Search Results

PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes. PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

This document is a 510(k) premarket notification for a medical device called PhotoFix® Decellularized Bovine Pericardium. It describes the device and claims substantial equivalence to a previously marketed device (K172085).

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria, especially in the context of an AI/ML powered device. The document is a traditional medical device submission for a physical implant, not an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a modified physical device (a new packaging size for an existing bovine pericardium patch) to a predicate device, based on non-clinical testing related to packaging integrity and shelf-life, not clinical performance metrics or AI/ML algorithm validation.

Ask a specific question about this device

PhotoFix is indicated for the following uses: intracardiac repair, suture line buttressing, pericardial closure, and vascular repair and reconstruction (for example: the carotid, iliac, femoral, and tibial blood vessels and arteriovenous access revisions).

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch that is prepared from bovine pericardium, stabilized using dye-mediated photooxidation, processed using ethylene oxide, and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.

PhotoFix is intended for single use only and cannot be resterilized. PhotoFix is supplied sterile in a sealed container with 22% buffered ethanol solution. Rinsing of the pericardium prior to implantation is not required.

This document is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on comparative testing of biomechanical properties. However, it does not contain the specific information required to complete the table or answer the detailed questions regarding acceptance criteria and study particulars for a device performance study in the way a clinical or AI-based diagnostic device submission would.

This document focuses on biomechanical performance testing comparing the new device to existing predicate devices, not on a human-in-the-loop or standalone algorithm performance study typical for AI/ML medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted or deduced:

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

Note on Acceptance Criteria: The document states that testing demonstrated that PhotoFix is substantially equivalent to the identified predicate devices for the biomechanical properties. This implies that the implicit acceptance criterion was meeting a comparable performance standard to these predicate devices, which are already legally marketed. Quantitative acceptance criteria are not explicitly listed in this summary.

Regarding the study that proves the device meets the acceptance criteria:

The study described is a comparative biomechanical testing study.

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

  • Sample Size: Not specified in the provided summary. The study involved comparative biomechanical testing of the PhotoFix device against two predicate devices (XenoSure and CorMatrix). The "test set" would refer to the number of PhotoFix samples tested for each biomechanical property.
  • Data Provenance: Not explicitly stated but clinical data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this was a laboratory biomechanical testing study, not a clinical study. It's an in-vitro/ex-vivo material property study.

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

  • Not applicable. This was a laboratory-based biomechanical performance test, not a study requiring expert consensus for ground truth. The "ground truth" would be the measured physical properties of the materials.

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

  • Not applicable. This was a laboratory-based biomechanical performance test.

• 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 type of study is for diagnostic devices, particularly AI/ML-based ones. This document describes a tissue patch for surgical repair.

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

  • No. This is not an AI/ML algorithm.

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

  • The "ground truth" for this type of study would be the measured physical and mechanical properties of the PhotoFix device and the predicate devices, obtained through standardized laboratory testing (e.g., force transducers, tensile testers, etc.). It is not clinical or expert-derived ground truth.

• 8. The sample size for the training set:

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

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

  • Not applicable. This is not an AI/ML algorithm.

Ask a specific question about this device

PhotoFix Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, suture line buttressing and pericardial closure.

PhotoFix® Decellularized Bovine Pericardium is indicated for the following uses: intracardiac repair, great vessel repair, suture line buttressing and pericardial closure.

The PhotoFix® Decellularized Bovine Pericardium ("PhotoFix") is a cardiovascular patch prepared from bovine pericardium which is stabilized using a dye-mediated photooxidation process, processed using ethylene oxide and sterilized using aseptic processing techniques. The photooxidation process creates crosslinks in the bovine tissue. No aldehyde chemistry is used during any phase of manufacturing including the tissue fixation or sterilization processes.

PhotoFix is intended for single use only and cannot be resterilized.

PhotoFix is supplied sterile in a sealed plastic container with 22% buffered ethanol solution. The package is designed to facilitate convenient aseptic transfer of the pericardium into the sterile field. Rinsing of the pericardium prior to implantation is not required.

The provided text is a 510(k) summary for the PhotoFix Decellularized Bovine Pericardium device. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device is not directly applicable to this document. This document describes an implantable tissue patch, not an AI/ML device.

The "Performance Testing" section describes tests related to the physical and biological characteristics of the tissue patch and its packaging, specifically:

• Chemical characterization testing
• Biocompatibility testing (cytotoxicity and hemolysis)
• Packaging shelf-life

The "Conclusion" states that the device is substantially equivalent to its predicate.

To directly answer your questions based on the provided document, in the context of this specific medical device (PhotoFix Decellularized Bovine Pericardium), rather than an AI/ML device:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a formal table with specific acceptance criteria and detailed performance results (e.g., numerical values for cytotoxicity, hemolysis rates, or specific shelf-life data with pass/fail criteria). It only states that "The results of the testing demonstrated that the packaging is non-cytotoxic, non-hemolytic, and maintains a sterile barrier. The packaging is equivalent to the predicate device."
   Acceptance Criteria (Inferred from regulatory context):
   * Biocompatibility: Non-cytotoxic, Non-hemolytic.
   * Sterility: Sterile barrier maintained for shelf-life.
   * Equivalence: Packaging equivalent to predicate device.
   Reported Performance:
   * Biocompatibility: "non-cytotoxic, non-hemolytic"
   * Sterility/Packaging: "maintains a sterile barrier"
   * Equivalence: "The packaging is equivalent to the predicate device."

2. Sample sizes used for the test set and the data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For biocompatibility and chemical characterization, the "ground truth" would be established by laboratory testing standards and methods (e.g., ISO standards for biocompatibility), not expert consensus in the diagnostic sense. For shelf life, it would be based on real-time or accelerated aging studies.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

PerClot Topical is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of mildly bleeding wounds such as surgical wounds (postoperative, donor sites, dermatological), cuts and lacerations and for the treatment of mild bleeding from topical ENT surgical wounds and nosebleeds. It is also indicated for control of bleeding from the skin at percutaneous needle access, vascular access, and percutaneous catheter access sites.

PerClot® Topical is a medical device composed of absorbable polysaccharide granules and delivery applicators. The granules are biocompatible, non-pyrogenic and derived from purified potato starch. The granules do not contain any human or animal components. PerClot granules have a molecular structure that rapidly absorbs water, forming a gelled adhesive matrix that provides a mechanical barrier to further bleeding and results in the concentration of platelets, red blood cells, and coagulation proteins (thrombin, fibrinogen, etc.) at the site of application. The gelled adhesive matrix thus promotes the normal physiological clotting cascade. PerClot granules are enzymatically degraded by alpha-amylase and glucoamylase and by macrophages.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PerClot Topical device:

This 510(k) summary for PerClot Topical does not describe a study involving an AI/Machine Learning device or a direct comparison to human performance. Instead, it outlines the regulatory pathway for a conventional medical device (a topical hemostatic agent).

Therefore, many of your requested sections regarding AI-specific criteria, such as multi-reader multi-case studies, ground truth establishment for training sets, or expert qualifications for interpreting AI outputs, are not applicable to this document. I will focus on the information that is present and indicate where the requested information is not relevant to this type of submission.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

"Study That Proves the Device Meets the Acceptance Criteria":

The document describes several types of testing that collectively demonstrate the device meets acceptance criteria:

• Bench Testing: Functional testing demonstrated "substantial equivalence" to the predicate device (NexStat® Topical Hemostat Powder).
• Performance Testing: Studies demonstrated that PerClot meets specific performance specifications related to water absorption (total and rate), adhesion/cohesion, and particle/granule size distribution. The document states, "The function of the product is directly related to these performance specifications."
• Pre-clinical GLP Evaluation: This study was conducted according to applicable standards and is reported to support PerClot's safety and effectiveness.
• Biocompatibility Studies: Performed in accordance with ISO 10993.

These tests, rather than a single overarching study, are presented as the evidence for meeting acceptance criteria.

Regarding AI/Machine Learning Specific Information (Not Applicable to this Document):

The following points are not applicable as this 510(k) pertains to a physical medical device (hemostatic particles) and not an AI/Machine Learning diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: Not applicable. No test set of data (e.g., medical images, patient records) is mentioned for an AI device. The testing involved functional, performance, pre-clinical, and biocompatibility assessments of the material itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment for an AI test set is relevant here. The ground truth refers to the physical properties and biological effects of the hemostatic particles.

4. Adjudication method for the test set: Not applicable. There is no test set in the context of AI evaluation.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For this physical device, the "ground truth" would be the established scientific and engineering principles for hemostasis, material science, and biocompatibility, as evaluated through the described bench, performance, pre-clinical, and biocompatibility testing. No "expert consensus" on interpreting data for an algorithm is mentioned.

8. The sample size for the training set: Not applicable. No AI training set is mentioned.

9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

Ask a specific question about this device

ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch® is indicated for the reinforcement, where weakness exists, of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadricens, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from bovine pericardium. Decellularized tissues undergo chemical microbial reduction and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch is comprised of a single tissue layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

The provided document K110581 is a 510(k) summary for the ProPatch® Soft Tissue Repair Matrix. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance metrics for a new, innovative device. Therefore, the information requested might not be fully present in the context of this specific document.

Here's an analysis based on the provided text, addressing your points where possible:

1. 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)

The document does not specify the sample sizes used for the testing, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The testing described is in-vitro biomechanical testing and decellularization efficiency assessment, not clinical study data involving patients.

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 is not applicable as the document describes a 510(k) submission for a surgical mesh, which relies on demonstrating substantial equivalence through laboratory testing rather than expert-derived ground truth for diagnostic accuracy.

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

This is not applicable as the document describes a 510(k) submission for a surgical mesh, focusing on physical and biological properties. There is no mention of adjudication methods, which are typically relevant for diagnostic studies involving human assessment.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic devices, which is not the nature of the ProPatch® Soft Tissue Repair Matrix.

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

A standalone performance assessment was not done. This concept is applicable to AI algorithms, not a physical medical device like a surgical mesh. The "performance" here refers to the device's biomechanical and de-cellularization properties as compared to a predicate, not an algorithm's output.

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

The "ground truth" in this context is the established properties of the predicate device. The studies aimed to demonstrate that the new device's properties (tensile, tear, bursting, suture retention, and decellularization) are substantially equivalent to those of the predicate device. This is based on objective, quantifiable laboratory measurements.

8. The sample size for the training set

This is not applicable. The ProPatch® Soft Tissue Repair Matrix is a physical surgical mesh, not an artificial intelligence or machine learning model that requires a training set.

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

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

Ask a specific question about this device

ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Non-Joint Related Repair

ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

Joint Related Repair

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

The provided document describes a 510(k) submission for the "ProPatch® Soft Tissue Repair Matrix" and specifically states that no new studies were performed to prove the device meets acceptance criteria. Instead, this submission is for minor changes to the Instructions for Use and a manufacturing change, and the device's equivalence to a previously cleared predicate device (K061892) is asserted based on identical indicated uses and technological characteristics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for a new study is not applicable to this particular 510(k) submission.

Here's an explanation based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. The document does not describe new performance or acceptance criteria for this 510(k) submission. It relies on the prior clearance of the predicate device.
• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No new test set or data are mentioned.
• 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. No new ground truth establishment is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set adjudication is described.
• 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 mesh, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this submission. The original predicate device's clearance would have relied on appropriate testing for surgical mesh, likely including mechanical properties, biocompatibility, and potentially animal or clinical data, which would have established its "ground truth" for safety and effectiveness.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

Summary based on the document:

This 510(k) submission (K101587) for the ProPatch® Soft Tissue Repair Matrix is a "Special 510(k)" or similar submission for minor changes (Instructions for Use and minor manufacturing change) to an already cleared device. The manufacturer asserts equivalence to the predicate device K061892 based on "identical indicated uses and technological characteristics." Therefore, this document does not contain information about new studies proving the device meets acceptance criteria, as its substantial equivalence is based on the previously cleared device.

Ask a specific question about this device

CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

The Cryor atch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period, harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing cryoprotectants, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.

CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.

Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

The provided text describes the CryoPatch SG Pulmonary Human Cardiac Patch, a medical device, and its 510(k) clearance. However, it does not contain information about formal acceptance criteria from a study, nor does it detail a study that explicitly proves the device meets specific performance criteria in the way you've outlined.

The document primarily focuses on the regulatory clearance process, establishing substantial equivalence to predicate devices based on:

1. Device Description: What the device is made of and how it is processed.
2. Intended Use: What the device is used for.
3. Predicate Devices: Other similar devices already on the market.
4. Scientific Evidence and Bench Testing: This section mentions types of tests conducted to support a change in device shelf life, specifically:
   • Biomechanical properties testing
   • Pulsatile flow characterization
   • Accelerated wear testing
   • Theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures.

Crucially, it does not provide the specific numerical acceptance criteria (e.g., "tensile strength must be > X MPa") for these tests, nor does it report the results of these tests against such criteria. It also does not involve human subjects, expert review, or ground truth establishment in the manner typically associated with AI/diagnostic device studies.

Therefore, I cannot populate your requested table and answer many of your questions in the way you've phrased them, as the information is not present in the provided text.

Based on the available text, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance
The document discusses bench testing on the device itself (tissue, patch), not a clinical 'test set' in the context of human data or AI. Therefore, these questions are not applicable to the provided text.

• Sample size for test set: Not applicable (bench testing, not a clinical test set).
• Data provenance (country of origin, retrospective/prospective): Not applicable. The testing is described as scientific and bench testing, likely conducted in-house by CryoLife, Inc. (USA-based).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable. The data is from bench testing of a physical device, not from human studies requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No human interpretation or adjudication for a test set is 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
Not applicable. This is not an AI or diagnostic device study. It's a regulatory submission for a physical tissue graft.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the human data sense. The "truth" for the bench tests would be the measured physical properties and histological observations of the tissue after storage and wear simulation.

8. The sample size for the training set
Not applicable. This is not a machine learning or AI study.

9. How the ground truth for the training set was established
Not applicable.

Ask a specific question about this device

CryoValve® SG Pulmonary Human Heart Valve (and Conduit) are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve (CryoValve SG) is a human heart valve aseptically recovered from qualified donors. The valve is dissected, treated with an antimicrobial solution, and treated to remove the cells and cellular debris that has not already been removed during the postmonten, and harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium, cretaining a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system nonly withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating room, Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valves are transferred to a liquid nitrogen freezer for long-term storage at -135°C to -196°C.

The provided text describes a 510(k) summary for the CryoValve® SG Pulmonary Human Heart Valve (and Conduit). This submission is for a medical device and not an AI/ML powered device. As a result, the requested information (performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.) specific to AI/ML device evaluations is not applicable and not present in the document.

The document focuses on:

• Intended Use: Replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves, including use in the Ross Procedure.
• Predicate Devices: Mentions previous 510(k) clearances (K033484 and K083106) for similar CryoValve® SG devices.
• Device Description: Details on aseptic recovery, antimicrobial treatment, cell and cellular debris removal, cryopreservation, packaging, and supercooling process. It also mentions reduced risk for HLA class I and class II alloantibodies compared to standard-processed valves.
• Scientific Evidence and Bench Testing: States that scientific analysis and testing were conducted to change the device shelf life, including biomechanical properties testing, pulsatile flow characterization, and accelerated wear testing. It refers to "theoretical and empirical (histological) evidence of tissue stability at cryogenic temperatures."

Since this is not an AI/ML device, the specific questions related to AI/ML acceptance criteria and studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) cannot be answered from the provided text.

Ask a specific question about this device

CryoPatch® SG Pulmonary Human Cardiac Patch is indicated for repair or reconstruction of the right ventricular outflow tract.

The CryoPatch® SG Pulmonary Human Cardiac Patch is derived from human pulmonary valve and artery tissue aseptically recovered from qualified donors. The patch is treated with an antimicrobial solution, and treated to remove the cells and cellular debris that have not already been removed during the post mortem period. harvesting, and the antimicrobial process. The patch is cryopreserved in a tissue culture medium, containing a cryoprotectant, within the innermost pouch of a three pouch packaging system. The packaging system not only withstands ultra cold temperatures, but also allows for aseptic introduction of the patch into the operating room. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long term storage at or below -135° C.

CryoPatch® SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch.

Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoPatch SG.

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found in device performance studies for AI/software devices.

Instead, this document is a 510(k) summary for a human cardiac patch (CryoPatch® SG Pulmonary Human Cardiac Patch), which is a physical biological device, not an AI or software model. The "studies" mentioned refer to evaluations of the biological and mechanical properties of the patch, and its substantial equivalence to predicate devices, rather than performance metrics like sensitivity, specificity, or AUC as one would expect for an AI system.

Here's a breakdown of why this document doesn't fit the requested criteria and what information it does provide:

1. A table of acceptance criteria and the reported device performance: This is not present for performance metrics. The document states: "CryoPatch SG has undergone biomechanical, histological, DNA content, and decellularization evaluation. In addition, a large animal study and clinical data support the substantial equivalence of the device to previously marketed devices." These are general categories of testing, not specific acceptance criteria with quantifiable outcomes. The closest to a "performance metric" is the statement regarding HLA class I and class II alloantibodies: "Implantation of the CryoPatch SG Pulmonary Human Cardiac Patch reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to standard-processed pulmonary cardiac tissues." However, no specific acceptance threshold or numerical performance is given.

2. Sample sized used for the test set and the data provenance: No information on sample sizes for specific tests is provided, nor data provenance in terms of country of origin or retrospective/prospective nature for these evaluations. It mentions "clinical data" and a "large animal study" generally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical patch would likely be established through laboratory analyses, animal models, and clinical follow-up by medical professionals (surgeons, pathologists), but the document does not detail this process in the context of "experts" as in AI ground truth assessment.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device where human readers would interpret outputs.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: For a physical medical device like this, "ground truth" would be established through:

   • Histological, DNA content, and decellularization evaluations: These are laboratory analyses using established scientific methods to assess the tissue's properties.
   • Large animal study: In vivo performance in an animal model.
   • Clinical data: Outcomes in human patients.
     The document doesn't provide specifics on how this ground truth was used to establish criteria or measure performance against them.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a physical medical device (a human cardiac patch) and its 510(k) clearance summary. It focuses on demonstrating substantial equivalence to predicate devices through various biological and biomechanical testing, animal studies, and clinical data, rather than meeting acceptance criteria for an AI or software device's performance.

Ask a specific question about this device

CryoValve® SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosihetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed.

Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

The CryoLife, Inc. CryoValve SG Human Pulmonary Heart Valve SG) is a human hent valvai The Cryolitie, fice C. you ve 35 Friman I. The valve is dissected, treated with an antimierobial solution, and asepted to remove the cells and cellular debris that has not already been removed during the posimorlem treated to renove the centual deenses. The valve is cryopreserved in a tissue vulture medium. period. hervesting, and the antitional process. The thee pouch packaging system. The packaging containing a cryqptolection, within the meether allows for aseptic introduction of the valve into the system not only while the lemperatures, our in begin prior to crystallization to feel have arm operating tolin. Supercenting of informations are transferred to a liquid nitrogen freezer for long-lerm storage at -- 135°C to -196°C.

Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA chass Implantion of the CTS varve SCF Camend Reactive Amibody measured at up to one year. Compared to the I and citiss II and mobile is misser on theat valve. Data have not been provided to evaluate the effect of standard-processed punnolary in the United United Online Form durability, or long-term resistance to rejection by the patient, of the CryoValve SG.

The provided document is a 510(k) summary for the CryoValve® SG Pulmonary Valve and CryoValve® SG Pulmonary Valve and Conduit, a human heart valve. It describes the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

The "Analysis Supporting Substantial Equivalence" section states: "A Clinical Data Analysis provides the needed assessment to support the product claim. The Analysis reviews A Cinnell Dall Analysis provides the necesses scientific rationale needed to make this change to the labeling." This vague statement implies a clinical data analysis was performed, but no details of this analysis are provided in the document. The document primarily focuses on regulatory clearance based on substantial equivalence to a previously cleared predicate device (K033484).

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document is about a heart valve, not an AI/ML device with performance metrics like sensitivity/specificity.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document is a regulatory submission for a medical device (human heart valve) which is substantially different from an AI/ML software device that would typically undergo performance evaluation against specific acceptance criteria.

Ask a specific question about this device