The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair - 2. SLAP lesion repair 3. Rotator cuff repair - 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site - 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW - 1. Biceps tendon reattachment - 2. Tennis elbow repair ANKLE - 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site - Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE - 1. Medial collateral ligament repair - 2. Lateral collateral ligament repair - 3. Joint capsule closure to anterior proximal tibia - 4. Posterior oblique ligament or joint capsule to tibia repair - 5. Extra capsular reconstruction / ITB tenodesis - 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER - 1. Bankart repair - 2. SLAP lesion repair - 3. Rotator cuff repair - 4. Capsule shift repair (glenoid rim)

The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER - 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW 1. Biceps tendon reattachment 2. Tennis elbow repair ANKLE 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction / ITB tenodesis 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 2. SLAP lesion repair 3. Rotator cuff repair 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)

Device Description

Bioknotless Plus Anchor / Lupine Plus are a preloaded, absorbable disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Bionotless Anchor / Lupine Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor systems may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

AI/ML Overview

The provided text is for a 510(k) summary for the Bioknotless Plus Anchor and Lupine Plus Anchor. This document is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study describing the performance of a new AI/software-as-a-medical-device (SaMD) or a new diagnostic tool.

The information requested in the prompt (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the rigorous validation of diagnostic algorithms or imaging AI. This document describes a physical medical device (suture anchors) and its substantial equivalence to existing predicate devices, primarily based on design, indications for use, and bench testing, not on clinical performance metrics like sensitivity, specificity, or reader agreement that would be relevant to an AI/SaMD.

Therefore, I cannot extract the specific details requested in the prompt because the document does not contain them as it pertains to AI/SaMD validation.

However, I can provide what is available in the document regarding the "study" referenced, which is bench testing for a physical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:
"Bench testing was performed demonstrating that the Bioknotless Anchor Plus / Lupine Anchor Plus met predetermined acceptance criteria."

However, the specific "predetermined acceptance criteria" (e.g., specific tensile strength values, insertion force ranges, etc.) and the exact "reported device performance" (e.g., actual measured strength values) are not detailed in this summary document. The summary only confirms that the criteria were met.

2. Sample size used for the test set and data provenance:
Not applicable/not provided. The document refers to "bench testing" which implies in-vitro mechanical tests, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/SaMD (e.g., expert consensus on clinical findings, pathology reports) is not relevant for bench testing of a physical anchor's mechanical properties.

4. Adjudication method for the test set:
Not applicable.

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/SaMD device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/SaMD device.

7. The type of ground truth used:
For bench testing of a medical device, the "ground truth" would be established physical/mechanical property standards or engineering specifications. The document implies these were used ("predetermined acceptance criteria"), but doesn't specify them.

8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

In summary: The provided 510(k) summary is for a physical medical device (suture anchors) and describes bench testing to show substantial equivalence to predicate devices. It does not provide the details required for the evaluation of an AI/SaMD device because the product is fundamentally different.

Summary

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K062170 page 142

510(k) SUMMARY

AUG 2 2 2006

Bioknotless Plus Anchor / Lupine Plus Anchor

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Kristine ChristoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone: 508-828-3359Facsimile: 508-977-6955e-mail: KChristo@Dpyus.jnj.com
Name of Medical Device	Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of softtissue to boneProprietary Name: Bioknotless Anchor / Lupine Anchor
Substantial Equivalence	Bioknotless Plus Anchor is substantially equivalent to:Bioknotless Anchor, K002639, manufactured by DePuy Mitek.Lupine Plus Anchor is substantially equivalent to:Lupine Anchor, K050771, manufactured by DePuy Mitek
Device Classification	Bone anchors/screws are classified by the FDA as Class II MedicalDevices under the generic category of Single/Multiple componentmetallic bone fixation appliances and accessories.Bioknotless Anchor / Lupine Anchor Systems carry FDA product codeMAI and is classified as single / multiple component metallic bonefixation appliances and accessories soft tissue fastener under 21 CFR888.3030.
Device Description	Bioknotless Plus Anchor / Lupine Plus are a preloaded, absorbable

Bioknotless Anchor Plus / Lupine Anchor Plus

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K062170

disposable suture anchors/ inserters assembly for soft tissue repair to bone in the shoulder, knee, ankle, foot, and elbow. The absorbable polylactic acid (PLA) anchor is an identical anchor as that of the Bionotless Anchor / Lupine Anchor in design and configuration. The absorbable anchor is a one piece suture anchor constructed of molded Poly (L-lactide) polymer. The anchor systems may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298). The Bioknotless Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: Shoulder, knee, ankle, foot, elbow The Lupine Anchor is indicated for use in soft tissue to bone

fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER: 1. Bankart repair,2. SLAP lesion repair 3. Rotator cuff repair, 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site, 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, 5. Biceps tenodesis, 6. Acromio-clavicular separation, 7. Deltoid repair ELBOW: 1. Biceps tendon reattachment, 2. Tennis elbow repair ANKLE: 1. Achilles tendon repair/reconstruction, 2. Lateral stabilization 3. Medial stabilization at the medial talus site, Foot: Hallux Valgus reconstruction, 4. Midfoot reconstruction KNEE: 1. Medial collateral ligament repair, 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia., 4. Posterior oblique ligament or joint capsule to tibia repair, 5. Extra capsular reconstruction / ITB tenodesis, 6. Patellar ligament and tendon avulsion repairs. ARTHROSCOPIC PROCEDURES SHOULDER:1. Bankart repair, 2. SLAP lesion repair, 3. Rotator cuff repair, 4. Capsule shift repair (glenoid rim)

Safety and Performance The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the Bioknotless Anchor Plus / Lupine Anchor Plus met predetermined acceptance criteria.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Bioknotless Anchor Plus and Lupjne Anchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Indications for Use

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

DePuy Mitek A Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts

Re: K062170

Trade/Device Name: Bioknotless Plus Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and acessories Regulatory Class: Class II Product Code: HWC, JDR, MAI Dated: July 28, 2006 Received: July 31, 2006

Dear Ms. Christo:

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.

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 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.

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Page 2 - Ms. Kristine Christo

ﻟ

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,

Paulare Buell

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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page 192

INDICATIONS FOR USE

510(k) Number (if known): K062 | 70

Device Names: Bioknotless Plus Anchor

Indications for Use: The Bioknotless Plus Anchor with is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

Bankart repair

1. SLAP lesion repair

Rotator cuff repair

4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
1. Biceps tenodesis

Acromio-clavicular separation
Deltoid repair

ELBOW

1. Biceps tendon reattachment
1. Tennis elbow repair

ANKLE

1. Achilles tendon repair/reconstruction

Lateral stabilization
Medial stabilization at the medial talus site

Foot: Hallux Valgus reconstruction

Midfoot reconstruction

KNEE

1. Medial collateral ligament repair
1. Lateral collateral ligament repair
1. Joint capsule closure to anterior proximal tibia
1. Posterior oblique ligament or joint capsule to tibia repair
1. Extra capsular reconstruction / ITB tenodesis
1. Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES SHOULDER

1. Bankart repair
1. SLAP lesion repair
1. Rotator cuff repair
1. Capsule shift repair (glenoid rim)

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Ey Distismon (0) Say Page 1 of Division of Ge and Neurological Devices

510(k) Number K062170

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INDICATIONS FOR USE

510(k) Number (if known): Kobo2170

Device Names: Lupine Plus Anchor

INDICATIONS FOR USE: The Lupines Plus The Lupine Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:

OPEN PROCEDURES SHOULDER

1. Bankart repair

SLAP lesion repair
Rotator cuff repair

4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site

4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus

Biceps tenodesis
Acromio-clavicular separation
Deltoid repair

ELBOW

Biceps tendon reattachment
Tennis elbow repair

ANKLE

Achilles tendon repair/reconstruction
Lateral stabilization
Medial stabilization at the medial talus site

Foot: Hallux Valgus reconstruction

Midfoot reconstruction

KNEE

Medial collateral ligament repair
Lateral collateral ligament repair
Joint capsule closure to anterior proximal tibia
Posterior oblique ligament or joint capsule to tibia repair
Extra capsular reconstruction / ITB tenodesis
Patellar ligament and tendon avulsion repairs.

ARTHROSCOPIC PROCEDURES SHOULDER

Bankart repair
SLAP lesion repair
SLAP lesion repair
Rotator cuff repair
Rotator cuff repair
Capsule shift repair (glenoid rim)

Prescription Use	√
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of __________

	(Division Sign-Off)
--	-----------------------------------------

510(k) Premarket Notification: Special

Bioknotless Anchor Plus / Lupine Anchor Plus

Division of General, Restorative,

and Neurological Devices

510(k) Number K062170

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.