(88 days)
The TIGER TRACK® screw system is intended for small bone extremity and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile.
The TIGER TRACK® screw system, diameters 3.5mm or smaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalangeal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia.
The size of the chosen screw should be adapted to the specific indication.
The TIGER TRACK® screw system is not for spinal use.
The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated
The TIGER TRACK® screw system is intended for single use only, and is available in a range of different diameters, lengths and materials depending on the indication. The TIGER TRACK® screw system has two categories of screws: self-compressive screws and non-compressive screws.
The self-compressive screws have a distal and proximal thread, separated by a cylindrical shaft where the fracture or osteotomy line should be placed. The difference of pitch between the distal and proximal thread provides compression between both segments. The TIGER TRACK® snap-off Weil screw doesn't have a proximal thread, the compression is done by its head and the distal thread. The non-compressive screws have a full thread allowing surgeons to only link both segments without any compression.
All devices of the TIGER TRACK® screws system are monobloc components. The TIGER TRACK® screw system PEEK range is manufactured dry with grades of PEEK (Zeniva ZA-500) per ASTM F-2026 from Solvay Advanced Polymers released with predicate K133036, Titanium range is made of alloyed Titanium ISO 5832-3 / ASTM F-136 and released with predicate K131722, Snap-off threaded pin HV18XX range is made of Cobalt Chrome according to the ISO 5832-7 / ASTM F-1058 and released with predicate K120739.
The feature design of the TIGER TRACK® screw system is substantially equivalent to the design features of other devices previously cleared for market.
The provided document is a 510(k) premarket notification for the Synchro-Medical TIGER TRACK® Screw System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials or detailed performance studies with acceptance criteria as might be seen for novel devices or software.
Therefore, the information you've requested regarding acceptance criteria and performance against those criteria, as well as details about ground truth, expert adjudication, MRMC studies, and training/test set sample sizes, is largely not applicable or not provided in this document as it pertains to a medical device where performance is proven through physical testing rather than AI accuracy.
However, I can extract the information that is present concerning the non-clinical tests performed:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pullout force | Not explicitly stated in the document | "met the acceptance criteria" |
| Torsional Strength | Not explicitly stated in the document | "met the acceptance criteria" |
The document states, "The results of these studies showed the TIGER TRACK® Screw System met the acceptance criteria," but it does not specify what those criteria were (e.g., minimum pullout force in Newtons, minimum torsional strength in N-m).
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: Not specified in the document for the non-clinical tests.
- Data Provenance: The document describes non-clinical laboratory testing (mechanical tests). This means the "data" is derived from physical test specimens. The manufacturer is Synchro Medical, located in France.
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)
This is not applicable. The device is a surgical screw system, and its performance is evaluated through mechanical testing, not by expert interpretation of images or other data that would require a "ground truth" established by experts in the context of diagnostic AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to expert review processes, which are not relevant for the mechanical testing of a surgical screw.
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 type of study is relevant for diagnostic AI or imaging systems, not for a surgical screw system. The document explicitly states: "No clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical tests would be the actual physical properties measured by scientific instruments, compared against established standards (e.g., ASTM F564-10 for pullout force, ASTM F-543 for torsional strength).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical testing for a surgical implant device.
9. How the ground truth for the training set was established
Not applicable.
In summary, the document details a 510(k) submission for a physical medical device (surgical screw system) that relies on non-clinical mechanical testing for "substantial equivalence." The concepts of AI performance, ground truth, expert adjudication, and training/test sets as you've outlined are generally not relevant to this type of device and submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Synchro Medical % Mark F. Schenk Mark F. Schenk Consulting 505 Berks Place West Lawn, Pennsylvania 19609
Re: K151241
Trade/Device Name: Synchro-Medical TIGER TRACK® Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 8, 2015 Received: June 9, 2015
Dear Mr. Schenk:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Synchro-Medical TIGER TRACK® Screw System
Indications for Use (Describe)
The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/ arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK @ screw system is intended to be permanently implanted without any other additional device and are delivered sterile.
The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.9mm), 3.0mm), is indicated for use in fixation for small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, tibeo-talar fusions, and cuboid fusions.
The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication.
The TIGER TRACK ® screw system is not for spiral use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | |
| Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | Department of Health and Human Services |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number " |
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Traditional 510(k) Summary
as required by section 807.92(c).
Synchro-Medical TIGER TRACK® Device K151241
| Submitter: | Synchro Medical6 rue des MerisiersF-68920 Wettolsheim les ErlenFRANCE |
|---|---|
| Contact Person | Danilo CampaniPresidentPhone: +33(0)3 89 23 75 64Fax:+33(0)3 89 27 14 52Email: dcampani@synchro-medical.com |
| Date Prepared | 07/07/2015 |
| Device Class | Class II |
| Trade Name | TIGER TRACK®. |
| Common Name | Synchro-Medical TIGER TRACK® Screw System |
| Classification Nameand Number | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | HWC |
| Predicate Devices | (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws;(K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex,TRIMit Family; (K071540) Small Bone Innovations International, SBITitanium Threaded Pin, Percufix; (K041456) & (K070617), FournituresHospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389),Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., HeadlessCannulated Screw System; (K132912) In2Bones, DUAFIT InterphalangealImplant; (K130859), Arthrosurface, Hammertoe Correction System,(K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System;(K133036) Amendia, Apollo Suture Anchor System, (K133235) ThreadedPeek K-Wire MTP Solutions, and (K022599) Newdeal K Wire. |
| Previous Submissions | There are no previous submissions |
| Device Description | The TIGER TRACK® screw system is intended for single useonly, and is available in a range of different diameters, lengthsand materials depending on the indication. The TIGERTRACK® screw system has two categories of screws: self-compressive screws and non-compressive screws.The self-compressive screws have a distal and proximal thread,separated by a cylindrical shaft where the fracture or osteotomyline should be placed. The difference of pitch between the distaland proximal thread provides compression between bothsegments. The TIGER TRACK® snap-off Weil screw doesn'thave a proximal thread, the compression is done by its head andthe distal thread. The non-compressive screws have a full threadallowing surgeons to only link both segments without anycompression.All devices of the TIGER TRACK® screws system aremonobloc components. The TIGER TRACK® screw systemPEEK range is manufactured dry with grades of PEEK (ZenivaZA-500) per ASTM F-2026 from Solvay Advanced Polymersreleased with predicate K133036, Titanium range is made ofalloyed Titanium ISO 5832-3 / ASTM F-136 and released withpredicate K131722, Snap-off threaded pin HV18XX range ismade of Cobalt Chrome according to the ISO 5832-7 / ASTMF-1058 and released with predicate K120739.The feature design of the TIGER TRACK® screw system issubstantially equivalent to the design features of other devicespreviously cleared for market. |
| Intended Use /Indications | The TIGER TRACK® screw system is intended for small boneextremity and large/long bone reconstructionfixation/arthrodesis procedures for general use in skeletallymature individuals. The TIGER TRACK® screw system isintended to be permanently implanted without any otheradditional device and are delivered sterile.The TIGER TRACK® screw system, diameters 3.5mm orsmaller (1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicatedfor use in fixation small bone fractures or for small bonereconstruction including: mono or bicortical osteotomies in thefoot or hand; distal or proximal metatarsal or metacarpalosteotomies; Weil osteotomy; fusion of the firstmetatarsalphalangeal joint and interphalangeal joint; fixation ofosteotomies for Hallux Valgus treatment (such as Scarf,Chevron, etc.); Akin type osteotomy; distal radius fractures(articular fragments). ulnar styloid fractures, radial headfractures, capirellumn fractures, humeral head fractures, glenoidfractures, intercarpal distal and proximal fusions, malleolarfractures, patellar fractures, osteochondral fractures,talonavicular fusions, tibeo-talar fusions, and cuboid fusions.The TIGER TRACK® screw system, for diameters 4.5mm and7.0mm, is indicated for use for fractures, correctiveosteotomies, pseudoarthrosis, degenerative transformations oflong bones in the hind foot and large bone intra-articularfractures of the humerus, femur, and tibia.The size of the chosen screw should be adapted to the specificindication.The TIGER TRACK® screw system is not for spinal use.The devices described in this manual must be accompanied witha form of immobilisation suited to the pathology being treated |
| Materials: | All devices of the TIGER TRACK® screws system aremonobloc components. The TIGER TRACK® screw systemPEEK range is manufactured dry with grades of PEEK (ZenivaZA-500) per ASTM F-2026 from Solvay Advanced Polymersreleased with predicate K133036, Titanium range is made ofalloyed Titanium ISO 5832-3 / ASTM F-136 and released withpredicate K131722, Snap-off threaded pin HV18XX range ismade of Cobalt Chrome according to the ISO 5832-7 / ASTMF-1058 and released with predicate K120739. |
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| Statement of | The purpose of this submission is to obtain market clearance for |
|---|---|
| Technological | the proposed the TIGER TRACK® Screw System. The TIGER |
| Comparison | TRACK® Screw System and its predicate devices have similar |
| indications for use and similar functionality. All devices are | |
| manufactured using materials with a long history of use in | |
| orthopaedic implants. |
| Nonclinical TestSummary | The following tests were performed to demonstrate that theTIGER TRACK® Screw System is substantially equivalent toother predicate devices. Pullout force per ASTM F564-10 Torsional Strength per ASTM F-543 The results of these studies showed the TIGER TRACK® ScrewSystem met the acceptance criteria. |
|---|---|
| Clinical Test Summary | No clinical tests were performed. |
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| Conclusion | The TIGER TRACK® Screw System is substantially equivalent |
|---|---|
| to its predicate devices. This conclusion is based upon the fact | |
| the TIGER TRACK® Screw System and its predicate devices | |
| have the same indications for use and have a similar design. |
§ 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.