(42 days)
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The design enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.
The provided text describes a 510(k) premarket notification for a medical device called the Hitch™ LactoSorb® Suture Anchor. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where specific acceptance criteria are defined and a device's performance against those criteria is measured using a test set with corresponding ground truth.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, and expert adjudication cannot be extracted from this document as it does not contain information about a clinical or standalone performance study.
Here's an attempt to address the points based on the provided text, heavily indicating when the information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use. |
Explanation: The document does not define specific, quantifiable acceptance criteria for the device's performance (e.g., a certain pull-out strength, a specific failure rate, or a particular clinical outcome threshold). Instead, the basis for approval is "substantial equivalence" to a legally marketed predicate device. The performance is reported as meeting this substantial equivalence through non-clinical testing.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size used for the test set: Not applicable. No clinical or standalone device performance test set is described.
- Data provenance: Not applicable. The "Non-Clinical Testing" mentioned likely refers to bench-top or mechanical tests, not human data. No country of origin is specified for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No ground truth was established for a test set as no such clinical or performance study involving human data or expert assessment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there is no human-involved test set requiring expert consensus.
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 device is a suture anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an implantable medical device, not an algorithm. The "Non-Clinical Testing" could be considered a form of standalone performance assessment in a mechanical sense, but it's not "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For the non-clinical testing, the "ground truth" would likely be engineering specifications, material properties, and mechanical test standards, rather than clinical or expert-derived ground truth.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned, no ground truth for it was established.
Summary:
The provided 510(k) summary is for a traditional medical device (a suture anchor) and primarily relies on demonstrating "substantial equivalence" to a predicate device through non-clinical laboratory testing. It does not involve AI, clinical studies with human participants, expert adjudication, or the establishment of ground truth in the manner that would be relevant for a diagnostic or AI-powered medical device. The information requested regarding acceptance criteria and study methodology is largely absent because the regulatory pathway chosen (510(k) for a device like this) typically focuses on comparative technological characteristics and function rather than detailed clinical performance studies with defined acceptance criteria for novel outcomes.
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K061657 page 14/
Image /page/0/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and black, with the exception of the letter "T", which has horizontal lines running through it. The overall design is geometric and modern.
JUL 25 2006
510(k) Summary
Arthrotek, Inc., Applicant/Sponsor: (A Wholly Owned Subsidiary of Biomet, Inc.) 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
May 25, 2006
Contact Person: Lester F. Padilla
Hitch™ LactoSorb® Suture Anchor Proprietary Name:
Common Name: Suture anchor
Classification Name: Fastener, fixation, biodegradable, soft tissue (21 CFR 888.3030)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Soft Tissue Screw and Washer (K012572) ●
Device Description:
Preparation Date:
The Hitch™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolide resorbable material, preloaded with #2 polyethylene surgical sutures. The disign enables the user to insert the implantable anchor by pushing the tip into the bone either through a pre-drilled hole, or by screwing it in through a tapped pre-drilled hole.
Intended Use:
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromio:lavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral ligament repair, posterior oblique ligament repair, joint capsule closure, illotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Summary of Technologies: The Hitch™ LactoScrb® Suture Anchor has similar or identical technological characteristics (design, materials, and functional performance) as the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the anchors are substantially equivalent to predicate anchors with similar indications for use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Arthrotek, Inc.
MAILING ADDRESS PO. Box 587 Warsaw, IN 46581 05837
트
SHIPPING ADDRESS 56 D. Bell Drive Warsaw, IN 46582
搜
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574267-137
IC MAIL biomet@biomet.com
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2006
Arthrotek, Inc. % Biomet, Manufacturing Corp. Mr. Lester F. Padilla Regulatory Affairs Associate P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K061657
Trade/Device Name: Hitch™ LactoSorb® Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC Dated: May 25, 2006 Received: June 13, 2006
Dear Mr. Padilla:
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
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Page 2 – Mr. Lester F. Padilla
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, 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,
Sincerely yours,
Barbara Buehrle
for
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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Indlications for Use
510(k) Number (if known): K061657
Device Name: Hitch™ LactoSorb® Suture Anchar
Indications for Use:
Indications for the Hitch™ LactoSorb® Suture Anchor include use in soft tissue reattachment Indications for the meet - Eactober books, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction
Elbow: Tennis elbow repair, Biceps tendon reconstruction, medial and lateral repairs, ulnar or radial collateral ligament reconstruction.
Knee: Extracapsular repair: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair, vastus medialis obliquus (VMO) muscle advancement.
Prescription Use X (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)
estorative.
510(k) Number K061657
Page 1 of 1
§ 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.