(86 days)
The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system.
The Starr Frame Steinmann Pins consist of various fixation pins and are offered in assorted dimensions and configurations to accommodate physician preferences, physical profiles of different patients, and varying injuries and conditions. The devices are constructed of implant grade 316LVM stainless steel. They are provided non-sterile and intended for single-use only.
The provided 510(k) summary (K082017) pertains to the "Starr Frame Steinmann Pins," which are bone fixation fasteners. This submission is for a medical device that demonstrates substantial equivalence based on established performance standards, rather than a diagnostic device relying on algorithm performance for clinical outcomes. Therefore, many of the requested elements for an AI/algorithm study (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable in this context.
The study presented focuses on compliance with recognized consensus standards for material and mechanical properties, not on an algorithm's performance in diagnosing or predicting.
Here's the breakdown of the information that is applicable from your request, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|
| ASTM F366-04: "Standard Specification for Fixation Pins and Wires" | The Starr Frame Steinmann Pins will comply with this standard. |
| ISO 5838-1:1995: "Implants for Surgery – Skeletal Pins and Wires – Part 1: Material and Mechanical Requirements" | The Starr Frame Steinmann Pins will comply with this standard. |
Note: The document states the device will comply with these standards, implying that testing to demonstrate this compliance was conducted or is guaranteed to be conducted as part of manufacturing and quality control. The specific test results (e.g., tensile strength, fatigue life) are not detailed in this summary; rather, the commitment to meet the standards is the reported "performance" for the purpose of 510(k) substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary as the study is not clinical performance data for an algorithm. The "test set" here refers to the physical pins themselves being tested against engineering standards, not a dataset of patient information. No patient data provenance is relevant for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device is based on established engineering and materials science standards (ASTM and ISO), not on expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. This 510(k) summary does not describe a study involving expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers' diagnostic accuracy, which is not applicable to a physical bone fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Starr Frame Steinmann Pins is defined by the material and mechanical requirements specified in the recognized consensus standards: ASTM F366-04 and ISO 5838-1:1995. This is a technical, engineering-based ground truth related to the physical properties and performance of the device under stress, rather than a clinical ground truth (e.g., pathology, outcomes data).
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. As there is no training set for an algorithm, there is no ground truth to establish for it.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.