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The DirectFlow™ Kit, SoftClamp™ Kit and StraightShot™ Kit are indicated for patients undergoing cardiopulmonary bypass. The DirectFlow, SoftClamp and StraightShot arterial cannulae are intended to deliver oxygenated blood for cardiopulmonary bypass. The DirectFlow and SoftClamp arterial cannulae also allow the hemostatic introduction and removal of the Heartport EndoClamp™ aortic catheter. The DirectFlow arterial cannula is intended for introduction and use through a thoracic trocar or incision. The AutoIncisor introducer is intended for use with Heartport arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

The subject device is substantially equivalent in intended use, technological characteristics, and materials to currently marketed Heartport arterial kits.

This document is a 510(k) summary for a medical device submitted to the FDA in 1999. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for a more modern AI/ML device submission.

Therefore, many of the requested sections below either cannot be answered or can only be addressed by stating that the information is not provided in this context.

Here's an analysis based on the provided text:

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

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

This information is not provided in the document. The document refers to "non-clinical test results" and "performance testing" but does not detail the sample size or data provenance for these tests. Given the nature of a 1999 510(k) for a physical medical device (cannulae), the "testing" likely involved engineering and biocompatibility tests rather than clinical data sets as would be relevant for AI/ML.

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 provided. As this is a physical medical device from 1999, the concept of "ground truth" derived from expert consensus on a test set (like for an imaging AI) is not applicable here. The "ground truth" for this device would be its ability to physically perform its function (e.g., deliver blood, allow introduction/removal of catheters) as per engineering specifications.

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

This information is not provided. Adjudication methods are typically relevant for human-led assessments of complex data, which isn't the focus of this device's 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, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-driven clinical decision support tools or imaging analysis, which this device (surgical cannulae) is not.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical surgical tool and does not involve an algorithm.

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

For this device, the "ground truth" would be related to its physical and functional performance according to engineering and biocompatibility standards. For example, testing for tensile strength, flow rates, biocompatibility, and ability to house the designated catheter. It is not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be.

8. The sample size for the training set

This information is not provided. This concept of a "training set" is not applicable to the development and testing of this physical medical device.

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

This information is not provided. Similarly, the concept of a "training set" and associated ground truth is not applicable here.

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The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.

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The provided text is a 510(k) summary for a medical device called the Heartport QuickDraw venous cannula. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer most of the requested questions about acceptance criteria and a specific study proving the device meets them.

Here's a breakdown of what can be gleaned and what is missing based only on the provided text:

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

Missing Information: The document states that performance testing demonstrated the device meets "established specifications" and that its materials have "proven biocompatibility," but it does not detail what those specific criteria or specifications are, nor does it provide quantitative performance data against them.

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

Missing Information: The document refers to "performance testing" but does not provide any details about the sample size used for the test set, the country of origin, or whether the study was 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)

Missing Information: This information is not present in the provided text. The device is a physical medical device (venous cannula), not an AI/diagnostic tool that would typically require expert-established ground truth for its performance evaluation in the way implied by this question.

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

Missing Information: This information is not present. As above, this type of adjudication is usually relevant for diagnostic assessments, not for the physical performance of a cannula.

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

Missing Information: This is completely inapplicable to the device described. The Heartport QuickDraw venous cannula is a physical device used in cardiopulmonary bypass, not an AI or imaging diagnostic tool that would be evaluated with an MRMC study or AI assistance.

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

Missing Information: This question is not applicable to the device described. It is a physical medical device, not an algorithm.

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

Missing Information: Not explicitly stated as the device's performance is likely measured against engineering specifications and relevant ISO standards for medical devices, rather than a diagnostic "ground truth."

8. The sample size for the training set

Missing Information: This is not applicable to the device described, which is a physical medical device and not an AI model requiring a training set.

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

Missing Information: Not applicable to the device described.

Summary of Study Information Provided in the Text:

The document states:

• "Performance testing demonstrated that the subject device meets established specifications."
• "The materials used in the Heartport QuickDraw venous cannula have proven biocompatibility."
• The overall conclusion is based on "intended use, product performance and biocompatibility information" and establishes "substantial equivalence to currently marketed predicate devices."

However, the 510(k) summary itself (the provided text) does not detail the specifics of this performance testing or biocompatibility assessment, nor does it include information about clinical studies with human subjects or detailed expert evaluations that would be typical for many AI-based or diagnostic devices. The acceptance criteria it refers to are internal "established specifications" and "proven biocompatibility," the details of which are not disclosed in this public summary. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than a de novo detailed clinical efficacy study with specific expert-adjudicated ground truth.

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The DirectFlow™ arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The DirectFlow cannula also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. The DirectFlow cannula is intended for introduction and use through a thoracic trocar or incision.

The subject device is substantially equivalent in intended use and method of operation to the currently marketed DirectFlow arterial cannula.

The provided text is a 510(k) premarket notification for the Heartport® DirectFlow™ arterial cannula. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the context of device accuracy or efficacy.

Therefore, the requested information elements such as device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, and detailed ground truth establishment are not present in the provided document. The document states that "Performance testing demonstrated that the subject device meets established specifications," but it does not elaborate on what those specifications are, nor does it provide a table of acceptance criteria and reported performance.

Below is a table reflecting the information that can be extracted (or is explicitly absent) based on the provided text:

Acceptance Criteria and Device Performance

There is no specific table of acceptance criteria or detailed device performance metrics provided in the document. The statement "Performance testing demonstrated that the subject device meets established specifications" is a high-level summary without specifics.

Study Information Table

Summary of Study (as described in the 510(k) Summary):

The "study" mentioned in the document is "Performance testing" which demonstrated that the device "meets established specifications." This is described under "Non-clinical Test Results." The primary purpose of this 510(k) submission is to demonstrate "substantial equivalence" to a predicate device based on intended use, technological characteristics, and biocompatibility, rather than providing detailed clinical or algorithm performance data.

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The Heartport® Endopulmonary Vent™ catheter is indicated for use in patients undergoing cardiopulmonary bypass. It is intended to remove blood from the pulmonary artery and assist in decompressing the heart.

The modified Heartport® Endopulmonary Vent™ catheter is equivalent in intended use and technological characteristics to the currently marketed Heartport® Endopulmonary Vent™ catheter.

The provided text describes a 510(k) summary for the Heartport® Endopulmonary Vent™ Catheter. It discusses the device's intended use and non-clinical test results, but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the way you've outlined.

The document states that:

• "Performance testing demonstrated that the Heartport® Endopulmonary Vent™ catheter meets established specifications."
• "The materials used in the Heartport® Endopulmonary Vent™ catheter have proven biocompatibility."

However, it does not provide details on what those "established specifications" are, what the "performance testing" entailed, or any specific numerical results. It also does not mention any clinical studies involving human readers, AI, or ground truth establishment in the context of device performance.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text.

Here's how I would attempt to answer based on the lack of information in the document:

Acceptance Criteria and Device Performance

Study Details (Based on available information in the document):

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "performance testing" and "biocompatibility" but does not detail sample sizes, types of data (e.g., in-vitro, ex-vivo), or provenance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. This document describes a non-clinical device (catheter) and discusses performance and biocompatibility testing, not an AI or diagnostic device requiring expert-established ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not specified.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for a physical medical catheter, not an AI-assisted diagnostic or imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical catheter, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not specified. The testing described appears to be engineering performance and biocompatibility rather than diagnostic accuracy against a "ground truth" as typically defined for algorithms or diagnostic tests.
7. The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Conclusion from the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, non-clinical test results (performance and biocompatibility), and materials. It does not provide the detailed information about specific acceptance criteria or the methodology of performance studies (e.g., sample sizes, expert involvement, ground truth establishment) common for diagnostic devices or AI algorithms. The "performance testing" mentioned is likely in-vitro or bench testing verifying physical characteristics and functionality of the catheter, not a clinical trial involving patients and expert interpretation.

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The Direct Aortic Return Cannula is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Direct Aortic Return Cannula also allows the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ catheter. The cannula may be introduced through a 12mm or larger trocar or incision.

The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.

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Here's a breakdown of the acceptance criteria and study information for the Heartport® Direct Aortic Return Cannula with Introducer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantifiable acceptance criteria such as "minimum flow rate of X mL/min" or "burst pressure of Y psi." Instead, it uses a more general statement.

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

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Non-Clinical Test Results" section is very brief and refers generally to "Performance testing."

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

This information is not applicable as the document describes a medical device (cannula and introducer) that is evaluated through non-clinical performance and biocompatibility testing, not through diagnostic accuracy studies requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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

An MRMC study is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool where human reader performance would be assessed.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as this is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

For a physical device like this, the "ground truth" for performance testing is typically defined by engineering specifications, material science standards, and accepted physiological parameters relevant to its intended use (e.g., flow rates, pressure resistance, material strength, sterility, biocompatibility). The document vaguely states "established specifications." For biocompatibility, the ground truth is established through in vitro and in vivo biocompatibility testing against recognized standards.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set with established ground truth. It is likely that the "specifications" for this device were established through engineering design, material selection, and existing industry standards for similar devices.

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The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The Heartport Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The provided 510(k) notification for the Heartport® Endoaortic Clamp™ Catheter does not include specific acceptance criteria or a study that proves the device meets such criteria.

Instead, the submission relies on substantial equivalence to predicate devices. The key statement regarding device performance is:

"Based on the equivalence in design to the predicate device, performance testing was not warranted for this device. The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter."

Therefore, most of the requested information cannot be extracted from this document as no new performance study was conducted.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The subsequent questions relate to a performance study, which was explicitly stated as "not warranted" for this device due to its substantial equivalence to a predicate device. Therefore, the answers to these questions are generally "Not applicable" or "Not specified in this document."

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

• Not applicable. No new performance testing was conducted for this submission.

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

• Not applicable. No new performance testing was conducted for this submission.

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

• Not applicable. No new performance testing was conducted for this 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

• Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool, and no performance study was conducted.

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

• Not applicable. This device is a medical catheter, not an algorithm. No standalone performance study was done for this submission.

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

• Not applicable. No new performance testing requiring ground truth was conducted for this submission. The device's "ground truth" for regulatory purposes is its substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.

8. The sample size for the training set

• Not applicable. This device is a medical catheter, not a machine learning model, so there is no concept of a "training set" in this context.

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

• Not applicable. As above, no training set for a machine learning model is relevant here.

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The Introducer Sheath with hemostasis valve is indicated for patients requiring introduction of catheters. It is intended for the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ Catheter.

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This document does not contain information about acceptance criteria, device performance, ground truth, or study details such as sample size, expert qualifications, or adjudication methods for a medical device.

The provided text is a 510(k) summary for the Heartport® Introducer Sheath from 1997. It explicitly states that "Performance testing of the subject device was not deemed necessary based on equivalence to the predicate device." This means that no specific performance study was conducted to establish acceptance criteria for the new device as its safety and effectiveness were established by demonstrating substantial equivalence to an already marketed predicate device (Heartport® Endoarterial Return™ Cannula).

Therefore, I cannot fulfill the request to provide the tables and information requested, as it is not present in the provided text.

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The Endoarterial Return Cannula with and without a hemostasis valve is , indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Endoarterial Return Cannula with hemostasis valve also allows the hemostatic introduction and removal of vascular catheters such as the Heartport™ Endoaortic Clamp™ Catheter.

The subject device is substantially equivalent in intended use and method of operation to the currently marketed Heartport™ Endoarterial Return™ Cannula and the BioMedicus® Cannula.

This document describes the premarket notification for the Heartport™ Endoarterial Return™ Cannula. The information provided is for a medical device and, as such, the concept of "acceptance criteria" and "device performance" as might be found in a software AI/ML context is not directly applicable in the same way. Instead, for a medical device submitted for 510(k) clearance, the primary "acceptance criterion" is substantial equivalence to a predicate device, demonstrated through performance testing against established specifications.

Here's an analysis based on the provided text, reformulating the AI/ML-centric questions for a medical device context:

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

For a traditional medical device like a cannula, "acceptance criteria" relate to engineering specifications and performance characteristics, rather than diagnostic accuracy metrics. The document only provides a high-level statement.

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

• Sample size: Not specified. Performance testing for medical devices often involves a series of physical tests with multiple samples, but the exact numbers are not detailed in this summary.
• Data provenance: Not specified. These would typically be internal laboratory tests conducted by the manufacturer (Heartport, Inc., USA).

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 to a non-AI medical device like a cannula. "Ground truth" in this context would be defined by engineering standards and validated test methods, not expert medical opinion on diagnostic images or data.

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

Not applicable. Device performance testing is based on objective measurements and established protocols, not expert adjudication.

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/ML device, and no human reader studies are mentioned.

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

Not applicable. This is not an AI/ML device.

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

For this device, the "ground truth" would be established by:

• Engineering specifications and standards: These define what constitutes acceptable material properties, dimensions, fluid dynamics, and mechanical integrity for a cardiovascular cannula.
• Biocompatibility testing standards: These define methods and criteria for assessing the device's interaction with biological systems.
• Clinical experience with predicate devices: The "substantial equivalence" claim implies that the established safety and effectiveness profile of the predicate devices serves as a benchmark.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Not applicable. As above, there is no AI/ML training set.

Summary of the Study (as presented in the 510(k) summary):

The provided document is a 510(k) summary for the Heartport™ Endoarterial Return™ Cannula. The "study" referenced is the collection of non-clinical performance testing and biocompatibility testing conducted by Heartport, Inc. to demonstrate the device's safety and effectiveness and its substantial equivalence to legally marketed predicate devices (Heartport™ Endoarterial Return™ Cannula and BioMedicus® Cannula).

The key findings reported are:

• "Performance testing demonstrated that the Heartport Endoarterial Return™ Cannula meets established specifications."
• "The materials used...have proven biocompatibility."

The FDA's letter (K971291) confirms that based on this information, the device was found substantially equivalent to predicate devices. This means it met the regulatory acceptance criteria for market clearance, rather than specific performance metrics against an AI model's "ground truth."

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The Heartport™ Maze System: Cryoprobe Set is intended for use in minimally invasive cardiac surgery procedures, including the surgical treatment of cardiac arrhythmias. The cryoprobes are applied to tissue and frozen to cause a block of electrical conduction through tissue by way of an inflammatory response, or cryonecrosis. The Set includes probes of varied tip shapes to optimize access to the treatment site.

The Heartport™ Maze System: Cryoprobe Set is specifically designed for introduction and use via a trocar or incision in minimally invasive cardiac surgery procedures. The Set includes probes of varied tip shapes to optimize access to the treatment site.

The provided text is a 510(k) summary for a medical device called the "Heartport™ Maze System: Cryoprobe Set." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that a 510(k) submission generally does not include studies demonstrating the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a de novo device might. Instead, it focuses on demonstrating substantial equivalence to existing devices. Therefore, the information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and detailed ground truth provenance is not typically found within a 510(k) summary.

The document states that the device meets applicable sections of ASTM F 882-84, which is a standard for cryosurgical medical instruments. This is the closest it comes to "acceptance criteria" and "device performance" in the traditional sense you're asking for.

Here's an attempt to answer your questions based only on the provided text, with the understanding that many of your specific points are not addressed by this type of regulatory submission:

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

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

• Not provided. 510(k) summaries do not typically detail specific clinical or non-clinical test sets with sample sizes in this manner, beyond referencing compliance with standards. The "Performance" section for "Non-Clinical Test Results" only states that it meets a particular ASTM standard.

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/Not provided. This type of detail relates to clinical studies and ground truth establishment, which are not part of this 510(k) summary.

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

• Not applicable/Not provided. This is not relevant to a 510(k) submission for substantial equivalence.

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

• No. This device is a cryoprobe, not an AI-assisted diagnostic tool.

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

• No. This device is a physical cryosurgical instrument for performing procedures, not an algorithm.

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

• Not applicable/Not provided. For the non-clinical performance test, "ground truth" would be defined by the standards and test methods within ASTM F 882-84. The document does not elaborate on this.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

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

• Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in the 510(k) summary is a non-clinical evaluation to demonstrate that the Heartport™ Maze System: Cryoprobe Set is "substantially equivalent" to predicate devices (Frigitronics® CCS-200 Cardiac Cryosurgical System and Spembly Medical Cardiac Cryounit and Cryoprobes).

• Performance: The device confirmed compliance with applicable sections of the ASTM F 882-84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments. No specific test results or metrics are included, only the statement of compliance.
• Biocompatibility: The materials used were evaluated and confirmed to have "established biocompatibility," likely based on their similarity to materials in the predicate devices.

This submission focuses on regulatory substantial equivalence rather than detailed clinical effectiveness data or specific performance metrics typical of studies for novel devices or algorithmic tools.

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The Heartport Thoracic Trocars are intended to provide access to the thoracic cavity by inserting them into incisions in the intercostal spaces, with minimal-to-no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiothoracic surgery procedures.

Not Found

The provided text is a 510(k) summary for a medical device (Heartport Thoracic Trocar) and does not contain the specific information requested in the prompt regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/ML-based medical devices.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than what would typically require the detailed study information outlined in your request.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance (Table): The document states "Performance testing demonstrated that the Heartport Thoracic Trocar is safe and effective, while meeting the anticipated clinical requirements for its intended use." It mentions evaluating "insertion force, removal force and compatibility with endoscopic instruments and vision equipment," but it does not provide specific quantitative acceptance criteria or reported numerical performance values for these aspects.
• Sample Size (Test Set) and Data Provenance: Not mentioned. The testing was "in vivo," implying animal or human cadaver studies, but details are absent.
• Number of Experts and Qualifications: Not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable; this is a physical medical device, not an AI assistance tool.
• Standalone Performance: The "Performance" section describes the device's function, but it's not a standalone algorithm in the sense of AI.
• Type of Ground Truth: Not applicable in the context of diagnostic accuracy. The ground truth for this device would be its physical properties and functionality (e.g., successful insertion, removal, compatibility).
• Sample Size (Training Set): Not applicable. This device does not have a training set in the AI/ML sense.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document describes a traditional medical device submission (trocar) and not an AI/ML-based device. Therefore, the detailed study design, ground truth, and acceptance criteria information requested for AI/ML product evaluation are not present.

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