(23 days)
The Hoffmann Xpress Line Extension is intended for complete and temporary fracture fixation for long bones and pelvis fractures. Specific indications include:
- Bone fracture fixation; .
- . Osteotomny;
- Arthodesis; .
- Correction of deformity; .
- Revision procedures where other treatments or devices have been unsuccessful; .
- Bone reconstruction procedures. .
This Special 510(k) submission is intended to addition of 500mm (length)/15mm (diameter) connecting tubes to the predicate Hoffmann Light System, now known as Hoffmann Xpress System.
The provided document is a 510(k) summary for a medical device called the "Hoffmann Xpress Line Extension." This device is an extension of an existing external fixation system, and the submission focuses on adding new connecting tube sizes.
Based on the content, the study conducted is a mechanical and functional testing study to demonstrate that the new components (500mm (length)/15mm (diameter) connecting tubes) are comparable to the predicate device. This is not a study assessing AI performance or human reader performance.
Therefore, most of the requested information (related to AI, human readers, ground truth establishment, training sets, etc.) is not applicable to this type of device and submission.
Here's a breakdown of the relevant information from the document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical properties comparable to predicate device | Demonstrated comparable mechanical properties to the predicate device Hoffmann Xpress (Light) System K073076. |
| Functional properties comparable to predicate device | Demonstrated comparable functional properties to the predicate device Hoffmann Xpress (Light) System K073076. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the provided 510(k) summary. For mechanical tests, this typically refers to the number of components tested under various conditions (e.g., fatigue, static strength).
- Data Provenance: Not specified. It's safe to assume the testing was conducted in a controlled laboratory environment. Retrospective or prospective designations are not applicable to this type of mechanical testing.
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. Ground truth in this context would be defined by engineering specifications and standards for mechanical testing, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations (like medical imaging diagnoses). Mechanical testing relies on objective measurements and comparison to predefined acceptance limits.
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
- No, 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
- No, not applicable. This is not an software/AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For mechanical testing, the "ground truth" is typically established by:
- Engineering specifications and standards: These define the required performance characteristics (e.g., strength, durability, material properties).
- Predicate device performance: The performance of the previously cleared device (Hoffmann Xpress (Light) System K073076) serves as the benchmark against which the new components are compared.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning or training sets.
9. How the ground truth for the training set was established
- Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.