(216 days)
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads. The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions: -PULLUP® for cortical tunnels having a diameter of 4.5 mm - PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm - The implant is supplied sterile, ready to use.
The provided document is a 510(k) premarket notification for a medical device called the PULLUP® Adjustable Juxtacortical Fixation Device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to establish safety and effectiveness from scratch.
Therefore, the document does not contain the detailed information on acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device, clinical trial, or diagnostic test. Instead, it demonstrates the device's performance through non-clinical performance testing to establish equivalence to predicate devices.
Here's an analysis based on the information available in the document, framed against your requested categories, with explanations for what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with corresponding performance metrics in the way one would expect for an AI/ML device or a clinical outcome study. Instead, it makes a general statement about non-clinical performance testing:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is as safe as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." |
| Device is as effective as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." |
| Device performs at least as safely and effectively as predicate devices | "Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices." and "Verification and validation tests demonstrate that the PULLUP® device is as safe, as effective, and performs as safely and effectively as its predicate device." |
The "non-clinical performance testing" would typically involve bench testing for mechanical properties (e.g., strength, fatigue, pull-out force) designed to show equivalence to the predicate devices. The specific metrics, thresholds, and results of these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore not provided. The document states, "No clinical data has been presented." The performance testing mentioned is non-clinical (i.e., bench testing, not human patient data).
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 information is not applicable. Since no clinical data or human-interpreted data is referenced, there's no ground truth established by experts in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there is no human interpretation of data requiring adjudication.
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
This information is not applicable. The device is a mechanical fixation device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a mechanical fixation device; there is no algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing, the "ground truth" would be established by validated engineering test methods and relevant ASTM/ISO standards for mechanical testing of orthopedic implants. This often involves measuring parameters like tensile strength, cyclic loading, and pull-out strength, comparing the results of the new device against the known performance of the predicate devices under identical test conditions. Specific details are not disclosed in this summary.
8. The sample size for the training set
This information is not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. There is no AI/ML algorithm requiring a training set.
In summary: The provided 510(k) summary is for a physical medical device. It relies on non-clinical performance testing to demonstrate substantial equivalence to predicate devices (Arthrex TightRope RT and Biomet ToggleLoc System) in terms of safety and effectiveness. It explicitly states that "No clinical data has been presented." Therefore, the detailed information requested regarding AI/ML device studies, human readers, ground truth establishment by experts, and clinical trial specifics (like sample size, data provenance, adjudication) is not relevant or available in this document.
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November 17, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SBM Sciences for Bio Materials Mr. Denis Clement CEO Zi Du Monge 65100 Lourdes France
Re: K151004
Trade/Device Name: PULLUP® Adjustable Juxtacortical Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 15, 2015 Received: October 15, 2015
Dear Mr. Clement:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Denis Clement
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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System
Image /page/2/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M in gray, with the words "Science & Bio Materials" written in a smaller font size below the letters. To the right of the letters are four gray triangles pointing to the right. The second triangle from the left has a blue gradient pattern.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151004
Device Name
PULLUP® Adjustable Juxtacortical Fixation Device
Indications for Use (Describe)
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publiching Sarvascer 3011 x 443-67201 FF
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SECTION 5
510(k) SUMMARY
1. GENERAL INFORMATION
| Type of 510(k) | TRADITIONAL |
|---|---|
| Trade Name | PULLUP® Adjustable Juxtacortical Fixation Device |
| CFR section | 21CFR 888.3040 |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Device panel | ORTHOPEDIC |
| Product Code | MBI |
| Class | II |
| Legally marketed predicate devices | K112990 TightRope RT manufactured by Arthrex, Inc.K130033 ToggleLoc System manufactured by BiometManufacturing Corp. |
| Submitter | SCIENCE FOR BIOMATERIALSSciences et Bio MatériauxZI du MongeF 65100 LOURDES - FRANCERegistration Number : 3004549189 |
| Contact | Denis CLEMENT, CEOTel : +33 (0)5 62 42 21 01Fax : +33 (0)5 62 42 21 00e-mail : denis.clement@sbm-fr.comRegulatory contact : Anne COSPIN-LATAPIEe-mail : anne.cospin@sbm-fr.com |
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Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System
Image /page/4/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M, with the B in a different color than the S and M. Underneath the letters is the text "Science & Bio Materials". To the right of the letters are three triangles, the middle one with a gradient pattern.
2. DEVICE DESCRIPTION
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads.
The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions:
- -PULLUP® for cortical tunnels having a diameter of 4.5 mm
- PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm -
The implant is supplied sterile, ready to use.
3. INDICATIONS FOR USE
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
4. PERFORMANCE DATA
Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices. No clinical data has been presented.
5. SUBSTANTIAL EQUIVALENCE
The PULLUP® device is substantially equivalent to its predicate devices Arthrex TightRope RT (K112990) and Biomet ToggleLoc (K130033). Verification and validation tests demonstrate that the PULLUP® device is as safe, as effective, and performs as safely and effectively as its predicate device.
Summary preparation date: October 20, 2015
§ 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.