(114 days)
The Lateral Button™ is intended to protect the suture / bone during transosseous fixation procedures.
The Lateral Button™ consists of an implanted Button preloaded on a disposable inserter necessary for its insertion into the bone tunnel, the inserter is removed upon completion of the procedure. The implant is made of implantable grade PEEK (polyether - etherketone). The inserter is made of Polycarbonate. The Lateral Button and its inserter will be supplied sterile for single use. The implant has an O.D. of 3.1 mm, overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threaded through the implant, which helps to distribute the pressure created by the suture and assists in the prevention of suture migration and damage to suture and/or bone. The implant will be supplied either as a stand alone device or as part of a kit i.e. with other devices already cleared for transosseous fixation procedures.
The provided text is a 510(k) Summary for the "Lateral Button™" device, which is a smooth or threaded metallic bone fixation fastener. The summary focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from the provided document. The document primarily describes the device, its intended use, and comparisons to a predicate device based on technological characteristics and design verification (static and dynamic testing).
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for performance, nor does it provide specific quantitative results of the "static and dynamic testing" beyond a general statement of "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance (static and dynamic testing). | "The performance is the same as verified by design verification. This consisted of static and dynamic testing in which the results demonstrated substantial equivalence to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "static and dynamic testing" as part of design verification, but does not specify the sample size used for these tests. The data provenance (country of origin, retrospective/prospective) is also not provided.
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 type of information is not applicable and not provided in the document, as the study described is a device performance test (static and dynamic) rather than a clinical study requiring expert assessment of outcomes or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not provided for the type of device performance testing described.
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 is not applicable. The device is a bone fixation fastener, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm. The "standalone" mentioned in the document refers to the implant being supplied as a standalone device or as part of a kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "static and dynamic testing," the "ground truth" would likely be engineering specifications, material properties, and established biomechanical testing standards for bone fixation devices. The document does not explicitly detail these "ground truth" sources, but it implies comparison to predicate device performance.
8. The sample size for the training set
This is not applicable. The device is a physical implant and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
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【12296 510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com |
|---|---|---|
| 1. | ManufacturerAddress: | T.A.G. Medical Products Corporation, Ltd.D. N. AshratKibbutz Gaaton 25130, Israel |
| Mfg. Phone: | Tel.: +972-4-985-8400 | |
| Contact Person: | Erez Adiv | |
| Date: | November 30, 2011 | |
| 2. | RegulationDescriptionDevice &Classification | Regulation number 21 CFR 888.3040Smooth or threaded metallic bone fixation fastenerDevice class: 2Product code MBI |
| 3.4. | Name:Predicate Devices:Description: | Lateral Button™K970423 - Innovasive Devices, Inc.The Lateral Button™ consists of an implanted Button preloaded on adisposable inserter necessary for its insertion into the bone tunnel, theinserter is removed upon completion of the procedure. |
| The implant is made of implantable grade PEEK (polyether - etherketone).The inserter is made of Polycarbonate. The Lateral Button and its inserterwill be supplied sterile for single use. The implant has an O.D. of 3.1 mm,overall length of 10 mm and an I.D. of 1.8 mm. In use, the suture is threadedthrough the implant, which helps to distribute the pressure created by thesuture and assists in the prevention of suture migration and damage tosuture and/or bone. The implant will be supplied either as a stand alonedevice or as part of a kit i.e. with other devices already cleared fortransosseous fixation procedures. | ||
| 5. | Intended Use: | The Lateral Button™ is intended to protect the suture / bone duringtransosseous fixation procedures |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to its indication for use, the Lateral Button is substantiallyequivalent to its predicate devices in that is intended for the same clinicalpurpose. |
| * With respect to technology, the performance is the same as verified bydesign verification. This consisted of static and dynamic testing in which theresults demonstrated substantial equivalence to the predicate device. | ||
| The material used PEEK (polyether - etherketone) is a standard materialused in surgical implant applications. | ||
| Based upon this, T.A.G. Medical Products Corporation, Ltd. believes that itsdevice is safe and effective because it performs and functions in the samemanner |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
T.A.G. Medical Products Corporation, Ltd. % MedicSense, USA Mr. George Hattub 291 Hillside Avenue Somerset, Massachusetts 02726
DEC - 1 2011
Re: K112296
Trade/Device Name: Lateral Button™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 14, 2011 Received: November 18, 2011
Dear Mr. Hattub:
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. George Hattub
forth in 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 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/ReportalProblem/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 vours.
Ernie 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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KII2296
Indications for Use
510(k) Number (if known):
Device Name: Lateral Button™
Indications For Use: The Lateral Button™ is intended to protect the suture/bone during transosseous fixation procedures.
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)
Michael Rivers for MXM
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Device
510(k) Number
§ 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.