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510(k) Data Aggregation
(55 days)
The Symbotex™ Composite Mesh is intended for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
Symbotex™ Composite Mesh is made out of a three-dimensional (3D) monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. Symbotex™ Composite Mesh will be proposed in 3 configurations:
Symbotex™ Composite Mesh flat sheet (SYM): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking to help surgeons center and orient the mesh.
Symbotex™ Composite Mesh flat sheet with sutures (SYMF): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking and pre-placed Dermalon® sutures to help surgeons, place and fixate the mesh.
Symbotex™ Composite Mesh with flap (SYMOS): 3D textile mesh(s) of various sizes with a green (dye D&C Green No6) bi-dimensional (2D) monofilament polyester flap providing a dedicated fixation area.
The provided document ("K131969") describes the Symbotex™ Composite Mesh, a surgical mesh for soft tissue reinforcement. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific numerical acceptance criteria (e.g., "bursting strength must be > X N/cm"). Instead, it states that the results of the bench and preclinical tests demonstrate that the device is substantially equivalent to the predicate devices. This implies that the performance of the Symbotex™ Composite Mesh met or was comparable to the established performance characteristics of the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Bench Testing Characteristics: | |
| Mesh thickness comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Pore size comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Surface density comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Bursting strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Bursting distension comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Breaking strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Elongation at break comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Tear strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Suturing strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Seam strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Suture assembly strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Trocar testing comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| In-vivo Performance: | |
| Minimizing tissue attachment comparable to predicate | Demonstrated in a preclinical test on a representative animal model in comparison with PARIETEX™ Optimized Composite Mesh (K110663). |
| Biocompatibility: | |
| Meet ISO 10993-1 for a permanent implant | Evaluated; Symbotex™ Composite Mesh is comprised of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1. |
| Shelf Life/Stability: | |
| Demonstrated adequate shelf life | Demonstrated by stability testing on materials and components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for bench tests. For the in-vivo preclinical test, the sample size is not specified beyond "a representative animal model."
- Data Provenance: The bench testing refers to "FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999." The in-vivo study was a "pre-clinical test." The document does not specify the country of origin for the data or if it was retrospective or prospective, though preclinical animal studies are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a surgical mesh, not a diagnostic AI system that requires expert interpretation for ground truth establishment. Performance is assessed through objective physical and biological tests.
4. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic AI system, expert adjudication for ground truth is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device (surgical mesh), not a diagnostic AI system. MRMC studies are typically performed for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth is established through standardized physical and mechanical measurements according to recognized guidance documents (FDA's Guidance for Surgical Mesh). This is objective, quantitative data.
- In-vivo Pre-clinical Test: Ground truth for "minimizing tissue attachment" would be established through direct observation, histological analysis, and potentially various scoring systems in the animal model. This is empirical biological data.
- Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards for material compatibility with biological systems.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device and does not involve machine learning or AI, and therefore no "training set" is used.
9. 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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(26 days)
The PARIETEX™ Optimized Composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
The PARIETEX™ Optimized Composite Mesh is available in rectangular and round shape. This device is made out of a three dimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and juts out 5 mm over the edge of the reinforcement. A bi-dimensional multifilament polyester textile flap is attached to the threedimensional reinforcement.
The provided text describes a 510(k) summary for the PARIETEX™ Optimized Composite Mesh, which is a surgical mesh. The document focuses on demonstrating the substantial equivalence of the proposed device to previously marketed predicate devices (PARIETEX™ Composite Mesh).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define specific numerical acceptance criteria (e.g., minimum tensile strength, maximum adhesion score). Instead, it states that the device is "equivalent in performance characteristics" to its predicates and demonstrates "improved mechanical properties" and "equivalent in-vivo minimizing tissue attachment property".
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Properties (e.g., strength, durability) | Improved mechanical resistance of the mesh |
| Minimizing Tissue Attachment In-vivo | Equivalent in-vivo minimizing tissue attachment property |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "pre-clinical study and bench testing" but does not explicitly state the sample sizes used for these tests. It doesn't specify if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies performed are bench and pre-clinical tests, not human-read studies requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable, as the tests described are bench and pre-clinical, not involving human interpretation with adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The studies were pre-clinical and bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical surgical mesh, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable in this context. The performance tests evaluate the physical properties and in-vivo behavior of the mesh itself.
7. The Type of Ground Truth Used
For the mechanical property improvement, the ground truth would likely be established through standardized engineering tests (e.g., tensile strength, burst strength) compliant with relevant ISO or ASTM standards. This is inherent in "bench testing".
For the minimizing tissue attachment property, the ground truth would be established through a pre-clinical in-vivo study, likely involving histological analysis and gross observation of tissue adhesion, comparing the new mesh to the predicate mesh in an animal model.
8. The Sample Size for the Training Set
Not applicable. The device is a surgical mesh with design modifications, not an AI/ML algorithm that requires a "training set". The "training" for the mesh is in its manufacturing process and design iterations based on testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this physical device.
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(26 days)
The PARIETEX™ Optimized Composite Mesh (PCO) is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
The PARIETEX™ Optimized Composite Mesh (PCO) is available in rectangular and round shape. This device is made out of a three-dimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and juts out 5 mm over the edge of the reinforcement.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PARIETEX™ Optimized Composite Mesh, structured to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K110812) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria as would be found in a full study report.
However, based on the text, we can infer the key performance areas and the general findings:
| Acceptance Criteria (Inferred from document) | Reported Device Performance (PARIETEX™ Optimized Composite Mesh) |
|---|---|
| Mechanical Resistance / Improved Mechanical Properties (implied from "higher mechanical resistance of the mesh" and "improved mechanical properties") | "demonstrate improved mechanical properties" compared to predicate devices. The knitting textile was modified to achieve this. |
| Handling Resistance of Film (implied from "film more resistant to handling") | The collagen film formulation was changed to achieve a film that is "more resistant to handling." Specific quantitative improvement is not detailed, but the change was made to address this. |
| Equivalent In-Vivo Minimizing Tissue Attachment Property (implied target for new collagen film formulation) | "equivalent in-vivo minimizing tissue attachment property" compared to predicate devices. This property is attributed to the absorbable hydrophilic film minimizing tissue attachment in direct contact with viscera. |
| Overall Performance Characteristics Equivalence (primary goal for 510(k) submission) | "equivalent in performance characteristics to the predicates PARIETEX™ Composite Mesh." This is the overarching conclusion drawn from all performance testing. |
| Safety and Effectiveness (fundamental requirement for device clearance) | Implied to be equivalent in safety and effectiveness for the stated indications for use (reinforcement of tissues during surgical repair, incisional hernias, abdominal wall repair, parietal reinforcement) based on the substantial equivalence determination by FDA. No adverse events are reported in this summary. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for the "bench testing" and "pre-clinical study." It only states that these tests were performed:
- Sample Size: Not specified.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. "Pre-clinical study" typically implies animal studies or in-vitro tests, which are prospective. "Bench testing" is in-vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and is not provided in a 510(k) summary for a surgical mesh. The testing performed involves objective measurements (mechanical properties, tissue attachment) rather than subjective assessments requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The listed studies (bench testing, pre-clinical study) are objective tests, not subjective assessments requiring expert adjudication.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, and the PARIETEX™ Optimized Composite Mesh is a surgical implant. There is no AI component mentioned or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
A standalone algorithm performance study was not done. This is not an AI/software device. The performance studies are for the physical properties and biological interaction of the surgical mesh.
7. The Type of Ground Truth Used
For the studies mentioned:
- Bench Testing: The ground truth would be based on objective physical measurements (e.g., tensile strength, burst strength, tear resistance) performed according to established test methods and standards (likely related to "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh").
- Pre-clinical Study: The ground truth for "minimizing tissue attachment property" would likely be derived from histological examination or macroscopic assessment of tissue ingrowth/adhesion in animal models, comparing the new device to the predicate. The "ground truth" here is the scientific observation and measurement of biological response to the implanted material.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a training set. The "design modifications" (new collagen film formulation, changes to knitting) were likely the result of R&D and engineering design cycles, potentially using iterative testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
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(301 days)
The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.
The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.
The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.
This 510(k) summary is for a medical device (SURGIMESH®XB surgical mesh) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.
Here's an attempt to address the points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:
Acceptance Criteria and Study for SURGIMESH®XB
The submission for SURGIMESH®XB is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) in the same way an AI diagnostic algorithm would, nor does it present a clinical trial with a test set, ground truth experts, or MRMC studies.
Therefore, the "acceptance criteria" for a device like SURGIMESH®XB are implicitly tied to demonstrating that its mechanical, material, and biocompatibility characteristics are "substantially equivalent" to predicate devices, which are themselves deemed safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing | "The biocompatibility results show that the material used in the design and manufacture of the device is non-toxic and non-sensitizing to biological tissues when used as intended." |
| Mechanical/Material Characteristics: Substantially equivalent to predicate devices | "The SURGIMESH®XB mesh's mechanical and material characteristics are substantially equivalent to its predicate devices." |
| Intended Use: Reinforcement of tissues during surgical repair for hernias and soft tissue deficiencies; temporary bridging of fascial defects; silicone layer minimizes tissue attachment to viscera. | "The SURGIMESH®XB has the same intended uses and similar indications... as its predicate device." |
| Technological Characteristics: Non-absorbable synthetic mesh, non-knitted, non-woven polypropylene fibers, one surface coated with silicone, supplied sterile, available in anatomic forms. | "The SURGIMESH®XB has... similar technological characteristics, and principles of operation as its predicate device." |
| Safety and Effectiveness: As safe and effective as predicate devices. | "Performance data demonstrate that the SURGIMESH®XB is as safe and effective as [listing 6 predicate devices]." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not Applicable. This submission does not describe a clinical "test set" in the context of diagnostic performance. The evaluation is based on material testing and comparison to predicates.
- Data Provenance: Not Applicable. No patient data or clinical study dataset is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not Applicable. No ground truth establishment by experts is described for this type of device submission.
- Qualifications of Experts: Not Applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not Applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is a surgical mesh, not an AI diagnostic device for human readers.
- Effect Size: Not Applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Applicable. The "ground truth" concept for a surgical mesh revolves around proven safety and effectiveness of similar devices and the demonstration of equivalent physical, mechanical, and biological properties. It's not based on case-level diagnoses or outcomes in a study, but rather on material science and biocompatibility testing.
8. The Sample Size for the Training Set
- Sample Size: Not Applicable. This is a surgical mesh, not an AI device that uses a training set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not Applicable.
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(113 days)
PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.
PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period.
This submission describes the PREVADH™ Mesh, a resorbable surgical mesh indicated for temporary wound support in abdominopelvic surgery. The device consists of three layers: a porous porcine collagen side, a non-porous layer of porcine collagen, polyethylene glycol, and glycerol, and a multifilament polylactic acid mesh inserted between the collagen layers.
Here's an analysis of the provided information regarding acceptance criteria and supportive studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (materials) | "Comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards." |
| Mechanical Properties | "Results of mechanical properties testing show that PREVADH™ Mesh has similar performance characteristics to the predicate VICRYL Mesh." |
| Porosity for fast tissue in-growth | "PREVADH™ Mesh is knitted in a design with large pores that allow fast tissue in-growth." |
| Minimization of visceral attachment | "The non-porous smooth side minimizes visceral attachment." and "the hydrophilic collagen film serves to temporarily separate the mesh from adjacent organs to minimize visceral attachment to the mesh which may occur during the healing process." |
| Resorption Profile (Porous side) | "The porous side is resorbed in less than 1 week." |
| Resorption Profile (Non-porous side) | "the non-porous smooth side is resorbed in approximately 3 weeks." |
| Resorption Profile (Polylactic acid mesh) | "The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh."
- Sample Size for Test Set: Not specified. The document only mentions "Bench and animal testing."
- Data Provenance: Not specified. It's common for animal studies for device clearance to be conducted in-house or by contract research organizations, but the specific origins are not detailed. These studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
No mention of human experts establishing ground truth for the "Bench and animal testing." The evaluations appear to be objective measurements (e.g., mechanical properties, resorption rates, tissue response in animals).
4. Adjudication Method for the Test Set:
Not applicable, as there's no mention of human-involved assessment in the "Bench and animal testing" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, and its evaluation focuses on material properties, biocompatibility, and animal efficacy, not interpretation of medical images by multiple readers.
6. Standalone (Algorithm only without human-in-the-loop performance) Study:
Not applicable. This is a medical device (surgical mesh), not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for the performance claims appears to be based on:
- Objective Measurements: Mechanical property tests, resorption rate measurements.
- Animal Observations: Assessment of tissue in-growth, visceral attachment minimization, and overall biological response in animal models.
- Material Standards: Compliance with ISO 10993-1 and/or USP standards for biocompatibility.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device requiring a training set.
Summary of Study and Justification for Equivalence:
The 510(k) submission for PREVADH™ Mesh relies on demonstrating substantial equivalence to legally marketed predicate devices: PARIETEX™ COMPOSITE (PCO) Mesh (K040998), Ethicon, Inc. VICRYL Mesh (K810428), and UGYTEX™ Mesh (K033376).
The studies conducted to support this claim include:
- Bench Testing: To evaluate mechanical properties and similarity to predicate VICRYL Mesh.
- Animal Testing: To assess performance characteristics such as tissue in-growth and minimization of visceral attachment, which are key functions of the device, particularly the hydrophilic film (similar to the PCO Mesh predicate).
- Biocompatibility Testing: Materials shown to be in compliance with ISO 10993-1 and/or USP standards.
The acceptance criteria are implied by the desired functional characteristics of a surgical mesh (biocompatibility, appropriate mechanical strength, desirable resorption profile, and minimization of adhesions), and the performance data presented aims to show that the PREVADH™ Mesh meets these characteristics and performs similarly to its predicate devices. The submission concludes that the technological characteristics are similar to the predicate devices, thereby supporting substantial equivalence for its intended use.
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(70 days)
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
| Acceptance Criteria (Inferred from Intended Use/Predicate Equivalence) | Reported Device Performance (Summary from Study) |
|---|---|
| Substantial equivalence in technological characteristics and intended use to predicate device(s) (Veritas® Collagen Matrix K002233, K030879, K040119, and others). | Stated to be substantially equivalent. The device is acting as its own predicate for previous uses in terms of testing and technological characteristics. |
| New Indication: Minimize tissue attachment to the device in case of direct contact with viscera. (This is the specific new indication for which a study was conducted.) | An animal study concluded that "Veritas® Collagen Matrix demonstrates minimal tissue attachment to the viscera when compared to a named predicate." |
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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