(141 days)
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws.
This 510(k) summary describes a medical device, the EXTREMITY MEDICAL Screw System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of typical AI/software performance evaluation. The document focuses on the regulatory clearance for a physical medical implant.
However, based on the structure of your request and the provided document, I can deduce information related to regulatory acceptance and the studies performed (or not performed) for this physical medical device.
Here's an interpretation framed to address your questions as much as possible, re-interpreting "acceptance criteria" and "study" in the context of a 510(k) submission for a physical implant:
1. A table of acceptance criteria and the reported device performance
For a physical medical device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This is primarily done through showing similar indications for use, design, materials, and equivalent mechanical properties.
| Acceptance Criteria Category (for 510(k) Equivalence) | Reported Device Performance/Comparison (EXTREMITY MEDICAL Screw System) |
|---|---|
| Indications for Use | Identical to predicate devices: "fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsal-phalangeal and metacarpal-phalangeal joints." |
| Device Design | Similar design to predicate devices (two metallic components: Metacarpal (distal) screw and a Lag Screw (proximal), designed to rigidly lock at an angle). |
| Material Composition | Similar materials to predicate devices. (Exact materials not explicitly detailed in summary, but implied to be standard for bone fixation fasteners, likely titanium or stainless steel alloys). |
| Mechanical Properties | Equivalent mechanical properties to predicate devices, verified through bench testing (pull-out strength and torque). |
| Surgical Technique | Verified in clinical simulations (cadavers). |
| Clinical Performance/Safety | No clinical testing performed; substantial equivalence based on nonclinical data. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of image data or an AI algorithm’s test set. For the bench testing, specific sample sizes for pull-out strength and torque tests are not provided in this summary. For clinical simulations in cadavers, the summary does not specify the number of cadavers used.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective data as it relates to clinical or imaging datasets, since no clinical or imaging studies were performed for device performance evaluation. The "data" here refers to bench test results which are typically generated in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts & Qualifications: Not applicable. This summary describes a physical implant which establishes "ground truth" through direct measurement (e.g., of mechanical properties) rather than expert interpretation of data. The adjudication of substantial equivalence is done by FDA reviewers based on the engineering and design comparisons provided by the manufacturer.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses of datasets, which is not relevant for the bench testing and cadaveric simulations described for this physical device.
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
- MRMC Study: No. This type of study (MRMC, AI assistance) is completely irrelevant to the submission for this physical medical screw system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the mechanical properties, the "ground truth" would be established by direct physical measurement using calibrated lab equipment for metrics like pull-out strength and torque, and by comparing these values to those of the predicate devices. For surgical technique verification, the "ground truth" would be the successful and safe application of the device in cadaveric models as assessed by trained surgeons.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical implant.
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Image /page/0/Picture/2 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, black letters, with a stylized figure forming the "X". Below "EXTREMITY" is the word "MEDICAL" in a smaller font.
510(k) Summary of Safety and Effectiveness: .
EXTREMITY MEDICAL Implant System
| Submitter: | EXTREMITY MEDICAL LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Jamy GannoePresidentPhone: (973) 588-8980Email: jgannoe@extremitymedical.com |
| Date Prepared | April 22, 2010 |
| 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 Midfoot Screw System, Extremity Medical K0829342. EXTREMITY MEDICAL Midfoot Screw System, Extremity Medical K0915773. 3.0 Cannulated Screw and Threaded Washer, Synthes K962823 |
| Device Description | The EXTREMITY MEDICAL Screw System consists of two metallic components a Metacarpal (distal) screw and a Lag Screw (proximal). The two components are designed to rigidly lock together to form an angle between the two components. The system includes common instrumentation for the application of surgical bone screws. |
| Indications for use | 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. |
| Statement ofTechnologicalComparison | The EXTREMITY MEDICAL Screw System and its predicate devices have the same indications for use; have a similar design; are made of similar materials, and have equivalent mechanical properties. |
| Nonclinical 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. |
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Image /page/1/Picture/0 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, black letters, with a stylized figure forming the "X". Below "EXTREMITY" is the word "MEDICAL" in smaller, black letters. The logo is simple and professional, conveying a sense of expertise and reliability.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the head, body, and tail feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 2 8 2010
Extremity Medical, LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054
Re: K093770
Trade/Device Name: Extremity Medical Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 1, 2010 Received: April 23, 2010
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 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.
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Page 2 - Mr. Jamy Gannoe
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/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,
Barbara Brent
Mark N. Melkerson Director Division of Surgical, Orthopedić 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: Indications for Use:
K093770 EXTREMITY MEDICAL Screw System
The Extremity Medical Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, metatarsalphalangeal and metacarpal-phalangeal joints.
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smute for mxm
(DWision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093770
§ 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.