(26 days)
Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.
The device is the same as flexible pins and ender nails that have been used to fix fractures in long bones for years in an intramedullary fashion. When these types of nails are used they will be used opposingly in pairs. The nail will be bent to provide three-point fixation. The ideal fixation points will be at the insertion site, the fracture site, and some point beyond the fracture site.
The provided document is a 510(k) premarket notification for a medical device (2mm Flexible Pediatric Nail) and its clearance letter from the FDA. It does not describe acceptance criteria or a study that proves the device meets specific performance criteria through clinical testing, as would be expected for an AI/ML device or a device requiring new clinical data.
This device, an intramedullary rod, was determined to be "substantially equivalent" to a legally marketed predicate device (Pediatric Fixation Rods - K000764) based on "non-clinical testing" via an "engineering justification." This means no new clinical studies were required to demonstrate its safety and effectiveness for its intended use, as it was deemed to have similar technological characteristics (materials, design, sizing, and indications) to already cleared devices.
Therefore, many of the requested categories are not applicable to this specific submission.
Here's a breakdown based on the provided information, noting where information is not applicable:
Acceptance Criteria and Device Performance Study for the 2mm Flexible Pediatric Nail
Since this device received 510(k) clearance based on substantial equivalence to a predicate device via non-clinical engineering justification, there were no specific "acceptance criteria" for clinical performance metrics (like accuracy, sensitivity, specificity) and no clinical study conducted to directly prove the device met such criteria. The "acceptance criteria" in this context were primarily met by demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not applicable for clinical performance) | Reported Device Performance (Not applicable for clinical performance) |
|---|---|---|
| Clinical Performance | Not applicable as no new clinical performance criteria were established or evaluated in a de novo study. | No clinical performance metrics (e.g., accuracy, sensitivity, etc.) are reported. |
| Substantial Equivalence | Device is substantially equivalent to predicate device (K000764) in materials, design, sizing, and indications (Non-clinical justification only). | Device was determined to be substantially equivalent based on engineering justification. |
| Safety and Effectiveness | No new risks posed compared to predicate device. | An engineering justification concluded no new risks. |
2. Sample size used for the test set and the data provenance: Not applicable. No test set (clinical data set) was used for performance evaluation. The substantial equivalence was based on engineering justification.
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. No test set was used requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set was used.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device, and no standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for a performance study. The substantial equivalence was based on a comparison to an existing device and engineering principles.
8. The sample size for the training set: Not applicable. This is not an AI/ML device; therefore, no training set was used.
9. How the ground truth for the training set was established: Not applicable. No training set was used.
§ 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.