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The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

The original NuVasive Surgical Mesh System consists of a series of specialized shapes and sizes of mostly flat embroidered mesh and a radiographic marker. The meshes typically contain pre-formed reinforced holes to provide secure and easy to find suture or tissue anchor locations.

The provided text is a 510(k) summary for a surgical mesh system. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information requested for acceptance criteria and a study proving device performance.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details of MRMC or standalone studies, or information on training sets and their ground truth establishment.

The document explicitly states:

• Summary of Non-Clinical Tests: (Not Applicable).
• Summary of Clinical Tests: (Not Applicable).

This indicates that no specific non-clinical or clinical studies for acceptance criteria and device performance, as typically understood for in vitro diagnostic or AI/ML-based devices, were performed or required for this 510(k) submission. The FDA cleared the device based on its substantial equivalence to a legally marketed predicate device, with identical indications for use and principles of operation, without requiring new performance data.

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The Surgcraft Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

The Surgicraft Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The provided text is a 510(k) summary for the Surgicraft Surgical Mesh System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria, performance metrics, or study details in the way requested by the prompt.

Instead, it lists types of tests performed (biocompatibility and mechanical testing) without providing the results or the acceptance criteria for those tests. It explicitly states "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device" and "Clinical Testing Not applicable to this device."

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

Here's what can be extracted based on the document:

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

• Cannot be provided. The document lists types of tests performed (Biocompatibility, Dynamic Tensile Fatigue, Static Tensile, Burst Strength, Suture Attachment Strength, Screw Pullout Strength, Tear Resistance, Screw Resistance) but does not provide specific acceptance criteria or reported performance values for these tests. It concludes "substantially equivalent" rather than reporting specific performance against criteria.

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

• Cannot be provided. The document does not specify sample sizes for any of the non-clinical tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned.

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. This device is a surgical mesh, not an AI/diagnostic device that would require ground truth established by experts for a test set. Clinical testing was deemed "not applicable."

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

• Not applicable. See point 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

• Not applicable. This is not an AI-assisted diagnostic device. Clinical testing was deemed "not applicable" and no human reader studies were conducted.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. For the non-clinical tests, the "ground truth" would be the measured physical properties or biological responses compared against established standards or predicate device properties, but specific details are not provided.

8. The sample size for the training set

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

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

• Not applicable. See point 8.

Summary of available information regarding compliance/testing:

• Study Type: Non-clinical testing only (Biocompatibility and Mechanical Testing). Clinical testing was explicitly stated as "Not applicable to this device."
• Biocompatibility Testing: Conducted according to ISO 10993 and Directive 93/42/EC, EN ISO 1099-1 FDA. Specific tests included:
  • Sensitization extract (0.9% sodium chloride)
  • Sensitization extract (sesame oil)
  • Genotoxicity (dimethyl sulfoxide extract)
  • Genotoxicity (0.9% sodium chloride extract)
  • Muscle Implantation study - 4 weeks
  • Cytotoxicity (according to EN ISO 10993-5, -12, EN ISO 9363-1, LM SOP 4-06-01)
  • Chemical Analysis (characterization of organic leachables, according to EN ISO 10993-1, -12, -18, LM P 8-01, LM SOP 9-01-01)
• Mechanical Testing: Included:
  • Dynamic Tensile Fatigue
  • Static Tensile
  • Burst Strength
  • Suture Attachment Strength
  • Screw Pullout Strength
  • Tear Resistance
  • Screw Resistance
• Conclusion: Based on engineering drawings, labeling, laboratory and mechanical testing, the device was found to be "substantially equivalent" to its predicate devices in terms of design, materials, indications for use, and other characteristics.

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The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.

The NuVasive Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. Thoodpoines are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

Here's an analysis of the provided text regarding the NuVasive Surgical Mesh System, focusing on the absence of information related to acceptance criteria and performance studies in the context of medical device performance evaluation.

Based on the provided 510(k) summary for the NuVasive Surgical Mesh System (K053215), there is no information available regarding acceptance criteria or a study proving the device meets specific acceptance criteria in terms of clinical performance metrics.

The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or determining specific performance statistics against predefined acceptance criteria through clinical studies.

Here's a breakdown of why many of your requested points cannot be answered from this document:

1. A table of acceptance criteria and the reported device performance: Not applicable. The 510(k) process for this device did not require the establishment of specific performance acceptance criteria beyond demonstrating substantial equivalence in design, materials, and mechanical properties to the predicate. No clinical performance metrics (like sensitivity, specificity, accuracy, etc.) are reported.

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 for clinical performance. The document mentions "Mechanical testing was presented" in "Summary of Non-Clinical Tests," but details about sample sizes, specific tests, or results are not included in this summary. These tests would be related to material properties and structural integrity, not clinical outcomes.

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. No clinical ground truth was established or used for performance evaluation in a clinical study as described in this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudications were performed as there was no clinical study evaluating performance against ground truth.

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 device is a surgical mesh; it does not involve image interpretation or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical mesh; it is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was used for performance evaluation in a clinical study as described.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as it's not an AI/ML algorithm.

Summary of Information from the Provided Text about Device Performance and Equivalence:

The provided document asserts substantial equivalence based on:

• Design: Stated as "substantially equivalent, if not identical."
• Materials of Composition: Made from "commercially available polyester suture fibers," asserting equivalence here too.
• Indications for Use: "to reinforce soft tissue where weakness exists," which aligns with predicate devices.
• Mechanical Testing: A "Summary of Non-Clinical Tests" states "Mechanical testing was presented." However, no specific acceptance criteria or results from this testing are included in the summary.
• No Clinical Tests: The "Summary of Clinical Tests" explicitly states "(Not Applicable)." This indicates that no clinical studies were conducted or provided as part of this 510(k) submission to demonstrate performance against specific clinical acceptance criteria.

Conclusion:

The NuVasive Surgical Mesh System (K053215) gained 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices through a comparison of design, materials, indications for use, and non-clinical (mechanical) testing. The summary explicitly states that clinical tests were "Not Applicable," meaning there was no study performed to establish specific clinical performance metrics against predefined acceptance criteria for this particular device under this submission.

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The mesh may be used to support soft tissue where weakness exists, or for the repair of hernias requiring the addition of a reinforcing, or bridging material, such as the repair of groin hernias.

The Inclose ™ Surgical Mesh System is comprised of a Mesh Implant and two suture assembles (Anchor Bands). The implanted components are provided sterile and preloaded on their respective disposable delivery instruments. The Mesh Implant is an expandable braided patch that is inserted through the aperture of the tissue defect and affixed to surrounding soft tissue with the Anchor Bands. Materials utilized in the construct of the implanted components consist of polyethylene terephthalate (PET). In addition, two platinum/iridium markers are placed on monofilament fibers and positioned toward the proximal end of the mesh. These two markers are located 180° from each other and are intended to facilitate identification of the Inclose™ Mesh Implant following surgery. Standard operating room sutures may also be utilized for fixation of the device.

The provided text describes a 510(k) summary for the Anulex Technologies Inclose™ Surgical Mesh System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study.

Therefore, many of the requested sections regarding acceptance criteria, device performance, study design, and ground truth establishment cannot be found in the provided text. The K050969 document for the Inclose™ Surgical Mesh System is a 510(k) premarket notification. These notifications primarily demonstrate substantial equivalence to legally marketed predicate devices, not novel performance claims through clinical trials with established acceptance criteria.

Here's what can be extracted based on the provided text:

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

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

• Sample size: Not applicable or not provided. This is a 510(k) submission, not a new clinical study with a test set. The submission relies on demonstrating equivalence to existing predicate devices.
• Data provenance: Not applicable. The "study" referenced is primarily bench and biocompatibility testing, not human-subject testing with a test set for performance evaluation in the usual sense for AI/medical device performance.

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

• Not applicable. No ground truth establishment for a test set is described or implied in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable. No adjudication method for a test set 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

• Not applicable. This device is a surgical mesh, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

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

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

7. The type of ground truth used

• Not applicable. No ground truth as defined for evaluating a diagnostic or AI device is mentioned. The "ground truth" for this device's safety and effectiveness implicitly relies on the established safety and effectiveness of its predicate devices, supported by bench and biocompatibility testing.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm requiring a training set.

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