(103 days)
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions: For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening hy distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
Framewalker is a "Single Use" walking aid designed to the foot ring portion of an external ring fixator. The Framewalker is intended for patients who are undergoing procedures requiring ring fixation of the lower extremity. The device is applied to the foot ring portion of a ring fixation frame in order to provide a stable platform below the foot to both protect the bottom of the foot and to allow a patient limited ambulation during treatment as determined by a physician.
The Quantum Medical Concepts, LLC Framewalker 2.0 is an external fixation system, a "Single Use" walking aid designed to be affixed to the foot ring portion of an external ring fixator. It is intended for patients undergoing procedures requiring ring fixation of the lower extremity. The device provides a stable platform below the foot to protect the foot and allow limited ambulation.
The provided documentation, K111993, indicates that no non-clinical or clinical testing was provided to establish acceptance criteria or device performance. The submission relied on demonstrating substantial equivalence to legally marketed predicate devices (E-Z Frame External Support Boot, K043289, and Ace Fischer External Fixation System, K083789) based on identical intended use and geometrically similar foot platform components.
Therefore, the requested information regarding acceptance criteria and performance studies is not available in the provided text. All sections below would be marked as "Not Applicable" or "Not Provided" in the context of this specific 510(k) submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | Not Provided |
Explanation: The 510(k) submission explicitly states "Non-Clinical Testing: None Provided." and "Clinical Testing: None provided." The approval was based on substantial equivalence to predicate devices, not on specific performance data or established acceptance criteria for the Framewalker itself.
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 Applicable (No test set data provided)
- Data Provenance: Not Applicable (No test set data provided)
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)
- Number of Experts: Not Applicable (No test set data provided)
- Qualifications of Experts: Not Applicable (No test set data provided)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable (No test set data provided)
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
- MRMC Study: No, Not Applicable (This device is a physical walking aid, not an AI-assisted diagnostic tool for human readers.)
- Effect Size: Not Applicable
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, Not Applicable (This device is a physical walking aid, not an algorithm.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Applicable (No ground truth data or performance studies were conducted for this device.)
8. The sample size for the training set
- Sample Size: Not Applicable (No training set data provided, as no algorithm or performance study was conducted.)
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not Applicable (No training set or ground truth was established for this device.)
§ 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.