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The Brilliant Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

The Brilliant™ Introducer Kit classifies into four types (Type I, II, III, and IV). Type I consists of a sheath introducer and a dilator. Type II consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator and a puncture needle. Type III consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator. Type IV consists of a sheath introducer, a dilator, a guide wire with a guide wire collimator, an Intravascular catheter (with needle) and a syringe. The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter. The guide wire is radio- detective under fluoroscopy. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. The sheath introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy. There is no radiocontrast agent in the dilator.

The provided text is a 510(k) premarket notification for a medical device called the "Brilliant Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested points regarding AI/algorithm performance studies cannot be answered from this document.

However, I can extract information related to the device's biocompatibility and performance testing, which are critical acceptance criteria for this type of medical device.

Here's the information that can be extracted and a clear indication of what cannot be derived from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through biocompatibility testing and general performance testing. The text does not provide quantitative acceptance criteria targets in the way one might for a software algorithm's accuracy, but rather indicates that the device "met the requirements" or "successfully passed" various tests based on established standards.

Table 1: Acceptance Criteria (as implied by successful testing) and Reported Device Performance

Additional Information Requests:

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

   • Sample Size: Not specified in the document for the biocompatibility or performance tests.
   • Data Provenance: The document does not specify the country of origin for the test data, nor whether the studies were retrospective or prospective. The applicant is Lepu Medical Technology (Beijing) Co., Ltd., which is located in P.R. China, implying the studies were likely conducted there or overseen by them.

2. 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 to the type of device and testing described. The "ground truth" here is established by standardized laboratory testing procedures (e.g., ISO, ASTM, USP standards) for biocompatibility and engineering performance, not by expert interpretation of clinical images or data.

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

   • This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, not for objective laboratory test results.

4. 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 is not an AI/software device that assists human readers.

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

   • Not applicable. This is not an AI/software device.

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

   • For biocompatibility: Ground truth is established by the specific endpoints and methodologies defined in the referenced international standards (e.g., cell viability for cytotoxicity, skin irritation scores for intracutaneous reactivity, sensitization response for maximization tests, mortality/organ effects for systemic toxicity, complement activation markers for complement assay, hemolytic index for hemolysis, temperature rise for pyrogenicity, clotting times for thromboplastin, and visual/histological assessment for in vivo thromboresistance).
   • For performance testing: Ground truth is established by engineering specifications and measurements (e.g., tensile force measurements, diameter measurements, visual inspection for coating integrity, particulate counts, chemical residue analysis, microbial culture for sterility, endotoxin assays).

7. The sample size for the training set

   • Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

   • Not applicable (no training set).

In summary, the provided document is a 510(k) premarket notification for a conventional introducer kit, primarily demonstrating substantial equivalence through adherence to existing medical device standards for biocompatibility and performance. It does not involve AI/machine learning components, and thus, metrics pertinent to AI/software validation are not present.

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The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer Sheath into the vascular system. The Guide Wire contains a wire collimator, which assists in funneling the wire through the lumen of the Puncture Needle. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The Dilator is used to provide support and stability to the Sheath Introducer during deployment into the vascular system. The proximal end of the Dilator includes a luer port and has a tapered, atraumatic distal tip. There is no radiocontrast agent on the dilator.

The document provided is a 510(k) premarket notification for a medical device called the "Shoocin™ Introducer Kit." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets acceptance criteria related to AI/ML or diagnostic performance studies.

Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and a study proving device performance (specifically, a diagnostic performance study for an AI/ML device) is not present in this document.

The document primarily focuses on:

• Substantial Equivalence: Comparing the modified device (Shoocin™ Introducer Kit) to its predicate (also Shoocin™ Introducer Kit, K123475) to demonstrate that changes (e.g., adding models, changing radiocontrast agent) do not alter its fundamental nature, intended use, or safety and effectiveness.
• Biocompatibility Testing: Results from tests performed according to ISO 10993 standards (e.g., cytotoxicity, intracutaneous study, sensitization, systemic toxicity, complement activation, hemolysis, pyrogen study, partial thromboplastin time, in vivo thromboresistance). These are biological safety tests.
• Performance Testing (Bench Tests): A list of physical and chemical bench tests performed on components of the introducer kit (sheath introducer, 3-way stopcock/valve, dilator, puncture needle, guidewire, particulate evaluation, chemical performance, biological sterility, bacterial endotoxin). These are engineering/material performance tests.
• Sterilization: The method used and the Sterility Assurance Level.

This document does not describe an AI/ML-based device, a study involving human readers, ground truth establishment for diagnostic images, or any of the other criteria relevant to the prompt's request for AI/ML device performance and acceptance criteria.

To directly answer your numbered points based on the provided document, I must state that the information is absent:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document lists performance tests for physical properties and biocompatibility, not diagnostic or AI performance.
2. Sample sizes used for the test set and the data provenance: Not applicable. The tests are bench tests and biocompatibility studies, not diagnostic studies with test sets of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is an introducer kit, not a diagnostic AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The ULTRASKIN™ Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.

The ULTRASKIN™ Hydrophilic Guide Wire consists of a Nitinol core wire, a plastic jacket with hydrophilic coating. The wire distal curve comes in different shapes such as straight, J angled and angled. The guide wire is radiopactitive under fluoroscopy.

The provided text describes the ULTRASKIN™ Hydrophilic Guide Wire, a medical device, and its supporting data for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility and performance testing.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely derived from international standards and internal performance testing, demonstrating safety and effectiveness compared to a predicate device.

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The Vasc Band hemostat is a compression device to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.

Vasc Band hemostat (Vasc Band) is a compression device that applies mechanical pressure to achieve hemostasis of vascular access sites. Vasc Band consists of an adjustable retention strap, inflatable compression balloon, inflation tube, and an inflation valve. A 22 ml inflation syringe is also included with the device. Vasc Band is available in five band lengths: 21 cm, 27 cm, 29 cm, and 37 cm.

The provided text is a 510(k) Summary for the Vasc Band hemostat. While it discusses the device's substantial equivalence to predicate devices and mentions "bench tests to provide evidence," it does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria in the way a clinical study or detailed performance report would.

The document is a regulatory submission, primarily focused on establishing substantial equivalence to legally marketed predicate devices, rather than providing an in-depth scientific study report with specific performance metrics against pre-defined acceptance thresholds.

Here's what can be extracted and what information is missing based on your request:

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

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

• Sample size: Not specified. The document mentions "bench tests" but does not detail how many units were tested or how many measurements were taken.
• Data provenance: Not specified beyond "bench tests." It's typically ex-vivo or in-vitro for bench tests, but this isn't stated. Country of origin of the data is not mentioned. Whether retrospective or prospective is not applicable to bench tests as described here.

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

• This information is not applicable and not provided. The "bench tests" would likely involve engineering or quality control personnel evaluating physical properties, not clinical experts establishing ground truth in a diagnostic sense.

4. Adjudication method for the test set

• This is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpreting ambiguous results, which is not described for these bench tests.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical hemostat and not an AI-powered diagnostic or assistive tool for human readers.

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

• This is not applicable. The Vasc Band hemostat is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the "bench tests," the "ground truth" would be the engineering specifications and performance standards for physical properties like balloon pressure and band size. This is implicitly "engineering specifications" or "physical measurements" rather than expert consensus, pathology, or outcomes data, as those apply to diagnostic or treatment efficacy studies.

8. The sample size for the training set

• This is not applicable. The device is not an AI/machine learning model that requires a training set.

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

• This is not applicable as there is no training set for this type of device.

In summary: The provided document is a regulatory submission for a physical medical device. It attests to the device's substantial equivalence to predicates based on "bench tests" verifying device design (balloon pressure and band size). It does not provide the detailed scientific study data, specific acceptance criteria values, or expert review processes that would be typical for validating diagnostic algorithms or complex clinical interventions. The focus is on demonstrating that the new device is fundamentally similar in function and safety to already-approved devices, rather than proving novel effectiveness through a comprehensive, quantitative clinical or AI performance study against acceptance criteria.

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The ShoocinTM Introducer Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

The ShoocinTM Introducer Kit consists of a puncture needle, a guide wire with a guide wire collimator, a sheath introducer, and a dilator. The puncture needle incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The flexible stainless steel guide wire is utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle and contains marking that are visible under fluoroscopy, which can determine in length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The provided text describes a medical device, the Shoocin™ Introducer Kit, and its substantial equivalence to a predicate device (Pinnacle Precision Access System). The acceptance criteria and the study proving the device meets them are primarily focused on biocompatibility and performance testing, rather than an AI/ML-based diagnostic or prognostic device study.

Here's an analysis of the provided information, structured according to your request, with an emphasis on what is and is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be meeting the standards of the predicate device and relevant ISO standards. The document explicitly lists performance tests and biocompatibility tests from ISO standards as criteria. The reported performance is that the device "successfully passed all" these tests.

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The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

This balloon dilatation catheter is not intended for the expansion or delivery of a stent.

Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The proximal shaft is a polymer coated stainless steel tube. The steel construction is designed to optimize proximal pushability with a smooth transition to a distal shaft specifically designed to be highly trackable. The semi-compliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guide wire. The proximal part of the guide wire enters the catheter's tip and advances coaxially out the catheter's proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guide wire.

Two marked sections are located on the hypo tube shaft to indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The product can be used to expand stenotic coronary vessel, and improve myocardial bleeding. This kind of balloon catheter possesses such merits as moderate compliance, high pressure resistance, minor diameter, etc.

The provided text describes a medical device, the Hoper™ PTCA Balloon Dilatation Catheter, and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or a comparative effectiveness study with human readers.

The "Performance Testing" section lists various in vitro performance tests and biocompatibility tests. It states that "The test results met all acceptance criterions, were similar to predicate devices, and ensured that the Hoper™ PTCA Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA, September 8, 2010)."

This indicates that acceptance criteria were met for these technical and biological safety aspects, but the specific numerical acceptance criteria and detailed study results for each test are not provided in the summary.

Based on the provided text, I cannot answer the specific questions about clinical acceptance criteria and related studies, as the document focuses on regulatory clearance based on substantial equivalence to predicate devices through technical performance and biocompatibility testing, rather than a clinical trial or AI performance evaluation.

Therefore, for the requested information, the answer is:

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

   • The document states that "The test results met all acceptance criterions" for the listed in vitro performance tests and biocompatibility tests.
   • However, specific numerical acceptance criteria or detailed quantitative performance data for each test (e.g., maximum allowable balloon inflation/deflation time, minimum bond strength, specific cytotoxicity results) are not provided in this summary. The summary only confirms compliance without detailing the criteria or results.

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

   • This information is not provided for the in vitro performance tests or biocompatibility tests. No clinical test set is described.

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 is not applicable, as no clinical test set or ground truth established by experts is mentioned in the provided text.

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

   • This is not applicable, as no clinical test set requiring adjudication is mentioned.

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:

   • This is not applicable. The device is a PTCA Balloon Dilatation Catheter, not an AI imaging analysis tool, and no MRMC study or AI assistance is mentioned.

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

   • This is not applicable, as the device is not an algorithm or AI system.

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

   • For the in vitro tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO, ASTM, FDA guidance documents) against which the device performance was measured. For biocompatibility, it's about meeting established safety limits for chemical and biological interactions. No clinical ground truth (like pathology or outcomes data) is mentioned as being used for these tests.

8. The sample size for the training set:

   • This is not applicable, as the device is not an AI system that requires a training set.

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

   • This is not applicable, as the device is not an AI system.

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The Radial Artery Compression Tourniquet Device is a compression device to assist haemostasis following a catheterization or other puncture into a blood vessel in a patient's arm, including radial artery catheterization, arterial or venous line removal, haemodialysis, and in patients on anticoagulation therapy.

The Radial Artery Compression Tourniquet devices consist of a plastic belt with an adjustable fastener on each end, two compression balloons, tubing and a unilateral valve. The plastic belt has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist and are made of clear plastic which allows the physician to view the access site during the haemostasis process. The inflation device introduces air through the unilateral valve filling two compression balloons (large and small) at the same time. The top small balloon is layered and internally connected to the bottom large balloon. The result of the balloon inflation is the haemostasis of the puncture site within the patient's wrist.

The provided text describes the Radial Artery Compression Tourniquet and its substantial equivalence to predicate devices, but it does not contain the specific information requested in points 1 through 9 regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document details the device's description, intended use, contraindications, warnings, and cautions. It also mentions "Tests Conducted," which include:

• Biocompatibility: Assessed against ISO 10993 Biological Evaluation of Medical Devices - Part 10 for Irritation and Sensitization and Part 5 Tests for Cytotoxicity. It states that the device "has been shown to meet the acceptance criteria, and did not raises additional safety and effectiveness concerns."
• Performance: A "side-by-side comparison of the predicate TR Band®, Terumo Corporation, K070423 performance of the balloon’s maintenance of internal pressure was performed with the Lepu’s device." The conclusion is that "The balloon profile performance characteristics of both devices are very similar when factoring the balloon size and volume inflation difference and do not impose any additional safety or performance issues."

However, this information is for a physical medical device (a tourniquet) and not for an AI/algorithm-based device. Therefore, the requested details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established are not present in the provided text.

Based on the provided text, the answer to the specific questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/algorithm would be:

1. Table of acceptance criteria and reported device performance: Not applicable for an AI/algorithm performance study. The document mentions biocompatibility acceptance criteria (meeting ISO 10993 standards) and performance comparison of balloon pressure maintenance to a predicate device, concluding similarity.
2. Sample size for the test set and data provenance: No test set information for an AI/algorithm is provided.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for an AI/algorithm.
4. Adjudication method: Not applicable for an AI/algorithm.
5. Multi reader multi case (MRMC) comparative effectiveness study: No MRMC study is mentioned.
6. Standalone performance: No standalone (algorithm only) performance is mentioned.
7. Type of ground truth used: Not applicable for an AI/algorithm. For the physical device, the "ground truth" for biocompatibility was meeting ISO standards, and for performance, it was comparable balloon pressure maintenance to a marketed predicate.
8. Sample size for the training set: No training set information for an AI/algorithm is provided.
9. How the ground truth for the training set was established: Not applicable for an AI/algorithm.

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