(29 days)
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of Small Bone Fragments
- · Weil osteotomy
- Mono-cortical fixation
- · Osteotomies and fractures fixation in the foot and hand
The design features of the CHARLOTTE™ Snap-Off Screw are summarized below:
Screw
- . Manufactured from ASTM F136 (Ti-6A1-4V ELI)
- . Available in one diameter and three lengths
- Self drilling and self tapping features on distal threads .
The provided document is a 510(k) summary for the CHARLOTTE™ Snap-Off Screw, a bone fixation screw. It details the device's intended use and design, and establishes substantial equivalence to a predicate device.
However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.
The 510(k) pathway for this device, a metallic bone fixation fastener, relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through an independent study as would be seen for an AI/ML product.
Therefore, many of the requested details regarding acceptance criteria, study sample sizes, expert ground truthing, and AI-specific performance metrics are not applicable to this particular submission.
Here's a breakdown of what can be extracted and what is not available based on the request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, the "Wright Pre-amendment No. 223 Knowles Pin," as confirmed by testing conforming to ASTM 543-02. No specific numerical acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for device performance itself are provided in this summary.
- Reported Device Performance: The document states that "The safety and effectiveness of the CHARLOTTE™ Snap-Off Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not provide specific performance metrics in terms of clinical outcomes or diagnostic accuracy, as it is a physical bone fixation 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. This submission is for a physical medical device (bone fixation screw), not an AI/ML device that would use a test set of data for performance evaluation in the same manner. The "testing" mentioned refers to mechanical testing (ASTM 543-02) to establish equivalence, not to a "test set" of clinical data for an algorithm.
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. As this is not an AI/ML device, there is no "ground truth" to be established by experts for a test set in the context of diagnostic or prognostic performance. The equivalence is based on engineering and material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth", in a very broad sense for this device, would be compliance with ASTM F136 for material and ASTM 543-02 for mechanical properties, demonstrating equivalence to the predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable.
Summary regarding the provided document:
The 510(k) summary for the CHARLOTTE™ Snap-Off Screw is focused on establishing substantial equivalence for a physical medical device. The "study" mentioned is "testing conforming to ASTM 543-02" to confirm the substantial equivalence in design features, material, and indications for use to a predicate device. This is a regulatory pathway for devices that are not AI/ML and therefore does not include the detailed performance study information typically associated with AI/ML device submissions.
§ 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.