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The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.

The provided text describes a 510(k) premarket notification for Fehling Surgical Instruments, Inc.'s SUPERPLAST Double-Occluder and SUPERPLAST Vascular Probe. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics, performance testing, and biocompatibility testing.

However, the document does not provide the specific details requested regarding acceptance criteria and the study proving the device meets them as would be expected for a product involving AI or complex performance metrics. The information is geared towards demonstrating substantial equivalence for a Class II surgical instrument, not an AI/ML powered device. Therefore, many of the requested fields cannot be populated from the given text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in a table format with specific numerical acceptance criteria. The performance testing focuses on demonstrating mechanical integrity and successful reprocessing.

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

• Sample size: Not explicitly stated for performance testing. It mentions "Devices were tested to the point of failure on the worst-case configuration," implying a selection of probes, but no specific number. For preliminary data on force to remove a probe, it's also not specified.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is unlikely to be relevant for mechanical and biocompatibility testing of a physical probe.

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

Not applicable as this is a physical medical device (vascular dilator) and the testing described is mechanical and biological, not related to expert interpretation for ground truth establishment.

4. Adjudication method for the test set

Not applicable for mechanical and biocompatibility testing of a 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

Not applicable. This device is a surgical instrument (vascular dilator), not an AI/ML-powered diagnostic or assistive tool for human readers.

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

Not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For mechanical testing, the "ground truth" would be the physical properties and failure points of the material and device design. For biocompatibility, it's compliance with ISO 10993-1 standards (absence of adverse biological reactions). For reprocessing, it's demonstrating effective cleaning and sterilization. These are established through standardized testing methodologies, not "expert consensus, pathology, or outcomes data" in the typical sense for an AI/ML context.

8. The sample size for the training set

Not applicable. This is not an AI/ML-powered device with a training set.

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

Not applicable. This is not an AI/ML-powered device with a training set.

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Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.

This document is a 510(k) summary for the Geomed Vascular Dilators, a surgical instrument. It is NOT for an AI/ML powered device, therefore most of the requested information regarding AI/ML studies is not applicable.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not detailed in this summary. The summary states that "Acceptance criteria were met for all tests performed," implying that the device successfully passed these tests.

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

The document does not specify the sample sizes for the individual tests (tensile strength, dimensional verification, cleaning, sterilization, drying time). The data provenance is not explicitly mentioned but can be inferred as internal testing performed by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, as part of their 510(k) submission. These are device performance tests, not clinical studies with human data.

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 as this is not a study involving human interpretation of data or a clinical study. The "ground truth" for these tests would be established by engineering specifications, validated cleaning protocols, and sterilization standards.

4. Adjudication method for the test set

This information is not applicable for device performance testing. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in observations or diagnoses.

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 device is a physical surgical instrument (vascular dilator), not an AI-powered diagnostic or assistive tool.

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 surgical instrument, not an algorithm.

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

For the device performance tests, the "ground truth" is based on:

• Engineering specifications and standards: For tensile strength and device dimensions.
• FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (03/17/2015): For cleaning and sterilization validation.
• Established industry standards for sterilization and drying: For sterilization and drying time validation.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model being trained.

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

This information is not applicable. There is no "training set" for this type of device submission.

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Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.

Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.

There are several types of dilators made from stainless steel or aluminum:

• Cooley Coronary Dilators
• Cooley Vessel Dilators
• Garrett Vascular Dilators
• Hiebert Vascular Dilators
• DeBakey Vascular Dilators
• Sarns-Style Dilators
• Myocardial Dilators

These dilators are available in a range of different length and diameters.

The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.

Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.

The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.

The provided document is a 510(k) premarket notification for a medical device: Fetzer Medical Vessel Dilators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials for new medical technologies like AI/ML devices. As such, the information you're asking for, particularly regarding acceptance criteria, study design for proving performance, and expert-driven ground truth establishment (which is typical for AI/ML diagnostic devices), is not present in this document.

The document focuses on non-clinical performance testing (reprocessing, sterilization, biocompatibility, mechanical tests) to demonstrate that the Fetzer Medical Vessel Dilators are as safe and effective as existing, legally marketed predicate devices.

Here's a breakdown of why your specific questions cannot be answered by this document and what is provided:

Why the document does not contain the requested information (related to AI/ML device performance studies):

• Device Type: The Fetzer Medical Vessel Dilators are manual surgical instruments, specifically vessel dilators. They are not an AI/ML diagnostic or therapeutic device.
• Regulatory Pathway: A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device. This involves comparing indications for use, technological characteristics (design, materials, performance), and demonstrating that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) or conducting large-scale clinical studies with human readers, ground truth consensus, or advanced statistical analyses like MRMC studies, which are common for AI/ML-driven diagnostic devices.
• Performance Data Scope: The "performance data" mentioned in this document refers to physical testing of the device (e.g., cleanability, sterilizability, mechanical strength), not diagnostic accuracy or clinical outcomes in patients.

What the document does provide regarding "Testing":

The document details performance testing conducted to show the device's characteristics are similar to the predicate devices and that it meets relevant standards for a surgical instrument.

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

• Acceptance Criteria (Implicit): For this type of device, the "acceptance criteria" are broad and relate to meeting industry standards and demonstrating comparable performance to the predicate device in specific functional aspects.

  • Automatic Reprocessing Validation according to ANSI/AAMI ST81: The implicit acceptance criterion is that "contamination...could be removed...by the given cleaning and disinfection instructions."
  • Sterilization testing: The implicit acceptance criterion is that "the device will be adequately sterilized under the validated sterilization parameters" to achieve a SAL (Sterility Assurance Level) of 10^-6.
  • Biocompatibility testing (ISO 10993-5): The implicit acceptance criterion is that materials are "non cytotoxic for the indicated contact duration."
  • Mechanical tests: The implicit acceptance criterion is that devices "were able to withstand the required pulling force without deformation or failure."

• Reported Device Performance:

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

• Test Sets: The document refers to "worst case devices" for reprocessing validation and "test specimens" for sterilization testing. The exact number of units or biological samples tested is not specified.
• Data Provenance: This is not applicable in the context of clinical patient data. The tests are laboratory-based. No country of origin for clinical data is mentioned as no clinical studies were performed. The tests are retrospective in the sense they were done before submission.

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

• Not applicable. The "ground truth" for these tests relates to measurable physical/biological parameters (e.g., residual protein levels, bacterial reduction, material cytotoxicity, mechanical force applied), not expert interpretation of medical images or patient outcomes.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus building among experts for subjective interpretations, which is not relevant for the objective laboratory tests performed.

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

• No. This type of study is for evaluating observer performance, typically in diagnostic imaging. It was not conducted for this surgical instrument.

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

• Not applicable. This relates to AI/ML algorithm performance. The device is a manual surgical tool.

7. The type of ground truth used:

• Laboratory-based measurements against established standards:
  • Reprocessing: Measured contamination levels (red blood cells, residual protein, organisms, total organic carbon) against AAMI TIR 30 guidelines.
  • Sterilization: Reduction of bioindicators/challenge suspension to achieve SAL 10^-6.
  • Biocompatibility: Cytotoxicity results per ISO 10993-5.
  • Mechanical: Resistance to pulling forces.

8. The sample size for the training set:

• Not applicable. This is typically for machine learning models. No training set for an algorithm was used.

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

• Not applicable. See point 8.

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The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.

The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.

The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Synovis Vascular Probe / Vascular Probe ES
Predicate Device: Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K910682

This submission focuses on a change in a component (new vinyl resin in the colorant of the polyurethane coating) of an already marketed device, rather than a completely new device. Therefore, the "study" described is primarily a series of verification and validation tests to ensure the new component does not negatively impact the pre-established safety and performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text does not specify the exact number of units or samples used for biocompatibility and tensile strength testing. It states "Testing conducted" and "Tensile strength testing was conducted on the Vascular Probes manufactured with the new vinyl resin."
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by the manufacturer, Synovis Surgical Innovations. Given it's a 510(k) submission for a component change, the data would be prospective for the specific tests, as they were conducted to evaluate the impact of the new resin.

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

• Not applicable (N/A). This submission is not a clinical study involving human assessment or interpretation for diagnostic accuracy. The "ground truth" for the tests performed (biocompatibility, tensile strength) is based on established scientific protocols and engineering standards, not expert clinical consensus on individual cases.

4. Adjudication Method for the Test Set

• Not applicable (N/A). As mentioned above, this is laboratory and bench testing, not a study requiring adjudication of clinical data or expert opinions. The results are objective measurements against predefined specifications.

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

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The Vascular Probe is an surgical instrument, not a diagnostic device of that nature.

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

• No, a standalone algorithm performance study was NOT done. This is relevant for AI/ML-driven diagnostic devices. The Vascular Probe is a physical surgical tool.

7. The Type of Ground Truth Used

• Laboratory Standard / Engineering Specification:
  • For Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process).
  • For Tensile Strength: Conformance to "current Vascular Probe finished device specifications."

8. The Sample Size for the Training Set

• Not applicable (N/A). This device does not involve algorithms or machine learning that would require a "training set." The tests are designed to verify material properties and biological compatibility.

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

• Not applicable (N/A). See the answer to point 8.

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INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.

Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.

The provided text describes a 510(k) submission for Instrumed Vessel Dilators. This is a traditional medical device, not an AI/ML powered device, therefore the typical AI/ML-related study criteria (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context. The acceptance criteria and supporting "studies" are focused on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, material analysis, and existing market data, rather than clinical trials with human subjects or AI model performance metrics.

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a 510(k) for a physical medical device:

Acceptance Criteria and Device Performance for Instrumed Vessel Dilators

The "acceptance criteria" for the Instrumed Vessel Dilators are primarily based on demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device meets specific performance characteristics and safety requirements, similar to the predicate. The "reported device performance" reflects how the Instrumed Dilators met these equivalence criteria through various non-clinical tests and evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

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

Given this is a physical device and not an AI/ML model, the concept of a "test set" for performance evaluation is different.

• Sample Size: The document does not specify exact sample sizes for each type of bench test (e.g., how many dilators were tested for tip retention, corrosion, etc.). It generally refers to "the proposed device" or "the new devices" in plural, implying a representative number were subjected to the specified tests.
• Data Provenance:
  • Bench Testing: Performed on the proposed Instrumed Vessel Dilators. The country of origin for this testing is not explicitly stated but assumed to be under the applicant's (INSTRUMED INTERNATIONAL, INC. in Schaumburg, IL) oversight. This is prospective testing performed specifically for the 510(k) submission.
  • Clinical Evaluation: Based on "literature research" and "market surveillance information." This includes "database evaluation," "scientific literature," and "data from market experience of the same or similar devices."
  • Market Experience: Data from Instrumed International's own sales (hundreds of dilators over 5 years to non-US markets) with "no reported customer complaint or potentially reportable event." This data is retrospective from global markets (markets other than US).

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

This question is not applicable to this type of device. The "ground truth" for a physical device like a dilator is established through engineering standards, mechanical tests, material specifications, and clinical consensus on safe and effective surgical practice. There is no concept of "experts establishing ground truth for a test set" in the way it applies to diagnostic AI systems. Expert surgeons would use these devices, but their role in a 510(k) for this product is primarily related to the general acceptance and understanding of dilator function and safety, not as ground truth adjudicators for a specific performance evaluation dataset.

4. Adjudication Method (for the test set)

This question is not applicable. The "test set" here refers to the physical devices undergoing bench testing. The outcomes of these tests (e.g., measured diameter, material composition, breakage force) are objective measurements against defined specifications or standards, not subjective interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially imaging-based ones) to assess how human reader performance changes with or without an AI aid. Instrumed Vessel Dilators are surgical instruments, not diagnostic tools, so an MRMC study is not relevant.

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

No, a standalone study was not done. This concept applies specifically to AI algorithms. The Instrumed Vessel Dilators are physical devices that are inherently used "with human-in-the-loop" (i.e., by a surgeon).

7. The Type of Ground Truth Used

The "ground truth" for the Instrumed Vessel Dilators is based on a combination of:

• Engineering Specifications and Standards: For dimensional accuracy, material properties (ASTM F 899-07), mechanical strength, and corrosion resistance.
• Predicate Device Performance and Safety Profile: The established safety and effectiveness of the legally marketed predicate devices (KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, K030788 AND DEBAKEY VESSEL DILATORS) serve as a de facto "ground truth" for what constitutes acceptable device performance and safety for this class of device.
• Clinical Literature and Market Surveillance: General medical understanding of appropriate indications for use and safe practices for vessel dilation.
• Biocompatibility Standards: To ensure the material is non-cytotoxic and safe for contact with human tissue.

8. The Sample Size for the Training Set

This question is not applicable. There is no AI model involved; therefore, no "training set."

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

This question is not applicable. There is no AI model involved; therefore, no "training set" ground truth to establish.

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GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.

GEISTER vessel dilators

This is a 510(k) premarket notification for a medical device (GEISTER Vessel Dilators), not a study report for an AI/ML device. Therefore, the document does not contain information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI/ML study.

The document is an FDA letter stating that the GEISTER Vessel Dilators are substantially equivalent to legally marketed predicate devices, allowing them to proceed to market. It outlines the regulatory classification, product code, and indications for use of the device.

To directly answer your request based on the provided document:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does not contain information relevant to an AI/ML device study. It is a 510(k) clearance letter for a Class II surgical vessel dilator and discusses substantial equivalence to predicate devices, not performance against specific acceptance criteria in a study format typically associated with AI/ML.

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

• A table of acceptance criteria and the reported device performance: Not applicable for this type of document.
• Sample size used for the test set and the data provenance: Not applicable.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.

The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8" thick, closed cell polyethylene foam material. Attached to the foam is a 1/2" wide, 20" long, 4 mil thick, polyvinyl chloride strip referred to as a "tail".

The provided text describes a medical device, the "RDI Cardiac Insulation Pad," and its submission for pre-market notification (K960312). However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other statistical measures typically found in AI/ML device studies.

The document focuses on:

• General Information: Device name, applicant.
• Indications for Use: To insulate the myocardium during open heart surgery.
• Device Description: Materials and construction.
• Classification: Class II.
• Safety and Effectiveness: Stating substantial equivalence to another device (Sorin/Shiley Inc. Cardiac Insulation Pad).
• Other Safety and Effectiveness Data: This section lists various tests primarily related to material biocompatibility, sterilization, pyrogenicity, and basic functional characteristics like thermal conductivity, tail pull strength, water absorption, and package integrity. Crucially, these are engineering and material property tests to ensure the device is safe and performs its basic physical functions, not a study evaluating its clinical effectiveness or diagnostic performance against acceptance criteria.

Therefore, I cannot provide the requested table or detailed information on acceptance criteria and a study proving device performance as it's typically understood in the context of AI/ML or diagnostic devices. The document does not describe such a study.

Here's how I would answer based on the provided text, highlighting what is present and what is missing:

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

The provided document describes engineering and material-related tests, not performance metrics related to clinical efficacy or diagnostic accuracy. Therefore, a table of acceptance criteria and reported device performance in the context of clinical outcomes or AI performance (e.g., sensitivity, specificity) cannot be generated from this text.

The document mentions "Functional Testing" and states the RDI Cardiac Insulation Pad was "Found to be similar to Sorin/Shiley" for:

• Thermal Conductivity
• Tail Pull Test
• Water Absorption

It also states:

• Fluid contact materials comply with Tripartite Biocompatibility Guidance.
• Sterilization is "Validated AAMI/ISO Method I validation for Gamma radiation sterilization."
• Pyrogenicity: "Non-Pyrogenic."
• Package Integrity: "Passed in accordance with ASTM F1140-88."
• Shipping & Distribution: "Passed in accordance with NSTA Project 1 A vibration/drop tests."
• Shelf life: "Successful two year shelf life Accelerated Aging."

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

Not applicable. The document describes material and functional tests, not a clinical or AI performance study with a test set. Therefore, there is no information on sample size for a test set or data provenance.

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. There is no mention of a test set requiring expert-established ground truth.

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

Not applicable. There is no mention of a test set or 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 document does not describe an AI device, let alone an MRMC study related to human reader performance with or without AI assistance.

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

Not applicable. This document describes a physical medical device, not an algorithm, and therefore no standalone algorithm performance was assessed.

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

Not applicable. The document describes tests of physical properties and safety characteristics, not a diagnostic or clinical performance study that would require a "ground truth" in the sense of a clinical outcome or expert diagnosis.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and no training set is mentioned.

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

Not applicable. As above, this is not an AI/ML device and no training set or ground truth for it is mentioned.

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