(30 days)
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Here's an analysis of the provided text regarding the Tiger Headless Cannulated Screws, focusing on acceptance criteria and supporting studies:
It is important to note that the provided 510(k) summary is for a medical device (bone screw), not an AI/ML powered device. As such, many of the typical questions for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) do not apply to this type of device submission. The acceptance criteria and "studies" are based on non-clinical (mechanical) testing rather than clinical performance or AI/ML algorithm evaluation.
Here's a breakdown based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Performance Aspect) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Static Axial Pull Out Strength | Equivalent to predicate devices |
| Static Axial Pull Through Strength | Equivalent to predicate devices |
| Driving Torque | Equivalent to predicate devices |
| Failure Torque | Equivalent to predicate devices |
| Overall substantial equivalence | Substantially equivalent to predicate devices in terms of intended use, design, materials, mechanical safety, and performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for material properties and performance claims.
- Data Provenance: Not applicable. The "data" comes from laboratory-based mechanical testing, not human clinical data or patient records.
- Retrospective/Prospective: Not applicable. This refers to the nature of clinical data collection.
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. For mechanical testing, "ground truth" is established by direct measurement against engineering standards and specifications. There are no human experts establishing a clinical ground truth for these tests. The tests themselves are the "truth." Engineers and lab technicians conduct the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used for resolving disagreements in human interpretation of data, typically in clinical studies or AI/ML evaluations. Mechanical testing results are quantitative and do not require 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
- No. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted systems in diagnostic or interpretative tasks involving human readers. This device is a bone screw and does not involve AI or human interpretation in its function or evaluation in this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a bone screw, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is established by ensuring the device's mechanical properties (pull-out strength, torque, etc.) meet or exceed recognized standards for bone fixation devices and are comparable to the legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for a training set.
Summary of the Study Proving Acceptance Criteria:
The study conducted to prove the Tiger Headless Cannulated Screws meet acceptance criteria was a non-clinical mechanical testing program. This involved subjecting the screws to a series of tests:
- Static Axial Pull Out Test: Measures the force required to pull the screw out of a material designed to simulate bone.
- Static Axial Pull Through Test: Measures the force required to pull the screw head through a material.
- Driving Torque Test: Measures the torque required to drive the screw into a material.
- Failure Torque Test: Measures the torque at which the screw (or its interface) fails.
The results of these tests were then compared to the performance of legally marketed predicate devices (Tiger Cannulated screws K081510, and 2.4 and 3.0mm Headless Compression Screws K050636/K021556). The acceptance criterion was that the Tiger Headless Cannulated Screws demonstrate equivalent mechanical performance to these predicate devices, thereby establishing "substantial equivalence" in terms of mechanical safety and performance.
No human clinical studies were performed for this 510(k) submission, as stated in the document: "No clinical studies were performed." The substantial equivalence claim is based solely on the non-clinical mechanical testing and comparison to the predicate devices.
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510(k) Summary for the Tiger Headless Cannulated Screws
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Tiger Headless Cannulated Screws
1. GENERAL INFORMATION
| Date Prepared: September 14, 2011 |
|---|
| Trade Name: Tiger Headless Cannulated Screws |
| Common Name: Bone Screw |
| Classification Name: Smooth & threaded metallic bone fixation fasteners |
| Class: II |
| Product Code: HWC |
| CFR section: 21 CFR section 888.3040 |
| Device panel: Orthopedic |
| Legally Marketed Tiger Cannulated screws (K081510) |
| Predicate Device: 2.4 and 3.0mm Headless Compression Screws (K050636/K021556) |
| Submitter: Trilliant Surgical LTD |
| 602 Sawyer Street, Suite 120 |
| Houston, TX 77007Telephone: 214-288-1035 |
| Contact: J.D. Webb |
| 1001 Oakwood Blvd |
| Round Rock, TX 78681 |
| 512-388-0199 |
| e-mail: ortho.medix@shcglobal.net |
2. DEVICE DESCRIPTION
Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.
Change from Predicate:
The change from the predicate device is a dimensional and geometry change.
Materials:
Ti-6Al-4V alloy per ASTM F136
Function:
The Tiger Headless Cannulated Screws are used to reduce and hold in place bone fragments, and are tightened to further compress the fragments and hold the reduction.
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The Tiger Headless Cannulated Screws are substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
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4. INTENDED USE
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
5. NON-CLINICAL TEST SUMMARY
The components were subjected to static axial pull out testing, static axial pull through testing, driving torque and failure torque.
The results of this testing indicate that the Tiger Headless Cannulated Screws are equivalent to the predicate devices.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
The Tiger Headless Cannulated Screws are substantially equivalent to the predicate devices in terms of indications for use, design, material, performance and function.
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Image /page/2/Picture/0 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 & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another person, representing the department's mission of protecting the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Trilliant Surgical LTD % J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681
Re: K112737
Trade/Device Name: Tiger Headless Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth & threaded metallic bone fixation fasteners Regulatory Class: II Product Code: HWC Dated: September 14th, 2011 Received: September 20th, 2011
Dear Mr. Webb:
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.
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Page 2 – Mr. J.D. Webb
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. 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/ucm1.15809.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,
Erine Keith
ForMark 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):
Device Name: Tiger Headless Cannulated Screws
Indications for Use:
The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lielandhens for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112737)
§ 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.