(145 days)
Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
The 3.7mm / 5.0mm Dynamic Locking Screws are similar to locking screws, but feature a pin-in sleeve design. This design allows for micro movement within the angularly stable system and the screw-plate interface. The motion is contained within the DLS. The DLS are designed to be used with all applicable legally marketed Synthes Locking Compression Plates (LCP).
The provided text is a 510(k) summary for the Synthes 3.7mm / 5.0mm Dynamic Locking Screws. It details the device, its intended use, and substantial equivalence to predicate devices, but it does not describe acceptance criteria for an AI/ML powered device or a study comparing its performance to those criteria.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not present in the provided text.
The document describes the device, its intended use, and the basis for its substantial equivalence to predicate devices, focusing on mechanical and functional testing for a traditional physical medical device, not software or AI/ML. The "acceptance criteria" discussed are in the context of demonstrating mechanical strength and functional properties comparable to predicate devices.
Summary of what is present in the document:
- Device: Synthes 3.7mm / 5.0mm Dynamic Locking Screws, designed to allow micro-movement within an angularly stable system.
- Intended Use: In combination with Synthes Locking Compression Plates (LCP) for long bone fractures, fixation of osteopenic bone, osteotomies, non-unions, and malunions.
- Proof of Concept/Substantial Equivalence: Functional and mechanical testing was conducted to demonstrate comparable mechanical and functional properties to predicate devices.
- Specific tests mentioned: fatigue strength, insertion torque, fretting corrosion, and pullout resistance.
- An in vivo ovine tibial osteotomy model was used to demonstrate a lack of adverse effects on bone healing compared to a predicate device.
To reiterate, none of the information requested regarding AI/ML device performance criteria or studies is available in this 510(k) summary.
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K11 0592(i/2)
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JUL 25 2011
5.0 - 510(k) Summary or 510(k) Statement
| Date Prepared: | 7/22/2011 |
|---|---|
| Purpose for Submission: | To introduce a new dynamic screw system (3.7mm / 5.0mm Dynamic LockingScrews) into interstate commerce. |
| Sponsor: | SynthesChristopher Hack, Esq.1301 Goshen ParkwayWest Chester, PA 19380Tel: 610-719-6940Fax: 484.356.9682 |
| Device Name: | 3.7mm / 5.0mm Dynamic Locking Screws |
| Classification: | Class II888.3030 - smooth or threaded metallic bone fixation fastenerHWC |
| Predicate Device: | K101696 - Zimmer Motion Loc Screw for NCB Polyaxial Locking PlateSystemK961413 - Synthes Anatomical Locking Plate SystemK963192 - Synthes 3.5/4.0mm Cannulated ScrewsK000682 - Synthes Large Fragment Dynamic Compression LockingSystemK000684 - Synthes Small Fragment Dynamic Compression LockingSystem |
| Device Description: | The 3.7mm / 5.0mm Dynamic Locking Screws are similar to lockingscrews, but feature a pin-in sleeve design. This design allows for micromovement within the angularly stable system and the screw-plateinterface. The motion is contained within the DLS. The DLS are designedto be used with all applicable legally marketed Synthes LockingCompression Plates (LCP). |
| Intended Use: | Synthes Dynamic Locking Screws (DLS) in combination with SynthesLocking Compression Plates (LCP) are intended for use in long bonefractures, the fixation of osteopenic bone, the fixation of osteotomies, andfor the fixation of non-unions and malunions. |
| SubstantialEquivalence: | The features of the subject components are substantially equivalent to thepredicate devices based on similarities in intended use and design.Mechanical testing demonstrates substantial equivalence of the subjectcomponents to the predicate device in regards to mechanical strength. Inaddition, the intended use, manufacturing methods, packaging, andsterilization of the predicate and subject components are identical. |
| Functional and mechanical testing demonstrates the comparablemechanical & functional properties of the subject device: 3.7mm / 5.0mmDynamic Locking Screws to the predicate devices. | |
| Testing conducted to support the substantial equivalence for the 3.7mm / |
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K110592(2/2
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5.0mm Dynamic Locking Screws was aimed to assess the fatigue strength of the subject device. The Dynamic Locking Screws were tested evaluated in fatigue, insertion torque, fretting corrosion, and pullout resistance.
Testing using an ovine tibial osteotomy model was conducted to demonstrate lack of adverse effect on bone healing as compared to a predicate device.
The results of the evaluations confirm that the subject device is substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes % Mr. Christopher Hack, Esq. Senior Regulatory Specialist 1301 Goshen Parkway West Chester, Pennsylvania
JUL 25 2011
Re: K110592
Trade/Device Name: 3.7mm/5.0mm Dynamic Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HWC Dated: June 22, 2011 Received: June 24, 2011
Dear Mr. Hack:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Christopher Hack, Esq.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eino Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment E - Indications for Use Statement
510(k) Number (if known):
3.7mm / 5.0mm Dynamic Locking Screws Device Name:
Indications for Use:
Synthes Dynamic Locking Screws (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Diff) (Division Sign-Dir))
Division of Surgical, Orthopedic, Division of Style
and Restorative Devices
510(k) Number K110592
AZ
§ 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.