Search Results
Found 1 results
510(k) Data Aggregation
(69 days)
The AT 030 is an appliance that serves to measure intraocular pressure, according to the Goldman method. Assessment of IOP may contribute to the diagnosis, and aid in the management of glaucoma.
The AT 030 applanation tonometer serves for measuring intraocular pressure, following the principle introduced by Professor Goldmann.
The AT 030 consists of the applanation tonometer with a measuring prism. The measuring prism, which includes a built-in optical doubling system, can be attached to the tonometer via the extensible measuring prism holder. The prism contacts the patient's cornea and the applanation surface is observed through the stereomicroscope of the slit lamps. The rotary knob of the graduated drum allows the user to vary the applied force. A scale on the tonometer indicates a value that can be converted into the intraocular pressure by using the conversion table supplied in the Instruction for Use.
The AT 030 applanation tonometer is compatible with the following ZEISS slit lamps: SL 120 (K133476), SL 130 (K133476), SL 220 (K162684), LSL VISULAS 532s (K013402), and LSL VISULAS 532s vite (K100035). The AT 030 works solely mechanically.
This device is a Tonometer, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance metrics, sample sizes for test and training sets, ground truth establishment methods (expert consensus, pathology, outcomes data), multi-reader multi-case studies, and standalone algorithm performance is not applicable.
However, I can provide the available information regarding the device's performance based on the provided text.
Here's a summary of the device performance and relevant testing:
1. Table of acceptance criteria and the reported device performance
| Feature | Acceptance Criteria (Predicate AT 900) | Reported Device Performance (AT 030) |
|---|---|---|
| Operation principle | Goldmann Tonometer | Goldmann Tonometer |
| Type | Manual contact tonometer | Manual contact tonometer |
| Indication | Intraocular Pressure (IOP) measurement | Intraocular Pressure (IOP) measurement |
| Type of Pressure Transducer | Measuring Prism | Measuring Prism |
| Measuring Prism | Article#: HSC 1000855 Cleared in K981432 (Identical/unmodified) | Article#: HSC 1000855 (Identical/unmodified) |
| Prism Material | Acrylic (PMMA) | Acrylic (PMMA) |
| Measurement technique | Requires maintaining a uniform applanation of the surface of the cornea. | Requires maintaining a uniform applanation of the surface of the cornea. |
| Applanation surface diameter | 3.06 mm | 3.06 mm |
| Measurement Range | 0 – 80 mm Hg | 2 – 80 mm Hg |
| Measurement reading | Reading of the value, multiplying x 10 yields the IOP in mm Hg. | Reading the value, multiplying x 10 yields the IOP in mm Hg. |
| Accuracy and repeatability | The measurement deviation in the measuring prism is in the measuring range from 0 - 58.84 mN and amounts to a maximum of ±1.5% and to a minimum of ±0.49 mN of the nominal value. | The measurement deviation in the measuring prism is in the measuring range from 0 – 58.84 mN and amounts to a maximum of ±1.5% and to a minimum of ±0.49 mN of the nominal value. |
The device (AT 030) claims substantial equivalence to the predicate device (Haag-Streit Goldmann manual tonometer AT 900) based on sharing the same intended use and technological characteristics, including the same operational principle, type, indication, pressure transducer, measuring prism, prism material, measurement technique, applanation surface diameter, and accuracy/repeatability. The only noted difference in the table is the lower bound of the measurement range (2-80 mmHg for AT 030 vs. 0-80 mmHg for AT 900).
Specific study and testing:
- Bench Testing: The AT 030 has been tested and shown to comply with the applicable requirements of ANSI Z 80.10-2014 Ophthalmic Instruments - Tonometers. It meets the requirements of a reference tonometer as specified in Annex A of ANSI Z80.10.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The device is a mechanical tonometer, and the performance demonstrated is through bench testing against a standard, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for a mechanical device is established through calibrated measurement standards, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is a mechanical device, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench testing, the ground truth is based on the requirements and specifications defined in the ANSI Z 80.10-2014 Ophthalmic Instruments - Tonometers standard, likely involving calibrated measurement references.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI device.
9. How the ground truth for the training set was established
- Not applicable. This is a mechanical device, not an AI device.
Ask a specific question about this device
Page 1 of 1