(17 days)
The use of the Kompressor compression screw is generally indicated for the reduction and fixation of fractures appropriate for the size of the device. It is indicated for use in the internal fixation of fractures, fusion, and revision. It is also indicated for reconstructive procedures where reduction and fixation of bone fragments is required (e.g. osteotomies). Contraindications would include any conditions which would contraindicate implants in general, including: Infection, Metal sensitivity or allergic reaction to foreign bodies, Any concomitant disease which may compromise the function of the implant, In those cases where avascular necrosis has rendered bone stock inadequate.
The Kompressor bone screw implant is a two-piece fixation device intended for use in the reduction, stabilization, and internal fixation of small bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and compress bone segments. The implant is available in a variety of sizes to accommodate various fracture types and sites. Materials: Titanium; Ti-6A14V-ELI per ASTM F136. The system functions to draw bone fractures together, thereby facilitating fixation.
The provided text is a 510(k) premarket notification for the KMI Kompressor Compression Screw System. This document focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria and reported device performance.
Therefore, many of the requested details about acceptance criteria, study design, sample size, expert involvement, and ground truth are not available in the provided text.
Here's an attempt to answer the questions based on the available information, with clear indications where the information is not present:
Acceptance Criteria and Device Performance Study for the KMI Kompressor Compression Screw System (K040356)
The provided submission does not contain a study report with specific acceptance criteria and reported device performance as would be found in a clinical trial or performance study for a novel device. Instead, this 510(k) relies on demonstrating "substantial equivalence" to a legally marketed predicate device (KMI Kompressor compression screw, K024233).
The "acceptance criteria" in this context are implicitly the requirements for substantial equivalence, meaning the modified device should not raise new questions of safety or effectiveness and performs similarly to the predicate. The "reported device performance" is essentially that its mechanical features and intended use align with the predicate, with changes limited to size ranges and broadened indications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as described in the 510(k)) |
|---|---|
| Mechanical Features: Maintain equivalent mechanical features to the predicate device. | The modified Kompressor compression screw system employs the "same mechanical features as the predicate, legally marketed device in that the essential configuration consists of a leading and a trailing thread, the varying ratios between non-tapping and tapping may and bone segments." |
| Materials: Use equivalent or compatible materials to the predicate device. | Materials: Titanium; Ti-6A14V-ELI per ASTM F136 (This is the same material as commonly used for bone implants, implying equivalence to suitable predicate materials, though explicit comparison to the predicate's material is not detailed in the provided text, it's assumed to be equivalent). |
| Intended Use: Device is safe and effective for its intended use, which may be broadened from the predicate but without raising new safety/effectiveness concerns. | The intended use for reduction, stabilization, and internal fixation of small bone fractures is maintained. Indications for use have been broadened to include applications other than small bones of the hand and wrist, with no significant differences predicted to adversely affect use. |
| Safety and Effectiveness: No significant differences that would adversely affect the use of the product. | "There are no significant differences between the modified Kompression Screw There are no sigmineant arreters systems currently being marketed which would adversely and the product." Changes were limited to a new range of sizes and broadened indications, implying no adverse effect on safety or effectiveness. |
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 for Test Set: Not applicable / Not provided. This submission does not detail a test set from a performance study. It relies on a comparison to a predicate device.
- Data Provenance: Not applicable / Not provided.
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 / Not provided. The submission focuses on comparing the new device's design to an existing, cleared device, not on evaluating its performance against a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 / Not provided. This is a submission for a mechanical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is a submission for a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this 510(k) is effectively the regulatory clearance of the predicate device and the accepted scientific and engineering principles for medical implants. No new "ground truth" derived from clinical data or expert consensus for this specific device would typically be required for a substantial equivalence determination under 510(k), especially given the minor modifications.
8. The sample size for the training set
- Not applicable / Not provided. This is a submission for a mechanical implant, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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.