(88 days)
The ICOS® SCREW is indicated for fixing the elective osteotomies of the forefoot and/or mid foot bones and for fractures fixation in the forefoot and/or mid foot and /or hindfoot, including:
*naviculo-cunéiform arthrodesis
*lapidus arthrodesis
*talus osteochondritis
*ankle arthrodesis
*arthrodesis, osteotomies or fractures fixation in the forefoot and/or midfoot and/or the hindfoot.
The I.CO.S Screw is a cannulated compression screw with non-threaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip. It comes in diameters from 4.0 mm to 6.5 mm and in length from 26 to 90. The I.CO.S® Screw is a cannulated compression screw made of titanium alloy. Its design includes a non-theaded shaft, allowing optimal compression. The head of this screw can be screwed and translated along the body in order to increase the compression controlled by the surgeon. It also has a self-tapping screw tip.
The provided text describes a 510(k) premarket notification for the I.CO.S® Screw, a cannulated compression screw. It details the device's characteristics, indications for use, and a summary of studies performed. However, the document does NOT contain information regarding:
- Specific acceptance criteria in a quantitative table.
- A comparative study with a "reported device performance" against acceptance criteria.
- Sample sizes for a test set (as no such study is described).
- Data provenance for a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with AI.
- A standalone (algorithm only without human-in-the-loop) performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on design, composition, function, and mechanical testing against recognized standards.
Here's a breakdown of what is available in relation to your request, and where information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria Mentioned: The document states, "The I.CO.S® Screw meet the ASTM standards (ASTM F136) for the material and design for medical application." It also mentions "Rupture torque of the I.CO.S.S. Screw was compared with requirements of the French Standard N° NF-S -90414."
- Reported Device Performance: "and found to have a resistance torsion in compliance with the selected standard" for the French Standard. For ASTM F136, it only states the device "meet" them.
- Missing Information: No specific quantitative table directly comparing acceptance thresholds with measured device performance values is provided. The document implies compliance rather than detailing specific numerical results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing Information: The document does not describe a "test set" in the context of clinical or algorithmic performance evaluation. The studies mentioned are material and mechanical tests, not clinical performance studies involving patient data or a "test set" of results.
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)
- Missing Information: Not applicable, as no clinical "test set" requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing Information: Not applicable.
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
- Missing Information: No MRMC study is mentioned. This device is a bone fixation screw, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing Information: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth (for mechanical testing): The "ground truth" or reference for the mechanical testing was the specified requirements of the ASTM F136 standard and the French Standard N° NF-S -90414.
- Missing Information: No clinical "ground truth" is described as no clinical studies are presented in this summary.
8. The sample size for the training set
- Missing Information: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Missing Information: Not applicable.
In summary, the provided document is a 510(k) premarket notification for a traditional medical device (a bone screw). The "studies" mentioned relate to material and mechanical properties, demonstrating compliance with existing standards (ASTM F136 and French Standard NF-S-90414) and substantial equivalence to legally marketed predicate devices. It does not include the type of performance data typically associated with AI/software medical devices or comprehensive clinical trials requiring the detailed information you've requested about test sets, experts, or ground truth for such studies.
§ 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.