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The OTW Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.

This product (balloon models 2.0 – 5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

OTW Takeru PTCA Balloon Dilatation Catheter (OTW Takeru) is an over-the-wire balloon dilation catheter, which consists of a distal tube, mid tube, proximal tube, balloon, guidewire transition tube, radiopaque marker(s), manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. OTW Takeru has a lumen at the distal end of the catheter through which a guidewire can be inserted. This lumen extends from the distal end of the catheter to the guidewire port on the manifold for the guidewire.

The maximum compatible diameter of a guidewire used together with OTW Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with OTW Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

This document is a 510(k) premarket notification for the OTW Takeru PTCA Balloon Dilatation Catheter. It describes the device, its indications for use, and its comparison to predicate devices, along with performance and biocompatibility testing. The document states that the device met all predetermined acceptance criteria, but it does not provide specific acceptance criteria or detailed study results for a device that involves AI (artificial intelligence) or includes human-in-the-loop performance. This device is a physical medical device (catheter) and the testing described is related to its physical properties and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI or human-in-the-loop performance, as this information is not present in the provided text.

Based on the provided text, here is the information related to the device's acceptance criteria and the studies conducted:

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

The document broadly states: "The OTW Takeru met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, specific numerical acceptance criteria and their corresponding reported device performance values are not provided 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)

The document describes "in vitro tests" and "biocompatibility testing." These are laboratory, bench-top, and biological tests, not clinical studies involving data from patients or human subjects in the typical sense of AI studies. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to clinical data or AI model evaluation are not applicable to the testing described here. No specific sample sizes for these bench tests are mentioned in the summary.

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 question is related to establishing ground truth for clinical data, usually in the context of AI model development or evaluation where human experts annotate or interpret data. This is not applicable to the performance testing described for this physical medical device.

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

This question is related to how discrepancies in expert ground truth assessment are resolved in clinical data annotation for AI. This is not applicable to the performance testing described for this physical medical device.

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

The document does not describe an MRMC comparative effectiveness study. This type of study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks, which is not applicable to the evaluation of this balloon dilatation catheter.

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

The device is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not applicable.

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

For the performance testing mentioned (e.g., "Balloon Rated Burst Pressure"), the "ground truth" would be established by validated measurement methods and engineering standards, not through expert consensus or pathology in a clinical data context. For biocompatibility, the ground truth is established by the results of standardized biological tests.

8. The sample size for the training set

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

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

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

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The RX NC Takeru PTCA Balloon Dilatation Catheter is indication of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.

This product is also indicated for the post-delivery expansion of balloon expandable stents.

RX NC Takeru PTCA Balloon Dilatation Catheter (RX NC Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque markers, mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. RX NC Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with RX NC Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with RX NC Takeru. The nominal inflated balloon diameters range from 2.0 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

This document describes the premarket notification (510(k)) for the RX NC Takeru PTCA Balloon Dilatation Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the performance testing was conducted via "in vitro tests." However, it does not specify the sample size for the test set used for any of the performance tests. The provenance of this test data is not explicitly mentioned but is implied to be from internal Kaneka Corporation testing as part of their design verification and validation. Given it's a 510(k) submission, this is typically part of the manufacturer's own testing for regulatory clearance, not from an independent study with external data provenance in the way clinical trials would.

For biocompatibility, testing was performed on a "reference device (RX Takeru)." The sample size for this is not specified.

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

This information is not provided in the document. The performance testing described consists of bench tests (in vitro) and biocompatibility tests. These types of tests typically rely on established engineering principles, international standards (e.g., ISO), and laboratory procedures, rather than human expert consensus for "ground truth" in the way a diagnostic AI algorithm might. Therefore, the concept of "experts establishing ground truth" for these specific tests would not directly apply.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable to the types of bench and biocompatibility tests described. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies where human interpretation of data (e.g., imaging, clinical symptoms) is involved and discrepancies need to be resolved to establish ground truth.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench testing and biocompatibility testing, not a clinical study involving human readers.

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

This question is not applicable as the device is a physical medical device (PTCA Balloon Dilatation Catheter), not an AI algorithm or software device.

7. The Type of Ground Truth Used

For the performance testing (in vitro tests), the "ground truth" is established by adherence to predefined engineering specifications, international standards (e.g., FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" and ISO 10993-1), and internal test protocols. The acceptance criteria for these tests define what constitutes acceptable performance for the device's physical properties and safety.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable, as the device is a physical medical device and does not have a training set.

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The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

Rx Takeru PTCA Balloon Dilatation Catheter (Rx Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque marker(s), mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Rx Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with Rx Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with Rx Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

This document describes the performance testing and acceptance criteria for the RX Takeru PTCA Balloon Dilatation Catheter.

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

The document states that the RX Takeru "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific numerical acceptance criteria and reported performance values are not provided in the given text.

The performance tests conducted include:

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. All the tests mentioned are "in vitro" (bench) tests and biocompatibility tests conducted according to international standards (ISO 10993-1). There is no mention of human subject data, therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable.

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

This information is not applicable. The tests performed are laboratory-based physical and chemical tests, and biocompatibility studies. "Ground truth" in the context of expert review for diagnostic devices is not relevant here. The "truth" is established by the results of the specified test methodologies and their adherence to predetermined acceptance criteria.

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

This information is not applicable. As these are not studies involving human interpretation or subjective assessments, adjudication methods are not relevant.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. This device is a PTCA balloon dilatation catheter, not a diagnostic imaging device with AI components.

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

This information is not applicable. The device is a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for the performance tests relies on adherence to established engineering and material science specifications, validated test methods (e.g., those recommended by FDA guidance documents like "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and international standards (e.g., ISO 10993-1 for biocompatibility). The "truth" is whether the device physically performs according to these criteria.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this document.

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

This information is not applicable for the same reason as point 8.

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The R2P Metacross RX PTA balloon dilatation catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

R2P Metacross RX PTA Balloon Dilatation Catheter (R2P Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. R2P Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with R2P Metacross RX in a PTA procedure is 0.035 inches. Additionally, sheath introducers with a minimum diameter of 6 Fr have been deemed to be compatible with R2P Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 8.0 mm with balloon working lengths of 20 mm to 200 mm. The catheter working length is 2000 mm.

The R2P Metacross RX is provided with the following accessory device:

• Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "R2P Metacross RX PTA Balloon Dilatation Catheter." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, the "Metacross RX PTA Balloon Dilatation Catheter (K150865)." The device is a rapid exchange balloon dilation catheter intended for dilating stenoses in various arteries and for stent post-dilatation.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes that "The R2P Metacross RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted.

Important Note: The document consistently states "The results from these tests demonstrate that the technological characteristics and performance of the R2P Metacross RX are substantially equivalent to the predicate device" and "The R2P Metacross RX met all the predetermined acceptance criteria." However, it does not provide the numerical values of these criteria or the test results. This is common in 510(k) summaries, which aim to briefly summarize the evidence of substantial equivalence rather than provide full detail which is present in the full submission.

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

The document mentions "bench testing" and "in vitro tests." This implies that the testing was conducted on samples of the manufactured device.

• Sample Size: Not explicitly stated. The phrase "the subject device" suggests that multiple units would have been tested to ensure reproducibility and statistical validity, but exact numbers are not provided.
• Data Provenance: The testing was conducted internally by or for Kaneka Corporation (the submitter) as part of their design verification and validation activities. It is a retrospective analysis of newly generated compliance data as part of the device development process. There is no mention of country of origin of the data beyond the submitter's location (Tokyo, Japan) or official correspondent's location (Rockville, MD, USA).

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

This section is not applicable to this type of device submission. The device is a hardware interventional catheter, not an AI/software device that requires expert-established ground truth for interpretation of images or other data. The "ground truth" for this device's performance is objective measurements (e.g., pressure, dimensions, time) obtained during standardized bench testing.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in cases like image annotation or diagnostic accuracy studies, which are not part of this 510(k) submission for a physical device.

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

This is not applicable. The device is a physical medical instrument (a balloon catheter), not an AI/software diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

The "ground truth" for this device's performance is derived from objective, quantitative measurements obtained during standardized bench tests. Examples include:

• Measurement of balloon dimensions and compliance.
• Pressure at which the balloon bursts.
• Time for inflation/deflation.
• Force required to kink or break the catheter.
• Particle counts.

These are not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set:

This is not applicable. This is a hardware device submission, not an AI/machine learning model where a "training set" of data would be used.

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

This is not applicable for the same reasons as point 8.

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The Crosperio OTW PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosperio OTW PTA Balloon Dilatation Catheter (Crosperio OTW) is an over-the-wire type of balloon dilatation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Crosperio OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosperio OTW in a PTA procedure is 0.014 inches. Additionally, the compatible size of a sheath introducer is 4 Fr. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1500 mm.

The provided text is a 510(k) summary for the Crosperio OTW PTA Balloon Dilatation Catheter, a medical device. It describes the device, its intended use, comparison to predicate devices, and performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Crosperio OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific reported device performance values in a table format. It lists the types of tests performed.

Types of In Vitro Tests Performed:

• Dimensional Verification
• Balloon Preparation, Deployment and Retraction
• Balloon Rated Burst Pressure
• Balloon Fatigue (Repeat Balloon Inflations)
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Flexibility and Kink Test
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate Evaluation
• Balloon Rated Burst Pressure (in Stent)
• Balloon Fatigue (Repeat Balloon Inflations; in Stent)
• Shelf Life Testing

Types of Biocompatibility Tests Performed:

• Cytotoxicity
• Sensitization
• Intracutaneous reactivity (irritation)
• Systemic toxicity (acute)
• Pyrogenicity
• Hemocompatibility (thrombogenicity, hemolysis, and immunology)
• Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay)

Reported Device Performance (General Statement):

"The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."

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

The document does not specify the sample size for the test sets used in the in vitro or biocompatibility tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as these were bench and lab tests on the device itself, not clinical data from patients.

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

This information is not applicable and therefore not provided in the document. The tests performed are engineering and biological evaluations of the device's physical properties and material safety, not diagnostic imaging or clinical performance requiring expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert assessment of data, not for bench testing of medical devices.

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:

This information is not applicable and therefore not provided. The Crosperio OTW PTA Balloon Dilatation Catheter is a physical medical device, not an AI software/algorithm. Therefore, an MRMC study related to AI assistance for human readers is irrelevant to this submission.

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

This information is not applicable and therefore not provided. As stated above, this is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

7. The type of ground truth used:

The "ground truth" for the performance and biocompatibility tests was established by engineering specifications, recognized standards, guidance documents (like the FDA's "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and established biological safety testing protocols (like ISO 10993). It is based on objective, measurable criteria inherent to the device's design and manufacturing, rather than expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set:

This information is not applicable and therefore not provided. Training sets are relevant for machine learning algorithms, not for physical medical devices being evaluated through bench testing.

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

This information is not applicable and therefore not provided. As there is no training set for a machine learning algorithm, there is no ground truth establishment method for it.

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The Crosstella OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosstella OTW PTA Balloon Dilatation Catheter (Crosstella OTW) is an over-the-wire type of balloon dilation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Crosstella OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosstella OTW in a PTA procedure is 0.018 inches. Additionally, the compatible size of a sheath introducer is 4 The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon or 5 Fr. working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.

Here is an analysis of the provided FDA 510(k) summary for the Crosstella OTW PTA Balloon Dilatation Catheter, focusing on acceptance criteria and study details.

Please note: This document describes a medical device (a balloon dilatation catheter) and its clearance based on substantial equivalence to a predicate device. The nature of the studies described are non-clinical bench and biocompatibility tests, not clinical trials involving human subjects to assess diagnostic accuracy or treatment efficacy in the way an AI/ML algorithm might be studied. Therefore, many of the requested points regarding AI/ML specific study design (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Crosstella OTW PTA Balloon Dilatation Catheter were based on bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters' dated September 8, 2010," and biocompatibility testing in accordance with "Draft Guidance for Industry and Food and Drug Administration Staff; Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" (dated April 23, 2013).

The document states, "The Crosstella OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

Below is a table summarizing the types of tests performed and the implicit reported performance against the acceptance criteria. Specific numerical values for the acceptance criteria and performance are not provided in this summary document, but the overall conclusion is that the device met these criteria.

Detailed Study Information (Specific to a Medical Device requiring Bench/Biocompatibility Testing)

Given that this is a 510(k) submission for a physical medical device (a catheter) and not an AI/ML algorithm, many of the requested points are not directly applicable. However, I will address them in the context of this device type where relevant, or state "Not Applicable" (N/A) if they pertain exclusively to AI/ML software.

1. Sample size used for the test set and the data provenance:

   • Sample Size (Test Set): The specific number of individual catheters or material samples tested for each benchmark test is not explicitly stated in this summary. However, device manufacturers typically test multiple units/lots to ensure reproducibility and statistical validity according to industry standards and FDA guidance.
   • Data Provenance: The tests would have been performed in a laboratory setting by Kaneka Corporation or a contracted testing facility. This is therefore prospective testing of newly manufactured devices under controlled conditions, not retrospective analysis of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. For bench and biocompatibility testing of a physical device, "ground truth" is established by direct measurement of physical properties against engineering specifications or by observing biological reactions in controlled in vitro or in vivo (animal) models. It does not involve expert interpretation of medical images or data from human patients. The "experts" would be engineers, chemists, microbiologists, etc., performing the tests and analyzing the results against predefined acceptance criteria.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, typically in diagnostic studies. For device performance testing, results are quantitative or qualitative assessments against objective criteria. Discrepancies would be resolved through re-testing, investigation of methodology, or review by senior technical personnel, not clinical adjudication.

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: N/A. This type of study is specific to AI/ML diagnostic tools. This submission is for a physical intervention device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, not an algorithm. Bench tests are "standalone" in the sense that they assess the device's inherent properties and performance without human clinical interaction beyond the operation of test equipment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A in the clinical sense. For this device, the "ground truth" for performance is defined by:

   • Established engineering specifications and industry standards: E.g., a balloon's rated burst pressure is compared against a specified pressure.
   • Biological responses in controlled environments: E.g., cell viability in cytotoxicity tests, or lack of adverse reaction in in vivo (animal, if applicable) biocompatibility tests.
   • Comparison to predicate device characteristics: Demonstrating that the new device performs "similarly" or "equivalently" to the predicate device across various parameters.

7. The sample size for the training set: N/A. There is no "training set" as this is not an AI/ML algorithm. Device design and manufacturing processes are refined through iterative development, but this is distinct from machine learning training.

8. How the ground truth for the training set was established: N/A. See point 8.

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The Crosstella RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosstella RX PTA Balloon Dilatation Catheter (Crosstella RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosstella RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosstella RX in a PTA procedure is 0.018 inches; hence, sheath introducers with a minimum diameter of 4 or 5 Fr have been deemed to be compatible with Crosstella RX. The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1500 and 2000 mm.

The Crosstella RX is provided with the following accessory device:

• . Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.

This document describes the Crosstella RX PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document focuses on the regulatory submission to the FDA (510(k) summary) and details of the device's design, indications for use, and a list of performance and biocompatibility tests conducted. While it states that the device "met all the predetermined acceptance criteria of design verification and validation," it does not provide the actual criteria or the results in a tabulated format.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, expert details for ground truth, or adjudication methods, as this information is not present in the provided text.

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The Crosperio RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosperio RX PTA Balloon Dilatation Catheter (Crosperio RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Crosperio RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosperio RX in a PTA procedure is 0.014 inches; hence, sheath introducers with a minimum diameter of 4 Fr have been deemed to be compatible with Crosperio RX. The nominal inflated balloon diameters range from 1.5 mm to 4.0 mm with balloon working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.

The Crosperio RX is provided with the following accessory device:

• Flushing Needle: provided per one catheter device for the purpose of flushing and filling . of the guidewire lumen with heparinized saline before use.

This document describes the Crosperio RX PTA Balloon Dilatation Catheter, a medical device, and provides a summary of its performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Crosperio RX "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide specific quantitative acceptance criteria or a detailed table of reported device performance values against those criteria. It only lists the types of tests performed and a general conclusion.

Types of Performance Tests Performed:

Reported Device Performance:
"The results from these tests demonstrate that the technological characteristics and performance criteria of the Crosperio RX are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."

"The Crosperio RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

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

The document describes in vitro (bench) and biocompatibility testing. It does not specify the sample sizes used for each test. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but as these are bench tests and biocompatibility tests, they would be conducted in a laboratory setting. There is no indication of human subject data involved in these tests.

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

This information is not applicable as the tests described are primarily physical and chemical performance tests conducted in vitro and biocompatibility assessments, not diagnostic or clinical accuracy studies requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the in vitro and biocompatibility testing described. Adjudication methods are typically relevant for clinical studies where multiple human readers or experts assess cases.

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

This information is not applicable. The document describes a medical device (balloon catheter) for angioplasty, not an AI-powered diagnostic tool requiring MRMC studies.

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

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

7. The Type of Ground Truth Used

For the in vitro performance tests, the "ground truth" would be the engineering specifications, established standards (e.g., ISO), and guidance documents (e.g., FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").

For biocompatibility testing, the "ground truth" relies on established biological safety standards (ISO 10993-1), which defines acceptable biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not a machine learning model, and therefore does not have a "training set."

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

This information is not applicable for the reasons stated above.

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The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.

Here's an analysis of the provided text regarding the Metacross OTW PTA Balloon Dilatation Catheter, addressing your specific questions.

It's important to note that the provided document is a 510(k) summary, which is a regulatory submission for medical devices. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a multi-reader, multi-case study that would be typical for AI-powered diagnostic devices. Therefore, some of your questions may not be fully answerable from this type of document, as it pertains to a physical medical device (a balloon catheter) and its performance, rather than an AI/software device.

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

The document lists performance tests but does not explicitly provide a table of acceptance criteria and quantitative reported performance against those criteria. It states that the device "met all the predetermined acceptance criteria of design verification and validation" and that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."

However, we can infer the types of performance criteria based on the tests conducted:

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

The document describes bench testing (in vitro tests) and biocompatibility testing. These are not clinical studies with patient data. Therefore, the concepts of "test set" in the context of clinical data, "country of origin of the data," or "retrospective/prospective" do not apply here.

For the bench tests, the sample sizes for each specific test (e.g., number of balloons tested for burst pressure) are not provided in this summary. Similarly, for biocompatibility, the number of samples or animal subjects (if applicable) is not specified.

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 question is not applicable. The product is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective engineering and biological tests, not through expert interpretation of clinical images or data.

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

This is not applicable for the same reasons as in question 3. No clinical adjudication method is mentioned as these are bench and biocompatibility tests.

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

This is not applicable. The device is a balloon catheter, not an AI-powered diagnostic system or an assistive AI for human readers. No MRMC study was conducted or would be relevant for this type of device.

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

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

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

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

• Engineering specifications and standards: For mechanical performance tests (e.g., burst pressure is compared against a specified pressure, dimensions against design drawings).
• Established biological safety standards: For biocompatibility tests (e.g., cytotoxicity is measured against established limits for cellular response).
• Predicate device characteristics: The ultimate goal is to demonstrate equivalence to the predicate device's established performance.

8. The sample size for the training set

This is not applicable. No "training set" in the context of machine learning or AI is involved. The device's design and manufacturing processes are developed based on engineering principles and existing knowledge.

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

This is not applicable as there is no training set in the AI/ML sense. The "ground truth" for the various performance tests (dimensional, mechanical, biocompatibility) is established through standardized methodologies, calibrated equipment, and predefined acceptance criteria based on regulatory guidance and engineering principles.

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The Metacross RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Metacross RX PTA Balloon Dilatation Catheter (Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Metacross RX in PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 6 or 7 Fr have been deemed to be compatible with Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 12.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1350 and 2000 mm.

The Metacross RX is provided with the following accessory device:
. Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.

This document is a 510(k) premarket notification for the Metacross RX PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices through performance and biocompatibility testing, rather than reporting on a clinical study with an AI component. Therefore, much of the requested information about acceptance criteria, study design, and AI performance is not applicable or cannot be extracted from this document.

However, I can extract information regarding the device's performance testing based on acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Metacross RX PTA Balloon Dilatation Catheter underwent various in vitro tests to demonstrate substantial equivalence to predicate devices, following the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' dated September 8, 2010.

While the specific numerical acceptance criteria for each test are not explicitly detailed in this document (e.g., a specific pressure value for burst pressure), the overall conclusion for each test implicitly indicates that the device met its predetermined acceptance criteria.

Overall Conclusion provided: "The Metacross RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

The remaining information requested in your prompt (Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for test set, training set sample size, how ground truth for training set was established) are related to studies involving algorithms or human-in-the-loop performance, particularly in the context of AI/ML devices. This document describes the regulatory submission for a physical medical device (balloon catheter) and does not involve AI/ML. Therefore, these points are not applicable and cannot be extracted from the provided text.

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