(83 days)
The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.
The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.
Prior to use, the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted 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 slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.
The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.
In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.
An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.
This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI or diagnostic device would.
Based on the provided text, the "acceptance criteria" and "device performance" are primarily framed around compliance with recognized consensus standards and demonstrating "substantial equivalence" to existing, legally marketed devices.
Here's an analysis of the provided information, structured around the requested points, with observations where information is not explicitly available:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Material Composition | ASTM F138-97: Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel | Meets requirements of ASTM F138-97 |
| ASTM F899-95: Stainless Steel Billet, Bar and Wire for Surgical Instruments | Meets requirements of ASTM F899-95 | |
| Surface Preparation | ASTM F86-91: Practice for Surface Preparation and Marking of Metallic Surgical Implants | Meets requirements of ASTM F86-91 |
| Fixation Pins/Wires | ASTM F366-82 (Reapproved 1993): Standard Specification for Fixation Pins and Wires | Meets requirements of ASTM F366-82 (Reapproved 1993) |
| Biocompatibility | Compliance with recognized consensus standards for tissue/bone contact materials | Tissue/bone contact materials have a long history of biocompatibility and meet referenced standards. |
| Technological Characteristics | Substantial equivalence to predicate devices (K994232 and K013424) on 17 characteristics | Seventeen (17) technological characteristics were compared and found to be equivalent to predicate devices. |
| Safety & Effectiveness | Performed as well as or better than the predicate device. | Believed to be safe and effective, and perform as well as or better than the predicate device due to standards compliance and technological equivalence. |
| Quality System | Device designed and manufactured under design controls compliant with Quality System Regulation | Designed utilizing design controls compliant with the Quality System Regulation; will be manufactured per specifications and good practices. |
2. Sample size used for the test set and the data provenance:
- The document describes bench testing for material and mechanical properties, not a clinical "test set" in the sense of patient data. There is no mention of a specific sample size for a test set of patient data.
- Data provenance for the bench testing is not specified beyond "Hand Innovations design review policy." There is no mention of country of origin or whether a "test set" involved retrospective or prospective data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a mechanical fixation system, not a diagnostic or AI device that requires expert-established ground truth for a test set of patient data. The "ground truth" here is compliance with engineering and material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no mention of a test set involving human judgment or interpretation.
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. This is a medical device for bone fixation, not an AI or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a mechanical medical device, not an algorithm. Bench testing was performed on the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is adherence to recognized consensus standards (ASTM F138, F899, F86, F366) for material properties and manufacturing practices, and technological equivalence to predicate devices. There is no mention of clinical outcomes data in the context of this 510(k) submission for establishing ground truth.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing follow established engineering principles and quality system regulations.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as point 8.
§ 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.