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The FlexCath® Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning.

The FlexCath® Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein.

It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.

The provided document is a 510(k) summary for the CryoCath Technologies Inc. FlexCath® Steerable Sheath & Dilator. This type of regulatory submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Based on the nature of this document, it describes the device and its intended use, and states that substantial equivalence has been demonstrated through bench testing and biocompatibility testing where dimensional and material differences existed. It does not contain information about clinical studies with acceptance criteria, human reader performance, or ground truth establishment in the way typically associated with AI/software devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document. The document states:

• "Information submitted in this Special 510k for the FlexCath® Steerable Sheath and Dilator is substantially equivalent to the predicate devices listed."
• "Where dimensional and material differences exist between the proposed device and the predicate devices, bench testing and biocompatibility testing demonstrated that these differences do not adversely affect safety and effectiveness."

This indicates that the "performance testing" referenced was likely bench testing and biocompatibility testing, and not a clinical study involving the detailed metrics you've asked for.

Therefore, here's a direct response to your points based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in this document. The document states substantial equivalence was demonstrated through bench and biocompatibility testing, not clinical performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available in this document. The document refers to bench and biocompatibility testing, not a test set of data.
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 available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available in this document.
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 available in this document. This device is a steerable sheath, not an AI or software device that would assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available in this document.
8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This is a physical medical device, not an AI/ML algorithm.

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The FlexCath™ Steerable Sheath & Dilator is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The FlexCath™ Steerable Sheath is a deflectable catheter introducer used to facilitate placing a catheter through the skin into the artery or vein. It is comprised of the following two (2) main sections: the shaft and the handle. A dilator is also part of the package.

The provided text does not contain any information about acceptance criteria or a study proving device performance for the FlexCath™ Steerable Sheath & Dilator.

The document is a 510(k) summary, which is a premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on the device description, intended use, and a comparison of technological characteristics to predicate devices. There is no mention of clinical studies, performance endpoints, sample sizes, expert involvement, or statistical analyses that would typically be associated with proving device performance against acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions because the information is not present in the provided text.

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The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis.

The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® XL Cryosurgical Device (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® XL Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost Cryosurgical Probe.

The provided text describes a 510(k) summary for a medical device seeking substantial equivalence to existing devices. It does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

The document states:

• Intended Use: "The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® XL Cryosurgical Device and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis."

Regarding "Performance Testing," the document only says:

• "Information submitted in this premarket notification for the SurgiFrost® XL information of Olyosurgical Console is substantially equivalent to the predicate devices listed."

This indicates that the submission relies on the device's substantial equivalence to predicate devices rather than providing new performance testing data against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred from the text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission hinges on substantial equivalence to predicate devices, not on meeting new, specified performance criteria with new data.

2. Sample size used for the test set and the data provenance: This information is not provided. The document does not describe any specific testing with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no test set is described, no ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.

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/not provided. The device is a cryosurgical system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable/not provided. The device is a cryosurgical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. The document does not describe any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established: This information is not provided.

In conclusion, the 510(k) submission for the SurgiFrost® XL Cryosurgical Device and Cryosurgical Console does not describe specific acceptance criteria and a study to meet them. Instead, it argues for substantial equivalence to existing predicate devices, implying that the safety and effectiveness are established by comparison to already approved devices.

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The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte" Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 6cm, 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 7cm and 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 7cm and 10cm Cryosurgical Probes to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CryoCath Technologies Inc. SurgiFrost® devices:

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

The provided 510(k) summary does not explicitly state specific acceptance criteria in a quantitative or qualitative manner, nor does it present a table of device performance against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a pre-defined performance against specific, novel acceptance criteria.

The core of the submission is that: "The SurgiFrost® 7cm, 10cm Cryosurgical Devices plus FrostByte™ Clamp and Cryosurgical Console is substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics. The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness."

Therefore, the "acceptance criteria" are implicitly the characteristics and performance demonstrated by the predicate devices, and the "reported device performance" is a claim of equivalence to those predicates.

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

The document does not describe any specific clinical test set data (e.g., patient samples, data from a clinical trial). The approval is based on a demonstration of substantial equivalence through design and technological characteristics, not on a clinical performance study with a defined test set.

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

As no specific test set or clinical study is described, there is no information provided on experts establishing ground truth.

4. Adjudication method for the test set

Similarly, since no test set is discussed, there is no adjudication method mentioned.

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 section is not applicable as the device is a cryosurgical system, not an AI-assisted diagnostic tool involving human readers.

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

This section is not applicable as the device is a cryosurgical system, not an algorithm. Its performance is inherent in its physical function and design.

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

Given the nature of the submission (substantial equivalence for a physical medical device) and the absence of a defined clinical performance study, there is no mention of a specific ground truth methodology being applied to establish device performance for this particular 510(k) submission. The "ground truth", if it can be called that, is effectively the established safety and efficacy of the predicate devices.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

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The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console are intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console freezes the target tissue and blocks the electrical conduction pathways by creating an inflammatory response or cryonecrosis. The SurgiFrost® 10 cm Cryosurgical Device used with or without the FrostByte™ Clamp, Cryosurgical Console and accessories act together as a System. The system is composed of the following components: Cryosurgical Control Panel and Power Cord, Cryosurgical Console, Tank Carrier, Gas Tank Regulator and Wrench, Gas Hose, SurgiFrost® Cryosurgical Device (Single Use), FrostByte™ Clamp (Single Use), Footswitch (optional). The SurgiFrost® Cryosurgical System consists of a compact, easy-to-operate Cryosurgical Console and associated accessories that include SurgiFrost® 10 cm Cryosurgical Probe to deliver cold temperatures to the targeted tissue. The control console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon gas. The Cryosurgical Console controls a single-use, disposable SurgiFrost® Cryosurgical Probe.

The provided 510(k) summary for the CryoCath Technologies Inc. SurgiFrost® 10 cm Cryosurgical Device plus FrostByte™ Clamp and Cryosurgical Console does not contain information regarding detailed acceptance criteria or a specific study proving the device meets distinct performance thresholds.

Instead, the document states that the device is "substantially equivalent to the predicate devices based on intended use, design, materials, technological, and operational characteristics." It also mentions "Performance Testing" but provides no details about the tests performed, their results, or the acceptance criteria used.

Therefore, I cannot populate the requested table or provide the detailed information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Here's an analysis based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against pre-defined acceptance criteria for this particular device. It doesn't detail performance endpoints such as temperature reach, cryoablation zone size, success rate of blocking electrical conduction, or any other quantifiable metrics.

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

Explanation: The document does not describe any specific "test set" or a study involving human subjects or data where performance was measured. The claim of "substantial equivalence" is typically supported by bench testing, non-clinical studies, and comparisons to the known performance of predicate devices, but the details of such tests are not provided in this summary.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

Explanation: Since no specific test set requiring expert ground truth is described, this information is absent. The regulatory approval process for these types of devices through 510(k) relies heavily on demonstrating similarity to already approved devices, rather than establishing new clinical effectiveness data requiring expert review of outcomes.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not mentioned.

Explanation: Without a described test set requiring human assessment or outcome review, an adjudication method is not relevant or not detailed in this summary.

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

• MRMC Study: Not mentioned.
• Effect Size of Human Reader Improvement with AI vs. without AI: Not applicable (as no AI component is described).

Explanation: This device is a cryosurgical system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: Not applicable.

Explanation: As this is a physical medical device (cryosurgical system), the concept of "standalone (algorithm only)" performance does not apply. The device's performance is inherently linked to its physical operation and use by a clinician.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not mentioned.

Explanation: Because no specific "test set" with performance outcomes is detailed, the type of ground truth used to evaluate performance is not discussed. For cryosurgical devices, ground truth for effectiveness would typically involve histological confirmation of cryonecrosis, electrophysiological evidence of conduction block, or clinical outcomes, but these are not specified as part of a formal performance study in this summary.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of a "training set" is not relevant.

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

• Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Explanation: As this is not an AI/ML device, the concept of establishing ground truth for a "training set" is not relevant.

Summary of the Document's Approach:

The provided 510(k) summary document focuses on establishing substantial equivalence to already legally marketed predicate devices. This regulatory pathway typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive new clinical effectiveness studies with explicit acceptance criteria and performance statistics for the new device, unless significant technological differences or new intended uses are introduced. The statement "The differences between the CryoCath devices are minor and raise no new issues of safety or effectiveness" reinforces this approach.

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I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the device associated with K030303, which was converted to P020045/S5 and approved in 2004.

Here's why:

• P020045/S5 is a very old PMA (Pre-Market Approval) amendment/supplement. The level of detail you're asking for, especially regarding specific study design elements like ground truth establishment for training sets, multi-reader multi-case studies, and specific sample sizes for training/test sets, was rarely reported in such granular detail in public summaries for devices approved nearly two decades ago.
• Public Summaries Limitations: While PMA approval documents do contain clinical study information, the publicly available "Summary of Safety and Effectiveness Data" (SSED) often provides a high-level overview rather than the deep dive into methodology you're seeking. The actual statistical analysis plan, raw data, and detailed clinical report are proprietary and not publicly accessible.
• Evolution of Reporting Standards: Reporting standards for AI/ML-based medical devices, especially concerning detailed validation methodologies, were not established or consistently applied in 2004, as AI in medical imaging was nascent compared to today.

To answer your question accurately, I would need access to the full, detailed clinical study report submitted to the FDA for P020045/S5, which is not publicly available.

If you are interested in a hypothetical example of how such information would be presented for a modern AI-powered medical device, I could construct one for you. However, I cannot generate specific details for this particular legacy approval.

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