(263 days)
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
The POGO Screw is a medical device designed for the fixation of bone fractures and reconstructive surgery.
Here's an analysis of its acceptance criteria and the study conducted to prove it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Accomplish the same function of providing compression fixation between bone segments. | "The POGO Screw and the predicate device accomplish the same function of providing compression fixation between a base bone and a bone fragment." |
| Design Characteristics | Accommodate a similar range of total lengths within each product design. | "Both devices accommodate a range of total lengths within each product design." |
| Materials | Be manufactured from comparable materials (316 surgical stainless steel). | "The components are manufactured from 316 surgical stainless steel." (Also applies to the predicate devices). |
| Intended Use | Indicated for use in the general management of fractures and reconstructive surgery. | "The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery." (Identical to predicate). |
| Safety and Efficacy | Not raise any new safety and efficacy concerns compared to legally marketed predicate devices. | "The POGO Screw does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices." |
| Substantial Equivalence | Demonstrably substantially equivalent to predicate devices to allow market clearance. | "The POGO Screw is substantially equivalent in design, materials, construction and intended use as those of the predicate." |
2. Sample Size Used for the Test Set and the Data Provenance
The documentation provided does not describe a test set with explicit sample sizes for clinical data, patient cases, or imaging. The evaluation of the POGO Screw for 510(k) clearance was based on bench testing and a comparison of its technological characteristics to predicate devices. Therefore, the concept of "data provenance" related to human data (e.g., country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the clearance was based on bench testing and comparison to predicate devices, not on the evaluation of a test set with human-labeled ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there was no test set involving human-labeled ground truth or adjudication.
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
An MRMC comparative effectiveness study was not performed. This device is a bone fixation screw, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The POGO Screw is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the POGO Screw's performance was established through:
- Bench Testing Data: This involved engineering tests to evaluate mechanical properties, strength, and other physical characteristics of the screw. While specific test types and results are not detailed in the summary, "Bench testing was conducted to support equivalency."
- Comparison to Predicate Device Specifications: The key "ground truth" was that the POGO Screw's design, materials, and intended use were demonstrably the same or highly similar to legally marketed predicate devices (Smith and Nephew Cannulated Screws and Stryker Medical Asnis III). This effectively meant the established safety and efficacy of the predicate devices served as a benchmark for the POGO Screw.
8. The Sample Size for the Training Set
This information is not applicable. There was no "training set" in the context of machine learning or AI for this device. The development process would have involved engineering design, material selection, and manufacturing, followed by bench testing and comparison to established standards and predicate devices.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there was no "training set." The understanding of "ground truth" for a device like the POGO Screw is developed through engineering principles, material science, biomechanical testing, and clinical experience with similar devices (the predicate 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.