon T-2 Tonometer 4. Predicate Model: 86HKX, Tonometer, AC Powered Document Control Number: K943939 The TX-10 is a tonometer designed using a non-contact measurement system. 5. Device Description: A ir puff gently measures the intraocular pressure with the help of an autoalignment system. Features quick and easy measurement that does not require any special skills. The TX-10 tonometer is intended to be used for the measurement of intraocular 6. Intended Use: pressure of the human eye. 7. Summary of Technological Characteristics: See the attached comparison chart. 8. Assessment of See Attachment 1 Performance Data:
1
| | TX-10 | T-2 | ISO
Specifications
(proposed) |
|--------------------------------------------|-----------|----------|-------------------------------------|
| Regression
Slope | 0.996 | 0.907 | 0.95 to 1.05 |
| Regression Y
intercept | 0.462mmHg | 1.08mmHg | -1.0 to +1.0 |
| Standard
Deviation of
Difference, Sd | 1.56mmHg | 2.12mmHg | 2.5mmHg |
| Coefficient of
Correlation | 0.926 | 0.858 | Unspecified |
Comparison in the measurement accuracy among Canon TX-10 and Canon T-2
:
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2
CANON TONOMETERS COMPARISON CHART
| MODEL | | CANON NON CONTACT
TONOMETER T-2 | CANON TONOMETER
TX-10 |
|-------------------------------------------|----------------------------|------------------------------------------------------------|----------------------------------------------------------|
| Specifi-
cation | Measuring Range
Setting | 030/060mmHg
(Automatic) | Same as T-2 |
| | Alignment Method | One bright dot with
alignment level display | Auto Mode
Monitor and auto fine
alignment |
| | | | Manual Mode
Monitor with two dots |
| | Increment | 1 mmHg | Same as T-2 |
| | Measuring Time | 3 millisecond
(0.003 second) | Same as T-2 |
| | Fixation Target | LED (green) | Same as T-2 |
| | Chin Rest | Manual | Power assisted
(driving at controller) |
| Safety Mechanism | | Mechanical Stopper | Software Controlled Stopper |
| Printout Format | | R/L, date, time, avarage, ID,
3 or 10 data for each eye | Same as T-2 |
| Display | | 5" (inch) B/W CRT | 4" (inch) Color LCD |
| Dimentions
(width x depth x height) mm | | 286 x 445 x 472 | Body
299 x 340 x 177
Controller
170 x 183 x 177 |
| Weight (kg) | | 22.0 | Body
16.0
Controller
1.5 |
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