(90 days)
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
• Scaphoid Fractures
• Capitate
• Metacarpal Fractures
• Phalangeal Fractures
• Ulnar Styloid Fractures
• Small Joint Fusion
• Humeral head Fractures
• Intercarpal Fractures
• Tarsal Fusions
• Patellar Fractures
• Interfragmentary Ulnar Fractures
• Small Hand and Wrist Bone Fractures
• Forefoot Interfragmentary Fractures
• Lunate Fractures
• Trapezial Fractures
• Metatarsal Fractures
• Radial Head Fractures
• Osteo-Chondral
• Ostero-Chondral Fractures
• Glenoid Fractures
• Interphalangeal Fractures
• Malleolar Fractures
• Metaphyseal Fractures
• Interfragmentary Radius Fractures
• Distal Metatarsal Osteotomies
• Midfoot Interfragmentary Fractures
The Instratek Mini Cannulated Titanium Headed and Headless Screw Set is comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy. The screws have Torx heads. Instruments provided in the set include drivers (fixed and rotating) and blades, countersink/depth gauge, screw pickup, drill bits, threaded and unthreaded kwires and a caddy/tray.
The provided document is a 510(k) summary for the Instratek Mini Cannulated Titanium Headed and Headless Screw Set. It is a submission to the FDA for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information (related to AI acceptance criteria, study design, ground truth, expert adjudication, MRMC studies, and standalone performance) is not applicable or cannot be extracted from this document.
However, I can extract information related to the device itself and the regulatory submission.
1. Table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or performance metrics for the device itself (e.g., screw strength, biocompatibility). Instead, it's a regulatory submission demonstrating substantial equivalence to predicate devices. The "performance" in this context refers to the device being considered "as safe and effective" as legally marketed predicate devices.
| Acceptance Criteria Type | Reported Device Performance (as claimed in submission) |
|---|---|
| Safety and Effectiveness | The device is "as safe and effective as the legally marketed predicate devices." |
| Technological Characteristics | "The proposed device has the same technological characteristics as the predicate devices." |
| Intended Use | Matches the predicate devices (listed in the "Indications for Use" section). |
| Materials | "comprised of screws in diameters 2.5mm through 4.0mm. The screws are all cannulated and constructed of anodized titanium alloy." (Implicitly, comparable to predicate devices). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not Applicable. This document is a 510(k) summary for a physical medical device (bone screws), not a study evaluating an AI algorithm. Therefore, there is no "test set" in the context of an AI study, nor is there data provenance as described for algorithms.
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. As explained above, this is not an AI study. The "ground truth" for this device's safety and effectiveness is established through comparison to legally marketed predicate devices, which implicitly have a history of safe and effective use based on clinical practice and regulatory oversight. There are no specific experts mentioned for establishing "ground truth" in the context of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. This is not an AI study, so there is no adjudication method for a test set.
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 algorithm, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and would not be relevant).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this 510(k) submission is based on substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices with a known history of safety and effectiveness, based on their design, materials, technological characteristics, and intended use. There's no specific "ground truth" in the sense of a definitive diagnosis or outcome used to evaluate an AI algorithm.
8. The sample size for the training set:
Not Applicable. This document does not describe the development or evaluation of an AI algorithm, so there is no training set mentioned.
9. How the ground truth for the training set was established:
Not Applicable. As there is no AI algorithm or training set, this question is not relevant to the provided text.
In summary, the provided text is a regulatory submission (510(k) summary) for a physical medical device (bone screws) to demonstrate substantial equivalence to predicate devices, not a study evaluating the performance of an AI algorithm. Therefore, most of the detailed questions about AI acceptance criteria, study design, and ground truth are not addressed by this document.
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:
SECTION 5. 510(K) SUMMARY
| Submission Correspondentand Owner: | Instratek, Inc.4141 Directors Row, Suite HHouston, TX 77092USA |
|---|---|
| Phone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyVice President | |
| Date summary prepared: | February 15, 2012 |
| Device trade name: | Mini Cannulated Titanium Headed and Headless Screw Set |
| Device common name: | Bone Screw |
| Device classification name: | Screw, Fixation, Bone.HWC at 21 CFR Part 888.3040 |
| Legally marketed device towhich the device issubstantially equivalent: | Osteomed K063298Osteomed K010783Koby Surgical K060026BioPro K101030Memometal K070039Vilex K973309, K991197, K991151Vilex K014154Instratek K960537, K960533, K950704 |
| Description of the device: | The Instratek Mini Cannulated Titanium Headed and HeadlessScrew Set is comprised of screws in diameters 2.5mm through4.0mm. The screws are all cannulated and constructed of anodizedtitanium alloy. The screws have Torx heads. Instruments providedin the set include drivers (fixed and rotating) and blades,countersink/depth gauge, screw pickup, drill bits, threaded and |
unthreaded kwires and a caddy/tray.
.
·
Traditional 510(k)
MAY 1 7 2012
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| Intended use of the device: | The Instratek Cannulated Titanium (Ti6AL4V) Headed & HeadlessMini 2.5 mm, 3.0 mm and 4.0mm bone screws are indicated for usein the treatment of bone fractures, osteotomies, arthrodesis,osteochrondritis, and tendon reattachment in small bones andinterfragmentary indications including specific long bone indications.The device is intended for, but not limited to, Hand Surgery,Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. Thesedevices are not intended for use in the spine.The Instratek Cannulated Titanium Headed & Headless Mini ScrewSet is intended for the following surgical indications:• Scaphoid Fractures• Capitate• Metacarpal Fractures• Phalangeal Fractures• Ulnar Styloid Fractures• Small Joint Fusion• Humeral head Fractures• Intercarpal Fractures• Tarsal Fusions• Patellar Fractures• Interfragmentary Ulnar Fractures• Small Hand and Wrist Bone Fractures• Forefoot Interfragmentary Fractures• Lunate Fractures• Trapezial Fractures• Metatarsal Fractures• Radial Head Fractures• Osteo-Chondral• Ostero-Chondral Fractures• Glenoid Fractures• Interphalangeal Fractures• Malleolar Fractures• Metaphyseal Fractures• Interfragmentary Radius Fractures• Distal Metatarsal Osteotomies• Midfoot Interfragmentary Fractures |
|---|---|
| Technologicalcharacteristics: | The proposed device has the same technological characteristics asthe predicate devices. |
| Testing: | No testing was conducted for inclusion with this submission. |
| Conclusions: | The results of the comparison of design, materials, intended use andtechnological characteristics demonstrate that the device is as safeand effective as the legally marketed predicate devices. |
.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is 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
Instratek, Inc. % Mr. Jeff Seavey Vice President 4141 Directors Row, Suite H Houston, Texas 77092
MAY 1 7 2012
Re: K120493
Trade/Device Name: Mini Cannulated Titanium Headed and Headless Screw. Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 15, 2012 Received: February 17, 2012
Dear Mr. Seavey:
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 r ou may, aroner or visions of the Act include requirements for annual registration, listing of general controle proficturing practice, labeling, and prohibitions against misbranding and ac vious, good manarating processor of 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 may be subject to additions, 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 I lease of advisou that i Drivision that your device complies with other requirements of the Act that I Dr has made a aond regulations administered by other Federal agencies. You must of any I caeral statutes and registments, including, but not limited to: registration and listing (21 compy with an the 1107 21 CFR Part 801); medical device reporting (reporting of medical
{3}------------------------------------------------
Page 2 -- Mr. Jeff Seavey
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-ithated adverse ovents) (21 CER Part 820); and if applicable, the electronic forth in the quality systems (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 11 you desire speerine as roo sortifices/CDRH/CDRHOffices/CDRH/CDRHOffices/ucm115809.htm for go to map.row.winday.com Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulations 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 Four may 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/ResourcesforYou/Industry/default.htm.
Sincerely yours
For M.H. Davis Cohen
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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SECTION 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Mini Cannulated Titanium Headed and Headless Screw Set
Indications for Use:
The Instratek Cannulated Titanium (Ti6AL4V) Headed & Headless Mini 2.5mm, 3.0mm and 4.0mm bone screws are indicated for use in the treatment of bone fractures, osteotomies, arthrodesis, osteochrondritis, and tendon reattachment in small bones and interfragmentary indications including specific long bone indications. The device is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. These devices are not intended for use in the spine.
The Instratek Cannulated Titanium Headed & Headless Mini Screw Set is intended for the following surgical indications:
- Scaphoid Fractures .
- Capitate .
- Metacarpal Fractures
- Phalangeal Fractures
- Ulnar Styloid Fractures .
- Small Joint Fusion
- Humeral head Fractures
- Intercarpal Fractures
- Tarsal Fusions
- Patellar Fractures
- Interfragmentary Ulnar Fractures
- Small Hand and Wrist Bone Fractures
- Forefoot Interfragmentary Fractures
- Lunate Fractures
- Trapezial Fractures
- Metatarsal Fractures
- Radial Head Fractures
- Osteo-Chondral
- Ostero-Chondral Fractures
- Glenoid Fractrures
- Interphalangeal Fractures
- Malleolar Fractures
- Metaphyseal Fratures
- Interfragmentary Radius Fractures
- Distal Metatarsal Osteotomies
- Midfoot Interfragmentary Fractures
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)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K120493 |
|---|---|
| --------------- | --------- |
Instratek, Inc.
§ 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.