(490 days)
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.
The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw. The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy
Here's an analysis of the provided text regarding the KLS Martin Sternal Talon, focusing on the acceptance criteria and supporting study information.
It's important to note that the provided documents (a 510(k) summary and FDA clearance letter) are for a medical device (implant), not a software algorithm or AI model. Therefore, many of the typical questions for AI performance studies (like sample sizes for test/training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance) are not applicable here. The "acceptance criteria" for a medical device involve demonstrating substantial equivalence to a predicate device through engineering tests and material properties, rather than diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary) |
|---|---|---|
| Material Properties | Made from TI-6AL-4V Titanium Alloy (biocompatibility and strength) | Confirmed Ti-6Al-4V Titanium Alloy. (Implied acceptability based on predicate device materials) |
| Intended Use | Stabilization and fixation of anterior chest wall fractures, including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures. | Device mechanism (two-piece clamping, ratcheted locking, curved foot plates) designed to achieve this intended use. Deemed substantially equivalent to predicate devices for this use. |
| Functionality | - Two-piece clamping device with various foot depths and lengths.- Utilizes a ratcheted locking system.- Three-position screw (open, close, lock).- Emergency re-entry (turning screw to open, cut points).- Interlocking design for stabilized fixation. | Device description confirms these features. (Implied successful functioning based on substantial equivalence) |
| Biocompatibility | (Not explicitly stated as a test in the summary, but implied by material choice and predicate comparison) | Usage of Ti-6Al-4V Titanium Alloy, a commonly accepted biocompatible material for implants. |
| Mechanical Strength/Fixation | (Not explicitly detailed as a specific test in the summary, but implied necessity for sternal fixation) | Designed to "interlock providing a stabilized fixation" and "apply pressure medially to ensure fixation." Substantial equivalence to predicate suggests comparable mechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the submission is for a medical device (implant), not a diagnostic algorithm. There is no "test set" in the context of an AI performance study. The evaluation is based on material properties, design, and comparison to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for a medical device like this is established through engineering principles, material science, and regulatory standards, not by expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring adjudication in this type of submission.
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 device is not an AI or diagnostic algorithm, so no MRMC study was performed.
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
The "ground truth" for this medical device submission is centered around:
- Substantial Equivalence: The primary ground truth is the demonstration that the KLS Martin Sternal Talon is "substantially equivalent" in intended use, indications for use, technological characteristics, and safety/effectiveness to existing, legally marketed predicate devices (e.g., Ethi-Pack Surgical Stainless Steel Suture, Pioneer Silicoat Sternal Cable, PectoFix DSF System, Synthes Sternal Fixation System, Sternal Band, Lorenz Sternal Closure System, KLS Martin Sternal Plating System).
- Material Science and Engineering Principles: The use of Ti-6Al-4V Titanium Alloy is a fundamental "ground truth" for biocompatibility and mechanical strength in implantable devices.
- Regulatory Standards: Compliance with relevant FDA regulations for Class II devices (21 CFR 888.3030) implies adherence to established safety and performance benchmarks.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of medical device submission.
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510(K) SUMMARY
SEP - 7 2006
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector RA/QA |
| Date of Summary: | 4 May 2005 |
| Device Name: | KLS Martin Sternal Talon |
| Trade Name: | Sternal Talon |
| Common Name: | Sternal Closure System |
| ClassificationName and Number: | Single/Multiple Component Metallic BoneFixation Appliances and Accessories (21 CFR888.3030) |
| Regulatory Class: | II |
| Predicate Devices: | Ethi-Pack Surgical Stainless Steel Suture(K931271) |
| Pioneer Silicoat Sternal Cable (K993286) | |
| PectoFix DSF System (K000694) | |
| Synthes Sternal Fixation System(K010943) | |
| Synthes (USA) Sterile Sternal Fixation System(K050041) | |
| Sternal Band (K930015) | |
| Lorenz Sternal Closure System (K033740) |
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051165
Intended Use:
Device
Description:
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy Sternal and reconstructive procedures.
The KLS-Martin Sternal Talon is a two-piece clamping device with various foot depths and lengths that utilizes a ratcheted locking system. Each piece of the device is placed on opposing sides of the sternum and is designed to interlock providing a stabilized fixation thus allowing for various sternal widths. The device has a three position screw which allows the ratchet to open, close and lock. In an emergency situation, the device can be reopened by turning the screw to the open position. A second emergency re-entry is provided by cut points adjacent to the screw.
The KLS Martin Sternal Talon is manufactured from TI-6AL-4V Titanium Alloy
Technological Characteristics:
Similarities to Predicate:
The KLS-Martin Sternal Talon is similar in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Stemal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Stemal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)
Differences to Predicate:
The KLS-Martin Sternal Talon is a two-piece interlocking system that does not utilize stainless steel sutures, titanium plates or titanium screws for fixation that are utilized in the Ethi-Pack Surgical Stainless Steel Suture C-2
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(K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413). The KLS Martin Sternal Talon uses curved foot plates to apply pressure medially to ensure fixation.
Substantial Equivalence:
The KLS-Martin Sternal Talon is substantially equivalent in intended use and indications for use as the Ethi-Pack Surgical Stainless Steel Suture (K931271), Pioneer Silicoat Sternal Cable (K993286), PectoFix DSF System (K000694), Synthes Sternal Fixation System (K010943), Synthes (USA) Sterile Sternal Fixation System (K050041), Sternal Band (K930015), Lorenz Sternal Closure System (K033740) and KLS Martin Sternal Plating System (K032413)
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Image /page/3/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 - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
SEP - 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KLS Martin L.P. % Ms. Jennifer Damato Director, Regulatory Affairs and Quality Assurance 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Rc: K051165
Trade/Device Name: KLS Martin Sternal Talon Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: June 16, 2006 Received: June 20, 2006
Dear Ms. Damato:
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 r rease of a result 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 - Ms. Jennifer Damato
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,
Barbara Brudno
Mark N. Melkerson 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
051165
510(k) Number (if known):
KLS Martin Sternal Talon Device Name:
Indications For Use:
The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures.
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)
Aulana buclins for Mayn
(Division Sign Off)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K051145
B-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.