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The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.

The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points.

This document describes the Ceramic Tipped Skull Pin, a medical device intended for use in Halo Traction Systems. The primary study presented is a laboratory test comparing the Ceramic Tipped Skull Pin to a predicate Titanium Skull Pin based on mechanical integrity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices. The document mentions "Both the Ceramic Tipped Skull Pins and Generation 80 (Titanium) Skull Pins were tested." This implies at least one of each type, but the exact sample size for the mechanical tests is not detailed.
• Data Provenance: Laboratory tests. The country of origin is not specified, but the manufacturer, Jerome Medical, is based in Moorestown, New Jersey, USA. The data is prospective as it involves new laboratory testing of the devices.

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

• Not Applicable. This study is a laboratory performance test against a recognized standard (ASTM F 1831-97) for mechanical integrity. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense of clinical or image-based studies. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standard.

4. Adjudication Method for the Test Set

• Not Applicable. As this is a laboratory test against a standard, there is no need for expert adjudication. The test results are objective measurements compared against the standard's requirements.

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

• No. This study is not an MRMC study. It does not involve human readers, AI, or clinical cases to assess diagnostic effectiveness or improvement with AI assistance. It focuses solely on the mechanical performance of a physical device.

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

• No. This is a hardware device. There is no algorithm or software involved to have a standalone performance.

7. The Type of Ground Truth Used

• Objective Standard Compliance: The "ground truth" is defined by the requirements of the ASTM F 1831-97 standard, section 11, for mechanical integrity of Halo Rings. The devices were tested to see if they met these predefined, objective criteria.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As there is no training set, this question is not relevant.

Summary of the Study:

The study was a laboratory comparison designed to demonstrate the mechanical integrity of the Ceramic Tipped Skull Pin against the predicate Titanium Skull Pin. Both devices were tested in accordance with ASTM F 1831-97, section 11. The key findings were that both the new Ceramic Tipped Skull Pin and the predicate Titanium Skull Pin met the requirements of this standard. The primary differences highlighted for the new device were the use of non-conductive materials for improved image quality and patient safety, and a thicker material for offset load strength, which were confirmed not to adversely affect product performance through these tests.

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This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.
This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.

The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Bone Band" device.

Unfortunately, the provided text does not contain information about a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device ("Bone Band"), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Instead of performance criteria and a study demonstrating compliance, the document provides a comparison of the characteristics of the submitted device to a predicate device. This is typical for a 510(k) submission where the primary argument for market clearance is that the new device is as safe and effective as an already legally marketed device, and therefore may not require extensive new clinical or performance studies if the differences are minor.

Therefore, for most of your requested points, the answer will be that the information is not present in the provided text.

Here's a breakdown based on the information available:

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

Note: The document states the predicate device is Stainless Steel, reusable, non-sterile. The submitted device has different characteristics in these attributes, but the 510(k) process aims to show these differences do not raise new questions of safety or effectiveness.

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

• Not applicable. The document does not describe a performance or clinical study; it focuses on a comparison of device characteristics to a predicate device.

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. No test set or ground truth establishment by experts is described for a performance study. The "ground truth" in a 510(k) is implicitly the safety and efficacy of the predicate device, which is already on the market.

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

• Not applicable. No test set requiring adjudication is described.

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 physical bone band, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a physical bone band.

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

• Not applicable. In the context of a 510(k) substantial equivalence, the "ground truth" is often the established safety and effectiveness of the legally marketed predicate device, rather than a specific ground truth for a new performance study.

8. The sample size for the training set

• Not applicable. No training set is involved for this type of device and submission.

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

• Not applicable. No training set or associated ground truth establishment is described.

In summary: The provided document is a 510(k) summary for a basic orthopedic surgical aid. The primary argument for market clearance is substantial equivalence to an existing predicate device, not the demonstration of performance against specific acceptance criteria through a new study. Therefore, most of the requested information regarding study design, sample sizes, ground truth, and expert evaluation is not present in this type of regulatory submission.

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The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.

The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.

The provided text is a 510(k) Premarket Notification for the Osteonics® FX-Cablelok™ Grip Components. This document establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria, a standalone study proving performance, sample sizes for test/training sets, or specific details on ground truth establishment or expert involvement in a study.

Therefore, I cannot provide the requested information as the provided text does not describe a study that proves the device meets acceptance criteria. The document focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

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