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Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of instruments and implants into the skeletal system.

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires are metal K-Wires and Pins in a variety of lengths, diameters, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile and are intended to be sterilized at the point of use. All devices are manufactured from medical grade Stainless Steel.

The provided document is a 510(k) summary for Pacific Instruments' Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not typically found in a 510(k) summary for this type of device.

Based on the document, here's what can be extracted and what cannot:

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

The document does not present acceptance criteria in the format of a clinical or performance study with specific metrics and thresholds. Instead, it states that the device was evaluated for conformance to dimensional, material, and mechanical property standards: ASTM F138-13, ASTM F36-10, and ISO 5838-1.

Acceptance Criteria (Implied by Conformance to Standards):

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of a clinical study. It refers to the "items in the scope" that were tested for conformance to standards. The sample size for these conformance tests is not specified, nor is the provenance of any data beyond indicating that these are standards for medical grade stainless steel and implants.

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

This information is not applicable and not present in the document. The "ground truth" for this device type is established by the industry standards for materials and mechanical properties, not by expert interpretation of clinical data in a test set.

4. Adjudication method for the test set

This information is not applicable and not present in the document as no clinical test set requiring adjudication was 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

This information is not applicable. MRMC studies are typically for diagnostic imaging devices involving human interpretation, often with AI assistance, which is not the nature of this device (orthopedic fixation pins and wires).

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

This information is not applicable. This device is a physical medical instrument, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for evaluating this device's performance is adherence to established industry standards for medical device materials and mechanical properties:

• ASTM F138-13 (Standard Specification for Wrought 17Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673))
• ASTM F36-10 (Standard Test Methods for Bendability of Metallic Flat-Rolled Materials (This may be a typo and meant to refer to a relevant standard for mechanical properties of pins/wires used in orthopedics, as ASTM F36 is generally not for surgical implants. Often, specific ASTM or ISO standards for mechanical testing of orthopedic implants, like bending or tensile strength for fixation devices, are cited. However, the document explicitly states F36-10)).
• ISO 5838-1 (Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements)

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for physical medical devices like fixation pins and wires, as they do not involve machine learning algorithms.

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

This information is not applicable for the same reason as point 8.

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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

This is a 510(k) summary for a medical device called "Ultima HA Coated Half Pins & Wires". The purpose of this summary is to demonstrate substantial equivalence to existing predicate devices, not to prove performance against specific acceptance criteria in a clinical study. Therefore, the information requested regarding acceptance criteria and study details is not present in this document.

Here's a breakdown of why the requested information cannot be provided from the given text:

• This is a 510(k) submission: 510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with specific performance metrics and acceptance criteria.
• Focus on Substantial Equivalence: The document explicitly states: "The safety and effectiveness of the Ultima HA Coated Half Pins & Wires are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification." This means the assessment is based on comparisons with existing devices, not a standalone performance study.
• No mention of a clinical study for acceptance criteria: There is no description of a study designed to measure the device's performance against specific acceptance criteria. The "analysis data" mentioned likely refers to bench testing and material characterization, not patient data.

Therefore, I cannot provide the requested information for the following reasons:

1. A table of acceptance criteria and the reported device performance: Not present. The device is being cleared based on substantial equivalence, not a direct performance test against pre-defined criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set from a clinical study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment activity from a clinical study is described.
4. Adjudication method: 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. This device is a bone fixation fastener, not an AI-assisted diagnostic tool.
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 (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document concludes that "any differences that may exist do not significantly affect device safety and effectiveness" and that the device is "substantially equivalent to the predicate devices." This is the primary "proof" for a 510(k) submission of this nature.

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DSI Pins and Wires are non-sterile, single-use pins and wires intended to be used for the fixation of bone fractures, bone reconstruction, or as a guide/aid for the insertion of other medical devices.

DSI Pins and Wires consist of various pins and wires for use in the fixation of bone fractures, bone reconstruction, or as a guide/aid for insertion of other medical devices. All DSI Pins and Wires included in this submission are manufactured of implant grade stainless steel. All DSI Pins and Wires included in this submission will be marketed non-sterile. Kirschner Wires, Steinmann Pins and Cerclage Wires are included in this submission.

This looks like a 510(k) summary for a medical device that does not involve AI or machine learning. The device, "DSI Pins and Wires," is described as a physical product (implant grade stainless steel pins and wires for bone fixation), not a software algorithm or diagnostic tool.

Therefore, the prompt's request for information related to AI/ML device studies (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, etc.) cannot be answered from the provided text.

The document focuses on:

• Device Description: Physical characteristics and materials.
• Intended Use: Clinical applications.
• Regulatory Classification: Class II medical device.
• Substantial Equivalence: A comparison to existing, legally marketed predicate devices, which is the standard regulatory pathway for similar physical devices.

There is no mention of any software, AI, or performance studies that would generate the kind of data requested in the prompt. The "performance" for such a device would typically relate to mechanical strength, biocompatibility, and sterilization validation, not the diagnostic accuracy of an algorithm.

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