Multifilament stainless steel sutures with crimps are intended for use in soft tissue to bone and bone to bone approximation and fixation during orthopedic procedures in the elbow, foot, ankle, knee, shoulder, and wrist for indications such as: Elbow - biceps tendon attachment; Foot and Ankle - achilles tendon attachment; Knee - patella tendon attachment to bone; Shoulder -biceps tendon tenodesis; Wrist - scapho-lunate approximation.

Device Description

Multifilament Stainless Steel Sutures with Crimps are available in a range of USP sizes (4-0 to #3) and lengths, attached to stainless steel needles of various types and sizes.

Multifilament SS Sutures are manufactured in IX19, 7X7 or 7X19 filament constructions. The sutures are identified by black and white tips which are used as a guide at the tip, and are removed prior to the end of the procedure. The sutures and tips were cleared for use under the PONTIS 510(k), K101126.

The washer is available in the following sizes:
000-0739_1-01 Washer, Plate - 0.012", .045"
000-0739_1-00 Washer, Plate - 0.012", .062"
000-0764 Washer, Plate, 2-Hole - 0.012"

The suture guide and the cannulated K-wire are available in one size.

AI/ML Overview

The provided text describes the "Multifilament Stainless Steel Sutures with Crimps" device by PONTIS Orthopaedics and its 510(k) summary, but it does not contain specific acceptance criteria or a detailed study proving the device meets them in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, principles of operation, and technical characteristics. The nonclinical tests performed are mentioned, but quantitative acceptance criteria and detailed performance results are absent.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance, nor can I provide information about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.

Based on the information given, here's what can be inferred about the "study" that supports the device, focusing on the mechanical testing mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in quantitative terms. The document indicates that testing demonstrated "substantially equivalent" mechanical properties to predicate devices.
Reported Device Performance: Not given in quantitative terms. The document states that testing demonstrated "substantially equivalent" mechanical properties for tendon to bone and bone to bone approximation compared to predicate devices.

Acceptance Criteria (Inferred qualitative goal)	Reported Device Performance (Qualitative statement)
Mechanical properties substantially equivalent to predicate devices	Mechanical properties are substantially equivalent for tendon to bone and bone to bone approximation.

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

Sample Size: Not specified.
Data Provenance: Not specified, but generally, bench testing for device submissions like this is performed in a laboratory setting, likely in the US where the submitter is located. It is prospective testing designed for the submission.

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

Not applicable. This device is a mechanical suture system, and its performance is evaluated through bench testing (mechanical and biocompatibility), not by expert interpretation of images or other data requiring a "ground truth" established by human experts in the context of diagnostic AI. Biocompatibility was "conducted under the predicate submission K081060".

4. Adjudication method for the test set:

Not applicable, as this refers to a process for resolving discrepancies in expert labeling or assessment, which is not relevant for the type of mechanical bench testing described for this device.

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 suture, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This is a mechanical surgical device, not an algorithm.

7. The type of ground truth used:

For mechanical tests: Engineering specifications and established test methods for evaluating suture strength, pull-out force, and cyclic loading for medical devices, with the "ground truth" being these measurable physical properties.
For biocompatibility: Established ISO standards for biocompatibility testing.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable, as this is a physical medical device, not an AI model.

Summary of the Nonclinical Tests Performed (from text):

The nonclinical tests performed to demonstrate substantial equivalence included:

Knot failure force compared to crimp failure force
Pull-out strength
Attachment strength
Static testing
Ultimate load following cyclic loading
Biocompatibility testing (conducted under the predicate submission K081060 as materials are the same).

The conclusion was that these bench tests demonstrated that the mechanical properties are "substantially equivalent" for tendon to bone and bone to bone approximation to the predicate devices.

Summary

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JUN 2 6 2014

ATTACHMENT 2

Image /page/0/Picture/3 description: The image shows the word "PONTIS" in a stylized font. There is a curved line above the word, and the letters are outlined in black. To the right of the word is the trademark symbol.

ORTHOPAEDICS

510(k) Summary

Owner's Name	Leonard Gordon
Submitter Address	2299 Post Street Suite 107San Francisco, CA 94115
Phone Number	(415) 567-8935
Fax Number	(415) 567-8934
510(k) Owner	PONTIS Orthopaedics, LLC
Contact Person	Leonard Gordon
Date Prepared	April 22, 2014
Trade Name	Multifilament Stainless Steel Suture with Crimp
Common name	Stainless Steel Suture
Classification Name	Smooth or Threaded Metallic Bone Fixation Fastener
Section	§ CFR 888.3040
Product Code	Primary - MBI
Predicate Device(s)	Mitek G11 Quick Anchor Plus - K041115Arthrex Swivelock - K101823Smith and Nephew Endobutton - K081098PONTIS Orthopaedics ferroFIBRETM - K081060Pioneer Surgical Technologies SilCoat Sternal Cable - K993286
Device Description	Multifilament stainless steel sutures with crimps are intended for use insoft tissue to bone and bone to bone approximation and fixation duringorthopedic procedures in the elbow, foot, ankle, knee, shoulder, andwrist for indications such as: Elbow - biceps tendon attachment; Footand Ankle - achilles tendon attachment; Knee - patella tendonattachment to bone; Shoulder -biceps tendon tenodesis; Wrist -scapho-lunate approximation.Multifilament Stainless Steel Sutures with Crimps are available in arange of USP sizes (4-0 to #3) and lengths, attached to stainless steelneedles of various types and sizes.Multifilament SS Sutures are manufactured in IX19, 7X7 or 7X19filament constructions. The sutures are identified by black and whitetips which are used as a guide at the tip, and are removed prior to theend of the procedure. The sutures and tips were cleared for use underthe PONTIS 510(k), K101126.
The washer is available in the following sizes:
000-0739_1-01 Washer, Plate - 0.012", .045"
000-0739_1-00 Washer, Plate - 0.012", .062"
000-0764 Washer, Plate, 2-Hole - 0.012"
The suture guide and the cannulated K-wire are available in one size.
Reason for 510(k)Indications for Use	New DeviceMultifilament stainless steel sutures with crimps are intended for use insoft tissue to bone and bone to bone approximation and fixation duringorthopedic procedures in the elbow, foot, ankle, knee, shoulder, andwrist for indications such as: Elbow - biceps tendon attachment; Footand Ankle - achilles tendon attachment; Knee - patella tendonattachment to bone; Shoulder -biceps tendon tenodesis; Wrist -scapho-lunate approximation.
TechnologicalCharacteristics	The Multifilament stainless steel suture is the same suture as wascleared under K081060. Each suture size and number of suture strandswill require a different crimp size.
	All biocompatibility testing performed, which was conducted under thepredicate submission K081060 remain applicable for this submission-as the materials are the same. This indicates that the components aresafe for their intended use.
	The PONTIS Multifilament Stainless Steel Suture with Crimps is asingle use, sterile implantable device, sterilized by ethylene oxide. Thepredicate devices are single use, sterile implantable device, sterilizedby gamma irradiation and ethylene oxide.
SubstantialEquivalence	The Multifilament Stainless Steel Suture with Crimps is substantiallyequivalent in design, manufacturing materials, intended use, principlesof operation, and technical characteristics to the predicates. The riskanalysis performed, raised no new issues of safety or effectiveness.
Nonclinical TestsPerformed	The verification and validation testing of the Multifilament StainlessSteel Suture with Crimps included knot failure force compared tocrimp failure force, pull out strength, attachment strength, static testingand ultimate load following cyclic loading. Bench testingdemonstrated that the mechanical properties are substantiallyequivalent for tendon to bone and bone to bone approximation.
Conclusions Drawn	Bases on the indications for use, technological characteristics andperformance test results, the Multifilament Stainless Steel Suture withCrimps is substantially equivalent to the predicate.

PONTiS Orthopaedics

. '

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is horizontally oriented and appears to be a header or title. The words are evenly spaced and the font is consistent throughout the text.

Public Health Service

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

June 26, 2014

PONTiS Orthopaedics LLC Leonard Gordon, M.D. President 2229 Post Street, Suite 103 San Francisco, California 94115

Re: K133579

Trade/Device Name: Multifilament Stainless Steel Sutures with Crimps Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 19, 2014 Received: May 20, 2014

Dear Dr. Gordon:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resources[orYou/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,

Lori A. Wiggins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 1

Statement of Indications for Use

510(k) Number: K133579

Manufacturer: PONTiS Orthopaedics, LLC

Device Name: Multifilament Stainless Steel Sutures with Crimps

Indications for Use:

Prescription Use XX (21 CFR Part 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Exemption (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page 1/1

PONTiS Orthopaedics

6/23/14

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.