(84 days)
The Metacarpal Fixation System is indicated for the fixation of transverse or short oblique fractures of the diaphysis or diaphyseal-metaphyseal junction of metacarpal bones.
The MFS is a sterile, single use, disposable device that is delivered non-toxic. The MFS 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 metacarpal 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 metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable pin. The implantable pin is then cut adjacent to the pin handle. Using the bending tube end of the exchange guide and bend tube, the implantable pin is bent to 90° with the apex of 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. In the event that it is desired to reform the implantable pin or implant a smaller pin, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable pin into the medullar space. Once the medullar space is accessed, the pin is removed. Another pin may be placed into the medulla by inserting it into the groove of the exchange guide. After the pin has been inserted into the medullar space, remove the exchange guide.
The provided text is a 510(k) premarket notification for a medical device (Metacarpal Fixation System) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with acceptance criteria for device performance as would be expected for a novel device or software. Therefore, much of the requested information about acceptance criteria, study details, and ground truth establishment is not present in this document.
However, I can extract the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Material | ASTM F138-97 (Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel for Surgical Implants) | Meets ASTM F138-97; 316LVM, ASTM F138-97 |
| Biocompatibility | Carefully selected for long history of biocompatibility (meets referenced standards) | Tissue/bone contact materials "carefully selected for their long history of biocompatibility" and meet requirements of referenced consensus standards. |
| Surface Prep/Marking | ASTM F86-91 (Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants) | MFS meets requirements of ASTM F86-91 |
| Fixation Pins/Wires | ASTM F366-82 (Reapproved 1993) (Standard Specification for Fixation Pins and Wires) | MFS meets requirements of ASTM F366-82 (Reapproved 1993) |
| Surgical Instruments | ASTM F899-95 (Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical Instruments) | MFS meets requirements of ASTM F899-95 |
| Sterilization | Demonstrably sterile with specified shelf life | Gamma radiation; 3 years shelf life |
| Drill Geometry | Compliant with ISO 5838-3 (Implants for Surgery - Skeletal Pins and Wires - Part 3: Kirschner Skeletal Wires) | Different from predicate device, but designed to be compliant with ISO 5838-3 trocar point requirements. |
| Mechanical Properties | "Extensive bench testing" to demonstrate substantial equivalence to predicate device in stiffness/yield, cutting geometry, and drilling. | "Extensive bench testing" conducted; concluded as "substantially equivalent" to predicate device in stiffness/yield, cutting geometry, and drilling. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "extensive bench testing" and a "cutting geometry comparison" but does not provide details on the number of devices or trials included in these tests.
- Data Provenance: The data is derived from "bench testing" of the Medcanica MFS and the MicroAire Surgical Equipment, Inc. K-wire. This implies in-vitro testing rather than human or animal studies. No country of origin is mentioned for the data, but the submission is to the US FDA by a US-based company. The data is implicitly prospective testing performed for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described is primarily mechanical/material bench testing, which typically does not involve expert adjudication for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided as the "test set" described is for bench testing of mechanical properties and material compliance, not for clinical evaluation requiring 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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical implant (Metacarpal Fixation System), not an AI-powered diagnostic or assistive tool. Therefore, questions regarding "human readers improve with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
A standalone performance study (algorithm only) was not done. This device is a physical medical implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is based on:
- Compliance with recognized consensus standards: (ASTM F138-97, F899-95, F86-91, F366-82, ISO 5838-3).
- Physical and mechanical properties confirmed through bench testing: Stiffness/yield, cutting geometry, and drilling performance compared to the predicate device.
- Material specifications: 316LVM, ASTM F138-97.
8. The sample size for the training set:
There is no training set discussed in this document. The MFS is a physical implant, not a learning algorithm or AI device that would require a "training set."
9. How the ground truth for the training set was established:
As there is no training set, this question is not applicable.
§ 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.