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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.

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

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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.

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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.

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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.

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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.

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