(89 days)
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. The In-Fast Bone Screw System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws with attached suture. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw/anchor anchor threaded with polypropylene suture which is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The screw/anchor is loaded into an inserter which is positioned in the vagina. Pulling force is applied on the user handle to pass the screw/anchor's tip into the bone cortex. The inserter's safety lock is released and screw/anchor is inserted into the prescribed depth in the pubic bone. In the In-Fast system, the screw is threaded into the bone by the inserter's rotating shaft.
This submission is for a medical device (In-Fast Bone Screw System), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance (e.g., sample size for test set, ground truth, MRMC studies, standalone performance, training set details) is not applicable.
The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance metrics against specific acceptance criteria for AI algorithms.
Here's a breakdown of what can be extracted from the provided text, reframed to address the spirit of your request where possible for a medical device:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally that the device is substantially equivalent to a legally marketed predicate device (or devices) in terms of intended use, technological characteristics, safety, and effectiveness. The "reported device performance" in this context refers to how the new device compares to the predicate.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (In-Fast Bone Screw System) |
|---|---|
| Substantial Equivalence - Intended Use | Indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Substantially equivalent to UroTac, Mitek GII Anchor, and Vesica Suture Anchor Systems. |
| Substantial Equivalence - Technological Characteristics | Bone screw and inserter for soft tissue fixation to the pubic bone by means of bone screws with attached suture. Mechanical properties and technical procedure "almost identical" to UroTac. Closely resembles the screw in Questus™. |
| Substantial Equivalence - Performance (Safety & Effectiveness) | "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k) cleared device." Specifically, "proven to provide substantially equivalent fixation strength" to Mitek GII Anchor. |
| Biocompatibility | All materials used are either commonly used in medical applications or have been proven to be biocompatible through biocompatibility testing. |
| Surgical Procedure | Cystourethropexy procedure is identical for both UroTac and In-Fast systems. Transvaginal sling procedure using In-Fast is substantially equivalent to the in situ sling technique used with Vesica Suture Anchor System. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria (i.e., substantial equivalence) is presented through a comparison to multiple predicate devices that have already been cleared by the FDA.
- Primary Predicate: Influence, Inc.'s UroTac Bone Screw System (K962372).
- Basis for Equivalence: "mechanical properties and technical procedure of the two systems are almost identical."
- Other Predicates for Comparison:
- Mitek GII Anchor (K920213): "proven to provide substantially equivalent fixation strength."
- Vesica Suture Anchor System (K932925): Substantially equivalent for use in the vaginal sling procedure.
- Questus™ Polyester Soft Tissue Anchor System (K953264 and K963200): Screw in In-Fast closely resembles the screw used in Questus™.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided as the submission relies on bench testing and comparison to predicates, not a clinical study with a "test set" in the AI/ML sense. The "test set" here would implicitly be the performance characteristics of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. Ground truth, in the AI/ML context, refers to a definitive label or outcome for data points. For a classic medical device 510(k), the "ground truth" is established by regulatory clearance of the predicate devices and the generally accepted understanding of their safety and effectiveness, supported by engineering (bench) tests and material science.
4. Adjudication Method for the Test Set
This is not applicable. There's no "test set" or adjudication process described in the context of evaluating an AI model's output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This is not relevant for a 510(k) submission for a bone screw system. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical implant and associated inserter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established performance of predicate devices: Their regulatory clearance implies their safety and effectiveness.
- Bench testing: Engineering tests demonstrating physical properties, fixation strength, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a "training set" or a ground truth established for one.
§ 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.