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The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

The Upstream GoBack Crossing Catheter is a sterile, single-use, single lumen crossing catheter. The Upstream GoBack Crossing Catheter is intended for use with 0.014" coated or noncoated guidewires. The effective length of the GoBack Crossing Catheter is 80 cm or 120 cm with an outer diameter of either 0.96 mm (2.9 Fr) or 1.4 mm. (4.0 Fr). The GoBack Crossing Catheter is made from three lavers; a reinforced polyimide shaft with stainless steel distal tip (in the 2.9 Fr device) or stainless steel and Nylon 12 distal tip (in the 4.0 Fr device), nitinol hypotube, and PTFE polymer sleeve over the nitinol hypotube inside the shaft. The nitinol hypotube has a pre-shaped curved lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube / needle can move at limited displacement inside the shaft by moving a sliding knob in the catheter handle. The nitinol tube (with the PTFE sleeve) and the polyimide shaft may rotate together using a rotation knob on the catheter handle.

The provided text describes a 510(k) premarket notification for a medical device called the "Upstream GoBack Crossing Catheter." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria for a novel AI or diagnostic algorithm.

Therefore, the information required to answer the prompt (acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/diagnostic algorithms) is not present in the provided text.

The text details the following regarding performance testing and a clinical study, but these are geared towards demonstrating equivalence, not proving a device meets a pre-defined acceptance criterion for an AI/diagnostic system:

Performance Testing Summary (Non-Clinical):

• Biocompatibility Testing: Performed per ISO 10993-1:2018 and FDA guidance, including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity (acute), hemocompatibility (hemolysis, complement activation and thromboresistance), LAL, and Material Mediated pyrogenicity.
• Device Dimensional and Functional Testing:
  • Performed on sterile 2.9 Fr and 4 Fr models: Particulates, Torque (at break and transfer), Force at break, Delivery, Radio-opacity, Surface, Needle tip protrusion, Catheter dimensions.
  • Performed on a sterile 2.9 Fr model: Air leakage, Liquid leakage, Force at break, Radio-opaque, RO marker movement, Bend to kink, Needle penetration, Transfer torsional forces.
• Other Performance Testing:
  • Demonstrated no coating abrasion or peeling when polymer-coated guidewires were passed through the catheter.
  • Established a 2-year shelf life.

Clinical Testing Summary:

• Study Design: Retrospective data.
• Sample Size: 151 patients.
• Data Provenance: Not specified (e.g., country of origin).
• Purpose: Demonstrated that the GoBack Crossing Catheter performed equivalently to the predicate in subintimal re-entry procedures. It also validated that the device can be used for both intraluminal lesion crossing and subintimal re-entry.
• Reported Performance:
  • Intraluminal crossing (62 subjects): Technical success rate of 88.7%.
  • Subintimal re-entry crossing (89 subjects): Technical success rate of 88.8%.
  • Major Adverse Event (MAE) rate across all procedures: 0%.
• Ground Truth: Implied clinical outcomes/procedural success, but not explicitly defined with expert consensus, pathology, or adjudication.
• Experts/Adjudication: Not mentioned.
• MRMC Study: Not applicable/not performed for this type of device submission.
• Standalone Performance: Not applicable/not performed.
• Training Set: Not applicable, as this is a medical device, not an algorithm requiring a training set.

In summary, the provided document does not contain the information required to populate the fields of the request, as it pertains to a traditional medical device (catheter) rather than an AI/diagnostic algorithm.

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The Upstream GoBack Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires.

The Upstream GoBack Crossing Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

The Upstream GoBack Crossing Catheter is a sterile, single lumen support catheter, that consists of a reinforced polyimide shaft with a stainless steel tip, and PTFE polymer coated nitinol hypotube inside the shaft. The nitinol tube has a pre-shaped lancet tip at the distal end and a hub at the proximal end for guidewire access. The nitinol tube can move at limited displacement inside the shaft, by moving a sliding knob in the catheter handle.

The Upstream GoBack Crossing Catheter is intended for use with 0.014" and 0.018" non-coated quidewires and the effective length of the catheter is 120 cm with an outer diameter of 1.4 mm.

The medical device described in the document is the Upstream GoBack Crossing Catheter.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details various performance tests conducted on the Upstream GoBack Crossing Catheter. The "acceptance criteria" for these non-clinical tests are generally implied to be that the device "functioned as intended" and "meets its intended design and performance specifications." For the clinical study, the acceptance criteria are clearly defined as primary safety and effectiveness endpoints.

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

• Sample Size for Clinical Test Set: 25 subjects.
• Data Provenance: Retrospective evaluation of clinical cases.
• Country of Origin: Leipzig University Medical Center and Bad-Krozingen Heart-Center, both in Germany.

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

The document mentions that the primary effectiveness endpoint (placement of a guidewire in the true lumen distal to a CTO) was "confirmed by the angiography core lab." It does not specify the number of experts, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the term "core lab" implies a specialized group responsible for blinded and standardized evaluation.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1). It states that the effectiveness endpoint was "confirmed by the angiography core lab," suggesting a standard review process by the lab, but the specifics of how discrepancies among reviewers (if any) were handled are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a physical medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance does not apply here.

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

No, a standalone algorithm performance test was not done. As mentioned, this is a physical medical device.

7. The Type of Ground Truth Used

For the clinical study:

• Technical Success (Effectiveness): Angiography core lab confirmation.
• Safety (MAEs): Clinical observation and assessment by medical professionals during and 24 hours post-procedure; likely based on standard clinical diagnostic criteria for adverse events.

8. The Sample Size for the Training Set

The document describes a retrospective clinical evaluation to support substantial equivalence. This is not a study to train an algorithm. Therefore, there is no training set used in the context of an AI/algorithm study. The 25 subjects were part of the clinical test set designed to evaluate the physical device's performance.

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

As there was no training set for an algorithm, this question is not applicable.

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The Unstream GR Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.

The Upstream GR Catheter is a sterile, single-use, dual-lumen catheter, having anchoring balloon and funnel at its distal tip, and Y-connector at its proximal end. The Upstream GR Catheter is intended for use with up to 0.035" guidewires. The Upstream GR Catheter is provided in 100 cm effective length and its shaft's outer diameter is 1.7mm (5F). A hub at the Y-connector center port, at the proximal end of the Upstream GR Catheter, allows guidewire access. The Y-connector side port is used for balloon inflation and deflation. The distal balloon is used for catheter anchoring and centering. The distal funnel is used as soft tip and soft stopper when an occlusion is reached.

The provided text describes the Upstream Peripheral Technologies GR Catheter and its 510(k) summary. It details the device's intended use, technological characteristics, and the safety and performance data used to demonstrate substantial equivalence to a predicate device.

However, the information provided does not pertain to an AI/ML device or a study involving human readers or ground truth established by experts. Instead, it describes a medical device (a catheter) and the engineering bench testing and biocompatibility assessments performed to support its marketing clearance.

Therefore, many of the requested elements for describing acceptance criteria and a study for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods relevant to AI/ML, are not applicable or present in this document.

Here's an attempt to answer the questions based only on the provided text, while highlighting where the requested information is not available due to the nature of the device and study described:

Acceptance Criteria and Device Performance Study (for a non-AI medical device: Upstream GR Catheter)

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All of these tests demonstrated that the Upstream GR Catheter meets its intended performance specifications." The specific quantitative acceptance criteria or results for each test are not detailed in this summary.

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

This information is not applicable/not provided for this type of medical device clearance. The "test set" in this context refers to physical units of the device subjected to various engineering and biocompatibility tests, not a dataset for an AI/ML algorithm. The provenance of the data would be the results from these lab tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The "ground truth" for this device is established by engineering specifications and recognized biocompatibility standards (e.g., ISO 10993, ISO 10555-1, ISO 10555-4), not by expert medical review of patient data.

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple expert readers, which is not relevant for the type of testing described (bench testing and biocompatibility).

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (a catheter), not an AI algorithm intended to assist human readers.

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

No, a standalone performance evaluation in the context of an "algorithm" was not done. This is a physical device.

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

The "ground truth" for this device's performance is based on:

• Compliance with international standards (e.g., ISO 10993 for biocompatibility, ISO 10555-1 and ISO 10555-4 for catheters).
• Internal engineering and design specifications for mechanical and handling characteristics.
• The performance of the predicate device (Endocross Ltd Enabler-P Support Catheter (K082339)) as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable/not provided. This is not an AI/ML device that requires a training set.

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

This information is not applicable/not provided. As above, this is not an AI/ML device.

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The Upstream Needle Holder is intended to facilitate the placement of guidewires into the vascular system.

The Upstream Needle Holder is a sterile, single lumen rigid polymer tube having male luer connector at the distal end to provide connection to standard needle, and female luer connectors at the proximal end for guidewire access. The Upstream Needle Holder with shut-off connector includes a standard shut-off connector. The shut-off connector includes a sliding element that opens and closes the connector lumen.
The Upstream Needle Holder is intended for use with guidewires of up to 0.0315" diameter. The Upstream Needle Holder is provided in a 23 cm length. The hub at distal end of the Upstream Needle Holder interfaces with a standard needle connection. The hub at the proximal end of the Upstream Needle Holder allows guidewire access, or connection of shut-off connector through which a guidewire is inserted and may be locked in position using the connector lock position.

Here's an analysis of the provided 510(k) summary regarding the Upstream Peripheral Technologies Needle Holder, structured according to your requested information.

It's important to note that this document is a 510(k) summary for a medical device and not a study report for an AI algorithm. Therefore, many of the requested points, particularly those related to AI algorithm performance, ground truth establishment for AI, and MRMC studies, will not be applicable. This device is a physical medical instrument, not a software algorithm.

Acceptance Criteria and Device Performance (Upstream Needle Holder)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary lists the types of tests performed but generally does not provide specific numerical acceptance criteria or detailed quantitative results for each test. It states a general conclusion for each category of testing.

General Conclusion from Document: "All of these tests demonstrated that the Upstream Needle Holder meets its intended performance specifications." And "In vitro verification testing demonstrates that the Upstream Needle Holder performs as intended and meets all design specifications with respect to their mechanical and handling characteristics, and that its materials are biocompatible."

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

This document describes the testing of a physical medical device, not an AI algorithm. Therefore, the concept of "test set" and "data provenance" (in the context of country of origin of data or retrospective/prospective studies) as typically applied to AI performance evaluation does not apply.

• Sample Size: The document does not specify the exact number of units tested for each in-vitro bench test or biocompatibility assessment. Standard practice for such device testing would involve a statistically relevant number of samples to ensure reproducibility and reliability, but specific numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI test set. The tests were performed in vitro (bench testing) and in vivo (biocompatibility animal testing, though specific to material interaction, not clinical data) as part of the device's development and regulatory submission.

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

Not applicable. This is not an AI algorithm requiring expert-established ground truth from diagnostic images or clinical data. The "ground truth" for the device's performance is established by direct physical measurements according to engineering specifications and biological assessments against established safety standards.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI algorithm requiring adjudication of diagnostic outputs. The "adjudication" of device performance is through direct measurement, observation, and adherence to predefined test methods and acceptance criteria.

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 is not an AI algorithm, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its physical and mechanical properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on well-established engineering principles, material science standards (e.g., ISO 10993 for biocompatibility), and functional requirements for medical devices of its type.

• For Biocompatibility: Ground truth is established by standardized biological tests demonstrating the absence of harmful biological reactions.
• For In Vitro Bench Testing: Ground truth refers to the device meeting its predefined design specifications and functional requirements (e.g., tensile strength values, leak tightness, dimensional accuracy, smooth guidewire passage). These specifications are engineering-driven and based on the intended use and safety profile required for an Introducer Catheter.

8. The Sample Size for the Training Set

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

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

Not applicable. This is not an AI algorithm; there is no "training set" or corresponding ground truth to establish in this context.

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The Upstream Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the vasculature and for guidewire exchange.

The Upstream Support Catheter is not intended for use in the coronary, cerebral or carotid vasculature.

The Upstream Support Catheter is a sterile, single lumen polymer coated stainless steel hypotube, with a tapered tip at the distal end and a proximal hub.

The Upstream Support Catheter is intended for use with 0.014" guidewires. The Upstream Support Catheter is provided in 95 cm length and its outer diameter is 0.8mm (0.0315"). A hub at the proximal end of the Upstream Support Catheter allows guidewire access.

The provided 510(k) summary for the Upstream Support Catheter does not describe an AI/ML powered device, therefore, many of the requested fields are not applicable. The device is a physical medical device (catheter) and the acceptance criteria and supporting studies are based on traditional engineering and biocompatibility testing, not AI/ML performance metrics.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission outlines benchmark and performance data based on in vitro bench testing for the physical properties and biocompatibility of the catheter. Specific numerical acceptance criteria and reported performance values are not explicitly listed in a comparative table format in the provided text. However, it states that "All of these tests demonstrated that the Upstream Support Catheter meets its intended performance specifications."

2. Sample Size for Test Set and Data Provenance

This information is not applicable to this device submission. The testing performed was primarily in vitro bench testing on the physical device itself. There isn't a "test set" in the context of diagnostic data, and thus no country of origin or retrospective/prospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. Ground truth for a physical catheter's performance is established through engineering specifications and standardized testing protocols, not through expert consensus on diagnostic data.

4. Adjudication Method for the Test Set

This information is not applicable. There is no "test set" requiring adjudication in the context of diagnostic performance.

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

This information is not applicable. The device is a physical catheter, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10555-1, ISO 10993), and internal performance requirements established by the manufacturer.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" for a physical medical device. The device design is based on engineering principles and material science.

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

This information is not applicable. There is no "training set" in the AI/ML sense. The "ground truth" for the device's design and manufacturing is established through the adherence to design specifications, material properties, and manufacturing processes aimed at achieving the intended performance and safety profile, informed by industry standards and preclinical testing.

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