SURGICRAFT SURGICAL MESH SYSTEM by SURGICRAFT LTD.

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.

Device Description

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.

AI/ML Overview

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.

Summary

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SURGICRAFT

510 (k) Summary

JUL 2 4 2008

A	510(k) Owner	Surgicraft Limited16 The OaksClews RoadRedditch, WorchesterEngland B98 7ST
	Contact	Donald W. GuthnerOrgenix, LLC111 Hill RoadDouglassville, PA 19518(646) 460-2984(484) 363-5879 (FAX)dg@orgenix.com
	Preparation Date	July 12, 2008
B	Trade Name	Surgicraft Surgical Mesh System consists of the:Surgical Mesh sizes 4 to 20cm (ACM###); Surgical Mesh sizes A to D (RCM###); Surgical Containment Mesh sizes 1 to 4 (GCM###);
	Common Name	Surgical Mesh
	Classification Name	Polymeric Surgical Mesh (21 CFR 878.3300, Product codeFTL)
C	Predicate Device(s)	K053215 -- NuVasive Surgical Mesh SystemK070961 - Biomerix Surgical Mesh
D	Device Description	The Surgicraft Surgical Mesh System consists of a series ofspecialized shapes of surgical mesh made fromcommercially available polyester suture fibers. All sizesincorporate regions of reinforced holes to assist secureanchoring of the mesh to tissue. The devices are available ina variety of different shapes and sizes to suit the individualpathology and anatomical conditions of the patient.

Surgicraft Limited / 16 The Oaks / Clews Road / Redditch / Worcestershire / UK / B98 7ST

Tel: +44 (0)1527 512600 / Fax: +44 (0)1527 551166 / Customer Service Fax: +44 (0)1527 512612 / Email: info@surgicraft.co.uk www.surgicraft.co.uk

のお気になっています。この時は、もちろんなので、その他の

App. 1 - 2

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K072370
pg 2 of 3

E Intended Use 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.
F Technological As was established in this submission, the subject device is Characteristics substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering drawings, labeling, laboratory and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
(ਜ Non-Clinical Testing No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act applicable to this device.
- Biocompatibility testing according to ISO 10993 .
  - O NAMSA reference T1261 300 Max Sensitization extract 0.9% sodium chloride NAMSA reference T1261 300 Max
  - o Sensitization extract sesame oil
  - NAMSA reference V0023 221 Genotoxicity o dimethyl sulfoxide extract
  - NAMSA reference V0023 221 Genotoxicity 0 0.9% sodium chloride extract
  - NAMSA reference T1250 802 Muscle o Implantation study - 4 weeks
- Toxicity was tested according to Directive 93/42/EC, ● EN ISO 1099-1 FDA
- . Cytotoxicity, 1. 929-Proliferation was tested according to EN ISO 10993-5, -12, EN ISO 9363-1, LM SOP 4-06-01
- Chemical Analysis (characterization of organic ● leachables) was tested according to EN ISO 10993-1, -12, -18, LM P 8-01, LM SOP 9-01-01

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K072370
pg 3 of 3

Mechanical Testing .
- Dynamic Tensile Fatigue ୍
- Static Tensile o
- Burst Strength o
- Suture Attachment Strength O
- Screw Pullout Strength o
- Tear Resistance ্ত
- Screw Resistance. ਼

H Clinical Testing Not applicable to this device

Conclusions Based on the 510(k) Summary and the information provided I herein, we conclude that the Surgicraft Surgical Mesh System is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.
J Additional Information The Surgicraft Surgical Mesh System is not a kit. Each sterile single-use implantable mesh device will be packaged Each non-sterile reusable instrument and separately. instrument case will be packaged separately

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'AUG 7 2008

Surgicraft Ltd. % Orgenix, LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, Pennsylvania 19518

Re: K072370

Trade/Device Name: Surgicraft Surgical Mesh System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: July 30, 2008 Received: July 31, 2008

Dear Mr. Guthner:

This letter corrects our substantially equivalent letter of July 24, 2008.

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Donald W. Guthner

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. McKenna

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K072370

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

(Division Sign-Of lestorative. Division of Gener and Neurologic 072370

510(k) Number _

Page 1 of App. 1 - 1

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.