(286 days)
For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
The provided text describes the "Memory Staple™" device and a study performed to demonstrate its substantial equivalence to predicate devices, but it does not detail acceptance criteria in the typical sense of a diagnostic device or AI algorithm, nor does it present a study that proves the device meets specific performance thresholds in that context.
Instead, the document is a 510(k) summary, focusing on demonstrating substantial equivalence for a medical device. The "study" mentioned here is a mechanical test and a clinical observation that supports this claim, rather than a clinical trial designed to prove diagnostic performance against set criteria for an AI tool.
Therefore, many of the requested categories for AI/diagnostic studies (like MRMC, ground truth establishment, training set details) are not applicable to this submission.
Here's an attempt to answer based on the provided text, adapted to the context of a medical device submission demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable as an "AI/diagnostic acceptance criteria" table. The substantial equivalence argument for the Memory Staple relies on:
- Intended Use: Similar to predicate devices.
- Material: Nickel-Titanium shape memory alloy (similar to one predicate).
- Mechanical Strength: Demonstrated to be stronger than a predicate device.
- Clinical Use Observation: Successful in a reported series.
| Acceptance Criteria (Proxy for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Bone fixations of osteotomies and arthrodeses of specific foot bones and joints. | Memory Staple: Intended for bone fixations of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot. (Matches predicate devices: Landos Standard Staple, Stryker Osteoclasp, Mitek Anchor II™ for bone fixation). |
| Material: Similar to a predicate device. | Memory Staple: Made of shape memory Nickel-Titanium alloy. (Similar to Mitek Anchor II™). |
| Mechanical Strength: At least equivalent to predicate devices. | Memory Staple: "had more than twice the strength of the Landos Staple" in prong separation tests. |
| Clinical Performance: Effective in clinical application (similar to predicates). | Memory Staple: "Successful clinical use... in 315 osteotomies of the great toe between 1991-1994 was reported by Barouk in 1994." |
Since this is not an AI/diagnostic study, the following points are largely not applicable.
2. Sample size used for the test set and the data provenance
- Mechanical Test: "Prong separation tests were performed on the Memory Staple and the Landos Standard Staple." The sample size for these tests is not specified in the document.
- Clinical Observation: 315 osteotomies of the great toe.
- Data Provenance: The document does not specify the country of origin for the clinical observation data, but it refers to a report by "Barouk in 1994." It is retrospective, as it covers use between 1991-1994.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For the mechanical test, the "ground truth" is a measurement of force. For the clinical observation, "successful use" would likely be determined by the treating physician (Barouk). No panel of experts for ground truth establishment is mentioned.
4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned for the mechanical tests or the clinical observation.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
- Mechanical Test: Direct physical measurement (prong separation strength).
- Clinical Observation: Physician-reported "successful clinical use," which implicitly refers to positive patient outcomes in the context of the device's function.
8. The sample size for the training set
Not applicable. This is not an AI device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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Kaluzak
| SUMMARY OF SAFETY AND EFFECTIVENESS |
|---|
| ------------------------------------- |
AUG - 5 |997
| MANUFACTURER IDENTIFICATION: | Medinov-AMP27 à 31 rue Lucien Langenieux42335 Roanne FRANCE |
|---|---|
| ESTABLISHMENT REGISTRATIONNUMBER (Manufacturer): | 9681744 |
| SPONSOR IDENTIFICATION: | Cheryl HastingsDePuy, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46580 |
| ESTABLISHMENT REGISTRATIONNUMBER (Sponsor): | 1818910 |
| PROPRIETARY NAME: | Memory Staple™ |
| PRODUCT CLASSIFICATION CODE: | 87JDR |
| PROPOSED REGULATORY CLASS: | Class II |
DESCRIPTION:
The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.
INTENDED USE AND INDICATIONS:
The Memory Staple is intended for bone fixations of osteotomies and arthrodeses of the mid-foot bones, the metatarsals, the phalanges, and associated joints of the foot
PREDICATE DEVICES:
The Memory Staple is substantially equivalent to: 1) The Landos Standard Staple 2) The Stryker Osteoclasp 3) The Mitek Anchor II™
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Memory Staple, the Landos Standard Staple and the Stryker Osteoclasp are all intended for bone fixation. The Memory Staple and the Mitek Anchor II are both manufactured from Nickel-Titanium shape memory alloy.
SUMMARY OF STUDIES:
Prong separation tests were performed on the Memory Staple and the Landos Standard Staple. The results showed that the Memory Staple had more than twice the strength of the Landos Staple. Successful clinical use of the Memory Staple in 315 osteolomies of the great toc between 1991-1994 was reported by Barouk in 1994.
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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 with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Manager Clinical Affairs DePuy, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K964226 Re : Trade Name: Memory Staple Requlatory Class: II Product Code: JDR Dated: May 30, 1997 Received: June 2, 1997
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਮ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
AUG - 5 1997
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Page 2 - Ms. Cheryl Hastings
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberrood in your sion, privalence 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page
ONFIDENTIAL
Indications For Use:
For Fixing the osteotomies and arthrodesis
of the mid fout bones, the metatarsals, the
phalanges, and associated joints of the foot.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K964226
Prescription Use ✗
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.