(23 days)
The Mitek Panalok RC QuickAnchor Plus with Orthocord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: rotator cuff repair
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus, , biceps tenodesis, acromio-clavicular separation .
Elbow: Biceps tendon reattachment
Ankle: Achilles tendon repair/reconstruction, lateral stabilization, medial stabilization at the medial talus site
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, rotator cuff repair, , capsule shift repair (glenoid rim)
Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC Anchor Plus Dual Suture (with ORTHOCORD) and Panalok are preloaded, PLA disposable suture anchor/ inserter assemblies designed to allow soft tissue repair to bone. The anchors are an identical anchors as that of the Panalok RC Anchor Plus (K041117) and Panalok Anchor (K970896) in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture, Panacryl Suture, Orthocord Suture.
This document is a 510(k) Pre-market Notification for medical devices, specifically suture anchors with an Orthocord suture. The primary claim for substantial equivalence is based on a comparison to previously cleared predicate devices, an important distinction from studies evaluating AI performance.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to consensus and voluntary standards. | Device descriptions and conformance to consensus and voluntary standards were the basis of the substantial equivalence determination. |
| ORTHOCORD suture conformed to the USP monograph for absorbable sutures. | "Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures..." |
| Suture compatibility and deployment met predetermined acceptance criteria. | "...and the suture compatibility and deployment met predetermined acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of an algorithm or AI. The testing mentioned is bench testing of mechanical properties.
- Sample size for bench testing: Not explicitly stated.
- Data provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not on patient data. Therefore, there's no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the bench testing was based on predefined engineering specifications and the USP monograph for sutures, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no need for adjudication as the testing involved objective physical measurements against established standards (e.g., USP monograph, predetermined acceptance criteria for suture compatibility/deployment).
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 document describes a traditional medical device (suture anchors) and its substantial equivalence to predicate devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-assisted performance improvement are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The "ground truth" for proving the device's performance (or substantial equivalence) was:
- USP monograph for absorbable sutures: A pharmacopeial standard for material properties.
- Predetermined acceptance criteria: Engineering specifications and performance metrics for suture compatibility and deployment.
- Predicate device characteristics: The design, configuration, and dimensions of the new anchors were identical to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and thus there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned in this document.
Summary:
The provided text is a 510(k) Pre-market Notification focusing on substantial equivalence for a physical medical device (suture anchors). The "study" mentioned is bench testing to confirm material properties (ORTHOCORD suture conformance to USP monograph) and mechanical performance (suture compatibility and deployment) against predetermined engineering acceptance criteria. It does not involve human readers, clinical data sets, AI algorithms, or the typical performance metrics associated with AI/software devices.
{0}------------------------------------------------
NOV 2 2 2006
510(k) SUMMARY
Panalok RC Quickanchor Plus w/ Orthocord Panalok RC Quickanchor Plus Dual w/ Orthocord Panalok Anchor w/ Orthocord
| 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 02767 |
| Telephone:508-828-3359Facsimile:508-977-6911e-mail:KChristo@Dpyus.jnj.com | |
| Name of Medical Device | Classification Name:Screw, Fixation, Bone StapleFastener, Fixation, Biodegradable, Soft Tissue |
| Common/Usual Name:Appliance for reconstruction of softtissue to bone | |
| Proprietary Name:Panalok Quickanchor PlusPanalok RC QuickAnchor Plus Dual SuturePanalok Anchor | |
| Substantial Equivalence | Panalok RC Quickanchor Plus (with ORTHOCORD) and Panalok RCQuickanchor Plus Dual Suture (with ORTHOCORD) are substantiallyequivalent to:Panalok RC Quickanchor Plus, K041117 , manufactured by DePuyMitek. |
| Panalok Anchor (with ORTHOCORD) is substantially equivalent to:Panalok Anchor, K970896 , 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 component |
| 510(k) Premarket Notification: Special | Confidential |
| metallic bone fixation appliances and accessories. | |
| Panalok RC Quickanchor Plus carry FDA product code JDR, and isclassified as a fixation screw/bone staple under 21 CFR 888.3030. | |
| Panalok Anchor carry FDA product code MAI, and is classified as aFastener, fixation biodegradable, soft tissue under 21 CFR 888.3030 | |
| Device Description | Panalok RC Anchor Plus (with ORTHOCORD), Panalok RC AnchorPlus Dual Suture (with ORTHOCORD) and Panalok are preloaded,PLA disposable suture anchor/ inserter assemblies designed to allowsoft tissue repair to bone. The anchors are an identical anchors as thatof the Panalok RC Anchor Plus (K041117) and Panalok Anchor(K970896) in design, configuration and dimensions. The anchorsystem may be sold with Ethibond Suture, Panacryl Suture, OrthocordSuture. |
| Indications for Use | The Mitek Panalok RC QuickAnchor Plus with Orthocord and MitekPanalok RC QuickAnchor Plus Dual Suture with Orthocord areintended for fixation of USP size #2 suture to bone for the indicationslisted below.Shoulder: rotator cuff repair |
| The Mitek Panalok Anchor with Orthocord are indicated for use in softtissue to bone fixation in association with adequate post- operativeimmobilization as follows:. | |
| Open Procedure Shoulder: Bankart repair, SLAP lesion repair, rotatorcuff repair, capsule shift/ capsulo-labral reconstruction at anteriorglenoid rim site, shift/capsulo-labral reconstruction at the lessertuberosity of the humerus, , biceps tenodesis, acromio-clavicularseparation . | |
| Elbow: Biceps tendon reattachment | |
| Ankle: Achilles tendon repair/reconstruction, lateral stabilization,medial stabilization at the medial talus site | |
| Knee: Medial collateral ligament repair, lateral collateral ligamentrepair, joint capsule closure to anterior proximal tibia, posterior obliqueligament 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,rotator cuff repair, , capsule shift repair (glenoid rim) |
{1}------------------------------------------------
Confidential
{2}------------------------------------------------
Safety and Performance The determination of substantial equivalence for these devices were based on a detailed device descriptions, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Panalok RC Quickanchor Plus (with ORTHOCORD), Panalok RC Quickanchor Plus Dual Suture (with ORTHOCORD) and Panalok Anchor (with ORTHOCORD) have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Confidential
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. 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
DePuy Mitek, a Johnson & Johnson Company % Ms. Kristine Christo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
NOV 2 2 2006
Re: K063273
Trade/Device Name: Panalok RC QuickAnchor Plus with Orthocord, Panalok RC OuickAnchor Plus Dual Suture with Orthocord, and Panalok Anchor with Orthocord Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MAI Dated: October 27, 2006 Received: October 30, 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.
{4}------------------------------------------------
Page 2 - Ms. Kristine Christo
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 af 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. 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, permite 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" (21CFR 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.
Janbare Prelin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K063273
Device Names: Panalok RC Quickanchor Plus, with Orthocord Panalok RC Quickanchor Plus Dual Suture with Orthocord
Indications for Use:
The Mitek Panalok RC QuickAnchor Plus with Orthooord and Mitek Panalok RC QuickAnchor Plus Dual Suture with Orthocord are intended for fixstion and Mitts I allation RC QuickAnchor Plus Dual
Suture with Orthocord are intended for fixation of USP size #2 suture to bone fo
Shoulder: rotator cuff repair
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)
Darlene Brens
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062273
Confidential
{6}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known):
Device Names: Panalok Anchor with Orthocord
Indications for Use:
The Mitek Panalok Anchor with Orthocord are indicated for use in soft tissue to bone fixation in association with adequate post- operative immobilization as follows:.
Open Procedure Shoulder: Bankart repair, SLAP Iesion repair, capsule shift/ capsule shift/ capsulo-labral reconstruction at anterior glenoid rim site, shift/capsulo-labral repair, at the lesser tubero cats of the humerus, , biceps tenodesis, acromio-clavicular separation .
Elbow: Biceps tendon reattachment
Ankle: Achilles tendon repair/reconstruction, lateral stabilization at the medial talus site
Knee: Medial collateral ligament repair, lateral ligament repair, joint capsule closure to anterior proximal tibia, posterior oblique ligament or joint capsule to tibia repair, extra capsular reconstruction / ITR tenodesis, patellar ligament and tendon avulsion repairs
Arthroscopic Procedures shoulder: Bankart repair, SLAP lesion repair, rotator cuff repair, , capsule shift repair (glenoid rim)
Prescription Use 1 (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
Confidential
510(k) Premarket Notification: Special Panalok RC Quickanchor Plus With Orthocord Dual Suture Panalok RC Quickanchor Plus With Orthocord Panalok Anchor With Orthocord
51
§ 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.