(144 days)
The MEMOMETAL Micro ARIM® is indicated for
- Hand: Ligament reconstruction
- Ankle: Midfoot reconstruction
- Foot: Hallux Valgus reconstruction
- Wrist: Scapholunate Ligament reconstruction
- Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence
MEMOMETAL Micro ARIM® anchors are single-use bone fixation appliances intended to be permanently implanted. Micro ARIM® anchors made of shape memory nickel titanium alloy. MEMOMETAL Micro ARIM anchors can be used in 2 versions with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed below: Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester suture (K012201) Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire suture (K041589) MEMOMETAL Micro ARIM® Anchors adopt an opened position after introducing into bone which allows a permanent fixation, thus supporting a secure ligament restoration.
The provided text is a 510(k) Premarket Notification for a medical device (MEMOMETAL Micro ARIM® anchor), not a study assessing AI software performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to a predicate device based on material, design, function, and intended use, rather than presenting a clinical study with detailed performance metrics against acceptance criteria that would typically be associated with software or AI claims.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against a clinical outcome. It focuses on conforming to a material standard and substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. This document does not describe a clinical study with a test set.
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)
- Cannot be extracted. This document does not describe a clinical study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. This document does not describe a clinical study with an adjudication method.
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
- Cannot be extracted. This document is for a physical bone anchor, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. This document is for a physical bone anchor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. This document does not describe a clinical study requiring ground truth.
8. The sample size for the training set
- Cannot be extracted. This document does not describe an AI training set.
9. How the ground truth for the training set was established
- Cannot be extracted. This document does not describe an AI training set or its ground truth establishment.
What can be inferred from the document regarding "acceptance criteria" and "study":
The document focuses on demonstrating that the MEMOMETAL Micro ARIM® anchor meets general safety and effectiveness requirements by:
- Material Conformance: "THE MEMOMETAL Micro ARIM® conform to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants." This is the primary acceptance criterion explicitly stated for the material. The "study" proving this would be material testing to verify compliance with this ASTM standard.
- Substantial Equivalence: "[THE MEMOMETAL Micro ARIM®] are substantially equivalent to their predicate devices MITEK MiniQUICKANCHOR Plus in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness." This is the overarching "acceptance criterion" for 510(k) clearance. The "study" demonstrating this involves a comparison of the new device to the predicate across various attributes as detailed in the submission, confirmed by the FDA's review.
In summary, for K071941, the "acceptance criteria" revolve around conforming to an industry standard for the material and demonstrating substantial equivalence to a legally marketed predicate device, rather than specific clinical performance metrics from a device-specific study against a defined ground truth.
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510k Premarket Notification Bone anchors MEMOMETAL TECHNOLOGIES
Annexe 1bis
SECTION 5: 510(K) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
| Submitter | MEMOMETAL TECHNOLOGIES | |
|---|---|---|
| Campus de Ker Lann - Rue Blaise Pascal | ||
| 35170 BRUZ - France | ||
| Phone : + 33 (0)2 99 05 50 66 | ||
| Fax :+ 33 (0)2 99 05 95 62 | ||
| Contacts | Gilles AUDIC Quality Manager | DEC 0 4 2007 |
| Bernard PRANDI General Manager | ||
| e-mail: gilles.audic@memometal.com | ||
| bernard.prandi@memometal.com | ||
| Preparation date | 07/04/2007 | |
| Trade Name | MEMOMETAL Micro ARIM® anchor | |
| Common Name | Bone Anchor | |
| Classification Name | Smooth or threaded metallic bone fixation fastener. | |
| Legally marketedpredicate devices | K992487 MINI QUICKANCHOR PLUS (MITEK) | |
| Description | MEMOMETAL Micro ARIM® anchors are single-use bone | |
| fixation appliances intended to be permanently implanted. | ||
| Micro ARIM® anchors made of shape memory nickel titaniumalloy. | ||
| MEMOMETAL Micro ARIM anchors can be used in 2 versions | ||
| with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed | ||
| : below: | ||
| Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester | ||
| suture (K012201) | ||
| Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire | ||
| suture (K041589) | ||
| MEMOMETAL Micro ARIM® Anchors adopt an opened | ||
| position after introducing into bone which allows a permanent | ||
| fixation, thus supporting a secure ligament restoration. | ||
| Indication for use | The MEMOMETAL Micro ARIM® is indicated forHand: Ligament reconstructionAnkle: Midfoot reconstructionFoot: Hallux Valgus reconstructionWrist: Scapholunate Ligament reconstructionPubis: Fixation in the pubis for bladder neck suspension toresolve stress urinary incontinence | |
| Performance data | THE MEMOMETAL Micro ARIM® conform to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium ShapeMemory Alloys for Medical Devices and Surgical Implants. | |
| Substantial equivalence | THE MEMOMETAL Micro ARIM® are substantially equivalentto their predicate devices MITEK MiniQUICKANCHOR Plus interms of intended use and indications for use, material, designand function. Any minor differences between these twodevices do not raise new questions of safety andeffectiveness. |
41
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510k Premarket Notification Bone anchors MEMOMETAL TECHNOLOGIES
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
DEC 0 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Memometal Technologies % Mr. Gilles Audic Quality Manager/ Director Campus de Ker Lann - Rue Blaise Pascal Bruz, France F35170
Re: K071941 Trade/Device Name: Memometal Micro ARIM® anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MBI Dated: November 15, 2007 Received: November 16, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Gilles Audic
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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pqc.fl
510k Premarket Notification bone anchors MEMOMETAL TECHNOLOGIES
INDICATIONS FOR USE
510(k) Number (if known): K071941
Device Name: MEMOMETAL MICRO ARIM® BONE ANCHOR
Indications for Use:
The MEMOMETAL Micro ARIM® is indicated for
- Hand: ligament reconstruction -
- Ankle: Midfoot reconstruction -
- Foot: Hallux Valgus reconstruction -
- Wrist: Scapholunate Ligament reconstruction -
- Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence
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)
Alush A. Mella
-11-Off Division S Division of General and Neurologic
510(k) Number K071941
Page 10
§ 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.