Search Results

MatriStem® Surgical Matrix RS (2-layer) and PSM (3-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hemia and body wall repair, colon and rectal prolapse repair, and esophageal repair.

MatriStem® Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

MatriStem® Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.

MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation.

The provided text describes a medical device premarket notification (510(k)) for MatriStem® Surgical Matrix products, which are composed of porcine-derived extracellular matrix scaffolds. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested criteria for studies proving device performance may not be directly applicable or available in this document. The document primarily details biocompatibility and mechanical testing to support substantial equivalence.

Here's the information extracted and interpreted based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics, as it is a 510(k) submission focused on substantial equivalence based on material and mechanical properties, and intended use. The "performance" reported relates to these characteristics and their comparison to predicate devices.

• Cytotoxicity
• Sensitization
• Irritation/Intracutaneous reactivity
• Acute systemic toxicity
• Pyrogenicity
• Subacute and subchronic toxicity and implantation
• Genotoxicity
• Hemocompatibility
• LAL endotoxin | "The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard." (The document states compliance without providing specific quantitative results for each test.) |
  | Mechanical Strength (Adequate for respective applications)
• Tensile strength
• Suture retention strength
• Delamination strength
• Tear strength
• Stiffness test | "The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications." (Specific quantitative values are not provided, but the document states that the devices have "comparable performance to the predicates" and the "available sizes...are consistent with the range of sizes of the predicate devices.") |
  | Substantial Equivalence to legally marketed predicate devices in terms of intended use, technological characteristics, safety, and effectiveness. | "MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix have the same intended use as predicate surgical meshes...The technological characteristics...are substantially similar to the cleared predicates...The minor differences...do not raise different questions of safety or efficacy and performance testing demonstrates that the devices have comparable performance to the predicates."
  "Based on direct testing and comparison to predicate devices, MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence..." |

The following points are generally not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence through non-clinical testing (biocompatibility, mechanical) and comparison to predicates, rather than a prospective clinical study proving specific performance criteria in patients.

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

• This information is not applicable as no clinical test set data from a study involving patients is presented. The "test set" for biocompatibility and mechanical testing would refer to samples of the device material itself. The document does not specify the number of material samples tested or their provenance beyond being the device materials.

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; relevant for clinical studies with expert review.

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

• Not applicable; relevant for clinical studies with expert review.

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 for AI/CAD-related devices.

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

• Not applicable; this is for AI/CAD-related devices.

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

• For the biocompatibility and mechanical testing, the "ground truth" would be established by validated scientific methodologies and ISO standards, rather than expert consensus or patient outcomes data. For substantial equivalence, the predicates serve as a comparative standard.

8. The sample size for the training set

• Not applicable; this is for AI/machine learning models.

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

• Not applicable; this is for AI/machine learning models.

Ask a specific question about this device

The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

The Miromatrix Biological Mesh RS is an implantable, animal-sourced, acellular surgical mesh that is derived from porcine liver tissue. The liver tissue undergoes perfusion decellularization and the resulting mesh is comprised primarily of collagen type I. The device is intended to function as a surgical mesh for soft tissue repair while providing a scaffold for tissue incorporation. The device is terminally sterilized in its packaging and is hydrated, moist and flexible when its packaging is opened. The mesh is available in sizes ranging from 1 cm x 2 cm to 20 cm x 30 cm, and may be trimmed or cut as required before being sutured to the surgical site.

This document is a 510(k) premarket notification for the Miromatrix Biological Mesh RS, declaring its substantial equivalence to a previously cleared predicate device, the Miromatrix Biological Mesh (K134033). As such, it does not describe a study involving acceptance criteria and device performance in the typical sense of a rigorous clinical or standalone performance study for an AI/device algorithm.

Instead, the core of this submission is to demonstrate that the new device (Miromatrix Biological Mesh RS) is substantially equivalent to a legally marketed predicate device (Miromatrix Biological Mesh, K134033). This means that the acceptance criteria are implicitly met by demonstrating sameness or very similar characteristics and performance to the predicate device, which has already been deemed safe and effective.

Here's an breakdown based on the provided text, addressing your questions where applicable, and noting where information is not present due to the nature of a 510(k) substantial equivalence submission for a physical medical device (not an AI algorithm):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as numerical thresholds in this document for a "new" device performance study. Instead, the "acceptance criteria" are effectively that the new device (Miromatrix Biological Mesh RS) is identical in materials and design and has similar indications for use and the same intended use as the predicate device (Miromatrix Biological Mesh, K134033). The "reported device performance" is essentially the equivalence shown in the comparison table.

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

• Sample Size: Not applicable. This is not a study assessing performance on a test set of data. It's a regulatory submission demonstrating equivalence of a physical medical device to an existing one.
• Data Provenance: Not applicable.

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

• Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of an AI algorithm. For this physical device, the "ground truth" for its safety and effectiveness is established by the prior clearance of the predicate device (K134033) and the demonstration that the subject device is essentially the same.

8. Sample Size for the Training Set

• Not applicable. This is not an AI algorithm.

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

• Not applicable. This is not an AI algorithm.

In summary: The provided text is a 510(k) premarket notification for a physical medical device (surgical mesh), not an AI algorithm. The core of such a submission is to argue that a new device is "substantially equivalent" to an already cleared predicate device. Therefore, the questions related to studies, test sets, training sets, ground truth, and expert adjudication, which are typical for AI/algorithm performance evaluations, are not addressed in this type of document. The "acceptance criteria" here are met by the demonstration of material, design, and functional similarity to the predicate device.

Ask a specific question about this device

The Biodesign Nipple Reconstruction Cylinder is intended for implantation to reinforce soft tissue where weakness exists, in plastic and reconstructive surgery of the nipple. The cylinder is supplied sterile and is intended for one-time use.

The Biodesign Nipple Reconstruction Cylinder is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material is identical to the predicates SurgiSIS® Mesh (K980431, K062696), SIS Plastic Surgery Matrix (K034039), and SIS Facial Implant (K050246, K070738) all manufactured by Cook Biotech Incorporated. The Biodesign Nipple Reconstruction Cylinder is a rolled SIS mesh and available in sizes from 0.7 cm in diameter and 1.0 cm to 2.5 cm in length. The cylinder is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The device is implanted using a skin flap procedure that prevents migration of the device. A PET marking template (Class I, 21 CFR 888.4800) and silicone (35A durometer) nipple shield (Class I, 21 CFR 880.5630 ) to be placed over the cylinder post-operatively, are included with the device. The use of the Biodesign Nipple Recosntruction Cylinder, an off-the-shelf graft, is advantageous in that a donor site is no longer necessary.

Here's a breakdown of the acceptance criteria and study information for the Biodesign® Nipple Reconstruction Cylinder, based on the provided 510(k) summary:

This device's submission is for substantial equivalence to existing predicate devices, not for a de novo marketing authorization. Therefore, the "acceptance criteria" are not defined as specific performance thresholds, but rather the demonstration that the new device performs similarly to
its predicates across various tests, without raising new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied to be performance comparable to the predicate devices. The reported device performance is presented as demonstrating this comparability.

2. Sample Sizes and Data Provenance

• Bench Testing: The sample sizes for suture retention strength and ultimate tensile strength are not specified. The tests were performed on "finished, terminally sterilized SurgiSIS® mesh" which forms the device.
• Biocompatibility Testing: The sample sizes for each specific biocompatibility test are not specified. The tests were performed on "sterilized SurgiSIS Mesh."
• Animal Testing: The sample size is not explicitly stated beyond "an animal study" in "a guinea pig model." It is implied to include multiple animals to assess performance over 5 months.
  • Data Provenance: The study was an animal study, likely conducted in a controlled laboratory setting. The country of origin is not specified but presumed to be within the Cook Biotech research facilities or contracted labs. The data is prospective within the context of the animal study.
• Clinical Testing:
  • Sample Size: 2 case studies and anecdotal evidence of 186 device implants (totaling 188 implants).
  • Data Provenance: The document does not specify the country of origin. The data appears to be retrospective (anecdotal evidence from past implants) and possibly some prospective observation for the "2 case studies."

3. Number of Experts and Qualifications for Ground Truth for Test Set

This device's submission relies on demonstrating substantial equivalence to already approved predicate devices. Thus, there isn't a "test set" in the traditional sense of a diagnostic algorithm where expert ground truth is established for novel readings.

• For the clinical testing, the "ground truth" implicitly comes from the clinical outcomes and observations made by the surgeons/clinicians performing the implants and follow-ups. The number of experts and their specific qualifications are not reported. Their assessment of "substantially equivalent to its predicates in its application" is based on their clinical experience.

4. Adjudication Method for the Test Set

Given the nature of the submission (substantial equivalence for a physical implant), there is no mention of an adjudication method in the context of expert review of data from a "test set" for a diagnostic algorithm. The clinical "data" comprises case studies and anecdotal evidence from implants managed by various clinicians.

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

No MRMC comparative effectiveness study was done or reported. This type of study is typical for diagnostic AI devices, not for assessing the substantial equivalence of a physical implant. The focus here is on the material, design, and performance characteristics compared to predicates.

6. Standalone Performance Study

This concept of "standalone performance" typically applies to diagnostic algorithms operating independently. Since this is a physical implant, it doesn't have a "standalone" algorithm-only performance. Its performance is assessed through its material properties, biological interaction (in animals), and clinical outcomes (in humans).

7. Type of Ground Truth Used

• Bench Testing: The "ground truth" is based on objective mechanical measurements (suture retention strength, ultimate tensile strength) and comparison to established predicate device performance or industry standards.
• Biocompatibility Testing: The "ground truth" is adherence to ISO 10993-1 standards for various biological responses.
• Animal Testing: The "ground truth" is histopathological analysis and observation of tissue response (minimal inflammation, increased soft tissue volume) in the guinea pig model, compared to expected healthy tissue response and the known behavior of SIS material.
• Clinical Testing: The "ground truth" is based on clinical outcomes, observations, and anecdotal evidence from patients who received the implant. This includes assessment of its ability to reinforce soft tissue in nipple reconstruction, functional outcomes, and reported complications. This is closer to outcomes data and expert clinical assessment rather than a single objective "ground truth" like pathology for a diagnostic image.

8. Sample Size for the Training Set

This submission does not involve a machine learning algorithm, so there is no "training set" in the context of AI. The development of the device (implant) relies on established knowledge of SIS material, previous predicate devices, and pre-clinical/clinical testing.

9. How Ground Truth for the Training Set was Established

As there is no training set for an AI model, this question is not applicable. The underlying "knowledge base" for the device's design and expected performance comes from decades of research and clinical use of SIS extracellular matrix material.

Ask a specific question about this device

The ReGen Collagen Scaffold (CS) is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.

The CS reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.

The ReGen Collagen Scaffold (CS) is a resorbable collagen matrix comprised primarily of bovine type I collagen. The CS is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue. The surgeon trims the device to the size necessary for repair of the damaged or weakened soft tissue.

This document is a 510(k) summary for a medical device (ReGen Collagen Scaffold (CS)), not a study report detailing acceptance criteria and performance. Therefore, most of the requested information regarding study details, sample sizes, and expert qualifications cannot be extracted directly from this document. This document primarily focuses on establishing substantial equivalence to predicate devices.

However, based on the text provided, I can infer and state the following:

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

The document does not explicitly state quantitative acceptance criteria or a direct table of reported device performance against such criteria. The "performance" is implicitly demonstrated through the claim of substantial equivalence to predicate devices based on biomechanical, biocompatibility, animal testing, and clinical studies.

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

• Test Set Sample Size: The document mentions a prospective, randomized multicenter clinical trial that had two separately controlled and randomized arms:
  • Acute arm: 157 patients with no prior surgery to the involved meniscus.
  • Chronic arm: 154 patients with one to three prior treatments to the involved meniscus.
  • Total patients: 311.
• Data Provenance: The study was a "multicenter clinical trial." The document does not explicitly state the country of origin, but given the submission to the FDA in the US, it is likely that the data originated from the US or included US sites. The trial was prospective and randomized.

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 information is not available in the provided text. The document refers to a clinical trial but does not detail how the "ground truth" (e.g., success or failure of the repair) was established by experts, nor does it specify the number or qualifications of such experts.

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

This information is not available in the provided text.

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

This is not applicable. The device is a "Collagen Scaffold" (surgical mesh), not an AI or imaging diagnostic 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

This is not applicable for a physical surgical mesh device.

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

Given that it was a clinical trial for a surgical mesh, the "ground truth" would likely be based on clinical outcomes data related to the reinforcement and repair of soft tissue injuries of the medial meniscus. This would typically involve measures of healing, function, pain, and potentially re-injury rates over the follow-up period.

8. The sample size for the training set

This is not applicable. For a physical medical device like a surgical mesh, there isn't typically a "training set" in the context of machine learning. The clinical trial data served as the primary evidence.

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

This is not applicable for a physical medical device.

Ask a specific question about this device