The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.

Device Description

Fixone All suture anchor consists of one "fix Suture" and one,two or three non-absorbable Sutures. The nonabsorbable suture is manufactured from UHMWPE. They are pre-loaded on a handled insertion device. This device is provided sterile, for single use only. This device is medical device. Prescription use only.

The color additive copper-phthalocyanine blue, color additive D&C green 6, color additive D&C violet 2 and color additive D&C black 4 are according to FDA regulations and it is approved for use in medical applications (§74.3045 – FDA), (§74.3206 –FDA), (§74.1602 –FDA) and (§74.3054 – FDA) respectively.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Fixone All Suture Anchor." This document primarily deals with the substantial equivalence of a new version of the suture anchor to previously cleared predicate devices. It focuses on engineering and biocompatibility testing rather than clinical study data involving AI or human readers evaluating image-based diagnostics.

Therefore, the information required to answer the prompt regarding acceptance criteria and study that proves the device meets the acceptance criteria, specifically related to AI in a clinical setting (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details), is not present in the provided text.

The document discusses acceptance criteria and proof of mechanical performance and biocompatibility for the suture anchor. Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical & Biocompatibility)

Please note that the acceptance criteria are generally implied by the "Requirements" column and "Pass" result, indicating the device met those requirements. Specific numerical requirements are given where applicable.

Anchor Performance

Test Item	Requirements	Reported Device Performance
Insertion Strength	Insert each anchor with 5mm/min rate into 10pcf/40pcf combined urethane block.	Pass
Pull-out (FAS-1652802iw)	Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined urethane block.	Pass
Fatigue test (FAS-1652802iw)	Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 cycles from 10pcf/40pcf combined urethane block.	Pass
Pull-out (FAM-7615802fg)	Pull out each anchor with 5mm/min rate from 10pcf/40pcf combined urethane block.	Pass
Fatigue test (FAM-7615802fg)	Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000 cycles from 10pcf/40pcf combined urethane block.	Pass

Suture Performance (USP 0, UHMWPE)

Test Item	Requirements	Reported Device Performance
Appearance	The test article shall be no damage to the appearance in visual inspection.	Pass
Length	The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm.	Pass
Tensile Strength	For USP 0 size suture, tensile strength must be larger than 2.16 kgf.	Pass
Needle Attachment	For USP 0 size suture, needle attachment must be larger than 1.50 kgf.	Pass

Suture Performance (USP 2, UHMWPE)

Test Item	Requirements	Reported Device Performance
Length	The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm.	Pass
Tensile Strength	For USP 2 size suture, tensile strength must be larger than 3.52 kgf.	Pass

Suture Performance (USP 0, USP 2, UHMWPE)

Test Item	Requirements	Reported Device Performance
Appearance	The test article shall be no damage to the appearance in visual inspection.	Pass
Diameter	For USP 0 size suture, diameter must be within 0.35~~0.399mm. For USP 2 size suture, diameter must be within 0.50~~0.599mm.	Pass
Tensile strength	With 25~35cm/min, record the load-displacement curves and maximum load. (N)	Pass

Biocompatibility (UHMWPE + PET)

Test Item	Test Method / Test Criteria	Reported Result
Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
Systemic toxicity test	ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass
Pyrogen Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
Intracutaneous reactivity test	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass
Maximization sensitization	ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass
Genotoxicity test	ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test	Pass
Implantation test	ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone	Pass
Hemolysis test	ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood	Pass
Subchronic toxicity	ISO 10993-11 Tests for systemic toxicity	Pass

Biocompatibility (Only UHMWPE)

(Same tests and results as UHMWPE + PET table, excluding PET interaction)

Test Item	Test Method / Test Criteria	Reported Result
Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
Systemic toxicity test	ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass
Pyrogen Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
Intracutaneous reactivity test	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass
Maximization sensitization	ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass
Genotoxicity test	ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test	Pass
Implantation test	ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone	Pass
Hemolysis test	ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood	Pass
Subchronic toxicity	ISO 10993-11 Tests for systemic toxicity	Pass

Sterilization/Endotoxin

Test Item	Test Method / Test Criteria	Reported Result
Endotoxin test	USP 43 <85>, Bacterial endotoxin test (LAL)	Pass

2. Sample size used for the test set and the data provenance:
This information is not provided in the context of an AI/image-based diagnostic test set. The document refers to "bench tests" performed on physical samples of the anchors and sutures. The number of samples for each mechanical test is not specified, only that "each anchor" or "the test article" was evaluated. The data provenance is implied to be from AJU Pharm Co., Ltd.'s internal testing, likely at their facility or a contracted lab. No country of origin for this specific testing data is given, but the company address is in South Korea (A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea). The data is retrospective of the device design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable for this type of device (mechanical and biocompatibility testing). Ground truth is established by objective physical measurements and standardized biological assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of 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 is not an AI-assisted diagnostic device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical tests: Physical measurements against engineering specifications (e.g., tensile strength, length, diameter, pull-out force).
For biocompatibility tests: Standardized laboratory assays with pass/fail criteria based on ISO standards.
For sterilization/endotoxin: Standardized laboratory assays (e.g., LAL test) with pass/fail criteria.

8. The sample size for the training set:
Not applicable. This is not a machine learning/AI device.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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March 23, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The seal is a stylized representation of a human figure, and the text is in a bold, sans-serif font. The logo is used to identify the FDA, a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

AJU Pharm Co., Ltd. % Peter Chung 300, Atwood Street Pittsburgh, Pennsylvania 15213

Re: K222423

Trade/Device Name: Fixone All Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 21, 2023 Received: February 21, 2023

Dear Peter Chung:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sara S. Thompson -S

For

Laurence D. Coyne. Ph.D. Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222423

Device Name Fixone All Suture Anchor

Indications for Use (Describe)

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Fixone All Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the suture anchor systems stabilize the damaged soft tissue.

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)

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510(k) Summary

[as required by 807.92(c)]

1. Applicant

Company : AJU Pharm Co.,Ltd. 1)
1. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
Tel : 82-31-765-4420 3)
Fax : 82-31-602-7818 4)
Prepared date : March 22, 2023 5)
1. Contact person : Peter Chung, 412-512-8802
1. Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
1. Submission date : August 08, 2022

2. Device Information

Trade name : Fixone All Suture Anchor 1)
1. Common name : Non-absorbable Suture Anchor
Regulation name : Fastener, Fixation, Nondegradable, Soft tissue 3)
1. Product code : MBI
1. Regulation number : 888.3040
Class of device : Class II 6)
1. Panel : Orthopedic

3. The legally marketed device to which we are claiming equivalence

K192709 AJU Pharm Co., Ltd. / Fixone All Suture Anchor

Reference Devices

K192032 AJU Pharm Co., Ltd. / Fixone Biocomposite Small Anchor K133224 CONMED Co. / Y-Knot RC All-Suture Anchor K110145 Biomet, Inc. / Biomet Sports Medicine Juggerknot Soft Anchor

4. Device description

5. Indications for Use :

6. Performance data:

Bench test were performed. Bench testing included biocompatibility, mechanical testing, sterility 1) testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

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Anchor

Test item	Requirements	Results
Insertion Strength	Insert each anchor with 5mm/min rate into 10pcf/40pcf combinedurethane block.
Pull-out	Pull out each anchor with 5mm/min rate from 10pcf/40pcf combinedurethane block.	Pass
Fatigue test	Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000cycles from 10pcf/40pcf combined urethane block.

FAS-1652802iw model was used for this test report shows the performance of Js type all suture anchor that has smaller length of flat suture. This performance test was done with FDA cleared device (K133224).

Anchor

Test item	Requirements	Results
Pull-out	Pull out each anchor with 5mm/min rate from 10pcf/40pcf combinedurethane block.	Pass
Fatigue test	Pull out each anchor with 20N to 60N cycle loading and 1Hz/40,000cycles from 10pcf/40pcf combined urethane block.	Pass

FAM-7615802fg model was used for this test report shows the performance of JM type all suture anchor that has smaller length of flat suture. This performance test was done with FDA cleared device (K110145).

Suture (USP 0, UHMWPE)

Test item	Requirements	Results
Appearance	The test article shall be no damage to the appearance in visualinspection.
Length	The length of suture was measured while the strand is laid out smooth,without tension, on a plane surface: the length of the strand is not lessthan 95.0 percent of 750mm.	Pass
Tensile Strength	For USP 0 size suture, tensile strength must be larger than 2.16 kgf.
Needle Attachment	For USP 0 size suture, needle attachment must be larger than 1.50 kgf.

Suture (USP 2, UHMWPE)

Test item	Requirements	Results
Length	The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface: the length of the strand is not less than 95.0 percent of 750mm.	Pass

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Tensile Strength	For USP 2 size suture, tensile strength must be larger than 3.52 kgf.
------------------	-----------------------------------------------------------------------

Suture (USP 0, USP 2, UHMWPE)

Test item	Requirements	Results
Appearance	The test article shall be no damage to the appearance in visualinspection.	Pass
Diameter	For USP 0 size suture, diameter must be within 0.35~~0.399mm.For USP 2 size suture, diameter must be within 0.50~~0.599mm.

Suture (USP 0, USP 2, UHMWPE)

Test item	Requirements	Results
Tensile strength	With 25~35cm/min, record the load-displacement curves and maximumload. (N)	Pass

2) Biocompatibility

UHMWPE + PET

#	Test item	Test method / Test criteria	Test result
1	Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
2	Systemic toxicity test	ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass
3	Pyrogen Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
4	Intracutaneous reactivity test	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass
5	Maximization sensitization	ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass
6	Genotoxicity test	ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test	Pass
7	Implantation test	ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone	Pass
8	Hemolysis test	ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood	Pass
9	Subchronic toxicity	ISO 10993-11 Tests for systemic toxicity	Pass

Only UHMWPE

#	Test item	Test method / Test criteria	Test result
1	Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Pass
2	Systemic toxicity test	ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	Pass
3	Pyrogen Test	ISO 10993-11 Test for systemic toxicity, pyrogen test	Pass
4	Intracutaneous reactivity test	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Pass
5	Maximization sensitization	ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity	Pass
6	Genotoxicity test	ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test	Pass

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7	Implantation test	ISO 10993-6, Tests for local effects after implantation, Annex D testmethods for implantation in bone	Pass
8	Hemolysis test	ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection oftests for interactions with blood	Pass
9	Subchronic toxicity	ISO 10993-11 Tests for systemic toxicity	Pass

The performance tests demonstrated that Fixone All Suture Anchor performs in a substantially equivalent manner to the predicate device.

#	Test item	Test method / Test criteria	Test result
1	Endotoxin test	USP 43 <85>, Bacterial endotoxin test (LAL)	Pass

Endotoxin level and EO sterilization will be monitored in an alternative plan to batch testing.

7. Predicate device comparison table

Manufacturer	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	Remark
510(k) No.	K192709		N/A
Intended Use	The non-absorbable suture anchors areintended to reattach soft tissue to bonein orthopedic surgical procedures. TheFixone All Suture Anchors may be used ineither arthroscopic or open surgicalprocedures. After the suture strands areanchored to the bone, they may be usedto reattach soft tissue, such as ligaments,tendons, or joint capsules to the bone. Inconjunction with appropriatepostoperative immobilization throughoutthe healing period, the suture anchorsystems stabilize the damaged softtissue.	The non-absorbable suture anchors areintended to reattach soft tissue to bone inorthopedic surgical procedures. TheFixone All Suture Anchors may be used ineither arthroscopic or open surgicalprocedures. After the suture strands areanchored to the bone, they may be usedto reattach soft tissue, such as ligaments,tendons, or joint capsules to the bone. Inconjunction with appropriatepostoperative immobilization throughoutthe healing period, the suture anchorsystems stabilize the damaged soft tissue.	Identical
Classificationname	Fastener, Fixation, Nondegradable, SoftTissue	Fastener, Fixation, Nondegradable, SoftTissue	Identical
Trade name	Fixone All Suture Anchor	Fixone All Suture Anchor	N/A
Model/type	14 model codes including FAS-1652802ew	61 model codes including FAS-1652802ew	N/A
Appearance	Image: Fixone All Suture Anchor	Image: Fixone All Suture Anchor	Identical
Productconfiguration	DriverSuture Anchor	DriverSuture AnchorNeedle for JM type	Different
Material	Non-absorbable Suture	Non-absorbable Suture	Identical
Suture
Absorbable	Non-absorbable	Non-absorbable	Identical
Suture diameter	0.50~0.599 (USP size 2)	0.50~~0.599 (USP size 2)0.30~~0.399 (USP size 0)	Different
Material	UHMWPE, PET	UHMWPE, PET	Identical
Sterilization	EO Gas sterilizationAccording to ISO 11135: 2014	EO Gas sterilizationAccording to ISO 11135: 2014	Identical
Biodegradable	Yes	Yes	Identical

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Manufacturer	AJU Pharm Co.,Ltd.	AJU Pharm Co.,Ltd.	Remark
Principle of operation	Manual	Manual	Identical
Shelf-life	5 years	5 years	Identical

Difference #1 Product configuration

JM type that include needle are added. This needle intended to penetrate suture to soft tissue.

The needle included in the JM type is identical to the needle included in the K192032 product, and the production process is also the same.

Difference #2 Suture Diameter

USP 0 size suture is added. Thinner suture could cause the early break than thicker suture. So, we have done the performance test report of USP 0 size suture.

9. Conclusion

The device is investigated for function to compare the operation of function between Fixone All Suture Anchor and predicate devices.

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.

Therefore, it is concluded that Fixone All Suture Anchor is substantially equivalent to the legally marketed predicate device.

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.