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The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening

The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.

The provided text describes the 510(k) summary for the Emerge Medical External Fixation System. It details the device, its indications for use, and a comparison to a predicate device. The performance data section is brief, stating that testing was conducted per ASTM 1451-02 (2001).

Based on the provided information, I can extract the following:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the test set or the data provenance. It only states that "Performance testing was conducted per ASTM 1451-02 (2001)". ASTM standards are generally laboratory-based mechanical testing protocols rather than clinical studies with patient data.

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. The performance testing described is mechanical testing against an ASTM standard, not an evaluation of clinical images or diagnoses that would require expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is mechanical testing, not a clinical study requiring adjudication of expert interpretations.

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 a medical device (external fixation system), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a medical device, not an algorithm. The performance testing is for the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing was adherence to the specifications and performance characteristics defined by the ASTM 1451-02 (2001) standard. This is a mechanical engineering standard.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

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