The PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand:

Collateral Ligaments around the PIP, DIP and MCP Joints .
. Flexor and Extensor Tendons

The PONTiSTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand:

Collateral Ligaments around the PIP, DIP and MCP Joints .
Flexor and Extensor Tendons ●

Device Description

The PONTISTM 3mm anchor is made of 316L stainless steel and incorporates non-absorbable UHMWPe sutures which are available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: PONTIS™ Ultra-High Molecular Weight Polyethylene Suture and PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily centered around demonstrating substantial equivalence to a predicate device (PONTIS™ Sutures and Suture Anchors with Optional Crimps K101126) and confirming safety and performance. Since this is a 510(k) submission for a modified device (suture material change), the "acceptance criteria" are implicitly met if the new device performs at least as well as the predicate and the changes do not raise new questions of safety or efficacy.

Acceptance Criteria Category	Specific Criteria (Implicitly Derived from 510(k))	Reported Device Performance
Intended Use Equivalence	Intended use is equivalent to predicate device.	Confirmed; same indications for use.
Operational Principle Equivalence	Operational principles are equivalent to predicate device.	Confirmed.
Indications for Use Equivalence	Indications for use are equivalent to predicate device.	Confirmed; same indications for use.
Biocompatibility	All components are biocompatible for intended use.	Confirmed; biocompatibility testing from predicate (K101126) remains applicable since core materials (except for suture type) are the same. UHMWPe sutures were cleared under K094028, indicating their safety.
Suture Strength (Knot Pull)	Suture strength (knot pull) is equivalent to products currently marketed for the same indications.	Documented and confirmed as equivalent to marketed products.
Anchor Insertion Torque	Anchor insertion torque is within acceptable ranges and equivalent to predicate/marketed devices.	Documented and confirmed.
Pull-out Failure Mechanism	Failure mechanism (pull-out or suture break strength) is acceptable and comparable to predicate/marketed devices.	Documented and confirmed.
Pull-out Failure Force	Pull-out failure force is equivalent to predicate/marketed devices.	Documented and confirmed.
Cyclic Pull-out Performance	Cyclic pull-out performance is characterized and equivalent to predicate/marketed devices.	Characterized and confirmed.
No New Safety/Efficacy Questions	Changes (suture type) do not introduce new questions of safety or efficacy.	Confirmed; testing demonstrated equivalence and no new safety/efficacy concerns.

2. Sample Size Used for the Test Set and Data Provenance

The provided text only refers to "a collection of tests" using "standardized foam bone model materials." It does not specify the sample size for the non-clinical tests. The data provenance is laboratory-based testing using in vitro standardized foam bone model materials, not human or animal data. Therefore, there is no country of origin or retrospective/prospective distinction.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these non-clinical tests is based on engineering measurements and comparisons to established benchmarks/literature values, not expert human interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical laboratory testing, there is no need for human adjudication methods like 2+1 or 3+1. The results are objective measurements.

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 a medical device (suture and suture anchor), not an AI/imaging device. Therefore, no MRMC study looking at human reader improvement with AI assistance was conducted.

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

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

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests was based on objective engineering and material science measurements of properties like anchor insertion torque, suture strength (knot pull), pull-out failure mechanism, pull-out failure force, and cyclic pull-out performance. These measurements were then compared against the literature documenting the comparative characteristics of suture anchors and against the predicate device (implicitly, or performance accepted for the predicate).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8)

Summary

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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 GordonPresident
Date Prepared	June 24, 2014
Trade Name	PONTISTM Ultra-High Molecular Weight Polyethylene Suture andPONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-HighMolecular Weight Polyethylene Braided Suture
Common name	1. Suture, nonabsorbable, synthetic, polyethylene2. Suture, Anchor
Classification Name	Class II 21 CFR § 888.3040 Smooth or threaded metallic bonefixation fastenerClass II 21 CFR § 878.5000 Nonabsorbable poly(ethyleneterephthalate) surgical suture
Section	§C.F.R. Section 878.4495
Product Code	PONTISTM Ultra-High Molecular Weight Polyethylene Suture• GAT (suture, nonabsorbable, synthetic, polyethylene)PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture• MBI (fastener, fixation, nondegradable, soft tissue)• GAT (suture, nonabsorbable, synthetic, polyethylene)
Predicate Device	PONTISTM Sutures and Suture Anchors with Optional CrimpsK101126
Device Description	Brief Description of the Device, SuturesThe PONTISTM 3mm anchor is made of 316L stainless steel andincorporates non-absorbable UHMWPe sutures which are
	available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps.
Reason for 510(k)	Modified Device (suture change only)
Indications for Use	The PONTIS™ Nonabsorbable Ultra-High Molecular WeightPolyethylene Braided Suture are indicated to secure soft tissue tosoft tissue reattachment in the hand:Collateral Ligaments around the PIP, DIP and MCPJoints Flexor and Extensor Tendons The PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicatedto secure soft tissue to bone reattachment in the hand:Collateral Ligaments around the PIP, DIP and MCPJoints Flexor and Extensor Tendons
TechnologicalCharacteristics	The PONTIS 3mm Suture Anchor is the same anchor clearedunder K101126. All biocompatibility testing performed, whichwas conducted under the predicate submissions K101126 remainapplicable for this submission as is contains the same materials.The suture material has changed to Ultra High Molecular WeightPolyethylene Suture. UHMWPe sutures, which was cleared underK094028. This indicates that the components are safe for theirintended use.The PONTIS 3mm Anchor with UHMWPe as well as thepredicate is a single use, implantable device, sterilized by ethyleneoxide.

510(K) Summary

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Substantial Equivalence The substantial equivalence of the PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Suture and PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture is based on the equivalence in intended use, operational principals, and indications for use to the predicate PONTISTM Sutures and Suture Anchors with Optional Crimp (K101126). The only difference is the suture type, which is being changed to Ultra High Molecular Weight Polyethylene Suture (UHMWPe) instead of stainless steel. The sutures will be secured by knots instead of an alternate crimp. The UHMWPe sutures were cleared to market under K094028. PONTiSTM UHMWPe Sutures and PONTiSTM 3mm Suture Anchors with UHMWPe suture are substantially equivalent to other sutures currently marketed in conjunction with suture anchors and present no substantial differences in design, intended use and function to previously approved products. Nonclinical Tests A collection of tests was conducted to determine safety and Performed performance on the proposed device. Additionally, the subject device labeling is consistent both with FDA's guidance as well as current medical practice. The PONTiSTM 3mm Suture Anchors with UHMWPe was compared in standardized foam bone model materials. The Anchor insertion torque, suture strength (knot pull), pull-out failure mechanism (pull-out or suture break strength) and pullout failure force were documented. In addition cyclic pull-out performance was characterized. In all performance tests the PONTiSTM UHMWPe Sutures and 3mm Suture Anchors with UHMWPe Suture secured by knots are equivalent to products currently marketed for the same indications as confirmed by a comparison to the literature documenting the comparative characteristics of suture anchors. The performance studies and biocompatibility reviews indicate that the PONTiSTM UHMWPe sutures are safe for their intended use. Conclusions Drawn The testing demonstrated that the products are equivalent and did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.

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	Based on the indications for use, technological characteristics andperformance test results, the PONTiS™ UHMWPe Sutures and3mm Suture Anchors with UHMWPe suture is substantiallyequivalent to the predicate PONTiS™ Sutures and Suture Anchorswith Optional Crimp K101126 and present no substantialdifferences in design, intended use and function.
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END OF 510(k) SUMMARY

and the comments of the comments of the comments of

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And Children Children Children

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20903-0002

July 24, 2014

PONTIS Orthopaedics, LLC Dr. Leonard Gordon President 2299 Post Street, Suite 103 San Francisco, California 94115

Re: K141711

Trade/Device Name: PONTiS Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures and PONTiS'100 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: June 24, 2014 Received: June 25, 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

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Page 2 - Dr. Leonard Gordon

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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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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Statement of Indications for Use

510(k) Number (if known): K141711

Manufacturer: PONTiS Orthopaedics, LLC

Device Name: PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures and PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture

Indications for Use:

The PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand:

Collateral Ligaments around the PIP, DIP and MCP Joints .
. Flexor and Extensor Tendons

The PONTiSTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand:

Collateral Ligaments around the PIP, DIP and MCP Joints .
Flexor and Extensor Tendons ●

Prescription Use(21 CFR Part 801 Subpart D)	XX	AND/OR	Over the Counter Use(21 CFR Part 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Elizabeth 詞&aank -S

Division of Orthopedic Devices

Regulation Number and Section

N/A