(108 days)
The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
The provided text refers to a 510(k) summary for a medical device called the "MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE)". This document is a premarket notification to the FDA, not a study report. It states that the device is substantially equivalent to a previously cleared predicate device based on performance data and a comparison to established standards. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study set.
However, based on the information available in the 510(k) summary, here's an attempt to structure an answer, highlighting what is and is not present:
The provided document is a 510(k) summary for a medical device and thus does not describe a clinical study in the typical sense with discrete acceptance criteria and a detailed study report. Instead, it demonstrates substantial equivalence to a predicate device based on compliance with recognized standards.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria from a clinical study for device performance. Instead, it states that the device conforms to established industry standards:
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples | Device conforms to this standard. |
| ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants | Device conforms to this standard. |
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 provided in the 510(k) summary. The document focuses on material and design conformance to standards, not a specific clinical testing sample.
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 provided in the 510(k) summary, as it describes a regulatory submission based on engineering and material standards, not a clinical study involving expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
An MRMC study is not mentioned and is not relevant to this type of device (a bone fastener) or the context of a 510(k) submission based on substantial equivalence through material and design standards. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the described medical device, which is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the conformance to established engineering and material standards. This is verified through laboratory testing against the specifications outlined in ASTM F564-02 and ASTM F2063-05. The document does not refer to clinical outcomes or expert consensus for "ground truth" in the context of diagnostic accuracy.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device or the regulatory submission. There is no machine learning model involved that would require a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set mentioned or implied.
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ﻜﻢ ﺍﻟﺘﻲ ﺗﻜﻮﻥ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ K112197
SECTION 5: 510(K) SUMMARY
NOV 1 7 2011
ﺮ ﺍﻟﻤ
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
| Submitter | MEMOMETAL TECHNOLOGIESCampus de Ker Lann - Rue Blaise Pascal35170 BRUZ - FrancePhone : + 33 (0)2 99 05 50 66Fax :+ 33 (0)2 99 05 95 62 |
|---|---|
| Contacts | Gilles AUDIC Quality ManagerBernard PRANDI General Managere-mail: gilles.audic@memometal.combernard.prandi@memometal.com |
| 510K number | K070598 |
| Preparation date | 05/25/2011 |
| Trade Name | MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) new device designs |
| Common Name | INTRAMEDULLARY BONE FASTENER |
| Classification Name | Smooth or threaded metallic bone fastener |
| Legally marketed predicate devices | K070598 MEMOMETAL Intramedullary Bone Fastener Smart Toe & X-Fuse |
| Description | MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy. |
| Intended Use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion |
| Indication for use | The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion |
| Performance data | The MEMOMETAL INTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) new device designs conform to ASTM F564-02 (2006) Standard Specification and |
| Test Methods for Metallic Bone Staples and to ASTM F2063-05 | |
| Standard Specification for Wrought Nickel-Titanium Shape | |
| Memory Alloys for Medical Devices and Surgical Implants. | |
| Substantial equivalence | The MEMOMETAL INTRAMEDULLARY MEMORY BONEFASTENER (SMART TOE & X-FUSE) new device designs aresubstantially equivalent to their predicate device MEMOMETALINTRAMEDULLARY MEMORY BONE FASTENER (SMART TOE &X-FUSE) (K070598) in terms of intended use and indicationsfor use, design and function and in term of material. Anyminor differences between these two devices do not raisenew questions of safety and effectiveness. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 17 2011
Memometal Technologies % Mr. Gilles Audic Campus de Ker Lann - Rue Blaise Pascal 35170 BRUZ - France
Re: K112197
Trade/Device Name: Memometal Intramedullary Bone Fastener (Smart Toe & X-Fuse) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: October 20, 2011 Received: October 20, 2011
Dear Mr. Audic:
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
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Page 2 - Mr. Gilles Audic
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ycm115809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Eunice 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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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE & X-FUSE) .
Indications for Use:
The MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
Prescription Use >| Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Owens for MXM
Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112197
§ 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.