Search Results

The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.

The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, fully-threaded cancellous screws, and partially-threaded cancellous screws in various sizes and geometries. The SPL Locking Screw is a metal locking screw with a resorbable threaded polymer collar.

The provided text describes a medical device, the Stabiliz Fixation System with SPL Locking Screw, and its 510(k) summary for FDA clearance. However, it does not include detailed acceptance criteria or a study that specifically proves the "device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement. This document is a regulatory submission for substantial equivalence to predicate devices, focusing on design, materials, and preclinical testing rather than clinical performance data as would be found in a study demonstrating diagnostic accuracy or efficacy.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text, nor can I answer questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for either test or training sets, as this information is not present in the document.

The document states:

• Preclinical Testing: "The non-clinical tests performed by the company include in vitro degradation testing, biomechanical loading study, corrosion testing, and biocompatibility testing. The results demonstrate that the Stabiliz Fixation System is substantially equivalent to legally marketed predicate devices."

This indicates that acceptance criteria would likely be related to the performance of these preclinical tests, such as achieving certain thresholds for degradation rates, load-bearing capacity, corrosion resistance, and biocompatibility, to demonstrate equivalence to the predicate devices. However, the specific values or criteria for these tests are not detailed. The document only states that the results demonstrate substantial equivalence.

Ask a specific question about this device

The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.

The provided text does not contain information about the acceptance criteria and study proving a device meets these criteria in the context of an AI/ML medical device. Instead, it details a 510(k) submission for a Stabiliz Fixation System, which is a physical orthopedic device (plates, screws).

The 510(k) submission process for such a device focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than defining specific performance acceptance criteria and conducting studies to prove them in the same way an AI/ML device would.

Therefore, I cannot provide the requested table and information based on the given input regarding an AI/ML device. The document describes a traditional medical device clearance process, not an AI/ML device study.

However, I can extract the information relevant to the provided device's "acceptance criteria" and "study" from the text, framed within the context of a 510(k) submission for a non-AI device.

Acceptance Criteria and Study for the Stabiliz Fixation System (Non-AI Device)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance (for mechanical testing)

• Sample Size: Not explicitly stated in the provided text. The document mentions "an analysis of strength" but does not detail the number of plates, screws, or test configurations used in the preclinical testing.
• Data Provenance: Not explicitly stated. The preclinical testing was "performed by the company" (Stabiliz Orthopaedics, LLC).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This is not applicable to preclinical mechanical testing for a traditional orthopedic fixation system. The "ground truth" for such devices is established through engineering standards and mechanical test methods.

4. Adjudication Method for the Test Set

• Not applicable to preclinical mechanical testing. Results are based on quantitative measurements against defined mechanical standards or comparative performance against predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study (MRMC) is relevant for AI/ML devices where human readers evaluate cases with and without AI assistance. The Stabiliz Fixation System is a physical implant; its assessment does not involve human readers interpreting images or data.

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

• No. This is not applicable as the Stabiliz Fixation System is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the preclinical testing, the "ground truth" would be established mechanical and material properties, and comparative performance data against legally marketed devices, demonstrating equivalent strength and function. This is typically based on engineering specifications and empirical measurements.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

Summary for AI/ML Context:

Based on the provided input, there is no information about an AI/ML device, its acceptance criteria, or a study to prove it meets those criteria. The document describes a 510(k) submission for a physical orthopedic fixation system.

Ask a specific question about this device