Search Results

Porcine Dermal Xenograft is intended for the management of wounds that include: Partial and full thickness wounds; Pressure, diabetic, and venous ulcers; Chronic vascular ulcers; Second-degree burns; Surgical wounds-donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence; Trauma wounds-abrasions, lacerations, and skin tears; Tunneled/undermined wounds; Draining wounds. The Porcine Dermal Xenograft provides an environment that supports wound healing and control of minor bleeding. The device is intended for single patient, one time use only.

Porcine Dermal Xenograft is an acellular, sterile, porcine dermal xenograft for use in treatment of topical wounds. The product is available in several sizes.

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and study proving device performance, although it's crucial to note that this document describes a medical device (a xenograft) and NOT an AI/ML powered device. Therefore, many of the typical questions for AI/ML device studies (like sample size for training, expert ground truth, MRMC studies, etc.) are not applicable to this submission.

The provided document, K113866, is a 510(k) summary for a Porcine Dermal Xenograft. This is a traditional medical device (a biological product derived from animal tissue for wound care), not an AI/ML powered device. As such, the "acceptance criteria" and "study" described are focused on bench testing and biocompatibility to demonstrate substantial equivalence to predicate devices, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML.

Let's address the points as best as possible given the nature of the device:

Acceptance Criteria and Device Performance (for a Porcine Dermal Xenograft)

Given that this is a Porcine Dermal Xenograft and not an AI/ML-powered device, the concept of "acceptance criteria" is tied to its material properties, biocompatibility, and functionality for wound management, as demonstrated through bench testing and comparison to predicate devices. There are no performance metrics like sensitivity, specificity, or AUC as would be seen for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a "test set" for performance metrics typical of AI models. The "sample" would refer to the number of xenograft units used for bench testing (e.g., tensile strength, hydration properties, porosity) and biocompatibility testing. This kind of detail is usually found in the full 510(k) submission, not the summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here comes from laboratory bench tests and in vitro or in vivo biocompatibility studies conducted by or for Brennen Medical. The country of origin for such data would typically be the location of the testing laboratories. The study is not retrospective or prospective in the sense of a clinical trial used for AI/ML validation; it refers to device specific analytical and biocompatibility testing.

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

• Not Applicable. This is not an AI/ML device where expert consensus is used to label medical images or clinical outcomes. Ground truth for a xenograft involves laboratory standards (e.g., specified ranges for material properties, pass/fail for biocompatibility tests). The "experts" would be the scientists and engineers conducting the tests and interpreting the results against established standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" of expert opinions as would be needed for an AI/ML test set. The results of the bench tests and biocompatibility tests are empirical measurements and observations against pre-defined acceptance criteria for those tests.

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

• No. An MRMC study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. This device is a physical wound dressing and does not involve human "readers" or image interpretation. Its "effectiveness" is demonstrated through its physical and biological properties for wound management, and comparison to predicate devices.

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

• Not Applicable. This is not an algorithm. The device "performance" is its intrinsic physical and biological characteristics.

7. The Type of Ground Truth Used

• Engineering and Biological Standards / Predicate Device Equivalence. The "ground truth" for this device's performance is established by:
  • Validated laboratory test methods: Meeting predefined specifications for physical properties (e.g., strength, porosity, sterility) through bench testing.
  • ISO 10993-1 Biocompatibility Standards: Pass/fail criteria for biological safety tests.
  • Comparison to predicate devices: Demonstration that the new device's characteristics and performance are "identical" or "substantially equivalent" to legally marketed predicate devices, which have already demonstrated safety and effectiveness for similar intended uses.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device and therefore does not have a "training set."

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

• Not Applicable. As there is no training set for this type of device, no ground truth needs to be established for it.

In summary, the provided document is a 510(k) summary for a traditional medical device (a xenograft). The "acceptance criteria" and "study" proving its performance are based on bench testing, biocompatibility testing against international standards (ISO 10993-1), and demonstrating substantial equivalence to already cleared predicate devices, rather than the AI/ML-specific performance metrics and study designs (like MRMC, training/test sets, expert ground truth) that your questions imply.

Ask a specific question about this device

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. Specifically indicated for: Plastic and reconstructive surgery; Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadriceps, or other tendons.

Porcine Dermal Matrix is a prescription, sterile, single use, hydrated, non-crosslinked, r orcine skin that has both the epidermal and subdermal sides removed leaving only the dermis. The product is available in several sizes.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Biocompatibility per ISO 10993-1 (MEM Elution, Bacterial Mutagenicity, Acute Systemic Injection, Guinea Pig Maximization, Intracutaneous Reactivity, Materials Mediated Rabbit Pyrogen, Eight Week Intramuscular Implant, Thirteen Week Intramuscular Implant, Six-Month Intramuscular Implant)	The product met all of the stated requirements of each test.
   Safety and Effectiveness for Intended Use	Demonstrated through bench testing.
   Substantial Equivalence to Predicate Devices	Performance is substantially equivalent to the predicate devices.

2. Sample Size for Test Set and Data Provenance:

   • The document does not specify a distinct "test set" in the context of an AI/ML device. The testing described is bench testing and biocompatibility testing on the product itself, not a dataset of medical cases.
   • Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set is not applicable to this device's evaluation.

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

   • This information is not applicable as the device is a surgical mesh, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for case evaluation.

4. Adjudication Method for the Test Set:

   • This information is not applicable for the same reasons above.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-assisted diagnostic tools where human performance is being compared with and without AI assistance. The Porcine Dermal Matrix is a physical surgical mesh.
   • Therefore, information on the effect size of human readers improving with AI vs. without AI assistance is not applicable.

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

   • No, a standalone study in the context of an algorithm's performance was not done. The device is a physical product.

7. Type of Ground Truth Used:

   • The "ground truth" for this device's evaluation was based on bench testing results (demonstrating mechanical properties and performance) and biocompatibility testing results (demonstrating biological safety according to ISO standards). It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML device would be assessed.

8. Sample Size for the Training Set:

   • This information is not applicable. The device is a physical product, not an AI/ML algorithm that undergoes a training phase with a dataset.

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

   • This information is not applicable for the same reasons as above.

Ask a specific question about this device

Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including but not limited to: Plastic and reconstructive surgery: Muscle flap reinforcement; Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias; Suture-line reinforcement; Reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Porcine Dermal Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar Achilles, biceps, quadraceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair.

Porcine Dermal Matrix is a prescription, sterile, pyrogen free, single use, porcine skin that has both the epidermal and subdermal sides removed. The product is available in several sizes.

The provided text is a 510(k) summary for the Porcine Dermal Matrix Surgical Mesh. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial for a novel drug or a high-risk device might.

Therefore, many of the requested points cannot be answered from the provided text, as the information is not typically included in a 510(k) summary for a Class II device like a surgical mesh.

Here's an attempt to answer based only on the provided text, indicating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

• Intended use
• Mode of action
• Design
• Does not raise new issues of safety or effectiveness | Substantially equivalent to DermMatrix, Permacol/Pelvicol, and SurgiMend surgical meshes.
• Equivalent in intended use, mode of action, and design.
• Introduction does not raise any new issues of safety or effectiveness.
• Biocompatibility testing per ISO 10993-1 demonstrated device is "safe and effective for its intended use, and that its performance is substantially equivalent to the predicate devices." |
  | Performance as Intended | "Test evaluations of Porcine Dermal Matrix show that the device performs as intended." |

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

• Sample Size for Test Set: Not specified. The document mentions "biocompatibility testing" and "bench testing" but does not provide details on the sample sizes used for these tests.
• Data Provenance: Not specified, beyond general "biocompatibility testing conducted per ISO 10993-1, bench testing and numerous clinical experiences." No country of origin is mentioned, nor is it explicitly stated if the data is retrospective or prospective.

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

• This information is not provided. The study design does not appear to involve human readers or ground truth established by experts in the context of diagnostic performance. The evaluation is based on material properties and biological compatibility.

4. Adjudication method for the test set

• Not applicable/not provided. This type of adjudication method (e.g., 2+1) is relevant for studies involving human interpretation (e.g., radiology reads), which is not the nature of the evidence presented for this device.

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

• No. An MRMC comparative effectiveness study was not done, as this is a surgical mesh with a focus on material properties and biological integration, not an AI-powered diagnostic device.

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

• Not applicable. This device is a medical product (surgical mesh), not an algorithm or AI system.

7. The type of ground truth used

• The "ground truth" for this device's substantial equivalence and safety/effectiveness relies on biocompatibility testing results (per ISO 10993-1) and bench testing results for its material properties and performance. It also relies on the established safety and effectiveness profile of the predicate devices with which it demonstrates equivalence. No pathology or outcomes data is explicitly detailed as "ground truth" for the current device's performance, but rather for the predicate devices and generally accepted biocompatibility standards.

8. The sample size for the training set

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

Ask a specific question about this device