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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.

1. 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.

2. 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.

3. 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.

4. Adjudication Method for the Test Set:

   • Not applicable, as no clinical test set was used for this 510(k) submission.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

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The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the eye or skin and an ultrasonic transducer.

The ClearScan™ ultrasound probe cover is indicated when it is necessary to have a sterile, single-use protective sheath with fluid coupling between the examined sufface and an ultrasonic transducer.

The ClearScan™ ultrasound probe cover is intended to be used as a sterile, single-use protective cover with fluid coupling between the examined surface and an ultrasonic transducer. The device provides a microbial barrier between the probe and the patient's tissue, helping to prevent the transfer of microorganisms, body fluids and particulate material to the patient and healthcare personnel. It provides a water path between the trausducer and the surface scanned.

The ClearScan™ material that contacts the eye or skin tissue is made of a soft pliable plastic film. The JlearScan is a sealable plastic sac that encloses the transducer and holds water to make the water path for scanning.

The ClearScan is made of a biologically-compatible, non-latex membrane. It has a special collar that permits it to be sealed around the body of the transducer.

Here's an analysis of the provided text regarding the ESI ClearScan Transducer Cover, focusing on acceptance criteria and study details:

Overall Assessment:

The provided document (K080119) is a 510(k) submission for a device that is essentially a non-latex cover for ultrasound transducers. The primary purpose of this device is to provide a sterile barrier and a water path for ultrasound scanning.

Crucially, this submission does NOT contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for diagnostic or therapeutic efficacy. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device (Civco Poly Ultrasound Transducer Cover K970573, K992152) and safety through biocompatibility.

Therefore, many of the requested sections below will indicate "Not applicable" or "Not provided" because the nature of this device and its 510(k) submission does not require comprehensive clinical performance studies to establish diagnostic accuracy or treatment effectiveness.

Acceptance Criteria and Reported Device Performance

Given the nature of the device (a sterile cover) and the 510(k) submission type, the "acceptance criteria" are primarily related to safety, sterility, and functional equivalence to its predicate. No specific performance metrics like sensitivity, specificity, or accuracy are provided as this is not a diagnostic algorithm.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable / Not provided. The submission states "Non-clinical tests" (biocompatibility and distortion assessment) but does not detail sample sizes for these tests within the provided summary. No clinical test set involving patients or data sets is described, as the submission states "Clinical tests: Not required."
   • Data Provenance: Not applicable / Not provided. Since clinical tests were deemed not required, there is no patient data provenance (e.g., country of origin, retrospective/prospective). Non-clinical tests would typically be laboratory-based.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. No "ground truth" in the diagnostic or performance sense was established for a test set, as no clinical efficacy study was conducted. The main "truth" being established was around biocompatibility and functional equivalence, which don't typically involve expert panels in this manner for this type of device.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. No test set requiring expert adjudication was described.

4. 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, non-AI-powered accessory (an ultrasound probe cover). No MRMC or AI-related studies were conducted or are relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this type of device primarily relates to whether the material is indeed biocompatible and if the cover functions as intended (e.g., provides a sterile barrier, holds water, doesn't cause artifact for imaging). For biocompatibility, this is typically established by recognized standards (e.g., ISO 10993 series) and laboratory testing. For functional aspects, it's engineering and material science validation. No clinical "ground truth" (e.g., disease presence/absence) was established for this submission.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an algorithm was used.

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