(66 days)
The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye for A-scan biometry of the eye.
The shell is a cylinder with an open top and open bottom,. The open bottom end is contoured at the rim to conform to the curvature of the eye. The ultrasonic transducer is placed in the Prager Shell® from above. Once placed on the eye the shell is filled with balanced salt solution (BSS) and the probe distal end is immersed in the BSS. It is not sold sterile and is reusable. Tubing kits are available to connect the shell to the BSS source. These kits are distributed by ESI but not manufactured by it.
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Table of Acceptance Criteria and Reported Device Performance:
Feature/Criterion Acceptance Criteria Reported Device Performance Intended Use To provide a water path between an ultrasound transducer and the eye for A-scan biometry. The device description and intended use clearly state: "The Prager Shell® is a plastic device intended to provide a water path between an ultrasound transducer and the eye. It is intended for A-scan biometry of the eye." This aligns with the stated predicate device (Water Bath for Sonometrics Coleman A-B scan system), which also provides a water path for eye ultrasound. Technological Characteristics Made of biologically-compatible rigid plastic, specific models for different transducers, mechanisms to lock onto transducers. The device is described as "made of a biologically-compatible rigid plastic." It is also stated that "Each model fits the transducers of specific ultrasound manufacturers" and that "They are fitted with mechanisms so that they may be locked in place on the transducers." However, explicit acceptance criteria for these characteristics (e.g., specific biocompatibility test results, or detailed fitting specifications) are not provided in the document. The statement implies compliance but doesn't detail the criteria. Safety/Biocompatibility Biocompatibility tests should be done, and the device should be equivalent in safety to the predicate device. "Biocompatibility tests have been done." The document concludes that "The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device." No specific test results or detailed criteria for biocompatibility are provided within this summary, only that the tests were conducted and the device was deemed equivalent in safety. Clinical Performance/Efficacy Equivalent in efficacy to the legally marketed predicate device for A-scan biometry. The document explicitly states "Clinical tests: Not required" and concludes "The Prager Shell is equivalent in safety and efficacy to the legally marketed predicate device." The basis for this equivalence in efficacy is presumed to be the similarity in intended use and technological characteristics to the predicate (a water bath for sonometry), rather than direct clinical efficacy testing of the new device itself. No specific efficacy metrics or performance results are provided from direct testing of the Prager Shell. Sterility Not sold sterile. The device "is not sold sterile and is reusable." This is a characteristic description rather than a performance acceptance criterion, but it is explicitly stated. -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. The document explicitly states "Clinical tests: Not required" and "Not required" under the performance data section. The device's equivalence was established through non-clinical biocompatibility tests and a comparison of technological characteristics and intended use to a preamendment predicate device, rather than through a clinical test set.
- Data Provenance: Not applicable, as no clinical test set was used for this 510(k) submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable, as no clinical test set was used for this 510(k) submission.
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Adjudication Method for the Test Set:
- Not applicable, as no clinical test set was used for this 510(k) submission.
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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 device is a passive accessory (a rigid water path for an ultrasonic transducer) and does not involve AI or human reader interpretation. No MRMC study was conducted or is relevant for this type of device.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device accessory, not an algorithm or software. No standalone algorithm performance evaluation was done.
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The Type of Ground Truth Used:
- Not applicable for performance evaluation based on a test set. The "ground truth" for the 510(k) submission was established by demonstrating substantial equivalence to a legally marketed predicate device (Water Bath for Sonometrics Coleman A-B scan system) based on:
- Identical intended use.
- Similar technological characteristics (biologically-compatible rigid plastic, forms a water path).
- Demonstrated biocompatibility through non-clinical testing.
- Therefore, the ground truth for this submission relies on regulatory comparison and non-clinical testing rather than clinical ground truth like pathology or outcomes data from a test set.
- Not applicable for performance evaluation based on a test set. The "ground truth" for the 510(k) submission was established by demonstrating substantial equivalence to a legally marketed predicate device (Water Bath for Sonometrics Coleman A-B scan system) based on:
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The Sample Size for the Training Set:
- Not applicable, as this is a physical device and not an AI/ML algorithm requiring a training set.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as this is a physical device and not an AI/ML algorithm requiring a training set.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.