(88 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, and the metatarsal bones of the foot.
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The awl handle is then withdrawn and removed for advancement of the implantable nail.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 losing 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.
Here's an analysis of the provided text regarding the Small Bone Fixation System, focusing on acceptance criteria and the study proving it:
Summary of Acceptance Criteria and Device Performance for the Small Bone Fixation System
The provided documentation does not detail specific, quantitative acceptance criteria for the device's clinical performance (e.g., fracture healing rates, complication rates). Instead, the acceptance criteria are rooted in compliance with recognized consensus standards and demonstrating substantial equivalence to predicate devices through technological characteristics, biocompatibility, and bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Type | Specific Criteria/Standard Adhered To | Reported Device Performance/Evidence |
|---|---|---|
| Material Standards | ASTM F138-97: Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) | "The materials meet the requirements of the previously referenced recognized consensus standards." |
| ASTM F899-95: Stainless Steel Billet, Bar and Wire for Surgical Instruments | "The materials meet the requirements of the previously referenced recognized consensus standards." | |
| Surface Treatment | ASTM F86-91: Surface Preparation and Marking of Metallic Surgical Implants | "demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy." |
| Device Specifications | ASTM F366-82 (Reapproved 1993): Fixation Pins and Wires | "demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy." |
| Biocompatibility | Assessed for tissue/bone contact materials | "Tissue/bone contact materials... have been carefully selected for their long history of biocompatibility." |
| Technological Equivalence | 17 technological characteristics compared to predicate devices | "Seventeen (17) technological characteristics of the Small Bone Fixation were compared to the predicate devices and found to be equivalent." |
| Safety and Effectiveness | Believed to be safe and effective, performs as well as or better than predicate device | "Since the Small Bone Fixation System meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate devices, we believe the device is safe and effective and performs as well as or better than the predicate device." |
| Quality System Compliance | Design controls compliant with Quality System Regulation (21 CFR Part 820) | "The Small Bone Fixation System for the Hand was designed utilizing design controls compliant with the Quality System Regulation." |
| Manufacturing Practices | Manufactured per specifications and good practices | "The Small Bone Fixation System will be manufactured per specifications and good practices that ensure the device is safe and effective for its intended use." |
Study Details:
The provided document describes a 510(k) premarket notification which, by its nature, relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive de novo clinical trials to prove safety and effectiveness from scratch.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the actual device itself being evaluated against standards and predicate comparison, not a human clinical trial test set.
- Data Provenance: The data provenance is primarily from bench testing and biocompatibility assessments conducted by Hand Innovations, Inc. (the manufacturer). It is internal company data derived from their design, material selection, and testing processes. There is no mention of data from human subjects or external clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth, in the traditional sense of clinical outcomes or expert consensus on medical images, is not established for a clinical test set in this 510(k) submission. The "ground truth" for material properties and technological characteristics is established by the specifications of the ASTM standards themselves and the design documentation/testing of the manufacturer.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The substantial equivalence determination is made by the FDA's Office of Device Evaluation based on the submission dossier.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study was not performed. This type of study typically involves comparing the diagnostic or prognostic performance of different medical devices or AI algorithms when interpreted by multiple human readers, often with or without AI assistance. This submission focuses on the physical and material equivalence of a surgical implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical surgical implant, not an algorithm or software-as-a-medical-device (SaMD). Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is primarily technical specifications defined by recognized consensus standards (ASTM standards) for materials and fixation pins/wires. Additionally, the technological characteristics of legally marketed predicate devices serve as a "ground truth" for comparison.
- Biocompatibility uses "long history of biocompatibility" of the selected materials as part of its evidence base.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this device.
§ 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.