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ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:

1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
2. Mechanical stabilization of middle ear and cochlear implants.
3. Attachment of middle ear implants to the ossicular bones.

ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.

Acceptance Criteria and Device Performance for ProCem™ Otologic Bone Cement

This document summarizes the acceptance criteria and supporting study for the ProCem™ Otologic Bone Cement, as derived from the provided 510(k) summary (K140644).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for ProCem™ Otologic Bone Cement are based on its substantial equivalence to predicate devices (SerenoCem, K003567 and EnvoyCem, K080032). The study conducted was primarily to demonstrate that ProCem™ meets physical and functional requirements comparable to these predicate devices.

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

The provided document describes "Design verification testing" but does not explicitly state specific sample sizes for each test (exothermic reaction, working time, snap set time, simulated preparation properties). The data provenance is not specified in terms of country of origin, but the studies were conducted by Ototronix LLC, the submitter, as part of their 510(k) application. This would be considered a prospective study conducted for regulatory submission.

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

There is no mention of experts being used to establish a "ground truth" in the context of clinical performance or diagnostic accuracy. The testing described focuses on the physical and functional properties of the bone cement itself, rather than interpretation of clinical outcomes by experts.

4. Adjudication Method for the Test Set

Not applicable. The described testing is focused on objective physical and chemical properties of the device, not on subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is a bone cement, not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone study was done. The "Performance Bench Testing" describes in-house design verification testing, demonstrating the physical and functional properties of the ProCem™ device on its own. This testing was performed independent of human interaction in a clinical setting for performance evaluation.

7. Type of Ground Truth Used

The ground truth for the performance bench testing was based on established engineering specifications and comparison to the known performance characteristics of the predicate device (SerenoCem). This involves objective measurements of physical and chemical properties.

8. Sample Size for the Training Set

Not applicable. The ProCem™ Otologic Bone Cement is a physical medical device (bone cement), not a software algorithm that would require a training set.

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

Not applicable, as there is no training set for this type of medical device.

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The Nystagram™ is a video nystagmograph intended to view, record, and measure eye movements in support of identification of balance disorders. The device is intended for use only by qualified, trained medical personnel to aid in diagnostic recommendations. This device does not provide any medical diagnosis and is intended to be part of a larger balance assessment battery.

The Nystagram™ is a device that views, records and measures both vertical and horizontal eye movements for support of identification of balance disorders. The results of the video nystagmograph (VNG) tests are combined with other clinical information to allow qualified medical personnel to determine the health of a patient's vestibular function system. The Nystagram™ system consists of a goggles system with a video camera and accelerometers to record eye movements and head position, computer monitors and other hardware and software to control the operation of the patient stimulus and the test administration functions. The system software is used for nystagmus analysis during oculomotor mobility, positional nystagmus, and caloric examinations. The results are presented in visual diagrams for clinical review.

The provided text describes the Nystagram™ Video Nystagmography System and its substantial equivalence to predicate devices, focusing on the comparative evaluation conducted. Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance

Study Information:

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

   • Sample Size: Five (5) subjects.
   • Data Provenance: Prospective. The study involved measuring the response of these subjects to stimuli within a 24-hour period by both the Nystagram™ and a predicate device. The audiologists were in Sugarland, Texas and The Woodlands, Texas, respectively.

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

   • Number of Experts: Two (2) independent Audiologists.
   • Qualifications of Experts: They are described as "independent Audiologist" without further specification of experience (e.g., years of experience).

3. Adjudication method for the test set:

   • The adjudication method was a direct comparison of clinical findings between the two devices as interpreted by two independent audiologists. The equivalency was demonstrated when interpretations of the data by each audiologist matched for each test and subject. This indicates a consensus approach where agreement between the two independent clinical evaluations served as the basis for equivalency.

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:

   • This was not a multi-reader, multi-case study in the context of AI assistance. It was a comparative performance study of two medical devices (Nystagram™ vs. a predicate VNG device) where human audiologists served as the evaluators of the device's output. The study aimed to show equivalence between the devices, not how human performance improved with or without AI. Therefore, there is no effect size related to AI assistance.

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

   • The provided text does not describe a standalone algorithm-only performance study. The device "views, records, and measures eye movements," and the "system software is used for nystagmus analysis." However, the "results are presented in visual diagrams for clinical review," and the device is intended for "use only by qualified, trained medical personnel to aid in diagnostic recommendations." The clinical equivalency study explicitly involved human audiologists clinically evaluating the resultant tracings and judging them as "Normal/Abnormal" or "Positive/Negative." This indicates human-in-the-loop performance is integral.

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

   • The ground truth was established through expert clinical evaluation/interpretation by the independent Audiologists. They clinically evaluated the tracings and judged the findings as "Normal/Abnormal" or "Positive/Negative." Equivalency was achieved when these expert interpretations from both devices matched.

7. The sample size for the training set:

   • The document does not mention a separate training set or its sample size. The study described is a comparative evaluation for establishing clinical equivalency, involving 5 subjects, which serves as the "test set" for this particular equivalency study.

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

   • Since no training set and corresponding ground truth establishment are explicitly described in the provided document, this information is not available. The document focuses on the comparative performance of the device in relation to a predicate device for regulatory clearance.

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