(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.
§ 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.