(36 days)
The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.
The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
This 510(k) summary is for the STØRM™ Operating Kit, which is an external fixation system. This medical device submission does not involve AI/ML technology or image analysis, but rather describes a physical surgical kit. Therefore, many of the requested categories related to AI/ML device performance, such as acceptance criteria based on accuracy metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable.
The submission focuses on demonstrating substantial equivalence to a predicate device based on similarities in intended use, materials, design, and mechanical performance.
Below is an attempt to address the request based on the provided document, highlighting where information is not applicable due to the nature of the device.
Acceptance Criteria and Study for the STØRM™ Operating Kit
As this submission is for a physical surgical kit (external fixation system components) and not an AI/ML-driven device, the acceptance criteria and study focus on substantial equivalence through material properties, design, intended use, and mechanical performance rather than diagnostic accuracy or algorithmic performance metrics.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Same as predicate device (K061607). | "Used in conjunction with the STØRM™ in the reduction and fixation of fractures of the lower leg or distal femur." — Matches predicate. |
| Technological Characteristics | Similar materials and design to predicate device. | "Components are made from stainless steel and are presented sterile." — Similar to predicate. |
| Material/Design | Components (Kirschner wires, bone screws, drill bit) should match the specifications and design of the predicate kit. | The device consists of "two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit." — Implied to be equivalent to predicate components. |
| Mechanical Performance | Mechanical performance demonstrating equivalence to the predicate device. | "Mechanical performance demonstrating substantial equivalence to the predicate devices." — No specific values or tests reported in this summary, but this statement indicates conformance. |
| Sterility | Components are sterile. | "Components are ... presented sterile." — Confirmed. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable in the context of a "test set" for an AI/ML algorithm. This submission relies on a comparison of device specifications and, presumably, mechanical testing of a representative sample of components, though specific sample sizes for such tests are not detailed in this 510(k) summary.
- Data Provenance: Not applicable in the AI/ML sense. The information provided is from the manufacturer, Intelligent Orthopaedics Limited, based in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualfications of those experts
- Not applicable. There is no "ground truth" establishment in the context of AI/ML or diagnostic accuracy for this type of device. The evaluation is against the specifications and performance of a predicate device.
4. Adjudication method for the test set
- Not applicable. There is no "adjudication method" as would be used to resolve discrepancies in expert readings for an AI/ML device. The assessment is made by the FDA's Office of Device Evaluation based on the submission documents proving substantial equivalence.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, "ground truth" would relate to accepted engineering standards, material properties, and established predicate device performance rather than clinical outcomes or pathology. The "truth" is established by showing the device meets its own specifications and is equivalent to a legally marketed predicate.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary of Device Acceptance (FDA's Determination):
The FDA granted substantial equivalence (K111001) for the STØRM™ Operating Kit. This determination was based on the similarities in intended use, materials, and design to the predicate device (K061607), and the assertion that "mechanical performance demonstrating substantial equivalence to the predicate devices" was provided. The specific details of the mechanical testing that supported this claim are not present in the provided 510(k) summary, but such data would have been part of the full submission package reviewed by the FDA.
§ 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.