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The COVIDIEN Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

The COVIDIEN Extended Tip Applicator is a single-use, disposable applicator intended for the simultaneous delivery of two non-homogenous solutions onto a surgical site. The COVIDIEN Extended Tip Applicator provides two (2) female luer fittings for connection to standard syringes containing two non-homogenous solutions. The shaft of the Extended Tip Applicator maintains two separate and independent lumens, which keep the two solutions separate and prevent premature mixing. The Extended Tip Applicator shaft is bendable up to 60 degrees to facilitate access to confined spaces at the surgical site.

The provided text describes a 510(k) premarket notification for the COVIDIEN Extended Tip Applicator. It does not contain information about acceptance criteria for a study, nor does it present "reported device performance' in the context of a comparative study with a human-in-the-loop or standalone AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's a breakdown of what can be extracted and what is missing based on your requested headings:

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

This information is not provided in the given text. The document states:
"Safety and effectiveness of the Extended Tip Applicator have been demonstrated in this submission. Biocompatibility testing assures the device complies with applicable sections of industry and safety standards. Performance testing ensures that the Extended Tip Applicator meets all of its functional requirements and performs as intended."
However, it does not detail specific acceptance criteria or the numerical results of performance tests.

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

This information is not provided in the given text. The submission mentions "Performance testing" but does not specify sample sizes or data provenance.

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 information is not provided in the given text.

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

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (applicator), not an AI/software device that would involve human readers or AI assistance. The document states that "Performance data, identical indications for use and identical operating principle demonstrate the Covidien Extended Tip Applicator to be substantially equivalent to a predicate device".

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

This is not applicable as the device is a physical medical instrument, not an algorithm.

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

This information is not provided in the given text. For a physical device, "ground truth" would typically refer to direct measurements or functional assessment against specifications.

8. The sample size for the training set

This information is not provided in the given text. As this is a physical device, there would not be a "training set" in the context of AI/machine learning.

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

This information is not provided in the given text and is not applicable as it's not an AI/machine learning device.

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The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.

The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.

The provided text details a 510(k) summary for the "Confluent Surgical Extended Tip Applicator." However, it does not describe acceptance criteria for a device, nor does it present a study proving the device meets acceptance criteria. Instead, it outlines the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study from the provided input.

Here's a breakdown of what the document does provide, and why it doesn't contain the requested information:

• Document Type: This is a 510(k) summary, which is a premarket notification to the FDA. It's a regulatory document demonstrating that a new device is as safe and effective as a legally marketed predicate device.
• Focus: The core of a 510(k) is to establish "substantial equivalence." This means the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
• Instead of Acceptance Criteria and Studies: The document states: "Safety and effectiveness of the Confluent Surgical Extended Tip Applicator have been demonstrated in this submission. The biocompatibility and in vitro bench testing data provide support that the Extended Tip Applicator is substantially equivalent to the currently 510(k)-cleared Dual Liquid Applicator."

To reiterate, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. These details would typically be found in a more comprehensive study report or a different section of a regulatory submission, not generally in the public 510(k) summary focused on substantial equivalence.

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The Confluent Surgical MicroMyst Applicator and Air Pump are indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

The Confluent Surgical MicroMyst Applicator will be configured using the following components: Applicator Air line with Filter Air Source

The provided text describes a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance metrics, or details of a study that would prove the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Confluent Surgical MicroMyst Applicator and Air Pump K050998) based on similar technological characteristics, indications for use, operating principle, design, materials, and manufacturing processes. It states that "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." but provides no details about this testing.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number and qualifications of experts for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report with performance metrics against pre-defined acceptance criteria.

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The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogenous fluids or solutions onto a surgical site.

The Confluent Surgical Dual Liquid Applicator will be configured using the following components: Y-Connector, Three Spray Tips; the Spray Tip consists of a polycarbonate Spray Tip, and a polycarbonate or nylon orifice cup, Plunger Cap.

The provided text is a 510(k) summary for a medical device called the "Confluent Surgical Dual Liquid Applicator." This type of document is for premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Key takeaway: This document describes a device that is a physical applicator, not an AI/ML powered device. Therefore, many of the questions related to AI/ML performance, training sets, ground truth establishment, and expert adjudication are not applicable.

Here's the information extracted and interpreted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the acceptance criterion is that the device demonstrates substantial equivalence to a predicate device.

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

This document does not describe a "test set" in the context of an AI/ML algorithm. The "testing" mentioned refers to characterization of the physical device's performance to demonstrate substantial equivalence. No specific sample size for a test set (e.g., number of images or cases) is provided or relevant for this type of device.

Data Provenance: Not applicable. The "data" refers to engineering and performance testing data for the physical device, not patient data in the typical sense of AI/ML studies.

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

Not applicable. This device is a physical applicator, not an AI/ML algorithm that requires expert-established ground truth from medical images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of cases requiring adjudication for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

Not applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML diagnostic or prognostic devices, not for a physical fluid applicator. The "ground truth" for this device's performance would be engineering specifications and functional testing results.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.

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The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.

The MicroMyst Applicator and Air Pump will be configured using the following components:
Applicator with flexible tip
Air line with filter
Air Pump

The provided text is a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted from this document.

Here's an attempt to address the points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the way a study for an AI/software medical device would.

Instead, the "acceptance criteria" for this device's regulatory clearance is demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that the device performs functionally similarly and safely to the predicates.

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

• Sample Size for Test Set: Not applicable/not specified. The document refers to "biocompatibility data and results of bench testing" but does not provide details on the sample size of these tests. This is not a study involving a "test set" of patient data for an algorithm.
• Data Provenance: Not applicable/not specified. Given it's bench testing and biocompatibility, concepts like "country of origin" or "retrospective/prospective" data sets for patient data do not apply.

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

Not applicable. This device is a physical medical device, not an AI/software device requiring expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological properties of the device and its function as demonstrated through engineering tests and biocompatibility assessments.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of expert review and adjudication for an AI algorithm.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is relevant for evaluating human performance with and without an AI-assisted device, which is not the subject of this 510(k).

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

Not applicable. This is a physical applicator and air pump, not an algorithm.

7. The type of ground truth used

The "ground truth" used for this device's clearance would be based on:

• Engineering specifications and performance metrics during bench testing.
• Results from biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies).
• Chemical and material characterization.
• Comparison to the established safety and performance profiles of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set or ground truth for algorithmic training.

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The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site.

The Confluent Surgical Dual Liquid Applicator will be configured using the following components:
• Y-Connector
• Three Spray Tips
• Plunger Cap

The provided text describes a 510(k) submission for the Confluent Surgical Dual Liquid Applicator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics described in the prompt's requested format.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or cannot be extracted from this particular 510(k) summary.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable / Not provided. The summary focuses on equivalence to a predicate device based on manufacturing, materials, and general performance data, not a direct clinical test set with human subjects or specific data provenance details. The evaluation appears to be based on design and engineering characteristics, and potentially pre-clinical (biocompatibility) data.

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 is not established in the context of this 510(k) summary, as it's not a study designed to evaluate diagnostic accuracy or human interpretation.

4. Adjudication method 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:

• No. This device is a liquid applicator, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" in this context would be whether the device physically performs its function safely and effectively, and is chemically and physically equivalent to its predicate. This is assessed through engineering tests and material comparisons, not typically a "ground truth" derived from expert consensus, pathology, or outcomes data in the way it applies to diagnostic devices.

8. The sample size for the training set:

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

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

• Not applicable / Not provided.

Summary of the Study (510(k) Submission for Substantial Equivalence):

The "study" presented here is a 510(k) premarket notification for the Confluent Surgical Dual Liquid Applicator. The objective of such a submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving performance against independent acceptance criteria through a clinical trial or a statistically powered study as described in the prompt's questions.

How Substantial Equivalence was demonstrated:

The submission provided:

• Biocompatibility data: To ensure the materials used are safe for patient contact.
• Results of bench testing: To confirm the device's functional performance and mechanical integrity.

The conclusion states that based on this data, and based on similarities in:

• Indications for use
• Operating principle
• Component shape and dimensions
• Materials
• Manufacturing processes

The Confluent Surgical Dual Liquid Applicator was shown to be substantially equivalent to the predicate device, the DuoFlo™ Dispenser Kit (K872526).

Therefore, the "acceptance criteria" here are met by demonstrating sufficient similarity and equivalent safety/performance to the predicate device as mandated by the 510(k) regulatory pathway. Specific numerical performance targets or clinical trial outcomes in human subjects are not typically required or provided for this type of device in a 510(k) unless specific performance issues or new risks are identified.

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