(74 days)
The Short Shaft Straight-In Bone Screw Fixation System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy).
This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency, sling procedure for male stress urinary incontinence resulting from prostatectomy). The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.
The provided text describes a 510(k) submission for a medical device, the "Short Shaft Straight-In Bone Screw Fixation System." It details the device's intended use and claims substantial equivalence to a predicate device (Influence, Inc.'s Straight-In Bone Screw System, K972622).
However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with advanced AI/ML medical devices. This is because the submission is for a mechanical fixation system, not a software-driven diagnostic or treatment algorithm.
Therefore, many of the requested categories (expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Claim: Substantial Equivalence to Predicate Device (Straight-In Bone Screw System, K972622) | The Short Shaft Straight-In and Straight-In systems are identical in design and materials. The only difference is a shorter inserter for improved maneuverability in open surgical procedures. Information and performance testing (not detailed in this document) demonstrated equivalence to the predicate devices with respect to performance. |
| Intended Use: Soft tissue fixation to bones in the pelvic region. | The device is indicated for use during open surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension, urethral sling procedures). |
| Technological Characteristics: Identical to predicate device. | The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission is for a mechanical surgical device, not a data-driven diagnostic tool. Performance equivalence was likely assessed through bench testing and comparison of design specifications with the predicate device. No "test set" in the context of data points is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As this is not an AI/ML device, there is no mention of expert-established ground truth for a test set in this document.
4. Adjudication method for the test set
Not applicable. No "test set" in the context of data is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are typically for diagnostic imaging software or similar devices involving human interpretation. This is a mechanical surgical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used
Not applicable. The "truth" here relates to the safety and effectiveness of the mechanical fixation system, assessed through engineering principles, material science, and comparison to a legally marketed predicate device, rather than a "ground truth" derived from expert labels or pathology.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a mechanical device, not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study Information Provided in the Document:
The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."
- Study Type: This would have been an un-detailed equivalence study focused on showing that the new device (Short Shaft Straight-In Bone Screw Fixation System) performs comparably to the predicate device (Straight-In Bone Screw System, K972622).
- Nature of Study: Given the device type (mechanical bone screw), this likely involved:
- Mechanical bench testing: To compare properties like screw strength, pull-out force, material properties, and dimensional conformity.
- Design analysis: A review of the design and materials to confirm their identity or equivalence to the predicate.
- Clinical rationale: Justification for the shorter inserter not negatively impacting performance, potentially through physician feedback or direct observation during simulated use.
- Key Finding: The only stated difference between the new device and the predicate is the shorter inserter for improved maneuverability. The 510(k) summary asserts that this difference does not alter the fundamental technological characteristics or performance of the device in comparison to its predicate.
§ 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.