Search Results

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Endoscopic Applicator, 41 cm

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for a medical device called "Endoscopic Applicator, 41 cm." It primarily discusses regulatory aspects, such as substantial equivalence, general controls, and compliance with federal regulations.

Therefore, I cannot provide the requested table and study summary based on the given input.

Ask a specific question about this device

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

Not Found

This document is a 510(k) premarket notification from the FDA regarding a medical device called the "Endoscopic Applicator". It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets that criteria.

Specifically, the document:

• Identifies the manufacturer (Micromedics Inc. d/b/a Nordson Medical).
• States the device name, regulation number, and product code.
• Confirms the device is substantially equivalent to legally marketed predicate devices.
• Outlines general controls and regulations the device must comply with.
• Provides contact information for various FDA divisions.
• States the Indications for Use for the Endoscopic Applicator: "The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar."

Therefore, I cannot provide the requested information as the document does not contain details about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device

The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable device intended for delivering a hemostatic agent to bleeding sites. The Malleable Tip Endoscopic Applicator is the identical to predicate with the addition of a malleable tip at the distal end which allows directional placement of hemostatic agents.

The Malleable Tip Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use. This is the identical packaging configuration as the previously cleared device.

The provided text describes a Special 510(k) Premarket Notification for the Micromedics Malleable Tip Endoscopic Applicator. This submission focuses on design verification and biocompatibility testing for a device that is largely identical to a predicate device, with the addition of a malleable tip.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life." However, specific acceptance criteria values (e.g., "Leakage rate must be less than X mL/min") and the exact results achieved for each test are not provided in this summary. Only the types of tests performed are listed.

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

The document does not specify the sample size used for any of the non-clinical tests (e.g., number of devices tested for leak testing, kink testing, etc.).
The data provenance is not explicitly stated in terms of country of origin, but the testing was performed by Micromedics, Inc. (a U.S. company). The testing is non-clinical, meaning it was not performed on human subjects and thus the concepts of "retrospective" or "prospective" human data do not apply.

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

This section is not applicable to this submission. The tests are non-clinical, focusing on mechanical and biological properties of the device. There is no human interpretative "ground truth" established by experts in the context of device performance in these tests.

4. Adjudication Method for the Test Set

This section is not applicable as there were no human-interpreted test results requiring adjudication. The tests were objective measurements against pre-defined acceptance criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on comparing human reader performance, typically in diagnostic imaging, which is not relevant to this device's non-clinical safety and performance evaluation.

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

No, this is not an AI/algorithm-based device. The performed studies are standalone in the sense that they evaluate the physical device's performance against specifications, without human interaction with an algorithm.

7. The Type of Ground Truth Used

The ground truth for these non-clinical tests are the pre-defined acceptance criteria for each test. For example, a "kink test" would have a predefined acceptable level of deformation or resistance, and the device's performance is measured against that objective standard. For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" in the context of this device's non-clinical evaluation, as it is not an AI/machine learning device.

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

This section is not applicable for the same reason as above.

Ask a specific question about this device

The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.

The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.

The provided text describes a medical device, the "360° Gas Assisted Endoscopic Applicator," and its non-clinical performance data for 510(k) clearance. However, it does not contain details of a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-enabled device.

The document describes a traditional medical device submission (a special 510(k)) for a physical applicator, not a software or AI-driven diagnostic device. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to the information provided.

Despite this, I will extract the relevant information concerning acceptance criteria and the "study" (non-clinical testing) that demonstrates the device meets these criteria, as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document refers to "test articles" but does not quantify the number of devices or components tested for each non-clinical test.
• Data Provenance: Not applicable in the context of clinical data. This refers to design verification and biocompatibility testing performed by Micromedics, Inc.

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

• Not applicable. This device is hardware for fluid application, not an interpretative AI or diagnostic tool requiring expert ground truth for a test set.

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

• Not applicable. This is not a study involving human interpretation or clinical adjudication.

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 is not an AI-enabled device; therefore, no MRMC study was conducted.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable. The "ground truth" for this device's performance is based on engineering specifications, standardized test methods (like ISO 10993 for biocompatibility), and internal design verification criteria, not clinical outcomes or expert labels.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML product.

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

• Not applicable. This device does not involve a training set.

Ask a specific question about this device

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.

The Endoscopic Applicator is a sterile, single-use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm (or larger) trocar. The Endoscopic Applicator is designed with a luer connector, which is used for connection to a syringe containing the hemostatic agent. The Endoscopic Applicator system consists of a cannula and stylet. The non-reflective cannula is a composite sheath constructed of PolyMed" (a high strength fiber with ester vinyl resin) with an Acrylonitrile Butadiene Styrene (ABS) over-molded luer lock. The stylet (obturator) consists of a PolyMed® composite rod, an ABS over-molded tip, and an ABS over-molded handle. The Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use.

This looks like a 510(k) premarket notification for a medical device called an "Endoscopic Applicator." The document focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive clinical trial data or performance metrics. As such, much of the requested information about acceptance criteria for AI performance is not present.

However, I can extract the available information regarding non-clinical performance and a general understanding of the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing "showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use over the labeled shelf life." However, the specific quantitative acceptance criteria for each test are not provided in this summary. Instead, it lists the types of tests performed.

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

• Sample Size: The document does not specify the exact sample size used for each non-clinical test. It generally refers to "test articles."
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by Micromedics, Inc. or a contracted testing facility (Intertek Testing Services is mentioned as a contact for Micromedics for this submission). There is no mention of country of origin for data in the sense of patient data, as this is a non-clinical submission. The testing would be considered "prospective" in the sense that it was performed specifically for this submission.

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

This information is not applicable. The tests performed are engineering and material science tests, not clinical evaluations requiring expert medical interpretation to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical engineering tests. The results of these tests (e.g., force required to bend, leak rate) would be objectively measured against pre-defined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This device is an Endoscopic Applicator, and the submission is focused on physical and mechanical properties, not the performance of an AI algorithm that would typically be evaluated with MRMC studies.

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

This information is not applicable. The device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering specifications, international standards (e.g., ISO 594-2 for Luer Lock, ISO 10993-1 for biocompatibility), and internal product design requirements.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI system that requires a "training set."

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

This information is not applicable for the reasons stated above.

Ask a specific question about this device

The Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger.

The Endoscopic Applicator device is a sterile single use, disposable device intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm trocar or larger. The Endoscopic Applicator consists of two components; (1) a minimally reflective stainless steel cannula and (2) a plastic stylet (obturator). The Endoscopic Applicator is designed with a luer connector, for connection to a syringe containing the hemostatic agent. The packaging used for the Endoscopic Applicator is a pouch that consists of a see-through laminated film and TYVEK. Alternatively, a second pouch may be used. Either package configuration is placed within a paperboard carton.

The provided text does not contain information about acceptance criteria or a study proving that an Endoscopic Applicator device meets acceptance criteria.

Instead, the document is a 510(k) summary for a medical device (Endoscopic Applicator) seeking substantial equivalence to a predicate device. It explicitly states that "performance testing was considered unnecessary" and "clinical data was deemed unnecessary to demonstrate equivalence of the new device to the predicate device for its intended purpose."

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

The Endoscopic Spray Applicator is intended to be used for the application of two nonhomogeneous fluids to a treatment site.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Gas Assisted Endoscopic Applicator." This document primarily focuses on the regulatory clearance process and does not contain the detailed technical information required to answer your specific questions about acceptance criteria, study design, or performance metrics.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory pathway for market entry based on comparison to existing devices. However, it does not provide the specific performance data from a clinical or technical study that would outline acceptance criteria and how the device met them.

Therefore, I cannot provide the requested information based on the text provided.

To answer your questions, I would need a document that details:

• The specific performance characteristics tested (e.g., fluid delivery accuracy, flow rate, pressure range, material compatibility).
• The quantitative acceptance criteria for each of those characteristics.
• The results of a study (bench, animal, or clinical) demonstrating that the device's performance met those criteria.
• Information on the study's design, sample sizes, ground truth establishment, and expert involvement.

Ask a specific question about this device

This Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5mm or larger trocar.

The Endoscopic Applicator is a re-usable applicator used to deliver hemostatic agents to bleeding surgical sites. The Endoscopic Applicator consists of two components; (1) a non-reflective stainless steel cannula, and (2) a stainless steel stylet (obturator). The Endoscopic Applicator is to be thoroughly cleaned and sterilized before each use, and can be used up to 20 times.

The provided text is a 510(k) summary for the Baxter Healthcare Corporation Endoscopic Applicator. This document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) submission for a device like the Endoscopic Applicator typically does not include studies demonstrating the device meets a set of acceptance criteria in the same way a diagnostic AI device would. Instead, the primary "study" in a 510(k) is the demonstration of substantial equivalence to existing, legally marketed predicate devices through a comparison of features, intended use, materials, and performance characteristics. The acceptance criteria are implicit in meeting the performance characteristics of the predicate devices and ensuring the new device does not raise new questions of safety and effectiveness.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types for test and training sets) are not applicable or not explicitly detailed in this type of regulatory submission. The document focuses on demonstrating similarity to already approved devices rather than proving performance against specific clinical metrics through direct studies.

However, I can extract information relevant to the equivalence demonstration as a proxy for how the "device meets acceptance criteria" within the context of a 510(k).

Acceptance Criteria and Device Performance (within the context of Substantial Equivalence):

The "acceptance criteria" for a 510(k) are essentially that the new device shares similar intended use, design, components, materials, and performance characteristics with predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" is a comparison of these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

G. Substantial Equivalence Statement: The Endoscopic Applicator is claimed to be "substantially equivalent to the predicate devices in intended use, design and components, materials, and performance characteristics." The differences (e.g., reusability vs. single-use, user sterilization vs. pre-sterilized) are implicitly argued not to raise new safety or effectiveness concerns.

Detailed Study Information (as requested, but largely Not Applicable for a 510(k) of this device type):

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

• Not Applicable / Not Provided. This 510(k) does not describe a clinical study with a "test set" in the context of evaluating diagnostic performance. The "test" is the comparison to predicates and potentially bench testing to ensure mechanical properties, but no clinical outcome data or diagnostic performance data is presented.

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

• Not Applicable / Not Provided. No "ground truth" for a test set is established in this document, as it is not a diagnostic device or a device requiring clinical performance evaluation against a diagnostic standard.

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:

• Not Applicable / Not Provided. This is a surgical instrument, not an AI-powered diagnostic device.

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

• Not Applicable / Not Provided. This is a physical surgical instrument.

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

• Not Applicable / Not Provided.

8. The sample size for the training set:

• Not Applicable / Not Provided. There is no "training set" as 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 Device Acceptance (Regulatory Perspective):

The "acceptance criteria" in this case are primarily regulatory and descriptive. The device "meets the acceptance criteria" by demonstrating that:

1. Intended Use is similar: The device delivers agents to surgical sites, similar to the predicate devices.
2. Technological Characteristics are similar: Despite some differences (e.g., dimensions within a functional range, reusability vs. single-use, user sterilization), the fundamental method of operation (delivery of agents through a trocar) and materials are considered functionally similar to the predicates.
3. Performance Data (implicitly): The submission implies that any necessary engineering or bench testing (not detailed here) would demonstrate the device performs as expected for a surgical applicator (e.g., structural integrity, sterility after user processing, material compatibility) and that these performances are comparable to the predicates or acceptable for its intended use without raising new safety or effectiveness concerns. The FDA's issuance of the 510(k) clearance (K031882) confirms that the agency found the device substantially equivalent to its predicates, thus "accepting" the device under those criteria.

Ask a specific question about this device