Search Results

QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.

This device is for Prescription Use (Rx) only.

QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.

QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.

QUATERA 700 has the following functions:

• · Irrigation and Aspiration
• · Ultrasound Capability
• · Diathermy
• · Anterior Vitrectomy
• Reflux

QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

The provided text is an FDA 510(k) clearance letter for a medical device called QUATERA 700. It asserts the device's substantial equivalence to a predicate device (also a QUATERA 700, but with older software) rather than presenting a performance study against specific acceptance criteria for a novel AI/software component.

Therefore, many of the requested details, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models, are not applicable or not present in this document.

The document focuses on non-clinical performance testing and substantial equivalence to an existing device, primarily due to minor software changes and component updates. There is no mention of an AI/machine learning component that would require the rigorous performance evaluation typically outlined by the questions.

However, I can extract and infer information relevant to the types of "acceptance criteria" and "study" that were performed to demonstrate substantial equivalence, based on the provided text, even if not in the AI-specific format you requested.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of quantitative performance metrics against specific predefined acceptance criteria in the way one would for an AI algorithm's diagnostic accuracy. Instead, the "acceptance criteria" for this 510(k) are essentially the demonstration of compliance with established medical device standards and the maintenance of equivalence to the predicate device. The "performance" is a statement of compliance or "passed."

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable in the context of an AI model's performance on a dataset. The "tests" performed here are primarily engineering verification and validation (e.g., software testing, electrical safety, bench testing for performance against standards). The document does not specify "sample sizes" for these types of tests (e.g., how many times an electrical test was run, or how many components were tested for sterility).
• Data Provenance: Not applicable in the context of clinical data for AI model evaluation. The "data" here refers to test results from engineering and lab assessments.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The "ground truth" for this filing is compliance with engineering standards, functional equivalence to a predicate device, and successful verification/validation testing. This is typically established through documented test procedures and adherence to regulatory guidelines, not clinical expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of discrepancies in expert readings for clinical test sets.

5. MRMC Comparative Effectiveness Study:

No. The document explicitly states: "Animal and Clinical testing was not conducted." Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. Standalone Performance:

Not applicable in the context of an AI algorithm's standalone performance. The device itself (QUATERA 700) performs specific surgical functions. Its "performance" is demonstrated through engineering tests and comparison to a predicate device, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international and national standards (e.g., ISO, IEC, FDA guidance documents).
• Successful completion of verification and validation testing protocols.
• Functional equivalence to the legally marketed predicate device, demonstrated through comparative tables of specifications.

8. Sample Size for the Training Set:

Not applicable. This device is a phacofragmentation system, not an AI/machine learning model that undergoes a "training" phase on a dataset of clinical cases.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI model.

In summary: The K230858 clearance for QUATERA 700 is for a surgical device that has undergone minor software and component changes. The "acceptance criteria" and "study" described in the document are primarily focused on demonstrating continued safety, efficacy, and substantial equivalence to an existing predicate device through engineering verification and validation, rather than a clinical performance study of a novel AI component.

Ask a specific question about this device

QUATERA 700 is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation, bipolar coagulation and anterior vitrectomy.

QUATERA 700 is a mobile phacoemulsification system designed for use in the ophthalmic surgical operating rooms during surgery of the anterior eye segment. When QUATERA 700 is used with compatible components and accessories, the system will perform the following surgical procedures: irrigation and/or aspiration, phacoemulsification of crystalline lens, anterior vitrectomy, and bipolar coagulation.

QUATERA 700 has fluidic, ultrasound and pneumatic modules for emulsification and aspiration of the cataractous lens from eye and maintain the pressure and volume of the eye intraoperatively. The required values are pre-set via a Graphical User Interface and controlled directly by the surgeon using the Foot Control Panel of the device and delivered in the eye via a range of accessories. The systems control mechanism verifies the output values and the pre-set values.

QUATERA 700 has the following functions:

• Irrigation and Aspiration
• . Ultrasound Capability
• Diathermy
• Anterior Vitrectomy ●
• . Reflux

QUATERA 700 is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

This FDA 510(k) summary document for the QUATERA 700 phacoemulsification system does not provide specific acceptance criteria or a detailed study report proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (EVA Ophthalmic Surgical System K142877) through non-clinical performance testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various non-clinical tests performed and states that "Testing passed" or "Testing showed that the defined specifications [were met]". The "acceptance criteria" are implied to be the standards and specifications referenced for each test.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample sizes used for any of the non-clinical tests (e.g., how many units were tested for electrical safety, how many components for biocompatibility). The testing is described qualitatively.
• Data Provenance: The data provenance is primarily from non-clinical bench testing conducted by the manufacturer, Carl Zeiss Meditec AG, located in Germany. These are laboratory tests and do not involve human subjects or retrospective/prospective clinical data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical engineering and laboratory testing, not a clinical study with human data requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as above. The "ground truth" for the non-clinical tests is based on the adherence to established industry standards and internal specifications, not expert adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not required since the system does not introduce a new methodology or new/expanded clinical claims." This indicates that the FDA deemed a clinical study unnecessary for this 510(k) submission, relying instead on substantial equivalence to the predicate device. Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described (QUATERA 700) is a phacoemulsification surgical system, not an AI or algorithm-only device. Its performance is inherent in its electromechanical functions and safety features. Therefore, a standalone "algorithm only" performance assessment in the context of AI is not applicable. The software testing was for the device's internal control software, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is established by:

• Industry standards and regulations: e.g., ISO, ASTM, IEC, USP.
• Manufacturer's defined specifications: These are the internal performance requirements for the device.

8. The Sample Size for the Training Set

This information is not applicable. The QUATERA 700 is a surgical hardware system with integrated software, not a machine learning or AI device that requires a "training set" in the conventional sense for deep learning models. The software testing mentioned is for the device's operational software.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. There is no training set for an AI model.

In summary, the provided document focuses entirely on demonstrating the substantial equivalence of the QUATERA 700 to an existing predicate device through non-clinical bench testing, adhering to recognized standards for safety and performance (biocompatibility, sterility, software, electrical safety, etc.). It explicitly states that clinical studies were not required.

Ask a specific question about this device