(10 days)
Intramedullary Hip Screws are indicated for intracapsular fractures of the femoral neck; trochanteric or subtrochanteric fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures using a supracondylar plate; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies secondary to femoral inequality; and prophylactic nailing of impending pathologic fractures. Asian Intramedullary Hip Screws and accessories are for single use only.
Intramedullary Hip Screws and accessories provide an intramedullary approach to the management of fractures of the proximal femur. Devices include intramedullary nails with various diameters, lengths and neck shaft angles. The long nails are available in a right or left hand configuration. Each nail includes a 4 " medio-lateral bend to allow for greater trochanteric insertion. Each nail is used with a choice of specially designed sliding lag screws or subtrochanteric lag screws in various lengths. Additional accessories are available such as a centering sleeve, a set screw, a compression screw and nail caps.
This is a 510(k) premarket notification for a medical device (Asian Intramedullary Hip Screw), not a study analyzing AI/algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design for AI, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.
Medical device clearance through the 510(k) pathway primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than generating acceptance criteria and performing extensive clinical performance studies as would be required for novel AI-powered diagnostics.
However, I can extract the relevant information regarding the device itself.
1. Acceptance Criteria and Reported Device Performance:
The concept of "acceptance criteria" in the context of this 510(k) submission relates to demonstrating substantial equivalence, not to performance metrics like sensitivity, specificity, or AUC as seen in AI studies. The reported "performance" here is based on a comparison to predicate devices.
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Match predicate devices | Identical to predicate devices (K040656, K993289, K040212, K952697). Indicatd for: intracapsular fractures of the femoral neck, trochanteric or subtrochanteric fractures; osteotomies; hip arthrodesis; supracondylar fractures and distal femoral fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; femoral neck fractures; subcapital fractures; comminuted neck and shaft fractures; femur reconstruction following tumor resection; leg length discrepancies; prophylactic nailing. |
| Technological Characteristics: Similar principle of operation, performance specifications, and method of operation to predicate devices. | "The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation." |
| Biomechanical/Mechanical Performance: Capable of withstanding expected in vivo loading without failure (implied equivalence to predicates). | "A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." (Details of the "test data" are not provided in this summary.) |
| Material Composition: Similar to predicate devices. | "Substantial equivalence... is based on its similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices." (Specific materials are not detailed in this summary.) |
The following points are Not Applicable (N/A) to this 510(k) submission, as it is for a physical medical device and not an AI or algorithmic diagnostic/decision support system:
- Sample size used for the test set and the data provenance: N/A (No test set of data in the context of AI performance for this device)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth established by experts in the context of AI performance for this device)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A
- 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: N/A
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A
- The sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
§ 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.