(85 days)
The DePuy Mitek MILAGRO BR Interference Screws are designed to attach soft tissues to bone in orthopedic surgical procedures for following indications: Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repair Knee: Collateral Ligament Repair
The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). Modular Drivers, Ratchet Handle, Guidewires, a Tap and Notcher are provided separately as reusable accessories to assist in the placement of the MILAGRO BR Screw. The proposed DePuy Mitek Milagro® Interference Screws are offered in diameters of 5, 6mm and in the length of 12mm.
The provided text describes the DePuy Mitek Milagro® Interference Screws and their substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study designed to prove the device meets specific acceptance criteria in the context of an AI/ML model for medical diagnosis or prognosis.
The document is a 510(k) summary for a medical device (interference screws) seeking clearance from the FDA. The "acceptance criteria" and "study" described in the prompt refer to the typical evaluation process for AI/ML-driven medical devices, often involving performance metrics like sensitivity, specificity, AUC, and comparison to human expert performance. This document, however, focuses on the physical and mechanical properties of the interference screws and their intended use.
Here's a breakdown of why the requested information cannot be extracted from the provided text, followed by what can be extracted:
Why the Requested Information (for an AI/ML Model) Cannot Be Provided:
- No AI/ML Model: The document describes a physical medical device (implants), not a software algorithm or AI/ML model. Therefore, concepts like "acceptance criteria for an AI model," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "training set," or "ground truth for training set" are not applicable to the content provided.
- Focus on Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This involves comparing technological characteristics, materials, and indications for use, often supported by non-clinical (bench) testing, rather than clinical efficacy studies in the way an AI/ML device would be evaluated.
Information Extracted from the Provided Text (Relevant to the Medical Device itself):
Since the prompt asks for a table of acceptance criteria and reported device performance, and the document is about a physical device's non-clinical testing, I will interpret "acceptance criteria" as the performance metrics evaluated during the non-clinical testing and "reported device performance" as the implication that these tests demonstrated substantial equivalence. However, specific numerical targets (e.g., "pullout strength > X N") are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance Metric) | Reported Device Performance (as implied by FDA Substantial Equivalence) |
|---|---|
| Insertion Torque | Demonstrated substantial equivalence to predicate devices. |
| Anchor Pullout (at T=0, 3, 6 and 12 week in-vitro physiological aging) | Demonstrated substantial equivalence to predicate devices. |
| Torque to Failure | Demonstrated substantial equivalence to predicate devices. |
Note: The document states, "Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices." It does not provide specific numerical values for the acceptance criteria or the device's performance, but rather confirms that the device met the necessary standards for substantial equivalence based on these non-clinical tests.
The remaining numbered points (2 through 9) are explicitly related to evaluating an AI/ML model, which this document does not describe. Therefore, the answer for those points is that the information is Not Applicable or Not Provided in the context of this medical device submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes non-clinical (bench) testing of a physical implant, not an AI/ML model evaluated with a test set of data. The "test set" would be the screws themselves and the materials used in the bench tests (e.g., bone surrogates). The sample sizes for these bench tests are not specified, nor is the provenance of the materials used.
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)
- Not Applicable / Not Provided. This concept relates to human expert annotation for AI/ML ground truth. For this physical device, "ground truth" would be the objective results of the mechanical tests, not expert consensus on images or other data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are used to resolve disagreements among human experts providing ground truth for AI/ML models. This is not relevant to the non-clinical testing of an orthopedic implant.
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 / Not Provided. An MRMC study evaluates the performance of human readers, sometimes with and without AI assistance. This document pertains to a physical medical device and does not involve human readers or AI assistance in its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided. This refers to the standalone performance of an AI algorithm. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Mechanical Test Results. For the non-clinical testing described (Insertion Torque, Anchor Pullout, Torque to Failure), the "ground truth" would be the objective, quantifiable measurements obtained from the mechanical tests performed on the implant, not expert consensus or pathology in a clinical context.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no "training set" or corresponding ground truth establishment process for this physical device.
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Image /page/0/Picture/1 description: The image shows the DePuy Synthes logo. The logo consists of the word "DePuy" in bold black letters, with a black circle to the left of the word. Below the word "DePuy" is the text "Synthes" in a smaller font. To the right of the logo is the tagline "never stop moving" in a smaller font.
5, 6x12mm MILAGRO INTERFERENCE SCREWS
DEC =1-3-2012
ATTACHMENT 1
5 10(k) SUMMARY - DEPUY MITEK MILAGRO* INTERFERENCE SOREWS
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Kristine Christo DePuy Mitek Regulatory Affairs
| TELEPHONE | 508-828-3359 |
|---|---|
| FACSIMILE | 508-977-6911 |
| KChristo@its.jnj.com | |
| DATE PREPARED | September 18th, 2012 |
NAME OF MEDICAL DEVICE
CLASSIFICATION NAME Fastener, Fixation, Biodegradable, Soft Tissue
COMMON/USUAL NAME
Bone Anchor
PROPRIETARY NAME
DePuy Mitek Milagro® Interference Screws
:
SUBSTANTIAL EQUIVALENCE
The proposed 6, 7 and 8 x15mm DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices.
FDA PRODUCT CODE
MAI, HWC
DEVICE CLASSIFICATION
This type of fixation screw was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or Threaded Metallic Bone Fixation Fastener.
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Image /page/1/Figure/1 description: The image contains the logo for DePuy Synthes, a company specializing in medical devices. The logo features the company name in bold, with the tagline "never stop moving" in smaller font to the right. A black circle is positioned to the left of the company name. The overall image appears to be a cropped section of a larger document or advertisement.
5, 6x12mm MILAGRO INTERFERENCE SCREWS
ATTACHMENT 1
Continues ...
5 I 0(k) SUMMARY - DEPUY MITEK MILAGRO® INTERFERENCE SOREWS
DEVICE DESCRIPTION
The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
Modular Drivers, Ratchet Handle, Guidewires, a Tap and Notcher are provided separately as reusable accessories to assist in the placement of the MILAGRO BR Screw.
The proposed DePuy Mitek Milagro® Interference Screws are offered in diameters of 5, 6mm and in the length of 12mm.
INDICATIONS FOR USE
The DePuy Mitek MILAGRO BR Interference Screws are designed to attach soft tissues to bone in orthopedic surgical procedures for following indications: Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repair Knee: Collateral Ligament Repair
TECHNOLOGICAL CHARACTERSTICS
The design specifications of the proposed DePuy Mitek Milagro® Interference Screws are substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K120589, K103831, K060830 and K032717 except that the proposed DePuy Mitek Milagro® Interference Screws are smaller in size. Technological characteristics including design construct, and indications are similar to the predicate devices. There have been no changes to the material used to manufacture the product, packaging, and or to the sterilization processes, sterilization contractors; these are identical to that used for the currently marketed DePuy Mitek Milagro® Interference Screw (previously cleared by the FDA under the premarket notification K032717, K060830, K103831 and K120589).
NONCLINICAL TESTING
Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 3, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.
SAFETY AND PERFORMANCE
Results of performance and safety testing have demonstrated that the nronosed device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Small Size DePuy Mitek Milagro® Interference Screws have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The image is a close-up of the text.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-002
DePuv Mitek, A Johnson & Johnson Company % Ms. Kristine Christo Regulatory Affairs Manager 325 Paramount Drive Raynham, Massachusetts 02767
Letter dated: December 13, 2012
Re: K122869
Trade/Device Name: 5, 6x12mm Milagro Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: September 18, 2012 Received: September 19, 2012
Dear Ms. Christo:
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 - Ms. Kristine Christo
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/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 yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image contains the DePuy Synthes logo. The logo includes the company name "DePuy" in a stylized font, along with the tagline "never stop moving". The logo also includes a small graphic element, possibly a stylized representation of a joint or bone structure, which is a common theme for medical device companies specializing in orthopedics.
ATTACHMENT 2
INDICATIONS FOR USE
510(k) Number (if known): K122869
Device Names: 5, 6x12mm Milagro® Interference Screws
Indications for Use:
The DePuy Mitek MILAGRO BR Interference Screws are designed to attach soft tissues to bone in orthopedic surgical procedures for following indications:
Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament repair
Knee: Collateral Ligament Repair
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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) Page 1 of _ |
Casey Hanley
For Division of Orthopaedic Devices
§ 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.