(90 days)
The OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.
The OSTEOMED Cannulated Screw System is comprised of screws and washers used for bone fixation of the hand and foot following trauma or osteotomy. The System features cannulated screws in the following dimensions:
2.0mm screw diameter - 6mm to 42mm screw length;
2.4mm screw diameter - 6mm to 52mm screw length;
3.0mm screw diameter - 10mm to 40mm screw length;
3.5mm screw diameter - 12mm to 52mm screw length;
4.0mm screw diameter - 12mm to 52mm screw length;
5.5mm screw diameter - 12mm to 52mm screw length;
6.5mm screw diameter - 20mm to 120mm screw length;
8.0mm screw diameter - 30mm to 140mm screw length;
The implants (screws and washers) of the OsteoMed Cannulated Screw System are made from Titanium alloy (ASTM F-136). Modifications to screws and washer of the subject system include redesign of the 4.0mm cannulated screw to increase the strength of the lag portion and addition of a 3.0mm diameter cannulated screw and washer.
The system instruments include depth gauges, screw drivers, drills, countersinks, k-wires, and preparation instruments to facilitate the placement of screws. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
The provided text describes a Special 510(k) Summary for the OsteoMed Cannulated Screw System. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail a study proving the device meets acceptance criteria in the same way a diagnostic AI device would. Instead, it focuses on demonstrating equivalence to existing devices through performance testing.
Here's an analysis based on the provided text, addressing your questions to the best extent possible given the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document states that the 3.0mm and 4.0mm cannulated screws underwent "verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use." It also says, "A performance comparison was performed and verified that the cannulated screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate device and reference device listed in this summary."
However, the specific "required mechanical strength criteria" (i.e., the acceptance criteria) and the particular "reported device performance" values are not explicitly detailed in the provided text. The text only mentions that the criteria were met.
Therefore, a table cannot be fully constructed from the provided information.
2. Sample sizes used for the test set and the data provenance
The document mentions "verification evaluation" and "performance comparison" for the 3.0mm and 4.0mm cannulated screws. This implies a test set of physical screws was used. However, the sample size (number of screws tested) is not specified.
Regarding data provenance, the testing would have been conducted by OsteoMed, likely in-house or by a contracted lab. This would be prospective mechanical testing of newly manufactured devices. The country of origin for the data is not specified but is implicitly associated with OsteoMed (Addison, Texas, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The OsteoMed Cannulated Screw System is a physical medical implant (bone screw). Its performance is evaluated through mechanical testing, not by expert interpretation of data or images. Therefore, clinical experts are not used to establish a "ground truth" for its mechanical performance.
4. Adjudication method for the test set
This question is not applicable. Since the device's performance is determined by objective mechanical tests (e.g., strength, torque), there's no need for human adjudication of results. The testing would follow established engineering standards and protocols.
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
This question is not applicable. The OsteoMed Cannulated Screw System is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance do not apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. As stated above, this is a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing performed, the "ground truth" would be objective measurements against established engineering standards or predetermined performance requirements for medical implants. For example, a certain screw might need to withstand a specific torsion force or bending moment. This is a physical, measurable ground truth, not a clinical or pathological one.
8. The sample size for the training set
This question is not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The manufacturing process involves quality control and established design principles, but not a data-driven training set for an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the reasons outlined in point 8.
In summary, the provided document is a regulatory submission for a physical medical device (bone screws) and focuses on demonstrating substantial equivalence through mechanical performance testing to predicate devices, rather than clinical acceptance criteria or AI study data. The document states that the devices met required mechanical strength criteria, but the specific numerical criteria and results are not included in this summary.
§ 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.