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The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Biomet Microfixation Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.

The subject submission seeks to add the 2.1 x 255mm Drill, 22mm Stop to the Lorenz Twist Drills family to be used in neurosurgical procedures.

2.1 x 255mm Drill, 22mm Stop manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterile, to be sterilized by the end-user prior to use.

This document is a 510(k) summary for a medical device (a drill for neurosurgical procedures), not a study report for an AI/ML powered medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or ground truth establishment for an AI/ML system.

The document focuses on demonstrating substantial equivalence of a new physical drill (2.1 x 255mm Drill, 22mm Stop) to an existing predicate device (Walter Lorenz Surgical, Inc; Lorenz Twist Drills - K062842). This is done through:

• Comparison of Indications for Use, Technological Characteristics, and Material: The document explicitly states that the subject and predicate devices are similar in these aspects.
• Performance Testing: Mechanical tests (Static Cantilever Bend Testing, Static Torsion Testing, and Lifecycle testing) were performed on the subject drill. The conclusion states that "the results have shown them to be substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, details of a study involving human readers, or ground truth establishment based on this document.

The document describes a traditional medical device submission, not an AI/ML one.

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The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Biomet Microfixation Pectus Blu Support Bar and Stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years, but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.

The Pectus Blu Support Bar and Stabilizers are made of titanium alloy (ASTM F136) and provided nonsterile for sterilization by the end user.

The provided text describes a medical device, the Pectus Blu Support Bar System, and its clearance process with the FDA. However, it does not contain any information about a study involving an AI device or its performance criteria. The document pertains to a traditional medical implant and its safety and effectiveness testing (mechanical, MR compatibility, biocompatibility).

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI device.

The prompt requires information about:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

None of this information is available in the provided text as it relates to an AI/software device. The document focuses on physical device characteristics and regulatory clearance for a metallic bone fixation appliance.

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The RibFix Advantage System is indicated for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

The RibFix Advantage System consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium (per ASTM F67) and titanium alloys (Ti-6A1-7Nb per ASTM F1295 and Ti-6Al-4V per ASTM F136 or ASTM F1472). The system is comprised of the following implants:

• . Titanium alloy RibFix Advantage Bridge with threaded locking posts
• . Commercially pure titanium locking caps
• . Commercially pure titanium washers (optional)
  When fully assembled, the bridge is placed on the underside of the rib, the threaded locking posts extends through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior side of the rib. Washers may be placed on the posts prior to assembling with locking caps. The combined threaded locking post/locking cap provides for fixation of the bridge. The devices are sold non-sterile and intended to be sterilized by the user prior to implantation. The system also includes reusable instrumentation to aid in implantation of the devices.

This document (K203474) describes a 510(k) premarket notification for the "Biomet Microfixation RibFix Advantage System." This system is for the fixation and fusion of rib fractures and osteotomies. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K183317, AdvantageRib System) and provides non-clinical performance data related to MR safety. It does not present acceptance criteria in the typical format of accuracy, sensitivity, or specificity commonly used for AI/software devices. Instead, the acceptance criteria are implicitly that the device performs equivalently or better than the predicate device in relevant non-clinical tests.

The document states: "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."

Here's a table based on the provided information, interpreting "acceptance criteria" as meeting the standards set for safe operation in an MRI environment:

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • The document primarily refers to non-clinical testing on the device itself for MR safety. It does not describe a clinical study or a test set of patient data.
   • For the MR safety evaluations, the "sample" would refer to the physical devices tested. The document does not specify the number of devices or components tested, but implies that a sufficient number were tested to satisfy the ASTM standards.
   • Data provenance: Not applicable in the context of clinical data. The non-clinical tests were conducted in a lab setting.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this is a non-clinical device clearance. Ground truth is established by the accepted ASTM standards for MR compatibility, which are developed by expert committees in their respective fields (e.g., engineers, physicists, medical professionals specializing in MRI safety).

3. Adjudication method for the test set:

   • Not applicable. The adjudication method relates to resolving disagreements among human reviewers on ground truth, which is not relevant for non-clinical engineering tests.

4. 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. This is a physical medical device (implants for rib fixation), not an AI/software device. Hence, an MRMC study is not relevant, and there's no "human readers improve with AI" component.

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

   • No. This is a physical medical device. Not applicable to standalone algorithm performance.

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

   • The "ground truth" for demonstrating device safety and equivalence is based on established engineering standards (ASTM) for material properties, mechanical performance, and MR compatibility. For substantial equivalence, it's also based on the established safety and efficacy profile of the predicate device.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not applicable.

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