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Synovis Collagen Matrix is intended for the reconstruction and repair of the pericardium.

Synovis Collagen Matrix is an implantable biologic patch comprised of non-crosslinked bovine pericardium.

The Synovis Collagen Matrix is an implantable biologic patch made from non-crosslinked bovine pericardium, intended for the reconstruction and repair of the pericardium. This device received 510(k) clearance (K122306) based on substantial equivalence to predicate devices, primarily Veritas® Collagen Matrix.

The device's safety and performance were evaluated through non-clinical testing, including bench testing and animal studies.

Acceptance Criteria and Device Performance:

Details of the Studies:

1. Sample size used for the Test Set and Data Provenance:

   • Bench Testing: The document does not specify the exact sample sizes for each bench test (suture retention, thickness, amine index, tensile, burst, sterilization validation, packaging, shelf-life, biocompatibility). These tests are typically conducted in a laboratory setting. Data provenance is implied to be from the manufacturer's internal testing.
   • Animal Studies:
     • Swine Model: Used for systemic toxicology and histological examination. The exact number of swine is not specified.
     • Canine Model: Used for pneumonectomy stump repair and chest wall defect repair. The exact number of canines is not specified.
     • Rat Model: Used for adhesion formation evaluation. The exact number of rats is not specified.
   • All animal studies were conducted prospectively as part of the device evaluation process. The country of origin for the data is not specified but is assumed to be part of the manufacturer's regulatory submission process.

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

   • The studies described are non-clinical (bench and animal studies). Ground truth for these studies is established through objective measurements (e.g., mechanical properties, chemical analysis) and histopathological examination by qualified veterinarians and pathologists, typically employed by contract research organizations or the device manufacturer. The specific number and qualifications of these experts are not provided in the summary.

3. Adjudication Method for the Test Set:

   • Not applicable as these were non-clinical bench and animal studies, not human clinical trials involving expert review and adjudication of patient data for diagnostic accuracy.

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

   • No. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Synovis Collagen Matrix is an implantable surgical patch, not an imaging device.

5. Standalone Algorithm Performance:

   • Not applicable. This device is a biocompatible surgical implant, not a standalone algorithm.

6. Type of Ground Truth Used:

   • For bench testing: Objective measurements of physical and chemical properties.
   • For animal studies: Histopathology (histological examination), clinical observation (e.g., absence of air leaks, hernia-free), and systemic toxicology (laboratory analysis).

7. Sample Size for the Training Set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is used for machine learning models, not for traditional medical devices like surgical implants. The animal studies served as preclinical evaluation, not "training."

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

   • Not applicable, as there is no training set for this device.

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Veritas Collagen Matrix (Dry) is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

Veritas Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.

Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.

Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age.

Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.

This document is a 510(k) summary for the Veritas® Collagen Matrix (Dry). It states that the device is acting as its own predicate, meaning it's substantially equivalent to a previously cleared version of the same product. The submission focuses on a new method of attachment of the buttress to the stapler (an adhesive).

Given this, the document does not describe a study to prove the device meets acceptance criteria related to its primary function as a surgical mesh. Instead, the testing described is limited to the new adhesive.

Therefore, for most of your requested points, the answer will be "Not applicable" or "No information provided" as the provided text doesn't contain a detailed study proving the overall device performance against specific acceptance criteria.

However, I can extract information related to the scope of the current submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document explicitly states: "Veritas Collagen Matrix (Dry) is unchanged and previous testing applies." This means the core functionality of the collagen matrix as a surgical mesh was not re-evaluated in this submission, as it was already cleared in previous 510(k)s (K041669 and K062915).

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

• Sample size: Not specified.
• Data provenance: Not specified.

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. The study is on device components (adhesive biocompatibility and functionality), not on human-interpreted clinical data requiring expert ground truth establishment in the traditional sense of diagnostic AI.

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

• Not applicable. (See #3)

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 is a medical device for surgical mesh and adhesive, not an AI or diagnostic imaging device that would typically involve MRMC studies.

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

• Not applicable. (See #5)

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

• Not applicable. The evaluation relates to physical and biological properties of the adhesive (biocompatibility, functional performance), not clinical ground truth in the context of disease detection or diagnosis.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. (See #8)

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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.

However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.

Here's an attempt to structure the information based on your request, highlighting what is present and what is not:

Acceptance Criteria and Device Performance for Veritas® Collagen Matrix

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
• Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.

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

• This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.

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

• No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.

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

• Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.

7. Type of Ground Truth Used

• The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.

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

• Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.

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Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.

Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Veritas Dry is intended to be used as a staple line buttress. Veritas Dry is composed of dehydrated non-crosslinked bovine pericardium, to facilitate easy loading of the pericardium strips onto the stapler forks, an anvil and a cartridge strip are secured in a mounting unit. One mounting unit is used for each stapler firing. Each Veritas Dry unit is provided sterile in a double pouch.

The provided text is a 510(k) summary for a medical device (Veritas Dry Collagen Matrix) and the associated FDA approval letter. This type of document is for premarket notification of a device claiming substantial equivalence to a predicate device, not for a de novo marketing authorization or a PMA. As such, it does not involve the kind of clinical study with acceptance criteria, ground truth establishment, or AI performance metrics that your request is looking for.

Instead, the submission focuses on demonstrating substantial equivalence to already approved devices. This is typically done through:

1. Comparison of technological characteristics: Showing that the new device has similar materials, design, and intended use as the predicate devices.
2. Performance testing: Conducting non-clinical (e.g., mechanical, biocompatibility) tests to demonstrate that the device performs as safely and effectively as the predicate devices.

Therefore, many of the requested fields are not applicable to this type of regulatory submission.

Here's an analysis based on the information available:

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

• Not Applicable in the traditional sense. This document doesn't define explicit "acceptance criteria" for clinical performance that would be met by a study with human participants or a machine learning algorithm.
• Implied Acceptance Criteria: The implicit acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness.
• Reported Device Performance (as stated in the document):
  • "Veritas Dry is substantially equivalent to the predicate devices, having equivalent technological characteristics and indications for use."
  • "Veritas Dry is substantially equivalent to the predicate devices in terms of physical characteristics and test results."
  • The "testing" mentioned would be non-clinical performance tests (e.g., mechanical strength, biocompatibility), not clinical efficacy or diagnostic accuracy. Specific quantitative results of these tests and their acceptance criteria are not provided in this summary but would have been part of the full 510(k) submission.

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. This is not a clinical study on human subjects or an AI model evaluation. The "test sets" would refer to samples used for non-clinical performance testing of the material itself. The specific sample sizes for these tests are not disclosed in this summary.

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. Ground truth in the context of expert consensus is not relevant for this type of device submission.

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. This is a surgical mesh, not a diagnostic imaging AI device.

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 clinical sense. For non-clinical performance testing, the "ground truth" would be established by validated test methods and established material science standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there's no training set.

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

• Not Applicable.

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Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Peri-Strips is intended to be used for reinforcement of suturelines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

An implantable surgical patch comprised of crosslinked bovine pericardium

The provided text is a 510(k) summary for a medical device called "Peri-Strips Staple Line Reinforcement." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include acceptance criteria, details of a study that proves the device meets specific performance criteria, or any of the detailed information requested in points 2-9 of your prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details).

Medical devices like the Peri-Strips Staple Line Reinforcement, when cleared via the 510(k) pathway, typically demonstrate substantial equivalence to a legally marketed predicate device. This process often relies on showing that the new device has the same technological characteristics and similar indications for use as the predicate, and does not raise new questions of safety and efficacy. This usually involves engineering testing (e.g., tensile strength, burst pressure) and biocompatibility testing, rather than clinical efficacy studies with the detailed metrics you've asked for that are more common for AI/ML-based devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, expert involvement, or AI/ML performance because the provided document does not contain this information.

Based on the provided text, the device is cleared on the basis of substantial equivalence to a predicate device, and the submission does not detail efficacy studies with specific performance metrics or the involvement of AI/ML.

Here is what can be inferred or explicitly stated from the document regarding comparative testing, but it does not fit the format of your requested table for acceptance criteria and device performance as those specific values are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical performance criteria (e.g., accuracy, sensitivity, specificity, or device-specific mechanical performance thresholds) or corresponding reported values are provided in the document. The basis for clearance is "substantial equivalence" to a predicate device, implying that its performance is presumed to be similar without needing to meet new, explicit, quantitative acceptance criteria for efficacy or exact performance metrics publicly disclosed in this summary. Engineering and biocompatibility testing would have been submitted, but the detailed results are not in this public summary.

Regarding the other questions:

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

   • Not provided. The document refers to "testing" as part of establishing substantial equivalence, but gives no details about sample sizes, data provenance, or study design (retrospective/prospective). This often indicates that the testing was primarily mechanical, chemical, or biocompatibility-related, rather than clinical efficacy studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable / Not provided. The device is a "Surgical Mesh" (an implantable patch/reinforcement), not an imaging or diagnostic device that typically relies on expert interpretation to establish ground truth for performance evaluation in the way an AI/ML diagnostic tool would. Expert review would be part of the design and risk assessment, but not typically in establishing "ground truth" for a performance test set as envisioned for AI.

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

   • Not applicable / Not provided. Since there's no mention of a test set requiring expert ground truth or interpretation, an adjudication method isn't relevant to the information provided.

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

   • Not applicable. The device is "Peri-Strips Staple Line Reinforcement," a physical surgical implant, not an AI/ML-based diagnostic or assistive device that would involve human readers or AI assistance.

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

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

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

   • Not applicable / Not provided. For a physical device like this, "ground truth" in the AI/ML context doesn't apply. Performance would be assessed through established physical/mechanical testing standards (e.g., burst strength, suture retention), biocompatibility, and potentially animal or limited human clinical data to assess safety and gross functional equivalence. These details are not in the summary.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no "training set."

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

   • Not applicable. This is not an AI/ML device, so there is no "training set" or associated ground truth establishment.

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Peri-Strips Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.

Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.

Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.

An implantable surgical patch comprised of crosslinked bovine pericardium

The provided document is a 510(k) summary for the Peri-Strips Staple Line Reinforcement device. It states that the device is "substantially equivalent to the predicate device in terms of testing and indications for use." However, it does not contain specific details about acceptance criteria or a study that proves the device meets those criteria in the typical sense of a performance study with detailed metrics.

Instead, the submission for this type of device (surgical mesh) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and intended use as the predicate, rather than conducting a separate clinical or performance study with defined acceptance criteria and statistical analysis as one might find for diagnostic AI/ML devices.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study is not detailed here.

Here's what can be inferred or stated based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in this document as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states, "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This is the primary "performance" metric reported in the context of a 510(k) for this type of device. Specific quantitative performance data from a clinical trial or a standalone study are not provided.

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 / Not Provided: The document does not describe a test set or data provenance for a performance study. Demonstrating substantial equivalence for this device likely relied on bench testing, material characterization, and comparison to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or diagnostic devices.

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

• Not Applicable / Not Provided: No such information is present, as there's no mention of a performance study involving expert assessment or ground truth establishment.

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

• Not Applicable / Not Provided: No such information is present.

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 / Not Provided: This device is a surgical mesh for staple line reinforcement, not an AI/ML diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not Applicable / Not Provided: This is a physical surgical device, not an algorithm.

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

• Not Applicable / Not Provided: This concept of "ground truth" as it pertains to diagnostic performance is not relevant for this type of device submission. The "truth" in this context revolves around material properties, biocompatibility, and functional equivalence to the predicate.

8. The sample size for the training set:

• Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.

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

• Not Applicable / Not Provided: No "training set" or "ground truth" establishment for training is mentioned.

Summary based on the document:

The provided document describes a 510(k) submission for a surgical device. The "acceptance criteria" for such a submission are primarily based on demonstrating "substantial equivalence" to a legally marketed predicate device. The study proving this substantial equivalence would have involved comparing the new device's technological characteristics, materials, and intended use to the predicate device, likely through bench testing and material characterization, rather than a clinical performance study with defined acceptance criteria and statistical analysis as one might find for AI/ML or diagnostic devices.

The document explicitly states: "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This statement, along with the detailed comparison of intended use, is the core of the "study" proving the device meets the regulatory acceptance criteria for 510(k) clearance.

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The Steerable Stylet is intended to allow the physician to define and vary the curvature of the distal end of a compatible pacemaker lead in patients requiring lead implantation for cardiac pacing.

The Steerable Stylet is a sterile, single-use, disposable implantation tool which assists defining and varying the curvature of the distal portion of the pacemaker lead during implantation.

The provided text describes a medical device, the "Steerable Stylet," and its submission for FDA approval (K040001). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through quantitative metrics.

Instead, the document focuses on the regulatory submission process, stating that the device is "substantially equivalent" to a legally marketed predicate device (The Locator Steerable Stylet, Model 4036, K972814). This substantial equivalence is based on "similar performance, technological characteristics, and indication for use." The "Testing" section broadly mentions that "Test results are included in submission" without detailing those results or the defined acceptance criteria.

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

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

• Acceptance Criteria and Reported Device Performance: This information is not provided. The document primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific quantitative acceptance criteria and the device's performance against them.
• Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): No details are provided regarding any specific studies conducted to establish performance metrics. The submission relies on demonstrating equivalence to a predicate device.
• Adjudication Method: Not applicable as no specific study with ground truth establishment is described.
• MRMC Comparative Effectiveness Study: Not mentioned or implied.
• Standalone Performance Study: Not explicitly described with quantitative results. The "substantial equivalence" claim suggests performance is in line with the predicate, but specific standalone metrics are absent.
• Type of Ground Truth Used: Not applicable, as no study with ground truth established is detailed.
• Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device in the sense that would require a training set.
• How Ground Truth for Training Set was Established: Not applicable.

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Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain information about acceptance criteria or a study proving the device meets them, as would be relevant for a diagnostic or AI-powered medical device.

The document is a 510(k) summary for a Surgical Mesh (Veritas Collagen Matrix), which is a physical implant. The approval process for such a device focuses on demonstrating substantial equivalence to a previously approved predicate device, primarily based on technological characteristics and intended use, rather than performance metrics from clinical studies in the same way a diagnostic algorithm would be evaluated.

Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and not present in the provided text for this specific type of medical device approval.

The "Technology/Device Testing" section only states: "The Veritas Collagen Matrix is substantially equivalent to the predicate device in terms of testing." This implies that the testing performed was sufficient to demonstrate substantial equivalence, but it does not detail specific performance metrics or studies in the way requested for a diagnostic AI.

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