(47 days)
The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
The IFS Cannulated Screw is a self-tapping, self-drilling screw with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.
The provided document is a 510(k) summary for a medical device called the "IFS Cannulated Bone Screw". This type of document is for demonstrating substantial equivalence to a predicate device, not for presenting a study proving a device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set sample size, how training set ground truth was established) are not applicable to the information contained within this document. The document focuses on regulatory compliance and comparison to existing, legally marketed devices.
However, I can extract the acceptance criteria as implied by the substantial equivalence declaration.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance for IFS Cannulated Bone Screw
There are no explicit "acceptance criteria" and "device performance" metrics in the conventional sense (e.g., sensitivity, specificity, accuracy) detailed in this 510(k) summary. Instead, the "acceptance criteria" for this submission are implicit in demonstrating substantial equivalence to a predicate device. The "study" described is a comparison of design attributes, materials, and intended use.
1. Table of acceptance criteria and the reported device performance:
| Feature/Criterion | Acceptance Standard (Implied by Substantial Equivalence) | Reported Device Performance (IFS Cannulated Bone Screw) |
|---|---|---|
| Design Characteristics | Similar design attributes to predicate devices (e.g., self-tapping, self-drilling, cancellous thread, guidewire placement). | Self-tapping, self-drilling screw with a cancellous thread, guided by guidewire placement. Available in partial or fully threaded; 3.0mm, 3.5mm, 4.0mm thread diameters; 10mm to 75mm length. |
| Material | Same or equivalent material as predicate devices. | 316L (same as the primary predicate device, Precimed Cannulated Screw System). |
| Intended Use/Indications for Use | Same intended use/indications for use as predicate devices. | Treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodeses of the hand and foot (identical to the primary predicate device). |
| Sterilization | Distributed non-sterile, with instructions for end-user sterilization per recognized standards to achieve a Sterility Assurance Level (SAL) of 10⁻⁶. | Distributed non-sterile. Sterilized by the end user per AAMI Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve SAL of 10⁻⁶. |
| Performance (Mechanical/Functional) | Functionally equivalent to predicate devices, implying similar mechanical performance for bone fixation in the specified anatomical regions (not explicitly detailed). | Stated to have similar design attributes, material, and intended use as predicate devices, thus inferring equivalent function and performance for bone fixation. No specific mechanical test results are reported in this summary. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document does not describe a clinical study with a test set of human subjects or data. The "study" primarily consists of a comparison of device characteristics against predicate devices for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth establishment by experts is described in this regulatory submission for a clinical test set.
4. Adjudication method for the test set:
- Not Applicable. No clinical test set or adjudication process 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. This device is a bone screw, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The ground truth in this context is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance and market history. The submission argues that the new device is "substantially equivalent" to these known and accepted devices.
8. The sample size for the training set:
- Not Applicable. This document does not describe the development or training of an algorithm.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth establishment for a training set is described.
§ 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.