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The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.

The Wilson-Cook® Colonic Z-Stent® is a self-expanding, tubular prosthesis used to maintain patency of malignant colonic strictures in patients having high operative risk and/or advanced disease. The Wilson-Cook® Colonic Z-Stent® Introduction System is used to place the Colonic Z-Stent®. This device and the introduction system are supplied sterile and intended for single use only.

The provided document is a 510(k) summary for the Wilson-Cook® Colonic Z-Stent®. It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) submission process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device (one that was on the market before May 28, 1976, or has been reclassified). This typically involves comparing characteristics like:

• Intended Use: The purpose of the device.
• Technological Characteristics: How the device functions and its design.
• Performance Data: Often non-clinical (e.g., bench testing, biocompatibility) or sometimes clinical if necessary to address specific performance questions not adequately covered by predicate device data.

The document states: "The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging procedures similar to devices currently manufactured and marketed by Wilson-Cook® Medical. This device is similar with respect to indications for use and design to predicate devices in terms of section 510(k) substantial equivalency."

This statement indicates that the submission relies on demonstrating similarity to existing predicate devices and adherence to manufacturing quality standards, rather than presenting a novel clinical study with explicit acceptance criteria for device performance in a clinical setting.

Therefore, I cannot extract the requested information (points 1-9) as it is not present in the provided text. The document is a regulatory approval notice based on substantial equivalence, not a clinical study report with performance metrics.

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The Mini Polyurethane Catheter is intended for use with single-chamber Vital Port" reservoirs for use in patient therapy requiring long-term vascular access for infusion therapy sampling sampling.

The Mini Polyurethane Catheter is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the Mini Polyurethane Catheter are identical to those used in predicate Vital-Port® system catheters. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.

This document, a 510(k) Premarket Notification for a Mini Polyurethane Catheter, is a regulatory submission for a medical device and describes its intended use and similarity to existing devices. It is a not a study that proves the device meets acceptance criteria but rather a notification of intent to market based on substantial equivalence. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable or cannot be extracted from this document.

Here's the breakdown of why and what information can be inferred:

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

Not applicable. This document does not describe specific acceptance criteria or performance data from a study. It focuses on demonstrating substantial equivalence to a predicate device.

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

Not applicable. No test set or data provenance is mentioned as part of a performance study. The submission relies on the established history of the predicate device and the materials used.

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)

Not applicable. There is no mention of a test set requiring expert ground truth establishment.

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

Not applicable. No test set adjudication is described.

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

Not applicable. This device is a physical medical catheter, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

Not applicable. This is not an algorithmic device.

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

Not applicable. Ground truth for a performance study is not discussed. The "ground truth" for this regulatory submission is the established safety and efficacy of the predicate device and the biocompatibility of the materials.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device or a study involving data training.

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

Not applicable. See point 8.

Summary of Extracted Information relevant to the prompt (though not fitting the direct questions due to the nature of the document):

• Device Name: Mini Polyurethane Catheter
• Intended Use: For use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.
• Predicate Devices: Catheters supplied with Vital-Port® systems manufactured by COOK Vascular™ Incorporated.
• Reason for Substantial Equivalence Claim:
  • Same intended use, design, and materials of construction as predicate catheters.
  • Biocompatibility of materials is established by their history of use in medical product manufacturing.
  • Will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to predicate devices.
• Regulatory Outcome: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing its market entry.

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The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.

The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects and/or in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.

This 510(k) Premarket Notification for COOK Vascular™ Intravascular Retrieval Devices does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it is a submission notifying the FDA of revisions made to previously cleared devices. The document claims "No changes have been made to the devices; they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics." Therefore, the submission relies on the prior clearance of the predicate devices for its regulatory approval.

Specifically, the document states:

• "The 510(k) submission serves to notify FDA of labeling revisions made to previously cleared devices. No changes have been made to the devices; they are substantially equivalent to the predicate devices, having the same intended use and technological characteristics."

Given this, I cannot provide the requested information about acceptance criteria or a study that proves the device meets them because such information is not present in the provided text. The submission is a claim of substantial equivalence based on no changes to the device itself.

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The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive microvascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for onetime use.

The Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use. The device is supplied sterile and is intended for one-Reasonable assurance of biocompatibility of time use. the materials comprising the Swartz Doppler Flow Probe is provided by their established history of use in medical product manufacturing.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA clearance letter for the Swartz Doppler Flow Probe and Monitor System (K964001).

The 510(k) summary outlines the device description, its intended use, and claims substantial equivalence to predicate devices based on indications for use, materials, and physical construction. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

However, neither document includes the specific details requested in your prompt regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The FDA clearance for this device, which was approved in 1998, relies on substantial equivalence to predicate devices rather than requiring extensive clinical performance studies as might be seen for novel or high-risk devices today. The closest information related to performance assessment is the requirement for a "postclearance special report" with "acoustic output measurements based on production line devices," but this is an engineering requirement, not a clinical performance study against acceptance criteria.

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The Vital-Port® Infusion Pal™ is intended to facilitate locating and stabilizing the port body for accessing the portal septum of a Vital-Port® Vascular Access System.

The Vital-Port® Infusion Pal™ is an open-ringed plastic disk that is intended to facilitate locating and stabilizing the port body for accessing Vital-Port® Vascular Access Systems. The Vital-Port® Infusion Pal™ is placed on the skin surface on the area overlying the port septum. The device is supplied sterile and intended for onetime use.

This K971140 submission describes a simple, non-active medical device (Vital-Port® Infusion Pal™). For such devices, acceptance criteria and detailed study data in the format requested (especially regarding AI/ML performance, ground truth, expert consensus, and MRMC studies) are typically not included as they are irrelevant to the device's function and regulatory review. The review focuses on substantial equivalence to predicate devices based on technological characteristics and intended use.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain explicit performance acceptance criteria or reported device performance in a quantitative manner as would be expected for a complex diagnostic or therapeutic device. For a simple device like the Vital-Port® Infusion Pal™, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to existing predicate devices based on intended use and technological characteristics, and by adhering to general controls (manufacturing, labeling, etc.).

Notes on the absence of typical AI/ML study information:

The Vital-Port® Infusion Pal™ is a physical, non-active medical device (a locating ring/port stabilizer). Therefore, the following are not applicable and are not found in the 510(k) submission:

• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study (Demonstration of Substantial Equivalence):

The "study" in this context is the 510(k) Pre-Market Notification process itself, which focuses on demonstrating substantial equivalence (SE) to a legally marketed predicate device.

• Device Name: Vital-Port® Infusion Pal™ (Locating Ring, Port Stabilizer)
• Predicate Device(s): "predicate vein stabilizers that are currently marketed"
• Basis for Substantial Equivalence:
  • Identical Intended Use: "facilitating location and stabilization for vessel access."
  • Similar Technological Characteristics: "open-ringed plastic disk" performing the same function.
  • Similar Manufacturing and Quality Control: "manufactured according to specified process controls and a Quality Assurance Program, undergoing manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Cook Vascular Incorporated."

The FDA's letter (K971140) confirms that they "have determined the device is substantially equivalent" based on the information provided in the submission. This determination serves as the "proof" that the device meets the regulatory requirements for market entry.

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The TARGET Vital-Port® Vascular Access System is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

The TARGET Vital-Port® Vascular Access System is for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. The device is supplied sterile and is intended for one-time use. The construction materials comprising the TARGET Vital-Port® Vascular Access System are identical to those used in predicate Vital-Port® systems. Reasonable assurance of biocompatibility of the materials comprising this device is provided by their established history of use in medical product manufacturing.

Totally implantable vascular access systems consist of a port reservoir or chamber with an attached catheter. The port reservoir is covered by a self-sealing silicone rubber septum through which fluids are administered or withdrawn. The attached catheter is surgically placed in the targeted vessel and the port reservoir is implanted under the skin; the system is accessed using a non-coring needle.

The provided text is a 510(k) Summary for the TARGET Vital-Port® Vascular Access System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data to prove novel safety and effectiveness.

Therefore, many of the requested elements for a study proving device acceptance criteria (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, specific acceptance criteria with performance metrics, ground truth establishment methods) are not present in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or a direct study measuring the TARGET Vital-Port® Vascular Access System's performance against these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices and summarizing the historical clinical performance and known complications of all totally implantable vascular access systems.

The "Summary Table Types and Causes of Safety and/or Effectiveness Problems" (Section 5) implicitly describes potential areas of concern and outlines common causes and mitigation strategies, which can be seen as addressing potential failure modes rather than setting acceptance criteria for the new device.

Device Performance for TARGET Vital-Port®: The document states that the TARGET Vital-Port® Vascular Access System "has the same intended use, design, and materials of construction as predicate Vital-Port® systems manufactured by COOK Vascular™ Incorporated." It also claims it "is similar with respect to indications for use, materials and physical construction to predicate devices." This implies that its performance is expected to be substantially equivalent to these predicate devices, whose performance is summarized by the cited literature concerning implantable vascular access systems in general. No specific performance data for the TARGET Vital-Port® itself is reported.

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

Not applicable/Not provided for the TARGET Vital-Port®. This submission relies on demonstrating substantial equivalence to existing devices through literature review of the general performance of implantable vascular access systems, rather than a specific clinical trial with a dedicated test set for the TARGET Vital-Port® device. The literature review covered 16 published articles dating from 1985 to 1991. The data provenance for these articles would vary by study (e.g., country of origin, retrospective/prospective), but this detail is not provided for each reference.

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

Not applicable/Not provided. No specific "ground truth" for a test set of the TARGET Vital-Port® was established as there was no de novo clinical study detailed in this summary. The "truth" is derived from the aggregated clinical experience reported in the cited medical literature regarding adverse events and complications of implantable vascular access systems. The authors of these 16 articles, presumably, are medical professionals, but their specific qualifications are not detailed here.

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

Not applicable/None specified. Since no specific test set and ground truth establishment process is described for the TARGET Vital-Port® in this document, no adjudication method is mentioned. The document relies on published findings from various independent studies.

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 document describes a medical device (vascular access system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

Not applicable. As stated above, this is not an AI algorithm study.

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

The "ground truth" in this context is based on aggregate outcomes data and reported complications from published clinical literature regarding similar totally implantable vascular access systems (Section 3 and Section 5). It's essentially a summary of real-world clinical experience and reported adverse events. For instance, "Venous thrombosis" or "Catheter embolization" are documented outcomes.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of device development as described in this 510(k) summary. The device's design is based on the established designs and materials of predicate devices, informed by the overall historical clinical experience of similar systems.

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

Not applicable. As there is no training set, this question is not relevant to the provided text. The device's safety and effectiveness are supported by its substantial equivalence to predicate devices and the historical performance of those predicate devices as detailed in the medical literature.

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"intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects."

The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements

The provided text describes a 510(k) summary for a medical device called the "Flexible Dilating Sheath." This summary, dated November 11, 1994, is a regulatory submission for premarket notification and not a study proving device performance against acceptance criteria.

Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

Specifically, the document focuses on:

• Device Identification: Trade name, common name, classification.
• Predicate Device: Comparison to existing Cook Pacemaker Corporation dilating sheaths.
• Device Description: Intended use (percutaneous dilation of tissue), sterility, single-use, biocompatibility (established history of use and toxicity testing).
• Substantial Equivalence: Manufacturing process, quality assurance, packaging, sterilization, indications for use, materials, and physical construction compared to predicate devices.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes, data provenance, or test sets.
3. Number or qualifications of experts.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document serves as a regulatory notification demonstrating substantial equivalence to a legally marketed predicate device, not as a clinical performance study.

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The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids.

The Non-Coring Needle is used for accessing a subcutaneous port to administer or withdraw fluids. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Non-Coring Needle is provided by their established history of use in medical product manufacturing.

The provided document is a 510(k) summary for a "Non-Coring Needle" submitted in 1996. It describes the device, its intended use, and its substantial equivalence to predicate devices.

However, the document does not contain any information regarding performance studies, acceptance criteria, or any of the detailed data points requested in your prompt. This 510(k) summary focuses on establishing substantial equivalence based on materials, intended use, and manufacturing processes, typical for devices of this nature and era, rather than providing data from clinical performance studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, study types (MRMC or standalone AI), or training set details because this information is not present in the provided text.

The closest relevant information is:

• Intended Use: "accessing a subcutaneous port to administer or withdraw fluids."
• Predicate Devices: Mentioned as "non-coring needles that are currently marketed, having the same intended use... and being of similar technology, having a stainless steel cannula and Luer hub."
• Substantial Equivalence: Claims similarity in "indications for use, materials and physical construction to predicate devices."

This document does not describe the type of performance study you're asking about, which typically involves quantitative metrics and human-in-the-loop assessments for diagnostic or AI-assisted devices.

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