(17 days)
The T2® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This Special 510(k) submission is a line extension to the T2® Recon Nail System to add an alternate material. The subject T2® Recon Nail System is a fracture fixation device comprised of Femoral Nails and associated instruments, Locking Screws, Set Screws, End Caps, and Lag Screws. The subject and predicate devices are intended to provide strong and stable internal fracture fixation while minimizing soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The provided text describes a 510(k) submission for a line extension to the T2® Recon Nail System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.
Therefore, many of the typical elements of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic or AI-based devices are not applicable to this submission. This is a claim of equivalent performance to an existing device, not a claim of specific performance metrics against a clinical standard.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: In a 510(k) for a line extension to an existing device, the "acceptance criteria" is typically demonstrating substantial equivalence to the predicate device. This means the new device performs at least as well as, and is as safe as, the predicate device. For mechanical devices like IM nails, this often involves showing comparable mechanical properties.
- Reported Device Performance: The submission states: "The subject device is made of titanium alloy and PEEK while the predicate device is made of titanium alloy. Mechanical testing demonstrates the comparable mechanical properties of the subject T2® Recon Nail System to the predicate device."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate device (T2® Recon Nail System made of titanium alloy) | Mechanical testing demonstrates comparable mechanical properties of the subject T2® Recon Nail System (made of titanium alloy and PEEK) to the predicate device. |
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 (N/A): This is a 510(k) for a mechanical device (intramedullary nail system). It relies on mechanical testing rather than clinical or performance data from human "test sets" in the way an AI/diagnostic device would. The "sample size" would refer to the number of devices tested mechanically, which is not specified in this summary.
- Data Provenance: The text does not provide information on the country of origin of the mechanical testing data, nor whether it was retrospective or prospective, as these are not standard reporting requirements for this type of submission summary.
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 (N/A): This submission does not involve establishing ground truth by human experts in the context of clinical diagnostic accuracy. The assessment is based on engineering principles and mechanical testing of the device's physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (N/A): No adjudication method is mentioned or relevant, as this is for mechanical device testing, not clinical "test sets" requiring expert review for ground truth.
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 (N/A): This is a mechanical device, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Equivalence: For this type of submission, the "ground truth" is typically established by accepted engineering standards and physical measurements demonstrating the mechanical properties (e.g., strength, fatigue life) of the device are comparable to the predicate device. The text states "Mechanical testing demonstrates the comparable mechanical properties."
8. The sample size for the training set
- Not Applicable (N/A): This is a mechanical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable (N/A): See point 8.
In summary:
The K051624 submission for the T2® Recon Nail System Line Extension is a 510(k) for a mechanical medical device. The primary "study" that proves it meets the "acceptance criteria" of substantial equivalence is mechanical testing. This testing would compare the physical and performance characteristics of the new device (made of titanium alloy and PEEK) against the predicate device (made of titanium alloy) to ensure they are comparable, especially concerning strength, durability, and biocompatibility (though biocompatibility isn't explicitly mentioned beyond material composition). The details of the specific mechanical tests (e.g., torsion, bending, fatigue) and the number of specimens tested are not included in this summary document.
{0}------------------------------------------------
T2® Recon Line Extension
510(k) Summary of Safety and Effectiveness: T2® Recon Nail System Line Extension
JUL 7 - 2005
| Submission Information | |
|---|---|
| Name and Address of the Sponsorof the 510(k) Submission: | Howmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430 |
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038 |
| Date Summary Prepared: | June 17, 2005 |
| Device Identification | |
| Proprietary Name: | T2® Recon Nail System |
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod and Accessories21 CFR §888.3020 |
| Device Product Code: | 87 HSB |
Description:
Description.
The T2® Recon Nail System is a family of IM Nails for various types of femoral fractures. This The 12 Tecon Fran Bystein is a line extension to the T2® Recon Nail System to add an alternate Special 210(x) submission is a there is no change in intended use for the subject device, which is provided below.
Intended Use:
The subject T2 " Recon Nail System is a fracture fixation device comprised of Femoral Nails and 1116 subject 1 = 1 coon Prashers, Locking Screws, Set Screws, End Caps, and Lag Screws. the subject and predicate devices are intended to provide strong and stable internal fracture The subjour and product tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of necks shart, communitied promotary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Statement of Technological Comparison:
Statement of Technological Obligation alloy and PEEK while the predicate device is made The subject as rios is normanical testing demonstrates the comparable mechanical properties of the subject T2® Recon Nail System to the predicate device.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Ms. Vivian Kelley, RAC Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey USA 07430
Re: K051624
Trade/Device Name: T2® Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 17, 2005 Received: June 20, 2005
Dear Ms. Kelley:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to regary the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ao novice, subject to the general controls provisions of the Act. The Tou may, merelore, market the act include requirements for annual registration, listing of general controll provision 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 your device is elassified (600 acal controls. Existing major regulations affecting your device It may be sugled to Sach addiness Regulations, Title 21, Parts 800 to 898. In addition, FDA can oc found in the overants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F least of advised that I DTC issualite of your device complies with other requirements of the Act that I DT has intace and regulations administered by other Federal agencies. You must of any I catelli stututes and registments, including, but not limited to: registration and listing (21 Comply with an the Net 8 requirements) and manufacturing practice requirements as set CI I rull 6077, idoomig (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by over of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{2}------------------------------------------------
Page 2 - Ms. Vivian Kelley, RAC
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manxemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale website premarket notification. "The PDT Intamge of cassement of the spermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ace at (240) 276-0120 . Also, please note the regulation entitled, comaci the Office of Comphalled at (210) 276 or art 807.97). You may obtain "Misbranding by relefence to premarket noulification of Set from the Division of Small
other general information on your responsibilities under the Act from work on 6800 638, other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or and index html Manufacturers, International and Consulter Pibelows of the many of the many in the samm
Sincerely yours,
Stupt hurla
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known): K
Device Name: T2® Recon Nail System
Indications For Use:
The T2® Recon Nail indications include fixation of subtrochanteric, interochanteric, ipsilateral neck/shaft, communited proximal femoral shaft fractures, femoral fixation required as a result of pathological disease, and temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Stypt Clurke
Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.