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The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen.

The pREBOA-PRO™ Catheter is designed with flow channels to enable precise, smooth control of inflation and deflation of the balloon. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use.

The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a guidewire. In addition, the catheter is compatible with guidewires up to 0.025" that may be used to facilitate subsequent vascular procedures after a REBOA procedure. An orange peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. Below the balloon core aortic pressure monitoring is possible through the side arm of the sheath. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line safety valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The orange peel-away sheath can be separated from the catheter shaft after insertion if needed. The device is a single-use, sterile device.

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The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.

The Bridge Plus Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) or the inferior vena cava (IVC) for the purpose of providing occlusion, emergency control of hemorrhage and perioperative occlusion in the event of an SVC or IVC tear or perforation during a vascular procedure.

The Bridge Plus Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a 12Fr dual lumen nylon shaft. This guidewire lumen is used to pass the catheter over a guidewire. The balloon has a length of 80mm and inflation diameter ranging from 20-29mm. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC or IVC prior to inflation.

This FDA 510(k) clearance letter pertains to a medical device, the Bridge Plus Occlusion Balloon, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance specifications and verification/validation testing described in the submission, rather than clinical study endpoints for AI/software devices. The provided document does not describe a study involving human readers or AI algorithms.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various Design Verification and Validation Testing categories. For these types of medical devices, the "acceptance criteria" would be the pre-defined performance specifications for each test, which the device must meet to be considered safe and effective and substantially equivalent to a predicate device. The "reported device performance" indicates that the Bridge Plus Occlusion Balloon met these specifications.

Note: The document does not provide the specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it states that "Performance testing data have demonstrated that the Bridge Plus Occlusion Balloon meets performance specifications to support substantial equivalence to the predicate devices." and that the conducted tests "validate and verify that the subject device met all specifications."

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

The document describes laboratory and bench testing rather than clinical studies with "test sets" of patient data. Therefore, the concept of sample size for a test set of data and data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device's submission. The testing was conducted on the physical device itself.

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

Since this is a physical medical device (occlusion balloon) and not an AI/software device, the concept of "ground truth established by experts" for a test set is not applicable. Device performance was evaluated against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

As this is not an AI/software device or a clinical study with subjective assessments, an "adjudication method" for a test set is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI products where human reader performance is being evaluated with and without AI assistance. The Bridge Plus Occlusion Balloon is a physical medical device for temporary vessel occlusion.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO for sterilization and biocompatibility), and performance benchmarks established by predicate devices. The device's physical and mechanical properties were tested against these pre-defined quantifiable criteria.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this physical medical device. Training sets are used for machine learning algorithms.

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

Since there is no "training set" for this physical device, the method for establishing its "ground truth" is not applicable.

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The radial compression device is designed to apply compression in order to achieve temporary hemostasis of the radial artery after a percutaneous transradial procedure.

The Radial Compression Device (RC-001) is designed to promote hemostasis of the radial artery post percutaneous puncture. The radial compression device is fixed on the arm and the square pad of the device is pressed against the puncture site. The square cushion is adjusted to apply pressure and temporarily compress the puncture site of the radial artery to achieve rapid hemostasis. The product is primarily composed of a plate, turn cap, screw rod, hook and loop band, tapered cushion, and square cushion. The Radial Compression Device is available in one model, RC-001.

This document describes a 510(k) premarket notification for the Ningbo DIZENGENS Medical Science Co., Ltd. Radial Compression Device (K232577). The document presents a summary of non-clinical performance testing to support the claim of substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance with specific metrics.
• Sample sizes used for a "test set" in the context of an algorithm's performance.
• Data provenance, number of experts, adjudication method, or ground truth details for an AI/algorithm study.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or ground truth establishment for a "training set."

The document primarily focuses on non-clinical performance testing for a physical medical device (a radial compression device), not an AI/software algorithm. The tests conducted are typical for a physical medical device.

Here's a breakdown of what is provided and what elements are missing or not applicable based on the provided text, in the context of your request for AI/algorithm study details:

1. Table of Acceptance Criteria and Reported Device Performance:

• Provided: A list of performance tests conducted. For each test, it states "All testing met the requirements and passed."
• Missing from provided text: Specific numerical acceptance criteria for each test and the corresponding numerical results obtained by the Radial Compression Device. For example, for "Bond strength testing," it doesn't state "Acceptance criteria: > X N, Result: Y N."

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

• Not Applicable in the provided text: This question is relevant for AI/algorithm performance evaluation. The document describes tests for a physical device (e.g., visual inspections, bond strength, biocompatibility), not an AI model. Therefore, there's no "test set" of data in the context of AI.

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

• Not Applicable in the provided text: This question is relevant for AI/algorithm performance. Ground truth for a physical device's non-clinical performance tests is typically established through established engineering standards, laboratory procedures, and physicochemical measurements, not through expert consensus on images or clinical data.

4. Adjudication method for the test set:

• Not Applicable in the provided text: This is relevant for AI/algorithm performance.

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

• No: The document does not mention any MRMC study, as it's for a physical device and not an AI assistant.

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

• No: The device is a physical Radial Compression Device, not an algorithm.

7. The type of ground truth used:

• Implicitly: For the physical device tests, the "ground truth" is based on engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility and sterilization), and validated laboratory measurements. For instance, biocompatibility is evaluated per ISO 10993, and sterilization per ISO 11135.
• Missing from provided text: No explicit mention of ground truth in the context of expert consensus, pathology, or outcomes data, as these are typically for diagnostic AI/software.

8. The sample size for the training set:

• Not Applicable: There is no AI/algorithm training set.

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

• Not Applicable: There is no AI/algorithm training set.

Summary of Provided Non-Clinical Performance Testing:

The provided document lists the following non-clinical performance tests conducted for the Radial Compression Device:

• Visual inspections
• Dimensional inspections
• Bond strength testing
• Turn Cap and Screw Function
• Distribution and Packaging Tests
• Device and Packaging Aging Evaluation
• Pressure applied at puncture site (to demonstrate adequate compression)
• Biocompatibility evaluation per ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis)
• Sterilization (EO gas, SAL of 10-6 per ISO 11135, EO/ECH residuals assessment per 10993-7)

For all of these tests, the document states: "All testing met the requirements and passed."

Conclusion:

The provided text serves as a 510(k) summary for a physical medical device. It details non-clinical performance testing for that physical device to establish substantial equivalence. It does not provide the information requested regarding acceptance criteria and studies for an AI/algorithm device, as the product is not an AI/algorithm.

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A surgical instrument used to occlude a blood vessel temporarily.

PICOCLAMP is Ethylene Oxide sterile single-use hemostasis clamp consisting of Polyetheretherketone (PEEK) and stainless steel (SUS series). PICOCLAMP is designed for use during surgery to temporarily occlude blood vessels during the anastomosis process. PICOCLAMP consists of three main direct patient-contacting parts, all of them are streilized; main body, axis, and spring. The body is consisting of two parts; the jaw which is used to occlude the blood vessel temporarily and the grip which functions to open and close jaws using the surgeon hand or the clamp forceps. The axis integrates the body and keep its parts intact. The spring functions to give clamping force to the jaws. Two types of clamps are provided: green color clamps used for arteries temporary occlusion and blue color clamps used for veins temporary occlusion. Both of the artery and vein clamp are having two types: single and double. PICOCLAMP is available in three different sizes; S (Small), M (Medium), and L (Large). PICOCLAMP is used for temporary occlusion of blood vessels with diameters ranging from 0.2mm to 2.0mm. The clipping power applied at the blood vessel differs depending on the size of the clamp and the pressure of the spring selected. Once the anastomosis process is complete, PICOCLAMP is removed from the patient.

This document is a 510(k) Premarket Notification from the FDA regarding the PICOCLAMP vascular clamp. It outlines the device's characteristics, indications for use, comparison with a predicate device, and the performance data submitted to demonstrate substantial equivalence.

Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. The document is a regulatory approval for a physical medical device (vascular clamp), not a software or AI/ML-driven device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI/ML, as the document does not pertain to such a device or study.

The performance data mentioned in the document are for:

• Sterilization & Shelf-life & Packaging Testing: This ensures the device remains sterile and functional over its shelf life and that its packaging is adequate.
• Biocompatibility Testing: This ensures the materials used in the device are safe for contact with biological tissues.
• Bench Performance Testing: This evaluates the physical performance of the clamp, such as clipping power, ability for repeated opening/closing, and resistance to dislodgement. These tests compare the proposed device (PICOCLAMP) to the predicate device to demonstrate substantial equivalence of their physical performance.

The document explicitly states:

• "Animal Performance Testing was not required to demonstrate safety and effectiveness of the device."
• "Clinical Performance Testing was not required to demonstrate the safety and effectiveness of the device."

In summary, none of the requested information regarding AI/ML acceptance criteria, test set sizes, expert ground truth, MRMC studies, standalone algorithm performance, or training set details can be extracted from this document, as it is completely unrelated to AI/ML device performance.

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The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

The provided text is a 510(k) summary for the preCARDIA Occlusion System. It details the device, its intended use, and a comparison with predicate devices. While it lists various performance tests conducted, it does not contain specific acceptance criteria or the reported device performance for an AI/ML-based device.

The document outlines bench testing and an animal study to evaluate the performance of the preCARDIA Catheter. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for an AI/ML context.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Details on MRMC studies or a standalone algorithm performance.
• The type of ground truth used relevant to AI/ML (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth was established for AI/ML training data.

The text is for a physical medical device (vascular clamp/occlusion system), not an AI/ML algorithm. Therefore, the concepts requested in the prompt, such as "acceptance criteria for an AI/ML model," "training set," "test set," "ground truth," "expert consensus," and "MRMC study," are not applicable to the content provided.

Based on the provided document, I cannot fulfill the request as it pertains to AI/ML device validation. The document describes the regulatory submission for a physical medical device and its associated non-AI/ML performance testing.

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The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.

The AAJT-S device is a wedge-shaped bladder that when inflated pushes in on the body Over the target area of application. One of the target areas is the lower abdomen, over the umbilicus, compressing all the structures within, including the descending aorta, to achieve the physiological effects of aortic compression. The other two areas are over the inguinal region or the axilla. In these two areas the region is compressed with the wedge- shaped bladder including the major vasculature that runs through that area.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S):

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided text does not include specific numeric acceptance values (e.g., "maintain pressure within X mmHg of initial pressure"). It states the qualitative criteria and that the tests were performed to confirm or evaluate these criteria.

Missing Information:

• There are no explicit quantitative acceptance criteria or specific performance values reported for the pressure testing (e.g., pressure drop over time).
• Similarly, for force testing, no specific force values or deformation limits are given.
• The document doesn't detail how the "pelvic fracture stabilization" indication was specifically proven or what criteria were used for that.

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

The provided text does not specify sample sizes for the performance tests (Pressure Testing, Force Testing, Biocompatibility Testing). It mentions these tests were "performed" but not the number of units or replicates used.

Data Provenance: Not applicable in the context of these non-clinical performance tests. These are laboratory tests conducted on the device itself, not patient data.

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

Not applicable. These are non-clinical performance tests conducted on the device, not clinical studies involving expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to clinical studies where experts might disagree on ground truth, requiring an adjudication process. The tests described are objective, non-clinical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes non-clinical performance tests of the device itself (pressure, force, biocompatibility), not a clinical study involving human readers or comparative effectiveness with or without AI assistance. The device is a physical medical device (tourniquet), not an AI-powered diagnostic tool.

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

Yes, in the sense that the described tests are standalone device tests. The device's performance was evaluated independently without human-in-the-loop interaction as part of the test (beyond operating the test equipment). However, it's important to clarify that this refers to mechanical device performance, not AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests is based on objective physical measurements and established international standards:

• Pressure Testing: The ground truth is the measured pressure (e.g., using a pressure sensor) and its change over time.
• Force Testing: The ground truth is the applied force and the device's structural integrity under that force, measured by mechanical testing equipment.
• Biocompatibility Testing: The ground truth is determined by the results of standardized assays (e.g., cytotoxicity assays, irritation/sensitization tests) as per ISO 10993 standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As above, this is a physical device, not an AI model.

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VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

This modified version of VIOLA includes an ergonomic handle with operating button and a straight distal end.

The VIOLA is comprised of:

1. A concentric 4 mm aortic punch with a detachable handle.
2. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
3. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) summary for a medical device called "VIOLA" and it focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions performance data in the form of "risk analysis," "bond strength testing," and "simulated use testing" that "passed successfully all acceptance criteria," but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Details about experts for ground truth or adjudication methods.
• Information on multi-reader multi-case studies or effect sizes.
• Details on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set or its ground truth establishment.

The document primarily states that the modified device's technological characteristics are similar to the predicate and that performance data demonstrates it is as safe and effective.

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The Radial Artery Compression Tourniquet is designed for temporary hemostasis of radial artery post percutaneous puncture.

Radial Artery Compression Tourniquets

The provided document is a 510(k) clearance letter for the "Radial Artery Compression Tourniquets" and does not contain the specific information about acceptance criteria, device performance, study details, or AI-related data as requested. This letter confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the detailed technical study information you're looking for.

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

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The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.

The LANDMARK REBOA Catheter consists of five elements:

• . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
• Catheter Handle (PA 12)
• Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
• Occluder Balloon (polyurethane)
• Guide J-tip (stainless steel, nitinol, acrylic) ●

The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.

Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.

Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:

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

The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."

The tests performed and implicitly, the criteria for passing them, are:

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

• Test Set Sample Size: Not explicitly stated for each bench test. The "In Vivo Testing" mentions an "acute Porcine model," implying a number of animals were used, but the specific count is not provided.
• Data Provenance: The bench testing and simulated use are laboratory-based, not patient data. The In Vivo testing was conducted using a Porcine (pig) model. The country of origin for the data is not specified, but the company is based in Salt Lake City, Utah, USA. The studies are prospective in nature, as they involve testing the manufactured device.

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 a physical medical instrument, and its performance is assessed through engineering and biological in-vivo tests, not through expert interpretation of images or other data for diagnostic accuracy. "Ground truth" for this type of device relates to its physical performance meeting specifications (e.g., does the balloon burst at X pressure, does it occlude the vessel completely).

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

Not applicable. As this isn't an algorithm or diagnostic study relying on human interpretation or consensus, there's no adjudication process as described (e.g., for reconciling differing expert opinions).

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. This device does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the device's performance in engineering and biological tests is derived from:

• Pre-defined engineering specifications and standards (e.g., pressure tolerances, material properties, dimensional accuracy).
• Observed physical and physiological responses in the animal model (e.g., successful occlusion, lack of damage to vessel walls, device integrity after deployment).
• Compliance with recognized standards like ISO 14971:2019 (risk analysis) and ISO 10993 (biocompatibility).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model.

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GEM™ BIOVER disposable microvascular clamps are instruments which are used for all microsurgical procedures. They are used to occlude vessels during anastomosis, which is necessary as a result of vessel damage or thrombosis.

The GEM™ Biover Microvascular Clamps (Clamps) are arterial and venous clamps in both single and double clamp configurations, available in varying sizes. The clamps are sterile, disposable clamps for single use. The clamps are used in microsurgery, plastic surgery, and hand surgery for the temporary occlusion of blood vessels during an anastomosis.

The clamps are available for arteries and veins. The clamping force is higher for the arterial clamps than for the veinous clamps. The clamps are identified by a product reference code and by the color of the clamp. The clamps for veins are green, and the clamps for arteries are yellow.

The clamps are packaged individually in two Tyvek pouches (double pouched). The devices in the Tyvek pouches are gamma sterilized and are placed in cartons of 10. The clamps are used once and are disposed of after use.

This document is a 510(k) summary for the GEM™ Biover Microvascular Clamps, asserting their substantial equivalence to a previously cleared predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in a robust statistical study.

Based on the provided text, the device is not an AI/ML powered device, nor is it a diagnostic device that requires high-level performance metrics, such as sensitivity, specificity, or AUC. The submission is for a physical medical device (microvascular clamps). Therefore, the information requested in the prompt regarding AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment is not applicable to this document.

The document states:

• "The GEM Biover microvascular clamps remain unchanged from the predicate device."
• "There are no engineering or performance changes to the device or its packaging."

The "performance data" section mentions:

• "The label design change and the outer carton sales unit design change were assessed and validated in a Packaging Summative Human Factors/Usability Study."
• "Historical complaint data were reviewed and indicate no use-related concerns, thus, there are no use-related risks or complaints that trigger a need for further Human Factors validation."

This indicates that the "performance" considered for this submission relates to packaging and user interface (labeling/carton design), and the study conducted was a human factors/usability study, not a clinical performance study measuring accuracy or efficacy of a medical algorithm.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, and ground truth for a diagnostic or AI-powered device, as these details are not present and are not relevant to this type of device submission.

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