The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.

AI/ML Overview

The provided text describes the Insightra Freedom Ventral Hernia Repair System, a surgical mesh device. However, it does not include detailed "acceptance criteria" for the device's performance in terms of specific metrics (like sensitivity, specificity, accuracy, or recurrence rates with statistical targets) nor does it delineate a formal study with a methodology typically associated with establishing such criteria.

Instead, the document highlights biocompatibility testing and bench testing, as well as a "simulated use" animal study, to demonstrate safety and effectiveness in support of a 510(k) submission, confirming substantial equivalence to predicate devices.

Therefore, many of the requested sections regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, and adjudication methods cannot be fully answered from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance
Biocompatibility per ISO 10993-1	Device is biocompatible per ISO 10993-1 standards.
Meets product specifications and intended use	Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended use. The Freedom Ventral Hernia repair was an effective repair.
Substantial Equivalence to predicate devices	All test results support substantial equivalence in design, function, and indications for use.
Effective in terms of recurrence rates	No specific recurrence rate target or value is given, but it is stated as "effective in terms of recurrence rates."
Lack of migration	Stated as "effective in terms of ... lack of migration."
Acute pain rates	Stated as "effective in terms of ... acute pain rates."
User needs met via whole system simulated use testing	Whole system simulated use testing in fresh porcine meat confirmed user needs.

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

Sample Size:
- For biocompatibility testing, the sample size is not specified.
- For bench testing, the sample size is not specified.
- For the in vivo simulated use animal test, the sample size (number of animals) is not specified.
Data Provenance: Not specified, but the animal testing was performed "per GLP requirements."

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 as this is a medical device for surgical repair, not an AI/diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance and biological response of the mesh based on engineering and biological tests.

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

Not applicable for this type of device and testing. The evaluation relies on standardized test methods and observations of physical and biological outcomes.

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 not an AI-assisted diagnostic device. The document does not describe any MRMC studies or AI assistance.

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

Not applicable as this is a surgical mesh device, not an algorithm or AI system.

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

The "ground truth" for this device's evaluation is primarily established through:
- Biocompatibility Standards: Adherence to ISO 10993-1.
- Engineering Specifications: Meeting predefined product specifications derived from design requirements.
- Simulated Use Observations: Performance observed in in vivo simulated use experiments (animal study) to assess physical attributes like deployment, securement, and general surgical utility.
- Comparative Analysis: Demonstrating substantial equivalence to predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' historical performance.
- Clinical Observations (implied): Phrases like "effective in terms of recurrence rates, lack of migration and acute pain rates" suggest a general understanding of desired clinical outcomes, though no specific clinical study data is provided in this summary.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2015

Insightra Medical Incorporated Mr. Neerav Parikh Regulatory Affairs and Quality Assurance Specialist 9200 Irvine Center Drive, Suite 200 Irvine, California 92618

Re: K142192

Trade/Device Name: Freedom Ventral Hernia Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL, OXJ Dated: April 3, 2015 Received: April 7, 2015

Dear Mr. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142192

Device Name

Freedom Ventral Hernia Repair System

Indications for Use (Describe)

The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This 510(k) Summary is provided per the requirements of section 807.92(c).

Date: May 6, 2015

Submitter Information:

Submitters Name:	Insightra Medical Inc.
Contact Person:	Neerav ParikhRA/QA Specialist
Address:	9200 Irvine Center Drive, Suite 200Irvine, CA 92618
Telephone:	949-215-1835
Fax:	949-625-8625
Email:	neerav@insightra.com
Device Name:
510(k) Number:	K142192
Trade Name:	Freedom Ventral Hernia Repair System
Common/Usual Name:	Surgical Mesh
Classification Name:	Surgical Polymeric Mesh

Predicate Devices:

. Atrium Prolite Mesh, K002093, FDA cleared on 7/24/2000
Covidien Surgipro Mesh, K905655, FDA cleared on 12/31/1990 .

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Device Description:

Intended Use:

The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.

Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use:

The Insightra Freedom Ventral Hernia Repair System and the predicate devices have similar technological characteristics. Specifically, the Insightra Freedom Ventral Hernia Repair System and the predicate devices are all designed as surgical polypropylene mesh devices to be used to support soft tissue during hernia repair. These devices are available in a variety of configurations available to accommodate the various patient anatomies and hernia defect types.

The Insightra Freedom Hernia Repair System differs from the predicate devices with the use of the Strap Passer. The Strap Passer is used during the surgical implantation procedure to pass the straps of the implanted mesh through the abdominal wall muscle. The straps are then trimmed below the level of the skin. The straps, used in this manner, provide an equivalent method of securing the mesh to the implantation site as compared to the predicate devices which use sutures, staples, or tissue anchors for attaching the mesh to the muscle tissue.

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There are no new types of safety or effectiveness questions due to the surgical implantation procedure for these types of devices and scientific methods exist for the evaluation of the new characteristics. Performance data provided in this premarket notification demonstrate substantial equivalence between the Insightra Freedom Ventral Hernia Repair System and the predicate devices.

Performance Data:

Biocompatibility testing in accordance to ISO 10993-1 standards was conducted and the results indicate that the device is biocompatible per these standards.

Bench testing results and in vivo simulated use experiments demonstrate that the proposed device design meets product specifications and intended use. In support of this submission, whole system simulated use testing was conducted in fresh porcine meat to ensure that the proposed Freedom Ventral Hernia Repair System user needs. The animal testing was also conducted per GLP requirements.

All test results provided in this submission support the safety and effectiveness of the device for its intended use utilizing the least burdensome approach and demonstrate that the proposed device is substantially equivalent to its predicate devices.

Conclusions Drawn from Clinical Studies:

The Freedom Ventral Hernia repair was an effective repair in terms of recurrence rates, lack of migration and acute pain rates. The Freedom Ventral Hernia Repair system enables broad margin coverage in the preperitoneal sublay and retromuscular sublay position. The results of testing demonstrate that the Freedom Ventral Hernia Repair is substantially equivalent to the predicate devices in design, function, and indications for use.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.