(21 days)
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.
Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):
- Open and closed femoral and tibial shaft fractures .
- Pseudoarthrosis and correction osteotomies .
- Pathologic fractures and tumor resections .
- Change of procedure following external fixation .
Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):
The Osteo R/A Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures .
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension .
- Ipsilateral femur fractures .
- Fractures proximal to a total knee arthroplasty ●
- Fractures distal to a hip implant .
- Nonunions and malunions ●
This submission involves no change to the components themselves. This submission covers use of predicate T2 Locking Screws with predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems.
The provided text describes a 510(k) premarket notification for T2 Locking Screws intended for use with existing Osteo Femoral and Tibial Nails. This is a medical device submission, and the focus of the documentation is on demonstrating "substantial equivalence" to predicate devices, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way a new drug or novel medical AI would.
Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission as they relate to AI/software performance rather than a hardware modification being compared to predicate devices. The study here is an engineering analysis and mechanical testing study, not a clinical or AI performance study.
Here's the information that can be extracted and how it relates to the provided context:
1. A table of acceptance criteria and the reported device performance
For a device modification like this, the "acceptance criteria" are typically defined by demonstrating that the modified device performs at least as well as, or equivalently to, the predicate device in key functional areas, often through mechanical testing to ensure structural integrity and proper fit. The document explicitly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: T2 Locking Screws are made of the same materials as previously cleared locking screws. | "The T2 Locking Screws are identical in materials..." |
| Design Similarity: T2 Locking Screws are similar in design to the originally cleared locking screws. | "...and are similar in design to the associated locking screws originally cleared for use with the specified Osteo Nail Systems." |
| Functional Equivalence/Safety: T2 Locking Screws can be safely used with the Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems without compromising performance or safety. | "Engineering analysis and testing have shown that the T2 Locking Screws are similar enough to the Osteo Locking Screws to be safely used with the associated Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems." This confirms that the modification does not negatively impact the intended function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the excerpt. For mechanical testing, the "sample size" would refer to the number of devices tested. Data provenance (country, retrospective/prospective) is typically not relevant for mechanical engineering tests of medical hardware.
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)
This is not applicable. Ground truth is not established by human experts in the context of mechanical testing for substantial equivalence. The "ground truth" for such a device is established by engineering specifications, material properties, and mechanical performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used in clinical trials or AI performance evaluations, not typically in mechanical testing for a hardware modification.
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
This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which is beyond the scope of this medical device submission for mechanical hardware.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. Standalone performance refers to AI algorithm performance, which is not relevant to this hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on engineering specifications, material science principles, and mechanical test results (e.g., tensile strength, fatigue life, torsional resistance) that demonstrate the T2 Locking Screws perform equivalently or acceptably when used with the specified nail systems compared to the original locking screws.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of a hardware modification submission.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.