(76 days)
The STERLING® Interference Screw HT is intended for use in an arthroscopic or open ACL and/or PCL reconstruction by a trained medical professional.
The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendonbone graft; fixation during posterior cruciate ligament reconstruction utilizing a bone-tendon-bone graft.
The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.
The provided text describes a 510(k) premarket notification for the STERLING® Interference Screw HT, a bone fixation screw made from processed bovine cortical bone. This document focuses on demonstrating substantial equivalence to a predicate device and includes details about an animal study and a viral inactivation study.
However, the information required for a comprehensive acceptance criteria and study description, particularly in the context of device performance metrics and evaluation methodology (like sample sizes, ground truth establishment, expert qualifications, and MRMC studies often associated with AI/software devices), is not present in the provided text.
The primary acceptance criteria and performance data available are related to comparability of remodeling in an animal model and viral inactivation efficiency. There are no reported device performance values in terms of statistical metrics (sensitivity, specificity, accuracy, etc.) because this is a physical medical device (a screw), not a diagnostic algorithm or AI.
Here's a breakdown of what can be extracted and what is missing based on your request:
Acceptance Criteria and Study for STERLING® Interference Screw HT
Given that the device is a physical bone fixation screw, the "acceptance criteria" and "device performance" in this context refer to biological and safety aspects rather than diagnostic or AI performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biological Performance | Comparable remodeling to allograft | Shown to remodel comparably to allograft |
| Safety (Viral Inactivation) | Reduction of panel of viruses to below detectable limits, with greater than six log reduction | Achieved greater than a six log reduction of a panel of viruses to below detectable limits |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Model: The text states "in an animal model" but does not specify the sample size (number of animals or implants) or the species used for the remodeling study.
- Viral Inactivation Study: The text refers to "a viral inactivation study" but does not specify the sample size (number of tests or replicates) or the specific viruses in the "panel of viruses."
- Data Provenance: The animal study and viral inactivation study are likely prospective studies conducted specifically for this submission. The text doesn't specify the country of origin for the studies, but the device is manufactured from bovine bone from a "closed herd located in the U.S.A."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. For a physical device like a screw, "ground truth" would typically refer to histopathological analysis for remodeling or detailed laboratory assays for viral inactivation. The expertise would lie with veterinary pathologists, microbiologists, and other laboratory scientists.
4. Adjudication Method for the Test Set
This information is not provided in the text. Methods like 2+1 or 3+1 adjudication are typically relevant for human-interpreted data (e.g., radiology reads), which is not the case here.
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, an MRMC comparative effectiveness study was not done. This type of study is specific to AI/software devices that assist human readers in diagnostic tasks. The STERLING® Interference Screw HT is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance study in the context of an algorithm's performance was not done. This is not applicable to a physical medical device.
7. The Type of Ground Truth Used
- Biological Performance (Remodeling): Implied ground truth would be histology and biological markers assessed in the animal model.
- Safety (Viral Inactivation): Ground truth would be established through laboratory viral assays determining the presence and quantity of infectious viral particles.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical device or an AI algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a bone screw) by comparing its material, design, and function to a predicate device, and by presenting evidence of its biological remodeling capacity and viral inactivation safety through an animal study and a viral study, respectively. It does not contain information related to AI or diagnostic performance metrics, expert evaluation, or ground truth establishment in the way these terms are typically used for AI-based devices.
§ 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.