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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.

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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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