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HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.

The provided text describes the 510(k) summary for the HERMES Medical Imaging Suite v5.2, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and the study proving the device meets them.

The document states that "The testing results supports that all the software specifications have met the acceptance criteria," and "Comparisons were made between Hybrid Display and e.cam computer / e.soft workstation (K023190), and between Hybrid Recon™ and Xeleris 2 processing and review workstation (K051673). The results showed a good compliance." However, it does not provide the quantitative acceptance criteria, reported device performance, or detailed information about the studies.

Therefore, I will fill in the table and other sections with what can be inferred from the text, and clearly state where information is Not Provided (NP).

Description of the Acceptance Criteria and the Study

The HERMES Medical Imaging Suite v5.2 underwent verification and validation testing following Hermes Medical Solutions AB design controlled procedures. The testing aimed to demonstrate that all software specifications met the defined acceptance criteria and that the device was substantially equivalent to its predicate devices. The primary focus of the comparison appears to be on the equivalence in processing, display, analysis, and management of nuclear medicine and other medical imaging data. Specific comparisons were made for the "Hybrid Display" and "Hybrid Recon™" features against existing, legally marketed workstations to show "good compliance," implying that their performance matched or was equivalent to the predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not Provided (NP). The document mentions "testing" and "comparisons" but does not specify the number of cases, images, or data points used in these assessments.
• Data Provenance: Not Provided (NP). The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

• Number of Experts: Not Provided (NP).
• Qualifications of Experts: Not Provided (NP).

4. Adjudication method for the test set

• Adjudication Method: Not Provided (NP).

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

• MRMC Study Done: No. The provided text refers to comparisons between software applications, not studies involving human readers or AI assistance.
• Effect Size of Human Readers Improvement with AI: Not Applicable (NA), as no MRMC study with AI assistance for human readers was mentioned.

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

• Standalone Performance Study: Yes, implied. The "good compliance" results for "Hybrid Display" and "Hybrid Recon™" against predicate devices suggest an evaluation of the device's processing and display capabilities independent of human interpretation or intervention, focusing on its functional equivalence to existing validated software.

7. The type of ground truth used

• Type of Ground Truth: Implied to be comparison against the performance and output of previously cleared, legally marketed predicate devices (e.g., e.cam computer / e.soft workstation, Xeleris 2 processing and review workstation). This is a form of predicate device equivalence, where the "ground truth" is established by the accepted performance of the predicate.

8. The sample size for the training set

• Sample Size for Training Set: Not Provided (NP). The document does not mention any machine learning or AI components that would require a distinct "training set."

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not Applicable (NA), as no training set for machine learning was mentioned.

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The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.

The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.

The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.

Soft (hydrophilic) Contact Lens

I'm sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for contact lenses. It does not contain information about acceptance criteria or a study that proves a device meets such criteria, nor does it include details about artificial intelligence, human readers, or ground truth establishment. Therefore, I cannot generate the requested table and information based on the given input.

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