(24 days)
The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws threaded with suture. It consists of a transvaginal inserter and bone screws with attached suture.
The provided text describes a 510(k) summary for the In-Fast Bone Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness through extensive clinical trials with the kind of detailed acceptance criteria and study designs that would be typical for a novel device or drug.
Therefore, many of the requested elements (sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types beyond basic compliance) are not applicable to this document as it pertains to a 510(k) submission for a device modification.
Here's an analysis based on the information provided:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The In-Fast Bone Screw System's acceptance criteria and proof of performance are primarily based on achieving "substantial equivalence" to a legally marketed predicate device (K970292), specifically regarding the addition of braided suture. The study conducted was a bench test of mechanical properties to ensure compatibility and compliance with established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with USP Monograph for Non-Absorbable Sutures | The suture "complies with the USP Monograph for Non-Absorbable Sutures." |
| Mechanical properties compatible with the In-Fast system | "The mechanical properties of the braided suture have been tested on the bench for compatibility with the In-Fast system." |
| Substantial equivalence to predicate device in terms of: | "The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics." |
| - Intended Use | (Implicitly met by not changing the intended use) |
| - Technological Characteristics | (Implicitly met by not fundamentally changing technology, only adding suture) |
| - Performance Characteristics | (Implicitly met through bench testing and USP compliance) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. This type of engineering bench test would typically use a sufficient number of samples to ensure statistical validity for mechanical properties, but the exact number is not provided in a 510(k) summary.
- Data Provenance: The study was a "bench test," meaning it was conducted in a laboratory setting. No country of origin is specified for the data itself, but the submitting company is American Medical Systems, Inc. (Minnetonka, MN, USA). The study is prospective in the sense that the testing was performed specifically to support this 510(k) submission.
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. For mechanical bench testing and compliance with a USP Monograph, the "ground truth" is established by adherence to standardized testing protocols and the specifications within the USP Monograph, not by expert consensus in the typical sense of clinical expert review. The experts involved would be engineers or quality control personnel familiar with testing methodologies and material science, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. This submission involves mechanical bench testing against a standard.
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 is a medical device for soft tissue fixation, not an image analysis or AI-driven diagnostic tool. Therefore, MRMC studies are not relevant nor mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance evaluation was primarily compliance with the USP Monograph for Non-Absorbable Sutures and the mechanical specifications for compatibility with the In-Fast system. This relies on established material science standards and engineering principles.
8. The sample size for the training set:
- Not Applicable. This type of device submission (510(k) for a modification) does not involve a "training set" in the context of machine learning or complex statistical modeling from a large dataset. The testing performed was for product validation, not model training.
9. How the ground truth for the training set was established:
* Not Applicable. As there is no "training set" in this context, this question is not relevant.
§ 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.