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Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.

The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device consists of a 6-French catheter terminating at a stainless steel housing in which a small diameter helical screw is attached to a drive shaft. A battery-operated motor rotates a flexible drive shaft connected to the helical screw at approximately 3,100 rpm. A central lumen within the device is provided for guidewire placement or infusion of fluids.

The provided text is a 510(k) summary for the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment methods, MRMC study details).

Here's an attempt to answer your questions based only on the provided text, highlighting what is missing or cannot be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that clinical studies "demonstrated" the device is as safe and effective as the predicate, but it does not provide quantitative acceptance criteria (e.g., a specific percentage of thrombus removal, a certain patency rate, or a defined complication rate). It also does not present detailed performance metrics for the Baxter PMT Device.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: The study is referred to as "clinical studies," implying human data, but no country of origin or whether it was retrospective or prospective is mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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

• MRMC Comparative Effectiveness Study: Not mentioned. This device is a mechanical thrombectomy device, not an AI or imaging interpretation device, so an MRMC study is not relevant in this context.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable. This is a medical device for mechanical thrombus removal, not an algorithm.

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

• Type of Ground Truth: Implied to be clinical outcomes related to "safety and effectiveness" in thrombus removal, but the specific metrics or "ground truth" used (e.g., successful removal confirmed by subsequent imaging, patency rates, complication rates) are not detailed.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI model requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of what the document does state about the study:

• Study Type: "Clinical studies" were performed.
• Purpose: To demonstrate that the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is "as safe and effective as the predicate device for the removal of thrombus within synthetic dialysis access grafts."
• Predicate Device: MICROVENA Amplatz Thrombectomy Device (ATD).
• Additional Testing: The device also underwent "design validation, as well as functional, animal and clinical testing."

The provided text serves as a regulatory summary indicating substantial equivalence, rather than a detailed scientific publication of study results. Therefore, many of the specific details requested about acceptance criteria and study methodology are not present.

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Single Lumen Introducers: The Baxter Healthcare Single Lumen Hemostasis Valve Introducers are indicated for use in patients requiring access of the venous system and to facilitate catheter insertion (e.g. pulmonary artery or infusion catheter). Multiple Lumen Access Products: The Baxter Healthcare Multiple Lumen Access Products are indicated for use in patients requiring access of the venous system, to facilitate catheter insertion (e.g., pulmonary artery or infusion catheter) and central venous pressure monitoring.

The Baxter Hemostasis Valve Introducers are used to access the venous system and to facilitate catheter insertion. The introducers are composed of a housing body to which a sheath is attached distally and a side port/extension tube is connected proximally. A valve is located in the housing body to provide a seal around a catheter when inserted through the Introducer and to prevent backflow when no catheter is present. A dilator is provided with the Introducer to ease insertion of the device into the vessel. The Baxter Hemostasis Valve Introducers are provided with and without AMC Thromboshield™ which is used on Baxter's catheters and introducer products. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

Here's an analysis of the provided 510(k) summary regarding the Baxter Hemostasis Valve Introducers:

Missing Information:

It's crucial to note that the provided 510(k) summary is for a medical device (introducer sheath), not for an AI/algorithm-based diagnostic device. Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of device submission and are not present in the document.

Acceptance Criteria and Device Performance for Baxter Hemostasis Valve Introducers

Given the nature of this medical device, the "acceptance criteria" are based on comparative technological equivalence to predicate devices and successful results in a series of in-vitro and biocompatibility tests. There are no performance metrics like sensitivity, specificity, or AUC that would be associated with an AI/diagnostic algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of an AI/diagnostic algorithm. For an in-vitro device, "test set" refers to the units of the device subjected to functional and biocompatibility tests. The document does not specify a numerical sample size for these tests, which is common for this type of submission. It implies that a sufficient number of devices were tested to demonstrate performance and establish comparability.
• Data Provenance: The in-vitro testing and biocompatibility testing were conducted directly on the manufactured Baxter Hemostasis Valve Introducers. No external patient data (country of origin, retrospective/prospective) was used, as clinical testing was explicitly waived due to equivalence with predicate devices.

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

• Not Applicable. This document pertains to a physical medical device, not an AI/diagnostic algorithm where expert-established ground truth on a test set would be relevant. The assessment was based on engineering and laboratory testing protocols.

4. Adjudication Method for the Test Set

• Not Applicable. There was no "test set" in the sense of patient cases requiring adjudication for ground truth. Device performance was evaluated against technical specifications and established standards through specific tests.

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

• No. An MRMC study is not relevant for this type of purely mechanical medical device.

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

• Not Applicable. This is a physical introducer sheath, not an algorithm.

7. The Type of Ground Truth Used

• Not Applicable in the traditional sense of AI/diagnostic algorithms. For this device, the "ground truth" for the in-vitro and biocompatibility testing involved objective measurements and adherence to pre-defined engineering specifications and international standards (e.g., ISO 10993-1-1994 guidance). For "equivalence," the predicate devices served as the benchmark.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" for a physical medical device. Manufacturing processes and design iterations, while involving testing, are not analogous to training an AI model.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth was established in this context.

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The intended uses of Baxter's Annuloplasty ring products with Duraflo Treatment are intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines and prevent further dilatation of the annulus.

1. The Carpentier-Edwards Classic™ Ring with Duraflo® Treatment (Models 4425 and 4525) is constructed of titanium alloy and has a sewing ring margin that consists of a layer of siloxane polymer rubber covered with a polyester knit fabric.
   The mitral ring. Model 4425, conforms to the configuration of a normal mitral orifice. It is kidney-shaped with one long curved segment corresponding to the posterior leaflet. The ring is open in the rectilinear portion corresponding to the anterior leaflet and has transverse colored threads indicating the anterior and posterior commissures.

The oval tricuspid ring, Model 4525, conforms to the configuration of a normal tricuspid orifice. The ring has one rectilinear segment corresponding to the septal leaflet and one long curved segment corresponding to the anterior and posterior leaflets. The ring is open at the anteroseptal commissure. Transverse colored threads indicate the site of the anteroposterior and posteroseptal commissures.

2. The Carpentier-Edwards Physio® Annuloplasty Ring with Duraflo® Treatment, Model 4450, is constructed of Elgiloy® bands separated by polyester film strips and has a sewing ring margin that consists of a layer of siloxane polymer tubing covered with a woven polyester cloth.
3. The Cosgrove-Edwards® Annuloplasty System with Duraflo® Treatment, Model 4600, is composed of a silicone rubber strip compounded with barium sulfate to improve radiographic visualization. This silicone rubber strip is covered with woven polyester velour cloth wrapped around the silicone and sewn together with a single seam using polyester thread.

The provided text is a 510(k) Summary for medical devices (annuloplasty rings) and the subsequent FDA clearance letter. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML or diagnostic performance.

The document discusses the substantial equivalence of new annuloplasty ring models (with Duraflo Treatment and 100% EO Sterilization) to existing predicate devices. The "testing summary" section lists various engineering and biocompatibility tests, not performance metrics related to diagnostic accuracy or AI/ML.

Therefore, I cannot provide the requested information based on the input text. The questions posed are highly specific to AI/ML device evaluations, which are not addressed in this 1998 medical device clearance document.

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The Fogarty® Valvulotome is intended to be used in the disruption of venous valves.
The Fogarty® Valvulotome is indicated for use in veins during in situ or autologous bypass graft procedures.

The modified Fogarty® Valvulotome, like the predicate device, consists of a flexible shaft with a cutting blade at the distal tip and a handle at the proximal end. The mode of operation for both devices is the same. The device is inserted into the vessel in an antegrade direction until the blade is located above the cusp of a venous valve. The location of the valve is visualized via an angioscope or is directly visualized through the vein wall in an open procedure. The blade is withdrawn retrograde through the cusp, thereby rendering it incompetent. After the blade disrupts one cusp, it is then rotated 180° to disrupt the adjoining cusp segment.
The Fogarty® Valvulotome, like the predicate device, contains an irrigation lumen that provides irrigation/fluid flow during the valvulotomy procedure.
The modified device is available in one size that accommodates various vessel sizes and a usable length of 81 cm.
A modification to the Fogarty® Valvulotome was implemented that enhanced the strength of the attachment of the blade holder to the stop.
The blade is on the modified Fogarty® Valvulotome is retractable whereas the blade on the predicate device was not. The size and shape of the blade have been changed to accommodate retractability.
The material used for the shaft and handle have been changed; the modified materials have been determined to be biocompatible.
The handle now includes a control button for extension and retraction of the blade and guidewire.

The provided text is a 510(k) summary for the Fogarty® Valvulotome, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study details you've outlined for AI/standalone device performance.

This document predates modern AI-powered medical devices and thus does not discuss AI performance, ground truth establishment for large datasets, or MRMC studies in the context you're asking about. The "acceptance criteria" discussed are primarily related to safety, biocompatibility, and functional performance, rather than diagnostic accuracy metrics.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for any of the tests.
• Data provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Baxter (the manufacturer). The clinical evaluation mentions in situ saphenous vein grafting procedures, implying human use, but no details on the patient cohort or study design are provided in this summary.
• Retrospective/Prospective: Not explicitly stated. The clinical evaluation would typically be prospective, but the details are missing.

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

• Not applicable/Not provided in this document. The "ground truth" here relates to successful valve disruption, biocompatibility, and functional performance, which are assessed through engineering tests and clinical observations rather than expert image interpretation.

4. Adjudication method for the test set

• Not applicable/Not provided in this document. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on diagnostic imaging, which is not the subject of this 510(k). Decisions would have been made by the testing teams based on the test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a manual surgical instrument (valvulotome), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.

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

• No. This device is a physical instrument requiring human operation, not an algorithm.

7. The type of ground truth used

• Biocompatibility testing: Ground truth was established by adherence to ISO 10993-1-1994 and FDA G95-1 guidelines, with results demonstrating non-toxicity and biocompatibility.
• Functional/Bench testing: Ground truth was based on the device meeting its predefined "performance requirements" (details of which are not specified in the summary, e.g., cutting efficacy, blade retraction reliably, shaft flexibility, irrigation flow).
• Clinical evaluation: Ground truth was the observation that the product was "capable of disrupting venous valves during in situ saphenous vein grafting procedures." This implies direct observation of the device's effect during surgery.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

• Not applicable. As above, no training set for an algorithm is involved.

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The Intramed SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.

The Intramed SBO System, like the CRI Occlusion System, was developed for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The system includes (1) a Coil Delivery Catheter, which is preloaded with an occlusion coil, and (2) an Introducer Catheter, which is used to visualize the side branches and mechanically direct the Coil Delivery Catheter into the side branch for occlusion.

The Coil Delivery Catheter consists of a flexible catheter shaft with an occlusion coil positioned in the distal portion of the catheter lumen. A guide wire is contained within the inner shaft immediately proximal to the occlusion coil. At the proximal end of the catheter, this guide wire connects to a plunger mechanism. When the plunger is depressed. the quide wire pushes the coil out of the catheter and into the side branch for occlusion.

The occlusion coil provided with the Intramed SBO System is purchased from Cook Incorporated. This product is a preamendment device that has been commercially distributed for vessel occlusion/embolizations. The use of this coil in the Intramed SBO System is within the intended use of the occlusion coils as marketed by Cook Incorporated.

The Introducer Catheter has a composite shaft with two lumens. One lumen contains a miniature diameter angioscope with self-contained optics for visualization during the procedure. The other lumen is used to pass the Coil Delivery Catheter to the site of the side branch to be occluded. The catheter has an actuator handle to advance or retract the angioscope by a small amount to provide visualization of the vessel when the angioscope is in the extended position and visualization of the tributary when in the retracted position. The proximal end of the catheter consists of a coil catheter receiver as well as an eyepiece and light source connector for the angioscope.

The provided text describes the Intramed Side Branch Occlusion System and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

The document discusses non-clinical testing (biocompatibility, functional/bench, cadaver testing) and a summary of clinical testing, but it does not provide:

• A table of specific acceptance criteria with quantifiable metrics.
• Reported device performance against those specific criteria.
• Details about sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for clinical studies.
• Information regarding MRMC studies or effect sizes.
• Information about standalone algorithm performance (as this is a medical device, not an AI algorithm).
• Details about training sets or how their ground truth was established.

However, I can extract the information that is present in the document about the testing performed, even if it doesn't meet all your requested categories.

Here's a summary of the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) notification for the Intramed Side Branch Occlusion System does not explicitly list quantifiable acceptance criteria in a table format, nor does it present a detailed study with specific metrics to demonstrate the device meets such criteria.

Instead, it relies on demonstrating substantial equivalence to predicate devices and describes various non-clinical and clinical evaluations performed to ensure safety and effectiveness. The "acceptance criteria" are implied by the successful completion of these tests and their findings of biocompatibility, proper function, and comparable performance to predicate devices.

Summary of Reported Testing and Findings:

Details Not Provided in the Document:

1. Sample size used for the test set and the data provenance: Not specified for any of the described tests (biocompatibility, functional, cadaver, or clinical evaluation).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and/or not specified for the type of testing described (which largely focuses on device function and clinical equivalence rather than diagnostic performance assessed by multiple readers).
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, as this is a medical device for intervention, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device, not an AI algorithm.
6. The type of ground truth used:
   • For biocompatibility: Standardized testing protocols against ISO 10993.
   • For functional/bench testing: Device specifications/requirements.
   • For cadaver testing: Direct observation of visualization, identification, and coil placement.
   • For clinical evaluation: "Safe and effective as the CRI system" implies direct comparison and clinical outcomes relative to the predicate, but the specific metrics for "safety" and "effectiveness" (e.g., complication rates, successful occlusion rates) and how they constituted ground truth are not detailed. It's likely based on established clinical practice and comparison to the predicate device's known performance.
7. The sample size for the training set: Not applicable, as this is a medical device, not an AI algorithm.
8. How the ground truth for the training set was established: Not applicable, as this is a medical device, not an AI algorithm.

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