(29 days)
The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.
Not Found
The provided text describes a 510(k) premarket notification for a medical device, the "Titanium-TSYTM Shoulder Plate Implant." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with strict acceptance criteria and performance studies like those often associated with novel high-risk devices or software.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, and MRMC studies is not explicitly available in the provided document. The 510(k) summary focuses on administrative information, device description, predicate device identification, and intended use to establish substantial equivalence.
Here's an explanation based on the provided text, addressing why certain information is absent and what can be inferred:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. For a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.
- Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, mechanical strength values) are reported in this summary. The substantial equivalence argument implies similar performance to the predicate.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size & Data Provenance: Not applicable and not mentioned. 510(k) submissions typically do not involve a "test set" in the sense of a clinical trial for performance evaluation. Substantial equivalence is often demonstrated through bench testing (for mechanical properties, biocompatibility), materials comparison, and comparison of design features to the predicate. No clinical data (prospective or retrospective) is presented here.
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):
- Experts & Qualifications for Ground Truth: Not applicable and not mentioned. Since there isn't a "test set" with clinical outcomes requiring expert interpretation for ground truth, such information is not part of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable and not mentioned for the same reasons as #3.
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: Not applicable. This device is a bone plate implant, a mechanical orthopedic device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. As mentioned, this is a mechanical implant, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is effectively the safety and effectiveness of the predicate device (TSYTM Shoulder Plate Implant, K040850). The new device aims to be substantially equivalent to that established "truth."
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for the same reasons as #8.
Summary based on the document:
The provided document is a 510(k) summary for the "Titanium-TSYTM Shoulder Plate Implant." The basis of its acceptance and clearance by the FDA is substantial equivalence to a previously cleared predicate device, the TSYTM Shoulder Plate Implant (K040850), cleared on June 24, 2004.
The document states: "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..."
This means the "study" that proves the device meets "acceptance criteria" is the comparison to the predicate device focusing on:
- Intended Use: The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture. This is the same intended use as the predicate.
- Technological Characteristics: While not detailed in this summary, a 510(k) submission would typically include comparisons of materials (titanium vs. whatever the predicate was made of, ensuring biocompatibility), design features, and possibly bench testing to demonstrate similar mechanical performance and safety profiles. The name itself, "Titanium-TSYTM," suggests a material change from the predicate "TSYTM Shoulder Plate Implant."
Without the full 510(k) submission, specific details of the comparison (e.g., mechanical test results, detailed material specifications) are not available. However, the FDA's clearance indicates that the submitted information was sufficient to demonstrate substantial equivalence and meet the regulatory requirements for Class II devices.
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K063033 Page 1/1
Titanium-TSYTM Shoulder Plate Implant
1 2006 NOV
510(k) SUMMARY
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Orthopedic Sciences, Inc.3020 Old Ranch Parkway,Suite 325Seal Beach, CA 90740 |
|---|---|
| Official Contact: | James K. Brannon. M.D. President/CEOTelephone (562) 799-5550 FAX (562) 799-5533 |
DEVICE NAME
| Classification Name: | Plate, fixation, bone |
|---|---|
| Trade/Proprietary Name: | Titanium-TSYTM Shoulder Plate Implant |
| Common Name: | Bone plate |
PREDICATE DEVICE INFORMATION
The predicate device for this modification is the TSYTM Shoulder Plate Implant, a component of the TSYTM Shoulder Plate Bone Graft Stabilization System, cleared by FDA on June 24, 2004 under K040850.
INTENDED USE
The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2006 NOV
Orthopedic Sciences, Inc. % James K. Brannon. M.D. President/CEO 3020 Old Ranch Parkway, Suite 325 Seal Beach. California 90740
Re: K063033
Trade/Device Name: Titanium-TSY" Shoulder Plate Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS Dated: September 25, 2006 Received: October 3, 2006
Dear Dr. Brannon:
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 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 - James K. Brannon, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mallery
Mark N. Melkerson Director Division of General, Restorative and Neurological 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: Titanium-TSY" Shoulder Plate Implant:
Indications For Use:
The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L063033
Page 1 of 1
§ 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.