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The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:

• Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
• Basal Neck Fractures .
• Slipped Capital Femoral Epiphysis (in pediatric patients) .

The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.

This document is a 510(k) premarket notification for the Hansson™ Pin System, a hip fracture fixation device. The notification describes a line extension to modify the existing system, expanding its indications for use and making minor design changes.

Here's an analysis of the provided text in relation to your questions:

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

The provided 510(k) summary does not contain acceptance criteria or performance data from a study. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, meaning they show the new device is as safe and effective as a legally marketed device, often through
comparison of technological characteristics or non-clinical performance data (e.g., mechanical testing). This particular document focuses on expanding indications and design changes, and relies on the substantial equivalence to the previously cleared Hansson Pin System (K964893) and the ASNIS II & III Cannulated Bone Screws.

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

There is no information provided in this document regarding a test set sample size or data provenance for a study.

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)

There is no information provided about experts, ground truth, or a test set in this document.

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

There is no information provided about an adjudication method or a test set in this document.

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

This document describes a medical device (a pin system for hip fracture fixation), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

This document describes a medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

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

Since no study with a "test set" is described, there is no information provided regarding the type of ground truth used. The 510(k) process for devices like this typically relies on established engineering principles, biocompatibility testing, mechanical testing (e.g., fatigue, tensile strength), and comparison to predicate devices, rather than clinical ground truth from human data in the way an AI diagnostic would.

8. The sample size for the training set

There is no information provided about a training set sample size, as this document does not describe the development or validation of an algorithm or AI model.

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

There is no information provided about how ground truth for a training set was established, as this document does not describe the development or validation of an algorithm or AI model.

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The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.

The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer sleeve and an inner sliding tongue, and is provided pre-assembled. The outer sleeve features a proximal window, where the inner sliding tongue's hook protrudes when properly introduced. Two pins are inserted into parallel drill holes through the femoral neck and into the femoral head. Fixation of the pin in the femoral head is achieved when the inner sliding tongue is intraoperatively pushed up partially through the proximal window, and the end hook curls around into the subchondral bone. The pins measure 6.5mm in diamctcr, are available in lengths ranging from 80mm to 150mm, and are made of ASTM F-138 Stainless Steel 316 LVM.

This document, a 510(k) premarket notification summary for the Hansson Pin™ System, does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.

Instead, the document focuses on:

• Device Identification: Naming the device, its common name, and classification.
• Predicate Device Identification: Stating that the Hansson Pin™ System is substantially equivalent to other legally marketed Class II femoral neck fracture fixation devices (Howmedica Knowles Hip Pins, Zimmer Knowles Hip Pins, and Howmedica Gouffon Hip Pin System).
• Device Description: Detailing the components, mechanism of action, dimensions, and material of the Hansson Pin™ System.
• Intended Use: Specifying the type of fractures the device is designed to treat.
• Statement of Technological Comparison: Highlighting similarities with predicate devices in materials, intended use, and surgical procedures, while noting a difference in the fixation method. It vaguely mentions that "testing performed substantiates the use of the subchondral bone end hook design for fixation of the pins," but does not provide any details about this testing, including acceptance criteria, study design, or results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method for the test set: Not applicable.
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, as this device is a physical medical device (femoral neck fracture fixation system), not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document describes a physical medical device, and the information provided is typical for a 510(k) summary focused on substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.

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