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This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.

The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.

The provided text describes a medical device, the "Tubing Extension Set" by Hurricane Medical, and its regulatory clearance as substantially equivalent to existing devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically describe for a software-based medical device (e.g., an AI algorithm).

The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed performance study with quantitative acceptance criteria for a novel device.

Therefore, for almost all the requested information, the answer will be "Not applicable" or "Information not provided in the given text."

Here's a breakdown of why based on your request:

1. A table of acceptance criteria and the reported device performance

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 / Information not provided. This document does not describe a clinical or performance study with a "test set" in the context of an AI/algorithm-driven device. The "study" mentioned is a review of existing literature and the physical properties of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Information not provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Reference is made to historical uses described by "Emery et. al." and "Jaffe et. al." in ophthalmic surgery literature.

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

• Not applicable / Information not provided. No test set or adjudication method is described.

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 / Information not provided. This device is a physical tubing extension set, not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable / Information not provided. This is a physical medical device, not an algorithm.

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

• Not applicable / Information not provided. The "truth" in this submission relies on established surgical practices using similar tubing, the physical and material properties of the tubing, and sterility validation for a physical product. Not a "ground truth" as typically defined for AI performance studies.

8. The sample size for the training set

• Not applicable / Information not provided. This is a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable / Information not provided. This is a physical medical device.

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These devices are used in ophthalmic surgery to reconstruct the lacrimal outflow system, dacryocystorhinostomy, and other lacrimal system reconstruction.

The referenced devices consist of two pieces of the same gauge size and leagues statules. Description: The reterenced devices consist of two pieces of the same from the relations two by frietion fft, gluing, or crimping.

{
"1_table_of_acceptance_criteria_and_the_reported_device_performance": {
"Characteristic": [
"Probe Material",
"Probe Size (DxL)",
"Probe Size (DxL)",
"Tubing Matcrial",
"Rod Material",
"Tubing Size (DxL)",
"Rod Size (DxL)",
"Adhesive Used",
"Probe Ends",
"Probe Malleability",
"Surgical Uses",
"Package Type",
"Packaged Sterile"
],
"Hurricane Medical": [
"Stainless Steel Wire",
"0.025" x 7"",
"0.90" x 1.75"",
"Medical Grade Silicone",
"Medical Grade Silicone",
"0.025" x 13"",
"0.080" x 15"",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"JEDMED": [
"Stainless Steel Wire",
"0.016" x 4"",
"N/A",
"Medical Grade Silicone",
"Medical Grade Silicone",
"0.025" x unknown",
"N/A",
"Yes",
"Olive Shaped (Rounded)",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"SOLAN": [
"Stainless Steel Wire",
"0.051" x 6"",
"N/A",
"Silicone",
"Silicone",
"Unknown x 12"",
"N/A",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
],
"VISITEC": [
"Stainless Steel Wire",
"0.025" x 7"",
"0.90" x 1.75"",
"Silicone",
"Silicone",
"0.025" x 14"",
"0.080" x 15"",
"Yes",
"Rounded/Blunt",
"Excellent",
"Single",
"Tyvek Pouch",
"Yes"
]
},
"2_sample_sized_used_for_the_test_set_and_the_data_provenance": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set of patient data. Therefore, this information is not applicable.",
"3_number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_the_qualifications_of_those_experts": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set requiring expert ground truth. Therefore, this information is not applicable.",
"4_adjudication_method_for_the_test_set": "The document describes a 510(k) submission for substantial equivalence based on technological characteristics and literature review, not a clinical study with a test set requiring adjudication. Therefore, this information is 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": "No MRMC comparative effectiveness study was done. This is a 510(k) submission for a medical device (lacrimal intubation sets and DCR sets), not an AI-based diagnostic or assistive technology. The evaluation is based on substantial equivalence to predicate devices.",
"6_if_a_standalone_i.e._algorithm_only_without_human-in-the_loop_performance_was_done": "No standalone algorithm-only performance study was done. This is a 510(k) submission for a medical device (lacrimal intubation sets and DCR sets), not an AI-based system. The evaluation is based on substantial equivalence to predicate devices.",
"7_the_type_of_ground_truth_used": "The concept of 'ground truth' as it applies to clinical study outcomes or diagnostic accuracy is not directly applicable here. The 'ground truth' for this 510(k) submission is the functional and safety characteristics of existing legally marketed predicate devices, against which the new device (Hurricane Medical's sets) is compared for substantial equivalence.",
"8_the_sample_size_for_the_training_set": "The document does not describe a training set as would be used for an AI/ML model or a clinical trial. The assessment is based on a comparison of technological characteristics to already marketed predicate devices and a literature review. Therefore, this information is not applicable.",
"9_how_the_ground_truth_for_the_training_set_was_established": "The document does not describe a training set as would be used for an AI/ML model or a clinical trial. The assessment is based on a comparison of technological characteristics to already marketed predicate devices and a literature review, not a training set with established ground truth. Therefore, this information is not applicable."
}

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These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.

Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron.
Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge.
Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery. Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton.
Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.

The provided text focuses on the summary of safety and effectiveness for several medical devices (Corneal Light Shield, Instrument Wipes, Surgical Spears and Sponges, Fluid Wicks) and their FDA 510(k) clearance. It does not contain information on acceptance criteria for a device, nor does it describe a study proving the device meets specific acceptance criteria using the detailed points requested in your prompt.

Specifically, the document discusses:

• Historical context and problem statement: The need for corneal protection during ophthalmic surgery due to light-induced retinal damage.
• Device description: Materials and sterilization methods for the Hurricane Medical products.
• Predicate device comparison: The 510(k) clearance process implicitly relies on substantial equivalence to predicate devices, but the technical details of how current devices meet specific performance metrics are not described.
• FDA Clearance: The letter from the FDA confirms the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text. This document is a regulatory summary for device clearance, not a detailed study report.

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