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Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After clacryocystorhinostomy Epiphora

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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Mono-Crawford Naso-lacrimal Intubation Device." This type of document primarily focuses on establishing substantial equivalence to a predicate device based on indications for use and technological characteristics.

It is crucial to understand that 510(k) submissions typically do not involve the kind of rigorous performance studies or acceptance criteria that are described in the prompt's questions for AI/diagnostic devices. The clearance is based on the device being as safe and effective as a legally marketed predicate, not necessarily on a new, comprehensive study demonstrating meeting specific performance metrics with statistical rigor.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not present in this document because they are not typically part of a 510(k) premarket notification for a physical medical intubation device.

However, I can extract the information that is available:

Acceptance Criteria and Study for Mono-Crawford Naso-lacrimal Intubation Device

Based on the provided 510(k) clearance letter (K061404), the "acceptance criteria" for a device applying for 510(k) clearance is primarily that it demonstrates substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This typically does not involve the quantitative performance metrics and statistical studies common for AI/diagnostic tools.

Here's a breakdown of the requested information, acknowledging the limitations of a 510(k) document for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (for 510(k) equivalence)	Reported Device Performance (as implied by clearance)
   Substantial Equivalence to Predicate Device	Achieved (FDA issued substantial equivalence letter)
   Same Intended Use as Predicate	Yes (Indications for Use are similar to common intubation devices)
   Similar Technological Characteristics as Predicate	Implied (not detailed in this letter, but reviewed in 510(k) submission)
   Safety and Effectiveness at least equivalent to Predicate	Implied (FDA found device to be safe and effective)
   Biocompatibility	Implied (not detailed in this letter, but reviewed in 510(k) submission for sterility and materials)
   Sterility	Implied (not detailed in this letter, but reviewed in 510(k) submission)

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

   • Not Applicable. This document pertains to a physical medical intubation device, not a diagnostic or AI device that would utilize a "test set" in the context of performance evaluation with data. The 510(k) process involves a comparison to a predicate device, often through engineering analysis, material testing, and sometimes small clinical data if there are new safety/effectiveness questions that cannot be addressed by comparison alone. This letter does not mention any specific clinical study data in this regard.

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

   • Not Applicable. See point 2. The "ground truth" here is regulatory compliance and demonstrating equivalence to a predicate device, which is evaluated by FDA reviewers.

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

   • Not Applicable. See point 2.

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 a physical intubation device, not an AI or diagnostic tool.

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

   • Not Applicable. This is a physical intubation device, not an algorithm.

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

   • The "ground truth" for 510(k) clearance is that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness for its stated indications for use. This "ground truth" is established through the FDA's regulatory review process, primarily based on documentation provided by the manufacturer (engineering drawings, materials specifications, comparisons to the predicate, sometimes non-clinical testing results, and very occasionally, limited clinical data if specific new questions arise).

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device.

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

   • Not Applicable. This is not an AI/machine learning device.

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Ocular dryness. The Snug Plug punctum plug is used to occlude the punctum in the treatment of ocular dryness.

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I am sorry, but based on the provided document, the information requested about acceptance criteria and the study proving the device meets those criteria is not available. The document is a 510(k) clearance letter from the FDA for the FCI Snug Plug® punctum plug, which primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance information.

The document does not contain:

• A table of acceptance criteria or reported device performance.
• Details about a study that would include sample sizes (test set, training set), data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter focuses on regulatory approval based on substantial equivalence, not on the detailed performance characteristics of a new study designed to meet specific acceptance criteria.

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Bicanalicular intubation is indicated in treatments of epiphora in adults (not to be used in infants), particularly in cases of:

• Meatic pathologies (meatic atresia)
• Canalicular pathologies (canalicular stricture)

Self-Retaining Bicanaliculus Intubation Set

This document is a 510(k) clearance letter from the FDA for a medical device (Self-Retaining Bicanaliculus Intubation Set). It confirms "substantial equivalence" to a legally marketed predicate device, allowing it to be marketed.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is purely a regulatory letter stating that the device has been cleared for market based on substantial equivalence. It does not include the technical details of any performance testing or clinical studies that might have been submitted to support that equivalence.

Therefore, I cannot fulfill your request for the specific information about acceptance criteria and study details based on the provided text.

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The Transnasal Lacrimal Stent is indicated in treatments of epiphora treated by dacryocystorhinostomy. Dacryocystorhinostomy (DCR) is the common surgical procedure used to correct nasolacrimal duct obstruction.

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The provided document is a 510(k) substantial equivalence letter for the Becker Transnasal Lacrimal Stent. It does not contain information about acceptance criteria or specific study details proving device performance. The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.

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Mesh wrapped Bioceramic orbital implants are designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.

Mesh Wrapped Bioceramic Orbital Implant

I apologize, but this document is not a study that proves the device meets the acceptance criteria. This is a 510(k) clearance letter from the FDA, indicating that the device, "FCI Mesh Wrapped Bioceramic Orbital Implant", is substantially equivalent to legally marketed predicate devices.

A 510(k) clearance does not typically include a detailed study proving performance against specific acceptance criteria in the way a clinical trial report would. Instead, it demonstrates substantial equivalence, often through comparisons of design, materials, and intended use to a previously cleared device, along with preclinical testing (e.g., biocompatibility, mechanical testing) rather than a clinical study focused on performance metrics like sensitivity or specificity.

Therefore, I cannot provide the information requested in your prompt based on the provided document. The document primarily focuses on regulatory clearance rather than a detailed performance study with acceptance criteria.

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The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.

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The provided text is a 510(k) premarket notification letter from the FDA to FCI Ophthalmics, Inc., regarding several ophthalmic devices: Disposable Vitrectomy Lenses, Disposable Infusion Cannula, and Surgical Knife.

This document confirms substantial equivalence of these devices to previously marketed predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is an administrative notification of regulatory clearance, not a performance study report.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

1. Regulatory Clearance: Granting permission to market the devices based on substantial equivalence.
2. Device Classification: Class II, Class I, and Class I for the respective devices.
3. Indications for Use: Describing the intended purpose of each component within the vitrectomy set.
4. General Regulatory Requirements: Reminding the manufacturer of ongoing obligations like registration, labeling, and good manufacturing practices.

Crucially, there is no mention of specific acceptance criteria (metrics, thresholds), study designs, sample sizes, expert ground truth establishment, or any performance data that would answer the questions posed.

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As a primary implant for patients who present with eye disease or severe damage such that the eye must be enucleated or eviscerated.

An existing orbital implant that is malfunctioning or not satisfying the patient in terms of performance, may call for a secondary implant procedure to install a bio-ceramic orbital implant.

Bio-ceramic Orbital Implant

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a Bioceramic Orbital Implant, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but not specific performance data or study results.

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Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or laceration) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant

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

Based on the provided FDA 510(k) letter (K991238) for the "FCI Crawford Probe Intubation Sets," it is not possible to extract information about acceptance criteria or a study proving device performance in the way typically expected for an AI/software device.

This document is a substantially equivalent (SE) letter for a physical medical device (FCI Crawford Probe Intubation Sets), not a software or AI device. The FDA's 510(k) pathway for physical devices primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as would be expected for a novel AI/software product.

Therefore, most of the requested information (like sensitivity, specificity, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present and not applicable to this type of regulatory submission.

However, I can extract the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not specify quantitative acceptance criteria for performance. The "acceptance" here is the FDA's determination of "substantial equivalence" to a predicate device.
• Reported Device Performance: The document does not report specific performance metrics (e.g., success rates, complication rates, sensitivity, specificity). The justification for market clearance is that the device is substantially equivalent to a previously approved device.

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

• Not applicable / Not provided. This 510(k) determination is based on a comparison to a predicate, not a clinical study with a defined test set.

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

• Not applicable / Not provided. Ground truth establishment, as typically understood for performance studies, is not part of this 510(k) submission type.

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

• Not applicable / Not provided.

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 / Not provided. This is a physical device, not an AI-assisted diagnostic tool.

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

• Not applicable / Not provided.

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

• Not applicable / Not provided. The "ground truth" for a 510(k) submission of a physical device is its functional similarity and intended use matching that of a predicate device.

8. The sample size for the training set:

• Not applicable / Not provided.

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

• Not applicable / Not provided.

Summary of Document Context:

The provided document is an FDA 510(k) clearance letter for a physical medical device called "FCI Crawford Probe Intubation Sets." The core of a 510(k) submission for such a device is to demonstrate substantial equivalence to a predicate device that is already legally marketed. This process typically involves comparisons of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., biocompatibility, sterility) to show that the new device is as safe and effective as the predicate. It does not generally involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human-AI interaction studies as would be seen for a software as a medical device (SaMD) or AI-powered diagnostic tool.

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Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

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I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a device called "Retinal Detachment Implants." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about:

• Acceptance criteria for the device's performance.
• A study that proves the device meets specific performance criteria.
• Device performance data (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document is purely an administrative clearance letter, not a technical report detailing performance studies.

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This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "Titanium Peg System," indicating that the device is substantially equivalent to legally marketed predicate devices.

The text does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any study.
• Information on expert reviews, adjudication methods, or MRMC studies.
• Results from standalone algorithm performance.
• Details about training sets.

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