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The RITLENG®+ products are indicated in the treatment of 12 months and older in cases of:

• Canalicular pathologies (stenoses, obstructions, lacerations),

• Congenital duct obstruction (Hasner valve stenosis),

• Dacryocystorhinostomy (conventional or laser).

The RITLENG®+ is a self-retaining nasal bicanalicular intubation for the lacrimal ducts. It consists of a silicone tube with two larger diameter portions, connected at each extremity with a PEEK thread guide. Each thread guide has a wide diameter part and a narrow diameter part. The silicone tube may be coated with polyvinylpyrrolidone (PVP) to improve its wettability. The central body of the intubation displays a marking intended for the intubation placement between the lacrimal puncta.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called RITLENG®+ and RITLENG®+ PVP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the same way one might describe a novel diagnostic AI algorithm.

Therefore, the information about acceptance criteria and a study proving the device meets them needs to be interpreted within the context of a 510(k) submission, where the "study" is primarily a non-clinical comparison and testing against established specifications and predicate device characteristics.

Here's the breakdown based on the provided text:

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The RITLENG®+ device is a bicanalicular lacrimal stent. For a 510(k) submission, the "acceptance criteria" are predominantly related to the device's technical specifications, safety, and functionality being comparable to a predicate device, as well as meeting relevant standards. The "study" refers to the non-clinical tests performed to demonstrate this equivalence and performance.

1. 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)

This document does not describe a "test set" in the context of clinical data for an AI/diagnostic device. The "tests" mentioned are non-clinical bench tests (e.g., cytotoxicity, chemical characterization, sterilization efficacy, material testing, package integrity, stability studies). Therefore, terms like "sample size," "data provenance," "country of origin," and "retrospective/prospective" are not applicable in the way they would be for a clinical study on human subjects or an AI product's performance. The "samples" for testing would be units of the device itself or its constituent materials. The provenance of this physical testing data is from the manufacturer (FCI SAS) and the testing laboratories they contracted.

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)

This is not applicable. The ground truth for non-clinical tests is based on scientific and engineering standards and validated test methodologies, not expert consensus in a medical diagnostic sense. For example, "ground truth" for cytotoxicity is determined by cell viability assays against established thresholds, not by a panel of experts.

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

This is not applicable as there is no "test set" requiring expert adjudication in the context of this 510(k) submission.

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

This is not applicable. This is a conventional medical device (lacrimal stent), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable. This is a conventional medical device.

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

The "ground truth" for this device's evaluation is primarily based on established engineering and material science standards (e.g., ISO 10993 for biocompatibility), validated test methods, and comparison to the characteristics of the predicate device. For instance:

• Biocompatibility: Results of cytotoxicity, chemical characterization tests against established safety thresholds.
• Sterility: Absence of microorganisms to a sterility assurance level (SAL) of 10^-6, confirmed by validated sterilization processes.
• Physical Properties: Measurement of dimensions, material strength, etc., against predefined specifications.
• Intended Use: Direct comparison of the stated indications for use with the predicate device.

8. The sample size for the training set

This is not applicable. This is a conventional medical device, not an AI product that requires a "training set."

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

This is not applicable.

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LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.

LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.

LacriJet® is a monocanalicular intubation device, with self-retaining punctal fixation for the treatment of monocanalicular lacerations and stenoses. The silicone stent acts as a conformer. The shape of the fixation head keeps the probe from migrating and from expulsing.

The provided text is a 510(k) Pre-Market Notification from the FDA regarding the LacriJet® device. It details the device's indications for use, its comparison to predicate devices, and a summary of non-clinical tests.

However, the document does not describe a study involving an AI/Machine Learning device that requires a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance. The LacriJet® is a physical medical device (a monocanalicular lacrimal stent), not a software or AI-based diagnostic/assessment tool.

Therefore, it is not possible to extract the requested information regarding acceptance criteria met by a study, sample size, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as these concepts are not applicable to the type of device and submission described in the FDA document.

The document primarily focuses on establishing substantial equivalence based on:

• Intended Use: Similar to predicate devices (MASTERKA, Eagle Vision Monocanalicular Stent, Mini-Monoka).
• Technological Characteristics: Made of the same medical-grade silicone as a predicate, similar design for the stent and fixation head. The primary difference is in the delivery system, which the submission argues does not raise new safety or effectiveness concerns.
• Non-Clinical Testing: Confirms the device meets established specifications related to biocompatibility, sterilization, package integrity, and shelf-life, demonstrating equivalence to the predicate device in these aspects.

In summary, the provided text does not contain the information requested in your prompt as it pertains to a physical medical device clearance, not an AI/ML-driven device validation study.

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The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of:

• Canalicular pathologies (stenosis, obstruction, lacerations),
• During Dacryocystorhinostomy (conventional or laser),
• Congenital nasolacrimal duct obstruction.

The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.

The provided document is a 510(k) premarket notification for the Lacriflow CL device. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (Lacriflow K120886). The primary focus of the document is to demonstrate "substantial equivalence" to the predicate device, especially considering modifications made.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this document is implicitly defined by demonstrating that the modified Lacriflow CL device performs comparably to the predicate Lacriflow (K120886) and that the modifications do not introduce new safety or effectiveness concerns. The performance is assessed through specific verification tests rather than against explicit numerical thresholds for clinical outcomes (e.g., sensitivity, specificity, accuracy).

2. Sample Size for Test Set and Data Provenance

The document describes design verification tests. These are engineering/performance tests conducted on the device components or the device itself, not clinical studies involving human patients.

• Sample Size for Testing: For the "Tensile Strength of the Tube," the predicate device's performance is listed as "14.2 N (Average of 9 samples)." This is the only explicit sample size mentioned in relation to a performance characteristic. For the other "Performance tests" listed in Table 2, specific sample sizes are not provided in this document.
• Data Provenance: Not applicable as these are laboratory/engineering tests described, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is defined by engineering specifications and comparative performance to the predicate device, verified through laboratory testing. There is no mention of experts establishing ground truth for a test set in the context of clinical, diagnostic, or interpretive performance.

4. Adjudication Method for Test Set

Not applicable. This is a technical performance assessment, not a clinical study requiring adjudicated interpretations of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a lacrimal stent, and the evaluation focuses on its physical and functional equivalence to a predicate device, not on diagnostic accuracy improvements with AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not conducted or described. This device is a physical medical device, not an AI/algorithmic diagnostic tool.

7. Type of Ground Truth Used

The "ground truth" for the evaluation described in this document is based on:

• Engineering Specifications and Performance Standards: The device's physical properties and functional performance (e.g., tip penetration, insertion load, bending strength, visual integrity) are evaluated against established engineering parameters and expectations for medical devices of this type.
• Predicate Device Performance: Comparison to the known performance and characteristics of the legally marketed predicate device (Lacriflow K120886) serves as a benchmark for substantial equivalence.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. As there's no training set for an AI/machine learning model, this point is irrelevant.

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The Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are:

• Canalicular pathologies (e.g., congenital or acquired stenosis, laceration)
• During dacryocystorhinostomy
• Congenital lacrimal duct obstruction

The Nunchaku is a bicanalicular intubation device for the treatment of epiphora in patients 12 months and older. The device consists of two lateral silicone tubes connected to a silicone body that is delivered pre-mounted on two guides facilitate insertion of the Nunchaku and are completely removed once insertion of the device is complete. The Nunchaku comes in two different model lengths (90 or 105 mm depending on length of tube required) and is provided as a sterilized product.

Based on the provided text, the device in question (Nunchaku) is a bicanalicular intubation device. The document describes non-clinical (bench-top) tests and results, but does not describe a study involving human readers or an AI algorithm, nor does it establish ground truth through expert consensus, pathology, or outcomes data for clinical performance. Therefore, I am unable to provide information on the following points:

• Acceptance criteria related to clinical performance or human reader studies.
• Sample sizes for test sets in a clinical study.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of clinical ground truth used.
• Sample size for a training set (as no AI algorithm is mentioned).
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and non-clinical testing.

Here's a summary of the provided information relevant to acceptance criteria and "studies" (non-clinical tests) that "prove" the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document lists several non-clinical tests conducted to validate the device's mechanical characteristics and biocompatibility. The "acceptance criteria" are implied by the statement "All non-clinical test results met the established specifications for the device" and "The biocompatibility test results met the required specifications for all tests."

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

• Sample Size: The document states "Bench top testing was performed on samples before and after sterilization." The exact number of samples tested for each non-clinical test is not specified in the provided text.
• Data Provenance: Not applicable as these are bench-top tests, not a clinical study involving patient data.

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

• Not applicable. The ground truth for these non-clinical tests is based on measurable physical properties and established ISO/USP standards, not expert clinical consensus.

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

• Not applicable for non-clinical testing.

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 study was mentioned or performed. The device is a physical medical device (stent) for intubation, not an AI-powered diagnostic tool for image interpretation or a device requiring human reader assistance with AI.

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

• Not applicable. The device is a physical medical device. There is no mention of an algorithm involved.

7. The type of ground truth used:

• For non-clinical tests, the "ground truth" is defined by established engineering specifications, mechanical properties standards, and biocompatibility standards (e.g., ISO standards, USP standards for endotoxins).

8. The sample size for the training set:

• Not applicable. These are non-clinical engineering and materials tests, not an AI model.

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

• Not applicable.

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The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:

• · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
• · During dacryocystorhinostomy
• · Congenital lacrimal duct obstruction

The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation.

This document describes the Oasis Lacrimal Intubation Set with Retrieval Device and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics in a pass/fail format. Instead, it focuses on demonstrating equivalence to a predicate device across several characteristics. The "performance" is implicitly deemed acceptable if it's equivalent to the legally marketed predicate.

However, we can infer the areas of assessment and the reported findings for each:

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

The document describes non-clinical bench testing. It does not specify a numerical "sample size" in terms of patients or independent test articles for each specific test performed. However, it indicates:

• Bench tests: A "series of bench tests" was conducted.
• Biocompatibility tests: These were conducted for Cytotoxicity, Sensitization, and Irritation.
• Provenance: The tests were conducted by "independent laboratories and internal comparative bench testing." No country of origin for the data is specified, nor is whether the testing was retrospective or prospective (it would inherently be prospective for product development).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This document describes a medical device (intubation set), not a diagnostic AI device requiring expert ground truth for interpretation. Therefore, these categories are not applicable. The "truth" here is established by engineering specifications, material properties, and functionality comparison against a predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is bench testing of a physical device, not a diagnostic assessment requiring expert adjudication of findings.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No. This is a 510(k) submission for a physical medical device, not a diagnostic AI system requiring MRMC studies.

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

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Engineering specifications and standards: For dimensional attributes, material properties (e.g., USP Class VI for silicone).
• Functional comparison to a predicate device: For durability and overall performance (e.g., "performed equivalently to the predicate device").
• Standardized biocompatibility test protocols: For cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

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

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

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The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:

a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.

b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.

c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.

This document describes the DacryoCATH, a lacrimal duct balloon catheter, and its substantial equivalence to a predicate device based on non-clinical performance tests. It does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance, as it is a physical medical device.

Therefore, many of the requested categories related to AI/algorithm studies cannot be filled from the provided text.

Here's a breakdown of the available information based on the provided text, and where gaps exist for the requested AI/algorithm-specific details:

Acceptance Criteria and Device Performance (as inferred from the non-clinical tests):

Instead of 'acceptance criteria' in the context of an AI-driven device, the document focuses on the safety and performance characteristics of a physical catheter. The "reported device performance" refers to the successful completion of these non-clinical tests, indicating the new design is substantially equivalent to the predicate.

Information not present for an AI/Algorithm Study:

1. Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device's non-clinical testing.
2. Number of experts used to establish ground truth for the test set and qualifications: Not applicable for a physical device's non-clinical testing. Ground truth in this context would implicitly be the physical standards met or not met during testing.
3. Adjudication method: Not applicable. Performance is determined by test results against established physical parameters.
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: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool that assists human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for biocompatibility and mechanical performance.
7. The sample size for the training set: Not applicable as this is a physical device.
8. How the ground truth for the training set was established: Not applicable.

Additional Information Available from the Document:

• Device Name: DacryoCATH
• Regulation Number: Unclassified (product code OKS)
• Regulatory Class: Class II
• Predicate Device: K113508, DacryoCATH
• Reason for 510(k) Submission (Special 510(k)): Change in patient contact materials and design.
• Material Changes:
  • Balloon Material: Changed from PET - polyethylene terephthalate to Nylon 12.
  • Hypotube: Changed from 304 stainless steel 24 gauge regular wall (OD .022" and ID .010") to 304 Stainless steel 24 gauge thin wall (OD .020" and ID .012").
  • Collar: Addition of a 304 stainless steel collar welded onto the proximal hypotube (previously none).
• Conclusion: After performing non-clinical performance studies, the data shows that the DacryoCATH (with the new design) is substantially equivalent to the predicate.

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The StopLoss Jones tube system is intended for use during repair of the lacrimal system for intubation and bypass to canalicular pathologies.

The StopLoss Jones Tube assembly consists of a flanged glass tube and silicone washer. The glass tube is Pyrex borosilicate glass and the silicone is NuSil. It is offered in a range of sizes as follows: ID 1.15 -1.25mm OD 1.90 - 2.10mm Lengths 9-22mm +/-0.5mm in 1mm increments The device is provided sterile for single use only.

The provided text describes a 510(k) premarket notification for the "StopLoss Jones Tube System." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical or AI-centric study.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types and how it was established for training and test sets, training set sample size) are not applicable to this type of submission.

Here's the information that can be extracted from the provided text, formatted to address your request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way one might for a software algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" can be inferred as the successful completion of various non-clinical tests demonstrating the device's functional integrity, biocompatibility, and sterility, in comparison to predicate devices. The "reported device performance" refers to the successful outcomes of these tests.

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

• Sample Size for Test Set: Not specified for non-clinical bench tests. For example, "a pig nose model" was used, but the number of models or tests conducted is not quantified.
• Data Provenance: The tests described are non-clinical bench tests and likely laboratory-based. The location or specific origin of the pig nose model (e.g., country) is not disclosed.

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

Not applicable. This is a medical device for surgical intubation, not an AI diagnostic/prognostic device requiring expert-labeled ground truth for a test set. The validation relies on engineering and biological testing.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1 for consensus) are relevant for subjective interpretations of data, often in clinical trials or AI performance evaluations, which is not the nature of this 510(k) submission.

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. This is not an AI-assisted diagnostic device. No human reader performance studies of this nature were conducted or described.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The concept of "ground truth" as typically applied in AI or diagnostic studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance is established by meeting predefined engineering specifications, material safety standards, and functional requirements through objective bench testing and validation studies (e.g., bond strength measurement, sterility testing, biocompatibility assessment).

8. The sample size for the training set

Not applicable. There is no machine learning "training set" for this physical device.

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

Not applicable. There is no machine learning "training set" for this physical device.

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Bicanalicular intubation is indicated in treatments of epiphora in adults. Indications for bicanalicular intubation performed with the Self-Retaining Bicanaliculus Stent II are:

• . Punctal stenosis
• . Canalicular stenosis within the lacrimal drainage system

The Self-Retaining Bicanaliculus Intubation Set II is a bicanalicular intubation device for the treatment of epiphora in adults. The device consists of two silicone anchors connected to a silicone body that is delivered pre-mounted on two guides and packaged with a disposable dilator. The guides facilitate insertion of the Self-Retaining Bicanaliculus Intubation Set II and are completely removed once insertion of the device is complete. The Self-Retaining Bicanaliculus Intubation Set II comes in three different model lengths (25, 30, or 35 mm depending on length of tube required) and is provided as a sterilized product.

The provided text describes a medical device, the "Self-Retaining Bicanaliculus Intubation Set II," and its substantial equivalence to a predicate device. It includes non-clinical test results and a brief summary of a clinical study, but it does not include the information requested in your prompt regarding acceptance criteria, a study proving the device meets these criteria, or details about AI algorithms.

The device is a physical medical device (lacrimal stent and intubation set), not an AI-powered diagnostic or predictive tool. Therefore, the questions related to AI studies, ground truth establishment for training/test sets, number of experts, adjudication methods, or MRMC studies are not applicable to the information provided.

I can, however, extract the relevant performance information from the clinical study summary provided, although it's not structured around explicit "acceptance criteria" for a new device submission, but rather a comparison to a predicate device.

Here's a breakdown of what can be extracted from the text in relation to your request, with an emphasis that the AI-centric questions are not relevant here:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of a new device approval challenge. Instead, it presents the results of a comparative clinical study against a predicate device to demonstrate substantial equivalence and performance. The "performance" is based on the success rate of treating epiphora.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: 21 patients (treated with SRS)
• Data Provenance: The study was published in "Clinical Ophthalmology 2012:6, 5-8" by Tabatabaie et al. This suggests a prospective clinical study. The authors' affiliations are not provided in this specific extracted text, so the country of origin is not explicitly stated. Often, authors from countries in the Middle East have names like "Tabatabaie," "Rajabi," "Estraghi," which might indicate a study from that region, but this is an inference based on names, not explicit information.

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)

This question is not applicable. The device is a surgical implant. "Ground truth" in this context would typically refer to clinical outcomes (successful alleviation of epiphora, absence of obstruction, etc.) observed by treating physicians or assessed by follow-up examinations, not expert consensus on an image or data interpretation. The study was a comparative clinical trial, so the "truth" was the observed clinical outcome in patients.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation of data (e.g., radiology reads) to establish consensus ground truth. This was a clinical trial observing patient outcomes. The "success" was likely defined by objective clinical criteria and physician assessment.

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

This question is not applicable. This is a physical medical device, not an AI system being evaluated to improve human reader performance.

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

This question is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the clinical study was outcomes data (successful outcome, device failures, adverse events). Success was defined as "successful outcome" which is typically based on clinical assessment and symptom resolution (e.g., resolution of epiphora).

8. The sample size for the training set

This question is not applicable. 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

This question is not applicable. This is a physical medical device, not an AI algorithm.

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The OphtaCath® Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.

The OphtaCath® lacrimal duct catheter is a sterile and single-use balloon catheter consisting of a semi-flexible stainless steel stylet covered by PBX tubing that ends with a nylon balloon. The balloon is covered by a protective polyethylene sleeve. The balloon is designed to be inflated to a known diameter and length at the specified pressure. Markings are placed at 10 mm and 15 mm · proximal to the working portion of the balloon. The overall length of the catheter is approximately 240 mm long. The catheter is available in a 2 mm inflated diameter. The 2 mm balloon has a length of 13 mm and a diameter of 0.90 mm before inflation. The 3 mm balloon has a length of 15 mm and a diameter of 1.0 mm before inflation. The Flamingo Inflation Device is an accessory to the OphtaCath®, and is a sterile, single-use inflation device for dilating the balloon catheter, monitoring balloon pressure, and deflating the balloon postoperatively. The OphtaCath® is sold as a unilateral kit that contains one 2 mm or 3 mm balloon catheter and an inflation device (OphtaCath® Unilateral Kits, 2-mm and 3-mm).

The provided text describes a 510(k) premarket notification for the OphtaCath® Unilateral Kit, a lacrimal balloon catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (LacriCATH) through non-clinical testing. It does not contain information about studies involving human subjects or AI algorithms. Therefore, much of the requested information about acceptance criteria, device performance from clinical studies, expert-established ground truth, MRMC studies, or training/test set details cannot be extracted from this document.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

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

The document mentions "established specifications for the device" for nonclinical tests, but it does not provide a table outlining these specific acceptance criteria. Instead, it offers a general statement that "All nonclinical test results met the established specifications for the device."

• Acceptance Criteria Mentioned (Implicit/General):

  • Manufacturability (manufacturing process validated)
  • Flexibility of the stylet (tested before and after sterilization)
  • Deflation time (tested before and after sterilization)
  • Compliance (tested before and after sterilization)
  • Burst strength of catheter and components (tested before and after sterilization)
  • Absence of leakages during inflation
  • Sufficient tensile strength of welds
  • Biocompatibility (tested to applicable standards)
  • Ethylene oxide sterilization effectiveness (validation studies performed)
  • Package integrity (studies performed, supports shelf-life)
  • Connectivity of kit components
  • Fluid fill volume of inflation device

• Reported Device Performance (General Statements):

  • "All nonclinical test results met the established specifications for the device."
  • "Test results demonstrate that the OphtaCath® catheter did not contain any leakages while being inflated and all welds were of sufficient tensile strength to resist breakage."
  • "The biocompatibility... met required specifications."
  • "The test results support the shelf-life and storage conditions for the device."
  • "Test results demonstrate the compatibility of the components."
  • "It can be concluded that the OphtaCath® lacrimal balloon catheter performs as intended without leakage or breakage; and that the assembled device performs as intended."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes pre-market notification for a medical device (lacrimal balloon catheter) and focuses on non-clinical bench testing and substantial equivalence to a predicate device. It does not involve a "test set" in the context of clinical data or AI algorithms. The "samples" referred to are physical devices used for bench testing. The sample sizes for these bench tests are not specified. There is no data provenance related to patient data as it's not a clinical study or AI algorithm evaluation.

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)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI-assisted devices that interpret patient data. This document describes a physical medical device (catheter) and its non-clinical performance.

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

This is not applicable for the same reasons as point 3.

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

This is not applicable. The document does not describe any MRMC studies, human readers, or AI assistance.

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

This is not applicable. The document does not describe any algorithms or AI performance studies.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications and standards (e.g., burst pressure, deflation time, tensile strength). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no AI algorithm being trained.

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

This is not applicable. There is no AI algorithm being trained.

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The LACRIFLOW is indicated in treatments of epiphora in patients 12 months and older, in cases of:

• Canalicular pathologies (stenosis, obstruction, lacerations),
• During Dacryocystorhinostomy (conventional or laser),
• Congenital nasolacrimal duct obstruction.

The LACRIFLOW is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the insertion of the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.

This document is a 510(k) summary for the KANEKA LACRIFLOW lacrimal stent. It establishes substantial equivalence to predicate devices and focuses on bench testing and biocompatibility rather than performance metrics from clinical studies.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide a comparative table of quantitative performance metrics for the device (e.g., success rates, complication rates) against specific acceptance criteria. Instead, it focuses on demonstrating that the device meets in-house standards and comparing physical characteristics with predicate devices.

The bench testing section mentions two specific tests:

It's important to note that "in-house standard" implies internal benchmarks, not necessarily publicly defined or clinically validated thresholds. The document asserts that "Result of the all performance tests showed that the LACRIFLOW was compliant with in-house standards and the test result did not raise any new safety and effectiveness concern."

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

This information is not explicitly stated in the provided document.

• For the Tensile Strength of the Lacrimal duct tube, a sample size of "9 samples" is mentioned.
• For the Stiffness of the Bougie, no sample size is given.
• The document describes bench testing, which typically does not involve human data or data provenance like country of origin or retrospective/prospective collection methods.

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

This information is not applicable as the document discusses bench testing and not clinical studies that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes bench testing and not clinical studies requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and basic performance, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study of an algorithm is not applicable here, as the device is a physical medical device (stent), not an AI algorithm.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" was established by in-house standards and direct measurement of physical properties. This is not clinical ground truth like pathology, expert consensus, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. As the device is a physical stent and the evaluation is based on bench testing and material properties, there is no "training set" in the context of an algorithm or model.

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

This information is not applicable for the same reasons as #8.

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