(76 days)
The Phalangeal Fixation System is indicated for the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.
The PFS is a single use, non-toxic, disposable, sterile device. The PFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube.
Prior to use, the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the Phalangeal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the phalangeal bone.
The awl handle is then withdrawn and removed for advancement of the implantable pin. Multiple pins, usually two, are implanted in the manner previously described. The pins are placed in a arrangement to minimize radial movement.
The implantable pin(s) is then cut at the taper near the proximal end of the pin. Using the bending tube end of the exchange guide the implantable pin is bent to 90° with the apex of the bend at the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed.
The provided text is a 510(k) summary for the Medcanica, Inc. Phalangeal Fixation System (PFS). It focuses on demonstrating substantial equivalence to a predicate device (MicroAire Surgical Equipment, Inc. K-wire) primarily through bench testing and comparison of technological characteristics, rather than clinical performance studies. Therefore, much of the requested information regarding acceptance criteria for device performance in clinical settings, human reader studies, and detailed ground truth establishment in a clinical context is not available in this document.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from equivalence claim to K-wire) | Reported Device Performance (PFS vs. MicroAire K-wire) |
|---|---|
| Technological Characteristics: Substantial equivalence to predicate device across eleven specific characteristics. | "This has been demonstrated through comparison of eleven technological characteristics." |
| Performance Characteristics: Substantial equivalence to predicate device across five specific performance characteristics. | "Analysis of the data shows the products to be substantially equivalent." |
| Biocompatibility: Materials meet requirements of recognized consensus standards. | "The tissue/bone contact materials... meet the requirements of recognized consensus standards." |
| Safety and Effectiveness: Manufactured per specifications and good manufacturing practices. | "The PFS will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use." |
Note: The document does not specify the exact eleven technological characteristics or five performance characteristics. It only states that comparisons were made and substantial equivalence was found.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "extensive bench testing of both devices." This implies a sample size adequate for the bench tests conducted, but no specific number is provided.
- Data Provenance: The study was "bench testing." This means it was conducted in a laboratory setting, not on human subjects. Therefore, there's no country of origin or retrospective/prospective classification in a clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This was a bench testing study comparing the physical and mechanical properties of two medical devices. Ground truth, in this context, would be established by validated testing methods and measurements, not by expert clinical review of test data in the way it would be for diagnostic AI.
4. Adjudication Method for the Test Set
- Not Applicable. As this was bench testing, there's no clinical adjudication process involving multiple human experts. The "adjudication" would be based on established engineering and materials science principles and validation of test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI device. It is a traditional medical device (K-wire for phalangeal fixation). Therefore, no MRMC study or AI-related comparative effectiveness was performed or would be applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- Bench Test Results / Engineering Specifications / Material Standards. The "ground truth" for this study would be the scientifically validated results from the bench tests (e.g., measurements of strength, biocompatibility, dimensions, material composition) and the established performance characteristics and specifications of the predicate K-wire as a benchmark.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the provided device (Phalangeal Fixation System).
§ 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.