(77 days)
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."
}
N/A