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PARIETEX™ PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.

PARIETEX™ PROGRIP™ Mesh will be available in 2 shapes:
Pre-cut, elliptic slit mesh with a self-gripping overlapping flap. Right or left side.
Rectangular simple mesh.
These meshes and the overlapping flaps of the pre-cut versions are made from knitted monofilament polyester with monofilament polylactic acid (PLA) resorbable pins on one side. The PLA pins facilitate placing, positioning and fixation of the overlapping flap and the meshes to the surrounding tissue. A colored yarn marker on the medial edge of the pre-cut mesh helps in orientation.

The acceptance criteria and study proving device performance are not explicitly detailed within the provided text beyond a general statement that "Bench and animal testing has been conducted to evaluate the performance characteristics of PARIETEX™ PROGRIP™ Mesh. Results of mechanical property testing show that PARIETEX™ PROGRIP™ has similar performance characteristics to the predicate PARIETEX™ Mesh."

Therefore, I cannot provide a detailed table of acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, or specifics on ground truth establishment for a training set.

Based on the provided information, I can deduce the following:

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

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

• Test set sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Bench and animal testing."

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

Not applicable. The study involved bench and animal testing, not human expert evaluations for establishing ground truth in the context of diagnostic performance.

4. Adjudication method for the test set

Not applicable. The study involved bench and animal testing.

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 mesh device, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.

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

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

7. The type of ground truth used

For mechanical properties, the "ground truth" would be established by predefined engineering specifications or comparison against the predicate device's measured performance. For material biocompatibility, the "ground truth" is adherence to ISO 10993-1 and/or USP standards.

8. The sample size for the training set

Not applicable. This is a medical mesh device, not a machine learning model requiring a training set.

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

Not applicable. This device does not use a training set in the context of machine learning.

Ask a specific question about this device

The PCO-OS and PCO-OB meshes are used for the reinforcement of tissues during surgical repair. They are indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

The PARIETEX COMPOSITE PCO-OS and PCO-OB Meshes are surgical meshes used during open (laparotomy) procedures or during laparoscopic procedures. The meshes are made from polyethylene terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance characteristics of the meshes but serves to separate the coated side of the meshes from underlying tissues to minimize tissue attachment and ingrowth. The PCO-OB and PCO-OS Meshes are offered in several sizes and shapes to accommodate the type and approach of the surgical procedure. The Sofradim PCO-OS and PCO-OB Meshes are identical to the predicate PARIETEX COMPOSITE (PCO) meshes (K002699 and K040998) with the exception of the addition of a bi-dimensional textile flap to the current threedimensional reinforcement on the PCO Mesh. This flap is manufactured and sewn to the three-dimensional textile with the same polyester yarn as described in the predicate PCO meshes as well as other PARIETEX meshes (K982532 and K003990). The bidimensional flap has been added to the parent PCO Meshes to ease placement and fixation of the mesh during open surgery.

The provided text is a 510(k) summary for a medical device (surgical mesh). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or a study specifically designed to prove that the device meets such criteria.

The "PERFORMANCE TESTING" section only states: "A study was conducted and demonstrated that the sewing of the additional flap does not adversely affect the safety or effectiveness of the device." This is a very general statement and lacks the specific details required for the requested table and study information.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are mentioned.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth and their qualifications: Not mentioned (as no specific performance study with ground truth is detailed).
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: Not mentioned.
6. Standalone performance study: Not mentioned.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

The document focuses on demonstrating substantial equivalence to existing predicate devices, primarily by highlighting that the new device (PCO-OS and PCO-OB Meshes) is identical to the predicate PCO meshes (K002699 and K040998) with only the addition of a bi-dimensional textile flap. The "performance testing" mentioned is merely to confirm that this modification does not adversely affect safety or effectiveness, not to establish specific performance metrics against pre-defined acceptance criteria for the entire device.

Ask a specific question about this device