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The EnCuff is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a non resorbable scaffold to assist with a soft tissue repair. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, to the supraspinatus, during rotator cuff repair surgery.

The Shelhigh EnCuff is a cross-linked Xenograft pericardium, rinsed with No-React® anticalcification process. The device is provided sterile in 2% benzyl alcohol solution.

The provided document is a 510(k) premarket notification for the Shelhigh No-React® EnCuff Patch, which is a surgical mesh. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical trials with defined acceptance criteria and performance studies in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain details of specific acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device). Instead, it focuses on demonstrating technological characteristics and intended use are substantially equivalent to a legally marketed predicate device.

However, based on the information provided, we can infer some "acceptance criteria" in the context of a 510(k) and outline the "study" (bench testing and comparison) used to support equivalence.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• "The device is provided sterile in 2% benzyl alcohol solution."
• "Identical to the Shelhigh No-React® pericardial patches currently manufactured by Shelhigh Inc." |
  | Material Properties (Bench Testing) | - "Shelhigh EnCuff material exhibits good tensile strength,"
• "shrink temperature,"
• "and suture retention."
• "The material reapproximates well around suture holes."
• "It is soft and pliable." |
  | Biocompatibility | "The material exhibits excellent biocompatibility, and passed the requirements of all tests." |
  | Substantial Equivalence Conclusion | "This device is, in respect to intended use and technological characteristics, substantially equivalent to the predicate devices." |

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

• Sample Size: Not applicable in the context of clinical test sets for performance metrics. The submission refers to material testing, where "sample size" would relate to the number of material specimens tested for physical properties. This specific number is not provided.
• Data Provenance: Not applicable in the context of clinical test sets. The material testing would be conducted in a laboratory setting by the manufacturer, Shelhigh Inc.

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

• Not applicable. This is a 510(k) submission for substantial equivalence based on material properties and intended use, not a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable.

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

• No, a MRMC comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a surgical mesh 510(k) submission.

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

• Not applicable. This device is a surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For the material properties, the "ground truth" would be established by standardized laboratory testing methods against pre-defined specifications (though the exact specifications are not detailed in this summary). For biocompatibility, it refers to "passed the requirements of all tests," indicating compliance with established biocompatibility standards.
• For the overall determination of substantial equivalence, the "ground truth" is a comparison to the characteristics and intended use of the legally marketed predicate devices.

8. The Sample Size for the Training Set

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

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

• Not applicable.

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The Shelhigh BioRing™ is intended for use in the repair of the human cardiac mitral valve.
The Shelhigh BioRing™ is indicated as a reinforcement for repair of the human cardiac mitral valve damaged by acquired or congenital disease, or a replacement for a previously implanted annuloplasty ring.

The Shelhigh BioRing™ consists of circular rings made of Polyester material and covered with No-React processed pericardium.

This document is a 510(k) summary for the Shelhigh BioRing and describes its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way typically expected for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for a performance study evaluating an AI/ML component is not applicable to this document.

However, I can extract the information that is present and indicate where the requested details are not available.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria for device performance based on a study, nor does it report specific performance metrics in that context. The "acceptance criteria" here are related to demonstrating substantial equivalence to predicate devices, focusing on materials, intended use, and technological characteristics.

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

Not applicable. This document does not describe a performance study with a test set. The evaluation is based on a comparison to predicate devices and material testing.

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

Not applicable. No test set or ground truth establishment by experts is described in this context.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method 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 an annuloplasty ring, not an AI/ML device. Therefore, no MRMC study involving AI assistance was conducted or would be relevant to this product.

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

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

7. The Type of Ground Truth Used

Not applicable. For this type of medical device (physical implant), "ground truth" would relate to factors like material specifications, biocompatibility test results, and clinical outcomes for the predicate devices, rather than an expert-adjudicated dataset. The document states that the materials "passed the requirements of all tests," implying a comparison to established standards for safety and performance (biocompatibility, tensile strength, suture retention).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component, thus no training set.

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

Not applicable. There is no AI/ML component, thus no training set or its associated ground truth.

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The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.

The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.

This document is a 510(k) summary for the Shelhigh No-React® Dura Shield, a Class II medical device intended as a dura substitute for closure of dura mater during neurosurgery.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum degradation rate) or a direct comparison of the device's performance against such criteria in a tabular format. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The reported performance aspects, derived from the text, are descriptive rather than quantitative, and are primarily focused on equivalence and biocompatibility:

• "Exhibits substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" to the predicate devices.
• "The Shelhigh No-React® performance in a substantially equivalent to the predicate device and there were no significant differences between the two devices which pose new questions of safety and effectiveness." |
  | Biocompatibility | - "The material exhibits excellent biocompatibility."
• "An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher level of biocompatibility."
• "The non clinical /Animal testing data showed that the Shelhigh No-React® patch has high level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage." |
  | Mechanical Properties | - "The material exhibits good tensile strength, shrink temperature and suture retention."
• "The material reapproximates well around suture holes."
• "It is soft and pliable making it convenient to implant." |
  | Sterility / Packaging | - "The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar." (Implied acceptance for sterility) |
  | Effectiveness of No-React® Process | - "Extensive validation of the effectiveness of the Patch with the Extonoro validation process, No-React® indicates that these differences do not pose new questions of safety and effectiveness." |

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

The document mentions an "animal study" to evaluate biocompatibility.

• Sample Size: The specific sample size for the animal study is not provided.
• Data Provenance: The study was an "animal study," but the country of origin or whether it was retrospective or prospective is not specified.

Physical/mechanical test information is "discussed above" in relation to substantial equivalence, implying laboratory testing, but specific sample sizes for these tests are not provided.

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

This document describes a device for surgical implantation, not an interpretive diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of a test set (e.g., for image interpretation) is not applicable in the way it might be for an AI diagnostic tool.

The "ground truth" for the animal study would be scientific observations of biocompatibility, tissue response, and macroscopic/microscopic examination, and these would be conducted by qualified veterinarians, histopathologists, and researchers, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set:

Given that this is not an interpretive diagnostic device, an "adjudication method" in the sense of reconciling expert opinions on diagnoses is not applicable.

For the animal study, it's reasonable to assume standard scientific practices for data collection, analysis, and interpretation were followed, potentially involving multiple researchers and statistical analysis, but a specific "adjudication method" is not described.

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

An MRMC study is typically performed for diagnostic devices where human readers interpret cases with and without AI assistance. This is a standalone medical device (dura substitute) for surgical implantation, not a diagnostic tool that assists human readers.

Therefore, an MRMC comparative effectiveness study was not performed, and is not applicable for this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This device is a physical implant, not an algorithm. Therefore, the concept of a "standalone" study for an algorithm's performance is not applicable. The performance evaluated is the physical and biological performance of the material itself.

7. Type of Ground Truth Used:

The primary "ground truth" used for this device includes:

• Physical/Mechanical Properties: Bench testing data (suture retention, tensile strength, shrink temperature).
• Biocompatibility: Animal study observations and histological findings. These would typically be confirmed by pathology and scientific consensus within the study.
• Clinical Outcomes/Safety in Predicate: The long history of successful use of glutaraldehyde processed bovine pericardium as a permanently implanted material (mentioned in the product description) provides a form of "ground truth" for similar materials.

8. Sample Size for the Training Set:

The concept of a "training set" is primarily relevant for AI/machine learning algorithms. This device is a physical product, not an algorithm, so there is no training set in that context.

The manufacturer likely has internal data and experience from manufacturing previous batches and product iterations, but this isn't a "training set" in the computational sense.

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

As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the development and testing of the Shelhigh No-React® Dura Shield would have been established through standard material science, biocompatibility testing, and preclinical animal models.

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Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.

The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine pericardium. rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.

The provided text describes a medical device, the Shelhigh No-React® UROPATCH™, and its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission highlights three key physical/mechanical properties used for comparison with the predicate device. These can be considered the de facto acceptance criteria addressed by the non-clinical testing.

Missing Information:

• Specific quantitative thresholds for "substantially equivalent" or "higher level" for most criteria. The document states they are "substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" and the UroPatch™ has a "higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage."

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

The document mentions an "animal study" to evaluate biocompatibility.

• Sample Size: Not specified.
• Data Provenance: Animal study. No country of origin is mentioned. Whether it was retrospective or prospective is not explicitly stated, but animal studies are typically prospective.

Missing Information:

• Specific number of animals used in the study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the submission describes non-clinical/animal testing, not a study involving human experts establishing ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is an animal study evaluating physical and biological properties of a patch, not a diagnostic device requiring adjudication of human readings.

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

This information is not provided and is not applicable to this type of device (a tissue repair patch). MRMC studies are typically for diagnostic imaging devices or AI tools that assist human interpretation.

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

This information is not provided and is not applicable to this type of device. The device is a physical tissue repair patch, not software or an algorithm.

7. The Type of Ground Truth Used

For the animal study:

• Ground Truth: "Higher level of biocompatibility" compared to a control group ("conventional glutaraldehyde treated patch"). This would likely involve histological assessment, cellular response markers, or other in-vivo biological endpoints. Specifics are not provided.

8. The Sample Size for the Training Set

This information is not applicable as the device is not a machine learning model or an algorithm that requires a training set. The "testing" involved non-clinical and animal studies to demonstrate physical properties and biocompatibility.

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

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

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of physical/mechanical properties and an animal study for biocompatibility. It does not contain the detailed information typically found in submissions for AI/ML-driven diagnostic devices, which would include extensive data on human expert review, training sets, and specific performance metrics against clinical ground truth.

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For repair of carotid endarterectomy and vascular patch grafting.

The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.

This document is a 510(k) summary for the Shelhigh No-React® VASCUPATCH™, specifically addressing its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested categories cannot be filled directly from the provided text. The document focuses on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices based on material properties and intended use.

Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not present:

Acceptance Criteria and Study for Shelhigh No-React® VASCUPATCH™

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not specified. The document mentions "An animal study," but does not provide details on the number of animals or samples used.
• Data Provenance: The animal study was conducted to compare the Shelhigh No-React® patch with a conventional glutaraldehyde treated patch. No country of origin is specified. This was a nonclinical/animal test.

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

• Not applicable. The study described is an animal study evaluating material properties and biocompatibility, not an assessment requiring expert interpretation of diagnostic images or clinical outcomes in humans to establish "ground truth."

4. Adjudication method for the test set:

• Not applicable. As noted above, this was an animal study of material properties and biocompatibility, not a study requiring adjudication of expert interpretations.

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 cardiovascular patch, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a cardiovascular patch.

7. The type of ground truth used:

• For the animal study on biocompatibility, the "ground truth" would be established through histological analysis, cellular assays, and potentially macroscopic observation of the animal tissue responses to the implanted materials.
• For the physical/mechanical properties, the "ground truth" is based on standardized laboratory testing methods for suture retention, tensile strength, and shrink temperature.

8. The sample size for the training set:

• Not applicable. This is a medical device (cardiovascular patch), not a machine learning algorithm requiring a training set in the conventional sense.

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

• Not applicable. (See #8)

Summary of Device Equivalence from the Document:

The provided text describes the Shelhigh No-React® VASCUPATCH™ as being substantially equivalent to a predicate device (Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496) and identical to another currently manufactured device (Shelhigh No-React® pericardial patch K974914). The equivalence is based on:

• Material: Glutaraldehyde fixed bovine pericardium, rinsed with No-React® detoxification process.
• Physical/Mechanical Properties: Substantially equivalent suture retention, tensile strength, and shrink temperature. Identical flexibility, wall thickness, and storage in benzyl alcohol.
• Intended Use: Repair of carotid endarterectomy and vascular patch grafting.
• Biocompatibility: An animal study showed higher cytocompatibility for the Shelhigh No-React® vs. conventional glutaraldehyde treated patches.

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The device is intended for use to reinforced the soft tissue of the lung, thereby sealing or reducing air leak that occur during pulmonary surgery.

The Shelhigh No-React® PneumoPledgets strips are glutaraldehyde fixed sheet of bovine pericardium. They are held on the stapler by a unique design of a loop on the anterior part of the PneumoPledgets. It holds the strip by inserting the pointed edge of the staple into the loop. The posterior part (if needed) is held by an "O" ring made of pericardium as well. The PneumoPledgets. strips are customized to fit all sizes and types of staples. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar.

The material exhibits good tensile strength, shrink temperature excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant.

Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.

This document describes a 510(k) premarket notification for the Shelhigh No-React® PneumoPledgets, a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria. Therefore, the information provided does not align directly with the typical structure of an AI/software-based device study.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a physical medical device (bovine pericardial patch), not an AI/software device. Its performance is evaluated through physical/mechanical properties and biocompatibility, not typical AI metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices.

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

• Sample Size for Test Set: Not explicitly stated. The study conducted was an animal study, not a human clinical trial. The text refers to "an animal study" without specifying the number of animals.
• Data Provenance: The study was an "animal study." No information on the country of origin. It would be considered prospective in the context of comparing the new device against conventional treatment in the animal model.

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

Not applicable for this type of device and study. The evaluation of biocompatibility in the animal study would likely be performed by veterinary pathologists or toxicologists, but no details are provided. This is not an image-based diagnostic AI device requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The animal study would involve direct observation and potentially histological analysis by trained personnel, not adjudication among human readers as in an AI study.

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 a physical medical device, not an AI diagnostic tool that assists human readers.

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

The ground truth for the animal study was based on direct biological and histological observations and measurements of biocompatibility in the animal model. This would include parameters like tissue reaction, inflammation, and potential adverse effects compared to the control group (conventional glutaraldehyde treated patch).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The device's manufacturing process and materials are established through engineering design, material science, and prior experience with similar glutaraldehyde-treated bovine pericardium.

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

Not applicable. There is no training set for an AI model. The "ground truth" for the device's design and manufacturing relies on established biological and material science principles for medical implants, including understanding the properties of bovine pericardium and the effects of glutaraldehyde processing. The "No-React®" detoxification process was validated to improve biocompatibility.

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The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as a patch for closure of the patient's pericardium after open heart surgery, The patch may be tailored during surgery to meet the surgeon's needs.

The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.

The Shelhigh No-React® Pericardial patch is a glutaraldehyde fixed sheet of bovine pericardium, rinsed with the detoxification process No-React®. The device is provided sterile in benzyl alcohol solution. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.

The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.

The provided text describes a medical device, the Shelhigh No-React® Pericardial Patch, and its substantial equivalence to a predicate device for 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested metrics for a clinical/performance study.

The document focuses on demonstrating substantial equivalence primarily through non-clinical (physical/mechanical properties) and animal testing, rather than human clinical trials with defined acceptance criteria and performance metrics.

Here's a breakdown of the available information based on your request, and where the information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in terms of number of animals or specific measurements.
• Data Provenance: Animal study. The country of origin for the animal study is not specified, but the submission is to the US FDA. The study is prospective in the sense that it was conducted specifically to support this regulatory submission.

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

• Not applicable/Not provided. The "ground truth" for physical/mechanical properties would be direct measurements. For biocompatibility, it's evaluated through animal study outcomes, not expert consensus interpreting data.

4. Adjudication method for the test set

• Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for interpreting results in human clinical trials or image-based studies where expert consensus is needed. The non-clinical and animal studies described here would rely on objective measurements and pathological 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

• No. This device is a pericardial patch, not an AI or image-reading device. Therefore, MRMC studies are not relevant.

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

• No. This device is a physical implantable medical device, not an algorithm.

7. The type of ground truth used

• Physical/Mechanical Properties: Direct laboratory measurements (e.g., tensile strength, suture retention force, temperature at which shrinkage occurs).
• Biocompatibility/Cytocompatibility: Histopathological evaluation of tissue response in animal models, and potentially in vitro cell culture assays for cytocompatibility.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm that requires a "training set." The materials used for manufacturing and testing are described, but not as a training set.

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

• Not applicable, as there is no "training set."

Summary of what the document does provide regarding acceptance criteria and studies:

The document primarily addresses substantial equivalence by comparing the Shelhigh No-React® Pericardial Patch to a predicate device (Shelhigh pericardial patch #K964467). The "acceptance criteria" can be inferred from this comparison:

• Physical/Mechanical Properties: The device must demonstrate "substantially equivalent physical/mechanical properties" as measured by suture retention, tensile strength, and shrink temperature, and "identical flexibility, wall thickness, shapes and sizes" to the predicate.
• Biocompatibility: The device must demonstrate acceptable biocompatibility, and ideally, higher level of biocompatibility as a result of the "No-React®" detoxification process, without raising new questions of safety and effectiveness.

The study that "proves" these criteria are met is described as:

• Nonclinical/Animal Tests: These tests demonstrated that the Shelhigh No-React® patch shows:
  • Substantially equivalent physical/mechanical properties to the predicate.
  • A higher level of biocompatibility and high level of cytocompatibility when compared with conventional glutaraldehyde-treated and stored material.

The document concludes that the differences (the addition of the No-React® detoxification process) do not pose new questions of safety and effectiveness, thus qualifying it as substantially equivalent.

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The Shelhigh Pericardial Patch is intended for use as a pericardial patch, and as an intracardiac patch.

Not Found

This document is an FDA 510(k) clearance letter for the "Shelhigh Pericardial Patch (without detoxification treatment)" and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, or the methodologies used to establish such criteria and conduct studies.

Therefore, I cannot provide the requested information based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not delve into the technical details of its performance or the studies behind it.

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