(89 days)
The Blue Shark is an external fixation device indicated for the rigid stabilization of complex fractures of the pelvic girdle. This external fixation device can be utilized for Type B and Type C fractures
The pelvic external fixators are composed of four different elements composing the frame of the fixator connected by screws and rings. The fixator is assembled on four steel screws that are implanted into the pelvis on the iliac crest depending on the selected implantation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Meridian Medical Blue Shark device.
Based on the provided text, the Blue Shark device is an external fixation system, and the submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving effectiveness through acceptance criteria and independent studies in the way a PMA (Pre-market Approval) would.
Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this type of submission.
Here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated or provided in the given text for the Blue Shark device. In a 510(k) submission for a device like an external fixator, "acceptance criteria" are typically related to mechanical performance (e.g., strength, durability, fatigue resistance) as demonstrated by bench testing, and comparisons to predicate devices. However, the document only broadly states "Meridian Medical Blue Shark and the Predicates, FEP and EBI XFIX ACCESS PELVIC FIXATOR devices have similar technological characteristics, similar design and materials and are equivalent."
Without specific test results or specifications for either the Blue Shark or its predicates, it's impossible to create this table.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/Not provided. The submission focuses on demonstrating "similar technological characteristics, similar design and materials" to predicate devices, rather than a clinical "test set" in the context of imaging or diagnostic device performance. For mechanical devices, testing is usually in-vitro bench testing. The specific number of devices tested is not detailed.
- Data Provenance: Not applicable/Not provided in detail. The "study" here is a comparison of technological characteristics to predicate devices. There's no mention of a patient-derived data set (e.g., retrospective or prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This question pertains to studies where expert judgment is used to establish "ground truth" (e.g., for diagnostic accuracy). For a mechanical external fixator, ground truth is established through engineering principles, material science, and mechanical testing results, not expert interpretation of patient data.
4. Adjudication method for the test set
- Not applicable. See point 3.
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 device is a mechanical external fixation system, not an AI-powered diagnostic or imaging device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used
- Implied Ground Truth (for substantial equivalence): The "ground truth" in a 510(k) for a mechanical device is often rooted in established engineering standards, biocompatibility testing, material properties specifications, and in-vitro mechanical testing data, all compared against the performance and characteristics of the legally marketed predicate devices. The submission asserts "similar technological characteristics, similar design and materials" to the predicates. The success of the predicate devices in the market serves as an indirect "ground truth" for safety and effectiveness.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device and submission type. This concept applies to machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of Findings:
The provided text describes a 510(k) submission for the "Blue Shark" external fixation system. This type of submission aims to demonstrate substantial equivalence to predicate devices, primarily through comparison of technological characteristics, design, and materials, often supported by bench testing (though specific test details are not provided here). It does not include the elements typically found in clinical trials or performance studies for diagnostic devices, such as extensive clinical test sets, expert ground truth establishment, or AI performance metrics. Therefore, most of the questions are not applicable to the information contained in this 510(k) summary.
§ 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.