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The ilwait timer oculopressor device is used to perform pre-operative ocular compression.

The device is used in the clinical and pre-operative ward, when the patient is supine, sedated and accompanied by a medical staff member.

The mass of the ilwait timer oculopressor provides even pressure across the eyelid to soften the eye. The timer function provides a reminder to monitor the compression duration.

The ilwait timer oculopressor is an orbital ocular compression applicator comprising a mass which applies a suitable force under gravity against the closed eyelid of a supine patient for the purpose of performing pre-operative ocular compression.

The static pressure applied by the device assists in the diffusion of anaesthetic agents that may accumulate or be resident under the conjunctival membrane (chemosis) and surrounding tissues following retrobulbar, peribulbar and subtenons anaesthetic administration, and softens the eye by forcing intraocular fluid from the globe via the natural pressure regulation pathways.

The ilwait timer oculopressor is located to the patient's head with an adjustable strap fitted to provide access to the left or right eye socket. The fixation of the device to this strap allows a static, balanced device position to be maintained.

The ilwait timer oculopressor incorporates a user-activated cumulative stopwatch timer to record total duration of application, with an upper limit (including programmed pauses) indicated by a visual and audible interface warning at 23 minutes.

The provided text is a 510(k) summary for the ilwait timer oculopressor, an ocular pressure applicator. It describes the device, its function, and claims substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any of the detailed aspects of a clinical study typically associated with AI/algorithm performance (e.g., sample sizes, ground truth establishment, MRMC studies, standalone performance).

The device described is a physical instrument for applying static pressure to the eye and incorporates a simple stopwatch timer. It does not appear to be an AI or algorithm-driven device. Therefore, the requested information elements related to AI/algorithm performance studies are not applicable to this submission.

Here's a breakdown of why many of your requested points cannot be answered based on the provided text:

• No AI/Algorithm mentioned: The device is purely mechanical with a user-activated timer. There is no mention of algorithms, AI, or software that performs analysis or makes decisions.
• No performance criteria beyond 'substantial equivalence': The document focuses on demonstrating substantial equivalence to a predicate device (Honan Intraocular Pressure Reducer) based on intended use, technological characteristics, and safety. It does not define specific performance metrics or acceptance criteria that would typically be evaluated in a study for a diagnostic or AI-powered device.
• No clinical study data provided: The submission is a 510(k) summary, which often relies on demonstrating equivalence rather than providing de novo clinical study results against defined metrics.

Given this, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer the questions about sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance, as these are not discussed in relation to this device.

The only "study" mentioned implicitly is the comparison to the predicate device to establish substantial equivalence, which is a regulatory pathway, not a performance study in the way you've framed the questions.

Summary of available information related to your request headings:

1. Table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to a predicate device rather than specific performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as the device is not an AI/algorithm-driven system and no reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document states: "Clinically the eye recovers naturally from compression within a short period and there are no cumulative effects known from safe, monitored compression at this level." This is a general statement about the known physiological effects of ocular compression, not a report of a specific study conducted for this device's submission.

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