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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 Graft Preparation and Delivery Device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Not Found

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Graft Delivery, DePuy Synthes." It is a regulatory letter that grants clearance for the device to be marketed.

This document does not contain the information requested in your prompt. The prompt asks for details about acceptance criteria and a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information.

The provided FDA letter focuses on:

• Regulatory clearance: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Describing what the device is intended for (delivery and premixing of bone graft materials).
• General controls and regulations: Reminding the manufacturer of their obligations under the Federal Food, Drug, and Cosmetic Act.

The letter does not include any performance data, study designs, or analytical results that would describe acceptance criteria or how the device met them. Such information would typically be found in the 510(k) submission itself (which is not provided here), not the final clearance letter.

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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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Intended for the application of two non-homogenous liquids.

The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar.

The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts:

• . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately)
• Stainless steel shaft connecting hub to Pebax ●
• Flexible Pebax portion connecting stainless steel shaft to distal tip
• Fixed-position distal tip. ●

Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media.

The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.

This document describes the Laparoscopic Spray Applicator with Spinning Luers and its substantial equivalence to a predicate device. It explicitly states that no clinical performance data was provided as a basis for substantial equivalence. Therefore, the device relies on non-clinical performance data to demonstrate its safety and effectiveness.

Here's an analysis of the provided information based on your requested criteria:

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

The document lists various tests performed and states that the "test articles met the pre-defined acceptance criteria." However, it does not provide the specific numerical acceptance criteria for each test nor the quantitative results of the device's performance. It only states that the device "met the pre-defined acceptance criteria."

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

The document does not specify the sample size used for any of the non-clinical tests. The data provenance is also not explicitly stated, but since it's an FDA submission for a device manufactured by Micromedics Inc. (d/b/a Nordson Medical) in St. Paul, Minnesota, it can be inferred that the testing likely occurred in the US and was prospective for the purpose of this submission.

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 as the study did not involve human interpretation or subjective assessment that would require external experts to establish a "ground truth" in the traditional sense (e.g., for image analysis). The ground truth was established through adherence to engineering specifications and international standards for device performance.

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

This question is not applicable as the non-clinical testing for this device did not involve subjective human assessment requiring adjudication. The results were based on objective measurements against pre-defined engineering and performance criteria.

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 comparative effectiveness study was done. This device is a laparoscopic spray applicator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

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

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

For the non-clinical performance tests, the "ground truth" was based on pre-defined engineering specifications, design requirements, and adherence to relevant international standards (e.g., ISO 10993 for biocompatibility, ISO 594-1 and -2 for luer connections). It was not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical studies or diagnostic evaluations.

8. The sample size for the training set

This question is not applicable. There was no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There was no training set.

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The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.

The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.

The provided text is for a medical device called "Graft Delivery Device with Integrated Stylet," which is classified as a piston syringe. The document describes a 510(k) premarket notification, indicating substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than clinical studies in most cases.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" will be derived from the non-clinical performance data and the concept of "substantial equivalence."

Here's the breakdown of the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the test articles met "pre-defined acceptance criteria," indicating a successful outcome for each test. However, the specific quantitative acceptance criteria values for each test are not provided in this summary. The "Reported Device Performance" is broadly stated as meeting these unquantified criteria.

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

The document does not explicitly state the sample sizes used for each non-clinical test. This information would typically be found in the full test reports, which are not included here.

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The tests are internal non-clinical performance tests conducted by the manufacturer (Micromedics, Inc.) to demonstrate the device's mechanical integrity and suitability for its intended use. This is inherently prospective in nature, as the tests are performed specifically for regulatory submission on the device under review. The country of origin of the data is implied to be the USA, where Micromedics, Inc. is based.

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

For non-clinical, mechanical, and biocompatibility testing, "ground truth" is established through engineering specifications, validated test methods, and international standards (like ISO 10993). This typically does not involve a panel of human experts in the same way clinical data does. The "experts" would be the engineers, quality control specialists, and external laboratory personnel who designed and executed the tests and evaluated the results against objective criteria. Their qualifications are inherent in their roles and adherence to industry standards.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective human interpretation of outputs (e.g., medical images) needs consensus. For non-clinical, objective performance tests, adjudication is not typically performed in this manner. The results are compared directly against pre-defined engineering acceptance criteria. A test either passes or fails based on objective measurements.

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. The document explicitly states: "Summary of Clinical Performance Data: None provided as a basis for substantial equivalence." This device relies on non-clinical data for its 510(k) submission.

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

This question is not applicable. The device is a physical medical instrument (a graft delivery device), not an algorithm or AI software. Therefore, there is no "standalone performance" in the context of AI without human-in-the-loop. The non-clinical performance tests evaluate the physical device's functionality.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is comprised of:

• Engineering Specifications: Designed performance parameters and tolerances for the device's physical and functional attributes.
• Validated Test Methods: Established procedures to objectively measure these attributes.
• International Standards: e.g., ISO 10993 for biocompatibility.
• Predicate Device Performance: Implicitly, the performance of the predicate devices informed the acceptable range for the new device's non-clinical performance to establish substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This question is not applicable, as there is no "training set" for a physical medical device.

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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.

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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.

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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 Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluids to a wound or body cavity.

The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use. The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.

The provided document describes a 510(k) submission for a medical device called the "Single Cannula Extended Applicator." This device is intended for medical purposes to irrigate or instill fluid to a wound or body cavity. The submission aims to demonstrate substantial equivalence to a predicate device, the "Biomaterial Spray Syringe" (K982372).

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details nonclinical tests performed to demonstrate the device's design suitability for its intended use. The document states, "All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed.

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

The document does not specify the sample sizes for the nonclinical tests (Leak test, Flow test, Pull test, Fit and sealing, ISO-594-1). It only states that "Micromedics, Inc. conducts risk analysis and design verification tests are based on the result of these analyses."

Regarding data provenance, all listed tests are nonclinical, performed by the manufacturer, Micromedics, Inc. Therefore, the data provenance is internal to the manufacturer, within the United States (where Micromedics, Inc. is located). The testing is prospective for the current device and retrospective in terms of experience with the predicate.

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 describes nonclinical tests, not a study involving expert-established ground truth for medical imaging or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate."

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not conducted. This device is a manual, mechanical applicator, not an algorithm or software. The "performance" is demonstrated through nonclinical engineering tests.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established by engineering specifications, recognized standards (like ISO-594-1), and design requirements derived from risk analysis. It does not involve expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm or a system that requires a "training set" for its development. Its performance is based on its mechanical design and materials.

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

This information is not applicable for the same reason as point 8.

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FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

The FibriJet® Graft Delivery System consists of the Graft Delivery Device, a dual liquid applicator, a blending connector and cups and lids. The Graft Delivery Device itself consists of a syringe barrel, end cap, plunger and funnel.

This 510(k) premarket notification for the FibriJet® Graft Delivery System does not contain the acceptance criteria or a study that proves the device meets specific performance acceptance criteria.

The document is a submission for regulatory clearance, primarily focusing on demonstrating substantial equivalence to predicate devices. It describes the device, its intended use, and provides contact information. It does not include:

• A table of acceptance criteria and reported device performance: There are no specific performance metrics (like delivery accuracy, consistency, force required, etc.) or corresponding acceptance limits mentioned.
• A study demonstrating performance: The document does not describe any clinical or non-clinical study that evaluated the device's performance against predefined acceptance criteria. Therefore, information regarding sample size, data provenance, ground truth establishment, expert involvement, or comparative effectiveness studies is absent.

The FDA's response (pages 1-2) confirms that they have reviewed the submission and found the device substantially equivalent. This type of clearance typically relies on comparing the new device's design, materials, and intended use to existing, legally marketed predicate devices, rather than requiring extensive de novo performance studies with specific acceptance criteria, especially for a Class II device like a piston syringe.

In summary, as per the provided text, the information requested in your bullet points regarding acceptance criteria and performance study results is not available. The document is a regulatory submission for substantial equivalence based on technological characteristics similar to predicate devices, not a detailed performance study report.

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