(34 days)
The CHARLOTTE™ 7.0 MUC Screw and Washer are indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures
- Fracture management in the foot or hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- Treatment of inferior tibio fibular diastasis
- Hindfoot arthrodesis
The CHARLOTTE™ 7.0 MUC Screw and Washer are manufactured from Stainless Steel conforming to ASTM F138. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients and the Washer are offered for straight or oblique screw placement.
The provided document describes a 510(k) premarket notification for a medical device, the CHARLOTTE™ 7.0 MUC Screw and Washer. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or detailed performance metrics against acceptance criteria typical for AI/software devices.
Therefore, many of the requested categories (e.g., sample sizes, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of traditional medical device submission.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance Conformance | The CHARLOTTE™ 7.0 MUC Screw and Washer was confirmed to be substantially equivalent to previously cleared predicate devices (CHARLOTTE™ High-Demand Compression Screw and Wright's Pre-amendment Tibia Bolt with Washers) by testing conforming to ASTM F543-02. This standard specifies mechanical tests for metallic bone screws. |
| Material Conformance | Manufactured from Stainless Steel conforming to ASTM F138. This standard specifies wrought 18 chromium-8 nickel stainless steel for surgical implants. |
| Design Features | Design features are substantially equivalent to the predicate devices. |
| Indications for Use (IFU) | Indications for Use are substantially equivalent to the predicate devices: Fixation of bone fractures or for bone reconstruction (e.g., long bones, small bones, foot/hand fractures, arthrodesis, osteotomies, tibio fibular diastasis, hindfoot arthrodesis). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices through material and mechanical testing, not a clinical test set with patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/provided. Ground truth, in the context of AI/software, refers to verified clinical diagnoses or outcomes. For this bone screw, "ground truth" would relate to the physical properties and performance against engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods are typically used in clinical studies to resolve discrepancies among expert readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices to assess changes in human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance evaluation was not done. This concept is specific to AI algorithms.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering standards and specifications:
- ASTM F138: For material composition of the stainless steel.
- ASTM F543-02: For mechanical performance testing of metallic bone screws.
- Comparison to predicate devices: The "ground truth" for its clinical utility and safety is its substantial equivalence to previously cleared devices which have an established record of safe and effective use.
8. The Sample Size for the Training Set
This information is not applicable/provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this traditional medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided, as there is no AI training set.
§ 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.