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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.

The Introducer Sheath System devices consist of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface in length of 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath with hemostasis valve
• A One or two dilator(s)

The provided text describes a 510(k) premarket notification for a medical device called the Catapult Guide Sheath / Introducer Sheath System. It details the device, its intended use, comparison to a predicate device, and the performance testing conducted to demonstrate substantial equivalence.

However, the questions you've asked are typical for the evaluation of AI/ML-driven medical devices, especially related to diagnostic or classification tasks (e.g., image analysis for disease detection). The device described in the document (Catapult Guide Sheath) is a physical medical device (an introducer sheath system) used for physical introduction of interventional and diagnostic devices into the vasculature, not an AI/ML software device.

Therefore, the provided document does not contain the information requested in your prompt regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML device. Many of the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are irrelevant to the type of device being reviewed in this FDA submission.

Here's why and what information is available:

• Type of Device: The Catapult Guide Sheath is a Class II physical medical device (introducer catheter). It's a tool, not a diagnostic or AI algorithm.
• Purpose of Submission (510(k)): This submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Catapult Guide Sheath Introducer Sheath System, K240957). This is a common pathway for physical devices with modifications or new physical devices that are very similar to existing ones. The core of the substantial equivalence argument relies on demonstrating that the new device performs similarly to the predicate device, especially after a material change (insourced HVA).
• "Acceptance Criteria" for this device: For this type of device, "acceptance criteria" are related to mechanical performance, biocompatibility, sterilization, and shelf-life, ensuring the device functions as intended and is safe. These are detailed in Table 2, listing the tests performed and the applicable standards.
• "Study that proves the device meets the acceptance criteria": The document lists a series of non-clinical (laboratory) tests that were performed. These tests are the "study" demonstrating the device meets the performance requirements for substantial equivalence.

Therefore, I cannot fill out the detailed table and answer the specific questions about AI/ML device evaluation based on the provided text. The text focuses on the mechanical, material, and safety performance of a physical device, not the diagnostic or predictive performance of an AI algorithm.

If your intention was to ask about the evaluation of a physical medical device, I can re-frame the answer based on the provided document.

Assuming you are asking for information relevant to the physical medical device described, here's an attempt to interpret your questions in that context, recognizing that most are geared towards AI/ML:

Device: Catapult Guide Sheath / Introducer Sheath System

1. Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to meeting specifications derived from regulatory standards and predicate device performance. The "reported device performance" are the results of the listed tests that demonstrated compliance.

2. Sample Size for the Test Set and Data Provenance

For a physical device, "test set" refers to the number of units tested. The specific sample sizes for each mechanical test are not detailed in this summary (they would be in the full submission). The data provenance is from non-clinical (laboratory) testing conducted by the manufacturer and external laboratories. It is not patient data, so "country of origin of the data," "retrospective or prospective" do not apply.

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

This question is not applicable. "Ground truth" in the context of AI/ML diagnostic devices refers to a definitive diagnosis or finding. For a physical device, the "ground truth" is established by the specifications and performance requirements derived from engineering principles and relevant ISO standards. No human experts are used to "establish ground truth" in this context; instead, engineers and technicians conduct specified physical and chemical tests.

4. Adjudication Method for the Test Set

Not applicable. There's no "adjudication" (e.g., consensus among readers) needed for a physical device's performance testing. Test results are quantitative measurements against defined criteria.

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

Not applicable. MRMC studies are for evaluating human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is not an AI diagnostic tool.

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

Not applicable. This is a physical device, not an algorithm. Its "standalone performance" refers to its mechanical and material properties as tested in the lab.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for performance is defined by:

• International standards (ISO, AAMI, ASTM, EN): These standards define acceptable limits and testing methodologies for medical device properties (e.g., leakage, tensile strength, biocompatibility, sterility).
• Predicate device performance: The previously cleared predicate device provides a benchmark for expected performance characteristics of the new device.
• Manufacturer's internal design specifications and risk analysis: Derived from the intended use and safety considerations.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

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

Not applicable. There is no "training set" or "ground truth" for training in the AI/ML sense for this device.

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The Catapult TM Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The Catapult ™ Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface of its distal 20cm.

The Catapult ™ Guide Sheath was previously cleared under K221914 in 4 French, 5 French, 7 French and 8 French sizes, each with effective lengths of 15 cm, 60 cm or 90 cm. This 510(k) adds a 130 cm length which is available in 4 French, 5 French and 6 French sizes.

The provided text does not contain information about the acceptance criteria and study proving a device meets them in the context of an AI/ML-driven device. Instead, it describes characteristics and performance tests for a conventional medical device, the "Catapult Guide Sheath," for which a 510(k) premarket notification was submitted.

The request asks for specific details related to AI/ML device studies (e.g., sample size for test set and training set, ground truth establishers, MRMC studies, standalone performance), which are not applicable to the non-AI device described in the document.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device. The provided text details the 510(k) submission for a medical device that is not an AI/ML device.

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The Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract

The propose device, Disposable Ureteral Guide Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. This device is divided into 4 types: Straight type (ZSR-UA), Y type (ZSR-UAY), W type (ZSR-UAW), Cross type (ZSR-UAC). The device is composed of guide sheath and dilator.The guide sheath consists of guide sheath tube and connector (straight, Y-shaped, W-shaped and cross-shaped). The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

The provided text describes the 510(k) premarket notification for a medical device called the "Disposable Ureteral Guide Sheath." It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. The document does not detail a study proving the device meets acceptance criteria related to AI/algorithm performance or human reader improvement.

Therefore, I cannot provide information on acceptance criteria for AI performance, sample sizes for AI test sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI. These sections are not relevant to the provided text.

However, I can extract information regarding the non-clinical performance testing acceptance criteria and results as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance testing, the document refers to compliance with standards. The 'Discussion' section under 'Comparison of technological characteristics with the predicate devices' (Table 1) provides some insight into the performance aspects considered, although explicit numerical acceptance criteria are not always stated, rather the outcome of testing.

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

This document describes non-clinical engineering and bench testing, not a clinical study involving a "test set" of patient data in the way an AI/ML device would.

• Sample Size: Not explicitly stated as a grand total for testing. For specific tests like "Coefficient of Friction," it mentions "25 repeated tests." For "Bending Resistance," it mentions "20 times of repetition."
• Data Provenance: This is bench test data, not patient data. The country of origin for the manufacturing company is Dongguan ZSR Biomedical technology Company Limited, China. The testing would have been conducted as part of their device development and validation process. It is neither retrospective nor prospective in the context of patient data studies; it's product validation testing.

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

Not applicable. This is not a study involving expert readers establishing ground truth for diagnostic accuracy, but rather bench testing against engineering specifications and industry standards.

4. Adjudication Method 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

No. This document does not pertain to an AI-assisted diagnostic device, nor does it describe an MRMC study.

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

No. This document does not pertain to an algorithm, AI, or software device. It is for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described would be the engineering specifications and industry standards (e.g., specific force values for tensile strength, visual inspection for defects after bending, a defined Sterility Assurance Level). For biocompatibility, the 'ground truth' is compliance with the ISO 10993 series of standards.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for this type of device.

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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The Catapult Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface up to 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath) with hemostasis valve
• A One dilator or
• A Two dilators for 15 cm version

The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are fixated onto a packaging pad. Products are sealed inside a medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.

The Catapult Guide Sheath is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is suitable for placement in patients for up to 24 hours.

Devices are sterilized using ethylene oxide. Maximum levels of remaining tested sterilant residuals meet requirement limits EO

The provided document is a 510(k) summary for the Catapult Guide Sheath, a medical device. It describes the device, its intended use, comparison to a predicate device, and performance data. However, the document does not contain any information about an AI/ML-based device.

Therefore, I cannot provide an answer to your request regarding acceptance criteria and a study that proves an AI/ML device meets them, as the provided text pertains to a traditional medical device (Catheter Introducer).

If you can provide a document that describes the acceptance criteria and study for an AI/ML medical device, I would be happy to assist you.

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The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The Prelude Guide Sheath Introducer is a sterile, disposable device consisting of a (a) a coil reinforced shaft with an atraumatic tip and the distal end: (b) a hemostasis valve with a side port and color-coded stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end.

This is a 510(k) summary for a medical device (Prelude Guide Sheath). The document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data and material comparisons, not on evaluating an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or readily extractable from this specific document.

However, I can provide the acceptance criteria and performance as described for the non-clinical tests.

Acceptance Criteria and Reported Device Performance

The document states that "The results of the testing demonstrated that the subject Prelude Guide Sheath met the predetermined acceptance criteria applicable to the performance of the device." The specific numerical acceptance criteria for each test are not provided in this summary, but the general categories of tests performed are listed. The "Reported Device Performance" for each test is simply that the device met those unstated criteria.

Here's a table based on the provided "Performance Tests" section:

The remaining requested information is largely irrelevant to this 510(k) submission, as it pertains to AI/ML algorithm validation for which this device is not. This submission focuses on the physical and material characteristics of a medical device (a guide sheath introducer) and its substantial equivalence to existing predicate devices, rather than the performance of an AI/ML system.

Therefore, the following information is not applicable or extractable from the provided document:

2. Sample sized used for the test set and the data provenance: Not an AI/ML study, so "test sets" in that context don't apply. The non-clinical tests would have their own sample sizes for a variety of physical or chemical tests, but these are not detailed as a single "test set" for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML study; no "ground truth" in the diagnostic/interpretive sense is established by experts here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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 (expert concensus, pathology, outcomes data, etc): 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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Single Use Guide Sheath Kit K-401, K-402

These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.

• Indications for use of each component

Single Use Guide Sheath SG-400C

The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.

Single Use Biopsy Forceps FB-433D

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.

The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.

The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.

This document is a 510(k) premarket notification for the Olympus Medical Systems Corp.'s Single Use Guide Sheath Kit K-401/K-402. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192164).

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims substantial equivalence to its predicate device (K192164) and does not explicitly list performance acceptance criteria in a table format with corresponding reported performance values for each criterion. Instead, it states that the only technological difference from the predicate is the outer diameter of the Guide Sheath SG-400C, and that this difference was validated.

Key Difference and Stated Performance:

The document states, "The difference above has been validated and it is demonstrated that this technological feature does not raise no new safety issues and are substantially equivalent to the predicate device."

Performance Data and Demonstrated Safety/Effectiveness (for SG-400C only):
The following performance tests were conducted to demonstrate safety and effectiveness for the SG-400C only (as FB-433D and BC-205D had no specification changes):

• Radiographic Testing
• Catheter Joint/Tensile Testing
• Dimensional Testing
• Simulated Use Testing
• Trackability Testing (insertion & withdrawal)

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

The document does not specify the sample sizes used for the performance tests (Radiographic, Catheter Joint/Tensile, Dimensional, Simulated Use, Trackability).
The data provenance is not explicitly stated. However, this is a submission by Olympus Medical Systems Corp. in Japan for a device manufactured in Japan, indicating the testing was likely conducted in Japan. The studies are premarket validation studies, typically prospective, but the specific experimental design (e.g., patient cases, benchtop models) and retrospective/prospective nature of data collection are not detailed.

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

Not applicable. This device is a medical instrument (guide sheath, biopsy forceps, cytology brush), not an AI/software device that requires ground truth established by experts for diagnostic or image interpretation tasks. The evaluation is based on engineering performance tests and adherence to standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/software device requiring expert adjudication for diagnostic tasks. Performance is assessed against engineering specifications and validated through physical and functional testing.

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

Not applicable. This is a medical device, not an AI diagnostic software. Therefore, an MRMC study and analysis of human reader improvement with/without AI assistance are irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation refers to engineering specifications, established medical device standards (e.g., ISO, ASTM, USP), and functional requirements for safe and effective operation. For example, dimensional accuracy, tensile strength, and successful trackability in simulated use are evaluated against predefined acceptable ranges or outcomes.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. As there is no training set for a physical medical device, there is no ground truth establishment for it.

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Single Use Guide Sheath Kit K-401, K-402

These instruments have been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically. This kit and its components are intended for adult patients only.

• Indications for use of each component

Single Use Guide Sheath SG-400C

The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and for ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.

Single Use Biopsy Forceps FB-433D

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination with a flexible bronchoscope within the tracheobronchial tree.

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with the bronchoscope within the tracheobronchial tree.

Single Use Guiding Device CC-220DR

This instrument has been designed to be used with an Olympus endoscope and guide sheath to the respiratory organs and to collect specimens within the respiratory organs. This device is intended for adult patients only.

Single Use Guide Sheath Kit K-401/K-402

The kit has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree and collect tissue, specimens, or cells bronchoscopically.

The compatible bronchoscope for the subject Single Use Guide Sheath Kit needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.

The guide sheath kit consists of the following components: Guide Sheath, Biopsy Forceps, with/without Cytology Brush. EU stoppers and US Stopper are also included in the kit as accessories. Each component and the accessory stoppers are sterile and packaged in individual package. All of them are collected into one carton box as one final kit product.

The single use guide sheath has been designed to be used with Olympus bronchoscopes, EndoTherapy accessories, and/or ultrasonic probes to guide the EndoTherapy accessories and/or the ultrasonic probes to the target area within the tracheobronchial tree.

This guide sheath is designed to function as an extended working channel. The function of the subject guide sheath is to facilitate obtaining multiple biopsy specimens by leaving the guide sheath in place after localization of the target tissue.

This instrument consists of an insertion portion and a handle portion. The insertion portion is composed of tube and X-ray tip.

The biopsy forceps has been designed specifically to collect tissue endoscopically for examination in conjunction with a flexible bronchoscope. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect tissue with the pair of forceps which is equipped at the distal end of the subject device. Finally, users withdraw the subject device biopsy forceps from the bronchoscope to collect the samples.

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytology examination in conjunction with bronchoscopes. The subject device is allowed to insert into the channel of a bronchoscope with the subject device guide sheath, and then collect specimens or cells with the brush which is affixed in the distal end of the subject device. Finally, users withdraw the subject device cytology brush from the bronchoscope to collect the samples.

The ET stopper and US stopper are included in the guide sheath kit as accessory. They are used to fasten the sampling devices (EndoTherapy accessories) or ultrasonic probe to the guide sheath, which serve as a mark to keep the sampling devices or ultrasonic probe in relative position to the guide sheath. The ET stopper are made of silicone rubber outside, molded with stainless steel plate inside.

Single Use Guiding Device CC-220DR

The Single Use Guiding Device has been designed to be used with an Olympus endoscope and guide sheath to guide the guide sheath to the respiratory organs and to collect specimens within the respiratory organs.

The compatible bronchoscope for the subject Single Use Guiding Device CC-220DR needs to have the working length 600mm or less (exclude the ultrasonic bronchoscope) and a working channel inner diameter that is no less than 2.0mm.

The subject device consists of a handle section and an insertion. The distal end in the insertion portion consists of a double-joint curette which bends by operating the handle section. The rotation grip in handle section also allows for rotation of the curette in the distal end. The subject device inserts into an endoscope with the guide sheath, and enables the guide sheath to be directed to the target area following the direction the curette in distal end to the target area. The curette can also collect the specimen by scraping the tissue.

Although this device is used together with the subject device guide sheath in Single Use Guide Sheath Kit, it is marketed independently as a single product.

The provided document is a 510(k) summary for medical devices (bronchoscope accessories) and does not describe acceptance criteria or a study proving device performance in the context of an AI/ML algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests, sterilization/shelf-life testing, and biocompatibility testing for medical hardware.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and studies from this document. The document lists different types of engineering and biological performance tests for the physical medical devices, but not for an AI/ML model's performance.

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The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.

The CEREBASE DA Guide Sheath is a single lumen, stainless steel braided catheter of variable stiffness with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The guide sheath is a straight shaped catheter that comes in four lengths; 70 cm, 80 cm, 90 cm, and 95 cm. The lubricious PTFE-lined inner lumen is designed to facilitate delivery of the interventional devices. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The guide sheath has an outer hydrophilic coating at the distal end that reduces friction during use. A hemostasis valve and a dilator are provided with the CEREBASE DA Guide Sheath within its sterile packaging. The dilator is a single lumen radiopaque catheter with a tapered distal end and a luer hub at the proximal end. The dilator is compatible with the CEREBASE DA Guide Sheath and up to 0.038 inch diagnostic guidewires. The hemostasis valve with side port is an off the shelf component used for flushing and insertion of catheters.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the CEREBASE DA Guide Sheath. This is a medical device, and the study in question is a premarket notification for substantial equivalence to an existing predicate device, not a typical AI/ML performance study. Therefore, some of the requested information regarding AI/ML specific criteria (like human-in-the-loop, training set details, or multiple expert ground truth) is not applicable or not provided in this document.

Here's the breakdown of the acceptance criteria and performance as presented:

Acceptance Criteria and Device Performance for CEREBASE DA Guide Sheath

The acceptance criteria for the CEREBASE DA Guide Sheath are primarily based on non-clinical performance testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Neuron MAX System).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established through various tests designed to ensure the device meets predefined requirements (design inputs) and industry standards (e.g., ISO 10555-1, ISO 11070). The reported performance for all tests was "Pass," indicating that the samples met the established acceptance criteria.

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

The document consistently states "Samples passed established acceptance criteria" for the performance tests. However, the specific number of samples tested for each criterion ("sample size") is not explicitly provided in the given text for the non-clinical tests. The document only mentions "test samples" or "samples."

For the In Vitro Modeling and In Vivo Testing, it states "In Vivo testing in a porcine model," indicating animal data.
For Biocompatibility, specific animal numbers are mentioned for certain tests:

• ISO Guinea Pig Maximization Sensitization (Guinea Pigs)
• ISO Acute Systemic Toxicity in Mice (Mice)
• USP Rabbit Material-Mediated Pyrogenicity (3 animals in Pyrogenicity test)
• In Vivo Thromboresistance Study (Implies animal model, potentially porcine as mentioned above for in vivo testing).

The data provenance is from non-clinical testing (bench testing, in vitro, and in vivo animal studies) and laboratory evaluations. The location/country of these studies is not specified, but the submission is from Medos International SARL in Switzerland to the U.S. FDA. The data is prospective as it was collected for the purpose of demonstrating device performance for this regulatory submission.

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

This type of information is not applicable to this submission. The "ground truth" for a medical device's performance in a 510(k) submission is established by meeting predefined engineering specifications, adherence to international standards (e.g., ISO), and successful outcomes in validated physical, chemical, and biological tests. There are no human "experts" in the sense of clinicians establishing ground truth from patient data, as this is not an AI/ML diagnostic or prognostic device study.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human-read interpretations of clinical data, typically in studies involving multiple human readers or AI algorithms. The testing here is objective, based on physical and chemical measurements and biological responses.

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 submission is for a percutaneous catheter, not an AI/ML-driven diagnostic or assistive device that would involve human readers.

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

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

The "ground truth" (or more accurately, the demonstration of acceptable performance) is based on:

• Engineering specifications and design inputs: The device was tested against its own design requirements.
• International standards: Adherence to established standards like ISO 10555-1, ISO 11070, ISO 10993 series, ISO 11135-1, EN ISO 11607-1, and USP requirements.
• Bench testing results: Objective measurements of physical properties (e.g., diameters, lengths, strengths, leaks, lubricity, kinking, torque, trackability).
• In Vitro modeling results: Performance in simulated environments.
• In Vivo animal testing results: Performance in a porcine model to meet customer requirements.
• Biocompatibility test results: Demonstrating no adverse biological reactions based on standard tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, thromboresistance).

The comparison is also made against the technological characteristics of a legally marketed predicate device (Neuron MAX System). The conclusion of "substantial equivalence" is the ultimate "ground truth" for regulatory clearance in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm that requires a training set.

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

Not applicable. This is not an AI/ML algorithm that requires a training set.

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The Guide Sheath is intended to introduce therapeutic devices into the vasculature, excluding the coronary and neuro vasculature.

The Surmodics Guide Sheath is designed to perform as a guide sheath and/or introducer sheath. The sheath is braid reinforced with an embedded radiopague marker band to identify the distal tip. It also has a hydrophilic coating over the working length to provide a lubricious surface to ease insertion. The device comes packaged with a dilator, which is either .018" or .035" guidewire compatible.

This highly flexible, braid reinforced sheath is designed to resist kinking and maximize strength while keeping a minimized profile. Incorporated in the sheath is a radiopaque marker band located approximately 5mm from the distal tip. The Guide Sheath has an atraumatic tip and has a hydrophilic coating over the working length.

The dilator hub is designed to snap into the Guide Sheath cross cut valve cap. Additionally, the dilator shaft design allows for simultaneous movement of the sheath and dilator assembly. The dilator features an atraumatic tip, which is designed to extend beyond the sheath tip by approximately 5 cm. The dilator shaft is radiopaque.

The Guide Sheath features a custom designed cross cut valve that is integrated into the sheath hub and includes a 3-way stopcock with sidearm extension tubing. No assembly is required.

The sheath is packaged in a dual sterile barrier configuration. The sheath and dilator will be placed individually in high density polyethylene (HDPE) coiled hoops, which are then placed in a poly-tyvek pouch within a shelf box.

I apologize, but the provided text from the FDA 510(k) summary for the Surmodics Guide Sheath does not contain information related to a study proving a device meets acceptance criteria for an AI/software device.

The document describes the acceptance criteria and performance of a physical medical device (catheter introducer) through various bench tests, packaging tests, and biocompatibility tests. It demonstrates substantial equivalence to a predicate device, as opposed to an AI or software product.

Therefore, I cannot fulfill your request for information regarding an AI device's acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or training set details, as these concepts are not applicable to the content provided.

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The Vessix™ Guide Sheath is designed to be used for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries.

Vessix™ Guide Sheath is a 7F guide sheath designed to perform as an introducer sheath and guide catheter for the introduction of interventional and diagnostic devices through the vasculature to the renal arteries. The Vessix Guide Sheath has been optimized for torque to allow access to both renal arteries during procedures. The guide sheath has an effective length of 45 cm and is available in two curve shapes: RDC (renal double curve) and LIMA (left internal mammary artery).

The guide sheath has a braided shaft design to maximize torque response, and a pre-formed tip shape (either RDC or LIMA) to enable access. It is equipped with a Tuohy-Borst valve (hemostatic valve) to prevent bleeding and a sidearm with a three-way stopcock to allow for flushing and introduction of contrast media. It is also packaged with a dilator to help with delivery over a guidewire. The guide sheath can accommodate guidewires with diameters less than or equal to 0.038 in (0.97 mm). The distal 15 cm of the outer surface of the guide sheath has a hydrophilic coating (Bioslide™). The distal tip is radiopaque to help with placement.

A polycarbonate hub is adhesively bonded to the proximal section of the guide sheath. It incorporates a luer fitting which serves as a junction to the hemostatic valve.

Here's an analysis of the provided text regarding the Vessix™ Guide Sheath. It's important to note that the provided text describes a 510(k) submission for a medical device (guide sheath), which involves proving substantial equivalence to a predicate device, not typically a clinical study with human readers or AI.

The information primarily focuses on bench testing and biocompatibility testing, which are common for physical medical devices, especially those that are fundamentally similar to existing technology. Therefore, many of the requested categories related to clinical studies, human readers, and AI assistance will be addressed by stating that such information is not applicable or not provided in this specific document.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" with numerical targets and then report specific "device performance" values against those targets in the format of a table as typically seen in clinical study reports. Instead, it lists the types of tests performed to demonstrate that the device meets requirements for its intended use and is substantially equivalent to the predicate. The "reported device performance" is implied to be "passed" or "conformed" to the requirements for each test.

The document states: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, this device may be considered substantially equivalent to the predicate device."

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

• Sample Size: The document does not specify the sample sizes for each of the bench or biocompatibility tests. This level of detail is typically found in the full test reports, not usually in the 510(k) summary itself.
• Data Provenance: The data comes from bench testing (in-vitro performance) and biocompatibility testing conducted by Boston Scientific Corporation for the Vessix™ Guide Sheath. This is not clinical human data; it's laboratory testing of the device itself.
• Country of Origin of Data: Not explicitly stated, but assumed to be performed according to international standards (e.g., ISO, ASTM) within the regulatory framework of the US (FDA).
• Retrospective or Prospective: Not applicable as this refers to device testing, not clinical data collection.

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

This information is not applicable to this type of device submission. The "ground truth" for bench testing and biocompatibility is established by engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and validated test methods. It does not involve human expert consensus in the way an imaging study would.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, often for assessing ambiguous cases or establishing ground truth from multiple expert opinions. This document describes laboratory and physical testing of a medical device.

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

No, an MRMC comparative effectiveness study was not done. The document does not mention any studies involving human readers, AI assistance, or comparative effectiveness in a clinical setting. The submission focuses on substantial equivalence based on technological characteristics and performance testing.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (guide sheath), not a software algorithm or AI-powered system, so this type of study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Engineering Specifications: Defined dimensions, material properties, and functional performance requirements (e.g., burst pressure, tensile strength, kink resistance).
• Biocompatibility Standards: Established criteria from standards like ISO 10993 for biological safety.
• Predicate Device Comparison: The predicate device (Terumo Destination Renal Guiding Sheath K081045) serves as a benchmark for substantial equivalence, implying that its performance characteristics (if not explicitly exceeded or matched) were considered acceptable.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "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 device.

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