(21 days)
1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.
The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)
- Lengths of implants are 16, 18, 20 and 25 mm. -
- Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
- Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
- Shelf life is same with SmartNail™ -
- Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.
The provided document is a 510(k) summary for the "Bionx Implants Inc. 1.5mm Bone Fixation Kit." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics typically associated with a new device's efficacy or safety study.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The document aims to show that the new device is functionally the same as an already-approved device, thus not requiring new clinical performance studies.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not explicitly stated. This document is a 510(k) submission aiming for substantial equivalence. It does not present a de novo study with specific performance acceptance criteria or a "reported device performance" against those criteria in the way new drug or novel medical device clinical trials would. The "acceptance criteria" here implicitly relate to demonstrating similarity to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. There is no "test set" or clinical data presented from a study to prove performance. The submission relies on technological characteristics and intended use equivalence to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set data or ground truth establishment by experts is described as this is a substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set data requiring adjudication is presented.
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 device is a bone fixation kit (a physical implant), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this submission is the predicate device's pre-established safety and effectiveness. The new device aims to be substantially equivalent to that.
8. The sample size for the training set
- Not applicable. No training set for an algorithm is relevant to this physical medical device submission.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Device Acceptance & Study Information from the Document:
The acceptance of the "1.5mm Bone Fixation Kit" into the market is based on its substantial equivalence to a predicate device, the "Bionx Implants Inc. SmartNail (K993074)." The "study" in this context is the detailed comparison of the new device's characteristics against the predicate device to support the claim of substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance (as implied by Substantial Equivalence):
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use (Same as predicate) | "1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments." (Identical to predicate's stated use, as per K993074 which is the predicate for this device) |
| Principles of Operation (Same as predicate) | Stated as having "the same...principles of operation" as SmartNail (K993074). Its function is to provide fixation for bone fragments. |
| Technological Characteristics (Similar to predicate) | Material: Composed of poly-L/D-lactide copolymer (Identical to SmartNail K993074). |
| Lengths: 16, 18, 20, 25 mm. | |
| Diameter: 1.5mm (Identical to SmartNail K993074 1.5mm). | |
| Design: Identical with SmartNail K993074. | |
| Shelf life: Same with SmartNail. | |
| Packaging: Similar, sterile, disposable. | |
| Safety and Effectiveness (No new issues) | "the minor technological differences... do not raise any new issues of safety or effectiveness." |
Data Provenance and Ground Truth:
- Data Provenance: The "data" proving equivalence comes from the specifications and characteristics of the new device and the known specifications and regulatory clearance of the predicate device (K993074). This is a descriptive comparison, not a clinical data collection.
- Ground Truth: The "ground truth" for the new device's safety and effectiveness is inferred from the established safety and effectiveness of the legally marketed predicate device.
Conclusion:
This 510(k) summary is a regulatory submission focused on demonstrating substantial equivalence, not a clinical trial report. As such, the concept of "acceptance criteria" and "study results" pertains to meeting the requirements for substantial equivalence by comparing the device features and intended use to a legally marketed predicate device, rather than presenting de novo clinical performance data.
§ 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.