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The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.

The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.

The provided text describes a 510(k) premarket notification for a medical device, the CTS Voyager Quad Cannula. It focuses on establishing substantial equivalence to existing predicate devices and does NOT include a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI algorithm or diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of submission. Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance for CTS Voyager Quad Cannula

This 510(k) submission is for a physical medical device (a cannula), not an AI/ML algorithm or a diagnostic test with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are related to functional performance and safety as demonstrated through bench and animal testing. The "device performance" reported is that the device "performs as designed and is suitable for its intended use."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in terms of numerical count for bench or animal testing.
• Data Provenance: The text states, "Functional bench testing and animal testing has been conducted." The country of origin for the data is not specified but would presumably be conducted by CardioThoracic Systems, Inc. in the USA.
• Retrospective or Prospective: These types of tests (bench and animal) are inherently prospective studies designed to evaluate the device's performance under controlled conditions.

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

• Not Applicable (N/A): This is a submission for a physical medical device. The "ground truth" is established by direct physical measurement and observation during bench and animal testing, evaluated by engineers, scientists, and veterinary staff, rather than by human expert interpretation of data points for an AI algorithm.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among human readers agreeing on a "ground truth" for diagnostic or AI studies. For physical device testing, results are typically determined by direct measurement, observation, and established acceptance criteria for functional performance and safety, with no "adjudication" in this sense.

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

• No: An MRMC comparative effectiveness study is not applicable to a physical medical device like a cannula. These studies are used for evaluating diagnostic performance, often for AI systems compared to human readers.

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

• Not Applicable (N/A): This is for a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Physical Performance and Safety Data: The "ground truth" for this device is derived from direct measurements and observations during functional bench testing and animal studies. This includes confirming the physical capabilities of the cannula (e.g., balloon inflation, fluid delivery/venting) and its safety profile by observing its effect on biological systems in animal models. It's essentially the verifiable physical and biological responses to the device's operation.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is not an AI/ML device, so there is no "training set."

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

• Not Applicable (N/A): This is not an AI/ML device, so there is no "training set" or ground truth establishment for it.

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The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.

The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.

Here's an analysis of the provided text regarding the 510(k) submission for the CardioThoracic Systems, Inc. Heart-LIFT Balloon Positioner, focusing on acceptance criteria and study details:

This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for devices that rely on performance metrics like sensitivity, specificity, accuracy, or reader studies. This is because the Heart-LIFT Balloon Positioner is a Class I device and its submission is based on substantial equivalence to a predicate device (Janke-Barron Heart Support manufactured by Baxter), rather than a detailed performance study with statistical endpoints.

Therefore, many of the requested categories (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

The "acceptance criteria" here are met by demonstrating that the new device is functionally similar and safe for its intended use compared to an already marketed equivalent.

Summary of Acceptance Criteria and Study Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated for a statistical "test set." The studies mentioned are "functional bench testing" and "animal testing." These are likely engineering and pre-clinical tests, not necessarily human clinical trials with defined statistical sample sizes for a diagnostic or AI device. Data provenance (country of origin, retrospective/prospective) is also not specified.

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

• Not applicable. The "ground truth" for this type of device, which is a surgical tool, would be its physical properties and its performance in a surgical environment (bench/animal testing), not expert interpretations of data like in an imaging study.

4. Adjudication method for the test set:

• Not applicable. This applies to expert reviews, which were not conducted for this type of device submission.

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, not done. This type of study is relevant for AI/diagnostic devices where human reader performance is a key measure. The Heart-LIFT Balloon Positioner is a surgical instrument.

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

• No, not applicable. This applies to AI algorithms.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through functional bench testing (evaluating physical properties and operational stability) and animal testing (evaluating its ability to lift and position the heart in a living system). This is more akin to engineering performance standards and pre-clinical safety/efficacy observations rather than expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The sample size for the training set:

• Not applicable. This is for AI algorithms, which this device is not.

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

• Not applicable. This is for AI algorithms, which this device is not.

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The CTS Blower/Mister is intended to clear an anastomotic site or other surgical sites for improved visibility.

The CTS Blower/Mister is comprised of a handpiece and malleable shaft enabling positioning of the device near the targeted site. Connectors on the device allow for hook-up to standard gas and saline sources. The device permits both an adjustable flow of gas and a mist of saline to be deposited at the targeted site.

The provided text describes a 510(k) premarket notification for the CTS Blower/Mister. However, it does not include detailed acceptance criteria or a comprehensive study demonstrating that the device meets those criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, patient population, functionality, and performance, with a brief mention of functional bench testing.

Therefore, for many of the requested points, the information is not available in the provided text.

Here is an analysis based on the given information:

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

The document does not explicitly state specific acceptance criteria (e.g., quantitative metrics) or
detailed reported device performance against such criteria. It generally states:

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 mentions "Functional bench testing has been conducted," but does not provide details on:

• Sample size (e.g., number of devices tested, number of test cycles).
• Data provenance (e.g., country of origin, retrospective or prospective).

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. The "study" mentioned is "functional bench testing," which typically involves engineering or lab personnel, not medical experts establishing ground truth for clinical outcomes or diagnoses.

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

Not applicable. This is typically relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 study is not mentioned. The device is a Blower/Mister for surgical visibility, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. The device is a physical instrument, not an algorithm. The "functional bench testing" can be considered a standalone performance evaluation of the device itself.

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

For the "functional bench testing," the ground truth would likely be engineering specifications, design requirements, or operational parameters (e.g., expected flow rates, mist dispersion patterns). The document does not specify the exact type of ground truth.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.

The Vascular Stitcher is a stainless steel surgical product designed for use with CTS compatible needle and suture in a semi-automatic or manually operated mode. The Vascular Stitcher is designed for use with or without trocar sleeves depending on the endoscopic technique or whether during minimally invasive surgical procedures.

This 510(k) Premarket Notification for the Vascular Stitcher does not contain the information you requested regarding acceptance criteria and a study to prove the device meets those criteria, as it is related to AI/ML software.

The document describes a medical device, the Vascular Stitcher, which is a physical surgical instrument (a needle holder/driver). The submission focuses on demonstrating substantial equivalence to predicate physical devices already on the market, rather than performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics for a software device. It states the Vascular Stitcher is a "stainless steel surgical product."
2. Sample size used for the test set and the data provenance: Not applicable to a physical surgical instrument submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) for the Vascular Stitcher primarily relies on demonstrating:

• Intended Use Equivalence: "The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures," which is equivalent to predicate devices.
• Technological Characteristics Equivalence: Stating it has "similar functions and is composed of similar materials as the predicate devices."
• Product Description: A stainless steel surgical product for use with compatible needles and sutures in a semi-automatic or manually operated mode.

The FDA's letter (K963965) confirms "substantial equivalence" to devices marketed prior to May 28, 1976, or reclassified devices. This is the primary method of approval for such a device, rather than a performance study against AI/ML-specific acceptance criteria.

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The CTS FloCoil Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This FloCoil Shunt is not an implant and is removed prior to completion of the anastomosis.

The CTS FloCoil Shunt consists of coil reinforced polymer shaft with a polymer seal on each end and tapered polymer tips. The polymer seals on each end contact the vessel wall and cause occlusion of the artery proximal and distal to the arteriotomy . The FloCoil Shunt is selected according to the outer diameter of the polymer seals and is available in various sizes for various vessel diameters. There is a hole in both tapered tip ends of the FloCoil Shunt to allow for the perfusion of blood through the shunt's inner lumen and beyond the arteriotomy. A polyester thread (tether) is attached to the FloCoil Shunt in the middle of the shaft. Attached to the tether is a radiopaque tab which is used to aid insertion and removal of the FloCoil Shunt.

The provided 510(k) summary for the CTS FloCoil™ Shunt (K970638) is for a medical device that helps reduce blood in the operative field during surgery and provides temporary blood flow. This submission is from 1997, and the information provided is characteristic of 510(k) summaries from that era, which often contained less detailed study information compared to current FDA submission requirements.

Based on the provided text, the specific details regarding the robustness of the studies (such as sample sizes, expert qualifications, and detailed statistical methodologies for acceptance criteria) are very limited. The submission focuses on functional performance testing, biocompatibility, and substantial equivalence to predicate devices rather than a rigorous performance study against quantitative acceptance criteria with specific metrics like sensitivity and specificity.

Here's an attempt to extract and describe the information based on your request, along with highlighting what is not present in the document.

Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria with a corresponding "reported device performance" in terms of metrics like sensitivity, specificity, accuracy, or AUC that would be typical for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the successful completion of functional performance testing and biocompatibility evaluation, and the "reported device performance" is a general statement of success.

Study Details:

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

   • The document does not specify a sample size for the "test set" in terms of human subjects or distinct cases. The "Functional Performance Testing" and "Biocompatibility Evaluation" refer to testing conducted on the device itself and its materials, not on a human population in a clinical trial.
   • Data provenance (country of origin, retrospective/prospective) is not applicable or specified, as no clinical study in human subjects is described. The testing appears to be lab-based or bench-top.

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

   • Not applicable. The "ground truth" for this device would be its physical and chemical properties and functional performance under laboratory conditions, as observed by engineers or technicians, not an expert medical consensus from a test set of medical outcomes.

3. Adjudication method for the test set:

   • Not applicable, as no expert review or clinical case adjudication is described.

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:

   • No MRMC study was conducted or is applicable. This device is a physical surgical shunt, not an AI or imaging diagnostic tool that would involve human readers interpreting results.

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

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

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

   • For functional performance, the ground truth would be established through engineering specifications and bench testing parameters. For biocompatibility, it would be standardized laboratory tests to assess material interaction with biological systems (e.g., cytotoxicity, irritation, sensitization).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device. The concept of a "training set" doesn't apply.

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

   • Not applicable.

Conclusion for this specific device (K970638):

The 510(k) summary for the CTS FloCoil™ Shunt (K970638) describes a physical medical device. The "acceptance criteria" and "study" are focused on demonstrating functional capability, material biocompatibility, and substantial equivalence to legally marketed predicate devices through bench testing and material characterization, rather than clinical performance metrics or AI algorithm validation. The questions regarding AI, expert consensus, and specific clinical study designs are not applicable to the information provided in this 1997 submission for this type of device.

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The CTS MIDCAB Coronary Shunt is intended to be used during minimally invasive direct coronary artery bypass ("MIDCAB") procedures in conjunction with or without the CTS MIDCAB™ Access Platform and Stabilizer. The CTS Coronary Shunt is designed to help reduce blood in the operative field by temporary occlusion of the artery and to provide blood flow distal to the arteriotomy. This CTS Coronary Shunt is not an implant and is removed prior to completion of the surgery.

The CTS MIDCAB Coronary Shunt is a hollow tube with atraumatic tips on each end and two seals which are utilized for proximal and distal occlusion of the artery. The atraumatic tips are tapered for easy insertion and removal from the artery. Each tip contains holes to provide for blood flow into and out of the CTS Shunt. The thread or tether is attached to a tab and is used to aid insertion and removal of the CTS Shunt. The blood is occluded and flows through the Shunt which reduces the blood in the operative field. Also included with the CTS MIDCAB Coronary Shunt is a Shunt Remover, which is a cylinder which can be used to withdraw the CTS Shunt following completion of the procedure.

The provided text is a 510(k) summary for a medical device (CTS MIDCAB™ Coronary Shunt) and does not describe a study that uses acceptance criteria and device performance metrics in the way typically seen for AI/ML-based medical devices or diagnostic tools.

Instead, this document describes a traditional medical device submission where the "acceptance criteria" are implied to be adherence to general safety and effectiveness standards, functional requirements, and biocompatibility, often benchmarked against predicate devices. The "study" refers to a series of tests performed to demonstrate this adherence.

Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for AI, training set size) are not applicable to this type of device submission as they pertain to the evaluation of AI/ML algorithms or diagnostic performance, which is not what this document addresses.

However, I can extract the relevant information from the document as it pertains to traditional device acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "All necessary testing was performed," but does not provide numbers for units tested.
• Data Provenance: Not applicable. This refers to testing of a physical medical device, not analysis of medical data. The tests would have been performed in a laboratory or simulated environment by the manufacturer.

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

• Not Applicable. This device is not an AI/ML diagnostic tool requiring expert ground truth for interpretation. Its performance is assessed through functional and biocompatibility tests.

4. Adjudication method for the test set

• Not Applicable. As above, no expert adjudication process is described or implied for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is a physical device, not an AI/ML diagnostic tool. MRMC studies are not relevant here.

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

• Not Applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in that it performs its physical function without human intervention after placement.

7. The type of ground truth used

• Not Applicable/Implied by engineering standards. For a physical device, "ground truth" is typically defined by engineering specifications, material properties, and biological safety standards (e.g., ISO standards for biocompatibility, functional tests against design specifications). There isn't a "ground truth" derived from expert consensus, pathology, or outcomes data in the way an AI diagnostic would require.

8. The sample size for the training set

• Not Applicable. This is a physical device. There is no concept of a "training set" as it would apply to AI/ML.

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

• Not Applicable. There is no "training set" for this type of device.

Summary Limitations: The provided 510(k) summary is a high-level overview intended to demonstrate substantial equivalence to predicate devices and adherence to general safety and effectiveness. It does not contain the detailed study protocols, specific acceptance criteria values (e.g., a specific pressure tolerance, a specific flow rate), or quantitative results that would be found in full test reports. This level of detail is typically reviewed by the FDA but is not always included in the public 510(k) summary document itself.

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The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.

The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.

The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.

The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.

The provided text is for a 510(k) summary for a medical device (CTS MIDCAB™ /SVH™ Bipolar Scissors) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. Typically, 510(k) summaries for surgical instruments like this focus on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and detailed study results that would be found for diagnostic devices or AI/ML-driven software.

Therefore, I cannot fulfill your request for the specific sections you've outlined based on the given information.

Here's why and what kind of information would be needed:

• Acceptance Criteria and Reported Device Performance: This would require a clearly defined set of performance metrics (e.g., cutting time, coagulation effectiveness, tissue damage assessment, safety parameters) with specific quantifiable targets and the results from testing to demonstrate achievement of those targets.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all components of a clinical or performance study that would establish the efficacy and safety of a diagnostic or AI/ML-enabled device. For a surgical instrument like the bipolar scissors, the "proof" often comes from bench testing, animal studies, and sometimes limited human use studies focused on safety and direct function, rather than large-scale diagnostic accuracy studies.

In the context of the provided 510(k) summary, the "study" is the substantial equivalence comparison to predicate devices, which relies on demonstrating similar intended use, technology, and performance, rather than an independent clinical trial with predefined acceptance criteria for novel performance.

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