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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

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.

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The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.

The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.

The provided text describes a medical device, the i[phi]s External Fixation Device, and its clearance through the 510(k) pathway. This pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than independent proof of safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.

The information that can be extracted relates to the substantial equivalence determination:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided text as the device followed the 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than direct proof against pre-defined acceptance criteria for performance. The text only states:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The 510(k) summary does not detail a "test set" in the context of a new efficacy study with human subjects. The substantial equivalence was demonstrated through "mechanical performance" (likely bench testing) and comparison to the predicate, not a clinical test set.

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 such clinical "test set" requiring expert ground truth establishment is described for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical "test set" requiring adjudication is described.

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. The device is an external fixation system, not an AI or imaging diagnostic device that would typically involve MRMC studies with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware medical device (external fixator), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the substantial equivalence claim, the "ground truth" was implicitly the performance and characteristics of the predicate device (K031919 – EBI XFIX DFS system) and the mechanical properties (e.g., strength, durability) of the i[phi]s fixator itself, assessed through engineering principles and testing. No clinical "ground truth" for efficacy in human subjects is described.

8. The sample size for the training set:

Not applicable. No "training set" in the context of an algorithm or AI model development is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No "training set" is mentioned.

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The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur

The STORM®® 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.

The document is a 510(k) premarket notification for a medical device (STORM® Operating Kit), which primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed performance study with acceptance criteria.

The key information provided is:

• Device Description: Components (Kirschner wires, bone screws, drill bit) and materials (stainless steel, non-sterile).
• Intended Use: Reduction and fixation of lower leg or distal femur fractures.
• Substantial Equivalence Claim: The device's components are considered substantially equivalent to specific predicate devices (K960385, K983121, K043185) based on similarities in intended use, materials, design, and "mechanical performance." However, no details of this mechanical performance or any specific acceptance criteria are provided in the excerpt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement.

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