(68 days)
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
The EXTREMITY MEDICAL Screw System
The provided text describes a 510(k) submission for the EXTREMITY MEDICAL Screw System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way a diagnostic AI/ML device would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set, ground truth) are not applicable to this type of device and submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Equivalence: Comparable pull-out strength and torque to predicate devices. | Bench testing (pull-out strength and torque) was performed and compared to predicate devices. |
| Surgical Technique Verification: Demonstrated suitability through clinical simulation. | Clinical simulations in cadavers were performed to verify the surgical technique. |
| Material Equivalence: Made of similar materials to predicate devices. | Stated: "are made of similar materials" to predicate devices. |
| Design Equivalence: Similar design to predicate devices. | Stated: "have a similar design" to predicate devices. |
| Indications for Use Equivalence: Same indications as predicate devices. | Stated: "have the same indications for use" as predicate devices. |
| Overall Substantial Equivalence: To predicate devices. | "The EXTREMITY MEDICAL Screw System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "tests" here are bench tests and cadaveric simulations, not clinical trials with human subjects.
- Data Provenance: Not applicable in the context of clinical data provenance. The bench testing and cadaveric simulations would have been performed in a lab setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not a diagnostic tool that requires ground truth establishment by experts in the same way an AI/ML device would. The "ground truth" for mechanical properties would be derived from engineering standards and measurements, and for surgical technique from established surgical practices.
4. Adjudication method for the test set
Not applicable. There was no "test set" in the sense of patient data requiring expert adjudication.
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/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (screw system), not an algorithm.
7. The type of ground truth used
For Bench Testing (pull-out strength and torque): The "ground truth" would be the measured physical properties of the predicate devices based on established engineering test methods and standards.
For Clinical Simulations in Cadavers: The "ground truth" would be the expert assessment of the surgical technique's feasibility and success in relation to the intended use, likely by orthopedic surgeons.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
Special 510(k) Summary of Safety and Effectiveness:
. ..
ﻣﻌﺘﺎﺩ: ﻣﻌﺪ
ﻬﺎ
prop
EXTREMITY MEDICAL Screw System
<121417
JUL 1 8 2012
·
... ...
11 |
| Submitter: | EXTREMITY MEDICAL. LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Jamy GannoePresidentPhone: (973) 588-8980Email: jgannoe@extremitymedical.com |
| Date Prepared | June 19, 2012 |
| Trade Name | EXTREMITY MEDICAL Screw System |
| Classification Nameand Number | Smooth or threaded metallic bone fixation fastener21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. EXTREMITY MEDICAL Screw System, Extremity Medical K0937702. EXTREMITY MEDICAL Screw System, Extremity Medical K0915773. EXTREMITY MEDICAL Midfoot Screw System, Extremity Medical K082934 |
| Device Description | The EXTREMITY MEDICAL Screw System |
| Indications for use | "The Extremity Medical Screw System is intended for fixation arthrodesis of themetatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular,calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints." |
| Statement ofTechnologicalComparison | The EXTREMITY MEDICAL Screw System and its predicate devices have thesame indications for use; have a similar design; are made of similar materials,and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength and torque was performed andcompared to the predicate devices. Clinical simulations in cadavers wereperformed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL Screw System is substantially equivalent to itspredicate devices. This conclusion is based upon indications for use, materials,design, test data and principles of operation. |
53
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Extremity Medical, LLC % Mr. Jamy Gannoe Chief Executive Officer and President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K121417
Trade/Device Name: Extremity Medical Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 27, 2012 Received: June 28, 2012
Dear Mr. Gannoe:
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
JUL 1 8 2012
{2}------------------------------------------------
Page 2- Mr. Jamy Gannoe
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/CDRHQffices/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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunice Keith
< Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
$\leftarrow$121417
Special 510(k) Premarket Notification
Indications for Use
510(k) Number (if known): Device Name:
Indications for Use:
EXTREMITY MEDICAL Screw System
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, Talonavicular, calcaneocuboid, metatarsal-phalangeal, and metacarpal-phalangeal joints.
Over-the-counter Prescription Use X AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Asht
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121417
§ 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.