(167 days)
The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus PEEK CF Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
The provided document is a 510(k) summary for a medical device (Parcus PEEK CF Interference Screw). It does not include information about AI/ML models, diagnostic performance, or studies involving human readers in the way typically associated with the requested criteria.
Therefore, most of the requested information, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for AI, cannot be found in this document.
The document mainly focuses on demonstrating substantial equivalence to predicate devices through comparisons of material properties and mechanical performance.
Here's an attempt to answer the questions based only on the provided text, recognizing that it pertains to a physical medical device clearance, not an AI/ML diagnostic:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The new device's material (PEEK CF) should be substantially equivalent to materials in existing cleared devices (Parcus Titanium Interference Screws, Smith & Nephew PEEK Interference Screws, and other PEEK CF implants). | The Parcus PEEK CF Interference Screw is "essentially the same as the Parcus Titanium Interference Screws aside from the difference in material." The carbon reinforcement in PEEK CF is noted to have a clinical history of 20+ years without biocompatibility reactions. Several PEEK CF medical implants are already on the market (e.g., Zimmer Spine BAK® Vista® Radiolucent Interbody Fusion System and the Depuy Spine OCELOT™ Stackable Cage System). |
| Mechanical Performance Equivalence: Pull-out strength and insertion torque should be comparable to predicate devices. | "The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size. Test results were compared to the results of the corresponding size of Parcus Titanium Interference Screws and demonstrated substantial equivalence." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions testing the "smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size." It does not specify the number of samples for each size or the specific provenance of the data (e.g., country of origin, retrospective/prospective). This was likely a mechanical bench test.
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. This device is a physical interference screw, not a diagnostic AI/ML system requiring expert ground truth establishment for a test set in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here would be established mechanical engineering principles and testing protocols for pull-out strength and insertion torque, comparing the device's performance to established benchmarks or predicate device performance. It's based on mechanical testing data. The material equivalence is supported by biocompatibility data (implied, by referring to 20+ years of clinical use of carbon fibers and existing PEEK CF implants).
8. The sample size for the training set
Not applicable. This is not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable.
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K091093 P142
Medical, LLC
SURGICAL INNOVATION >> VALUE DRIVEN
SEP 3.0 2009
510(k) Summary
| Submitter: | Parcus Medical, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234 |
|---|---|
| Company Contact: | Barton BracyPhone: (920) 746-2972Fax: (920) 746-8665 |
| Date Prepared: | April 13, 2009 |
| Trade Name: | Parcus PEEK CF Interference Screw |
| Common Name: | Interference Screw |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code HWC and MBI |
Predicate Devices:
Device Description:
The Parcus PEEK CF Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.
Intended Use:
The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Substantial Equivalence Summary:
The Parcus PEEK CF Interference Screws are essentially the same as the Parcus Titanium Interference Screws aside from the difference in material.
The only difference between the materials for the Parcus PEEK CF Interference Screw and the Smith & Nephew PEEK Interference Screw is that the Parcus Interference Screw is carbon reinforced. Carbon fibers have been used clinically for more than 20 years as a reinforcement component for implant materials without obvious leachable-related biocompatibility reactions.
Page 15 of 154
839 S NEENAH AVE., STURGEON BAY, WI 54235
1-877-746-2972
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Image /page/1/Picture/1 description: The image shows the logo for PARCUS Medical, LLC. The word "PARCUS" is in large, bold, black letters. To the right of the word "PARCUS" is the text "Medical, LLC" in a smaller font size.
SURGICAL INNOVATION >> VALUE DRIVEN
Furthermore, there are currently several medical device implants on the market made from PEEK CF (e.g. Zimmer Spine BAK® Vista® Radiolucent Interbody Fusion System and the Depuy Spine OCELOT™ Stackable Cage System).
Therefore the Parcus PEEK CF Interference Screw is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are the same. Any differences between the PEEK CF Interference Screw and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.
Summary Performance Data:
The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus PEEK CF Interference Screws as well as an intermediate size. Test results were compared to the results of the corresponding size of Parcus Titanium Interference Screws and demonstrated substantial equivalence.
Page 16 of 154
839 S NEENAH AVE., STURGEON BAY, WI 54235
1-877-746-2972
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized depiction of a bird or eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
SEP 30 2009
Parcus Medical, LLC c/o Mr. Barton Bracy VP Marketing and Product Development 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235
Re: K091093
Trade/Device Name: Parcus PEEK CF Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: September 23, 2009 Received: September 30, 2000
Dear Mr. Bracy:
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
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Page 2 - Mr. Barton Bracy
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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic 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): _ Koq1093
Device Name: _ Parcus PEEK CF Interference Screw
Indications for Use:
The Parcus PEEK CF Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
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A 16 Mar Mala Mark The Rand Care March Car The Partier College Production 15 Se Mar Movies
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oputti for mxw
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091093
Page 13 of 154
§ 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.