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510(k) Data Aggregation
(30 days)
COMPACT TOUCH Ophthalmic Ultrasound System
The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- Visualization of the interior of the eye and the orbit by A and B scans.
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement.
- Measurement of corneal thickness by ultrasonic means.
The COMPACT TOUCH Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical trial or performance study report. Instead, it is a 510(k) summary for a medical device (COMPACT TOUCH® Ophthalmic Ultrasound System) seeking FDA clearance based on substantial equivalence to an existing predicate device (K094038).
The document focuses on explaining that the new device has the same indications for use and similar technological characteristics to the predicate device, with some minor modifications. The "performance data" section primarily lists compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, usability, and particular requirements for ultrasonic medical diagnostic equipment. It also mentions hardware and software validation activities.
However, I can extract the relevant information regarding the performance improvement stated and the basis for equivalence as outlined in the document.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for a full "acceptance criteria and study results" breakdown.
Device Name: COMPACT TOUCH® Ophthalmic Ultrasound System
Predicate Device: Quantel Medical Compact Touch (K094038)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the form of specific thresholds (e.g., sensitivity, specificity, accuracy targets) for its diagnostic functions or biometric measurements, as would be typical for a clinical performance study. Instead, the "acceptance criteria" are implied by showing equivalence to the predicate and highlighting an improvement in measurement accuracy for one specific probe.
| Acceptance Criterion (Implied by Equivalence / Improvement) | Reported Device Performance (New Device) |
|---|---|
| B-Scan Probe Measurement Accuracy | Improved to ± 0.115 mm |
| (Predicate Device Performance) | (± 0.2 mm) |
| Safety and Effectiveness | (Not explicitly quantified, but stated as unimpaired despite modifications) |
| Compliance with Consensus Standards | Demonstrated compliance with listed IEC and AAMI ANSI standards |
| Software Validation | Performed, appropriate for Moderate level of concern |
| Electrical Safety | Complies with electrical safety standards (degree of protection changed from BF to B) |
| Electromagnetic Compatibility (EMC) | Complies with EMC standards |
| Usability | Complies with usability standards |
| Indications for Use | Same as predicate device |
| Technological Characteristics | Similar to predicate device (A-scan/pachymeter identical, B-scan frequency increased, other minor changes) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or test subjects for evaluating the improved measurement accuracy (± 0.115 mm). It states that the improvement is "due to the increase of the frequency of the probe" and that "IEC 60601-2-37 tests have been followed...". This suggests the performance claim for accuracy is likely derived from laboratory testing or phantom measurements, rather than a clinical study on a patient population.
Data provenance (country of origin, retrospective/prospective) and details of the "test set" are not provided, as it seems no clinical human subject test set was used for the accuracy claim or overall equivalence beyond technical standard compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical test set with human subjects is described for evaluating the stated performance improvement, there is no mention of experts being used to establish ground truth in such a context. The evaluation appears to be based on technical specifications and compliance with standards.
4. Adjudication Method for the Test Set
As no clinical test set for human subject performance validation is described, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any assessment of human readers improving with or without AI assistance. This device is an ultrasound system purely for diagnostic imaging and biometric measurement, not an AI-powered diagnostic interpretation tool.
6. Standalone (Algorithm Only) Performance Study
The document describes the device as an "Ophthalmic Ultrasound System" which performs imaging and measurements. It mentions "calculations" and "software revised to accommodate the other device changes". However, there is no standalone algorithm-only performance study described in the context of diagnostic interpretation or classification. The performance discussed relates to the physical measurement capabilities of the ultrasound system.
7. Type of Ground Truth Used
For the improved measurement accuracy of ± 0.115 mm, the ground truth is implicitly derived from technical specifications and calibration procedures of the ultrasound system, likely using phantoms or reference standards in a laboratory setting, rather than expert consensus, pathology, or outcomes data from human subjects. The primary "ground truth" for the overall device's safety and effectiveness in the context of this 510(k) is its substantial equivalence to the predicate device, which itself would have undergone its own validation.
8. Sample Size for the Training Set
This document pertains to a hardware device with associated software for measurement and display. It is not an AI/Machine Learning device that undergoes a "training" process with a large dataset. Therefore, there is no training set sample size mentioned.
9. How the Ground Truth for the Training Set Was Established
As it is not an AI/Machine Learning device, there is no training set and consequently no ground truth establishment process for a training set mentioned.
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(93 days)
COMPACT TOUCH STS
The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.
The provided text describes a 510(k) summary for the Quantel Medical COMPACT TOUCH STS Ophthalmic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, extensive performance data, and detailed study methodologies is not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria (Not explicitly stated/Quantitative) | Reported Device Performance (Summary) |
|---|---|
| Implicit Acceptance: Device uses similar technology and physical output characteristics to predicate device. | Device uses similar technology and physical output characteristics as the Sonomed Inc. VuMax Ophthalmic Ultrasound System (K060626). |
| Implicit Acceptance: Meets design specifications. | Laboratory testing verifies the device meets design specifications. |
| Implicit Acceptance: Similar indications for use. | Indications for use are similar to previously cleared devices. |
| Implicit Acceptance: Comparable risks and benefits. | Risks and benefits are argued to be comparable to predicate devices. |
| Implicit Acceptance: No new questions of safety or efficacy. | No new questions of safety or efficacy are raised. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission states, "No Clinical testing is required." The evaluation was based on laboratory testing to verify design specifications and demonstrate substantial equivalence, not on a clinical test set with patient data.
- Data Provenance: Not applicable, as no clinical test set data is described. The "laboratory testing" mentioned implies internal testing data, likely from the manufacturer's facilities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Since no clinical test set was used and no "ground truth" for patient data was established in the context of this submission, the number and qualifications of experts are not relevant or provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states, "No Clinical testing is required." Therefore, no MRMC study, either with or without AI assistance, was conducted or reported.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study was done and the device is a standalone ultrasound system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, in a sense, but not in the context of an AI algorithm. The device itself, as an ophthalmic ultrasound system, is a standalone diagnostic tool. The "Performance Data" section describes "Laboratory testing following the guidance 'Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers' (Sept 9, 2000)" to verify it met design specifications. This implies testing the device's physical performance, imaging capabilities, and measurement accuracy in a controlled laboratory setting, independent of human interpretation for substantial equivalence purposes.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "laboratory testing," the ground truth would have been established through validated measurement standards, phantoms, and calibrated equipment, rather than clinical ground truth like pathology or expert consensus on patient cases. The goal was to verify the device's technical specifications and ensure it produced accurate ultrasound images and measurements in a controlled environment, consistent with its design.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The COMPACT TOUCH STS is an ophthalmic ultrasound system, not an AI/ML-based device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
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(113 days)
COMPACT TOUCH
The QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- Visualization of the interior of the eye and the orbit by A and B scans.
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement.
- Measurement of corneal thickness by ultrasonic means.
The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Compact TOUCH Ophthalmic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria with quantifiable metrics (e.g., accuracy, precision values) for the device's performance. Instead, it relies on a claim of "substantial equivalence" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| A-scan Probe Performance | "identical to that used by the predicate, AVISO K051851." |
| Axial Length measurement | (Not explicitly quantified, but implied to be equivalent to predicate) |
| IOL power calculation | (Not explicitly quantified, but implied to be equivalent to predicate based on axial length measurement) |
| B-scan Probe Performance | "identical to that used by the predicate, AVISO K051851." |
| Diagnostic imaging of the eye | (Not explicitly quantified, but implied to be equivalent to predicate) |
| Pachymetry Probe Performance | "identical to that used by the predicate, POCKET K993674." |
| Corneal thickness measurement | (Not explicitly quantified, but implied to be equivalent to predicate) |
| Overall System Performance | "met design specifications and was substantially equivalent to the predicate devices." |
| Safety and Efficacy | "risks and benefits for the Compact TOUCH are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the Compact TOUCH." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The study described is "Laboratory testing," which suggests it was likely performed in a controlled environment, but the origin of any data used for comparison (if any beyond predicate device specifications) is not mentioned. It is not possible to determine if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The submission states "No Clinical testing is required," meaning there was no human-based evaluation of diagnostic output that would necessitate an adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The document explicitly states "No Clinical testing is required." Therefore, no assessment of human reader improvement with or without AI assistance was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in a way. The "Laboratory testing" was performed to verify that the device met design specifications and was substantially equivalent to predicate devices. This type of testing would assess the device's performance directly against established specifications or the performance of other devices, without human-in-the-loop diagnostic interpretation. However, the exact methodology for this testing is not detailed beyond referencing a guidance document.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this submission appears to be based on the design specifications of the Compact TOUCH and the established performance of the predicate devices. The device's components (probes) are explicitly stated to be "identical" to those used in the predicate devices, implying that their performance characteristics are known and accepted.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is an ultrasound system and its probes, not an algorithm that undergoes machine learning training in the context commonly understood today (e.g., AI with neural networks). The "training" in this context would refer to the engineering and validation processes that led to the design specifications of the device and its probes, which are stated to be identical to previously cleared devices.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable in the context of machine learning training data. For a hardware device like this, the "ground truth" for its design and manufacturing would be established through engineering specifications, previous validation studies for the predicate devices, and adherence to relevant industry standards and guidance documents (e.g., "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"). The claim of "identical" probes to predicate devices means the extensive testing and validation performed for those original devices serve as the foundation for the current device's performance claims.
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