(76 days)
The I.T.S. Epiphysis Screw is a titanium implant fracture fixation screw system for a slipped femoral capital epiphysis and alternative cancellous bone screw fixation where accurate screw placement is required such as in the pelvis, ankle, knee, etc.,
Indications for Use include fracture fixation of large bone fragments, such as femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses.
The system is not intended for spinal use.
The I.T.S. Epiphysis Screw is a self-tapping and self-drilling screw with a cancellous thread that can be guided into a position via a guidewire pin. Screws are available partially threaded in lengths from 50mm to 120mm in 5mm increments. A full complement of instrumentation is available to assist in placement. The screws are manufactured from 6-4 ELI Titanium alloy with a Tiodize, Type II surface.
Here's an analysis of the provided text regarding the acceptance criteria and study for the I.T.S. Epiphysis Screw:
Missing Information:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the manner you've requested for a clinical trial or AI device validation. Most of the information you've asked for (such as MRMC studies, sample sizes, ground truth establishment, expert qualifications, and detailed performance metrics beyond basic equivalence) is not present in these regulatory documents.
The 510(k) process for this type of device (a bone screw) relies heavily on comparing the new device's design, materials, and intended use to existing, legally marketed predicate devices to show that it is "substantially equivalent" and thus as safe and effective. It does not typically involve the kind of rigorous, quantitative human-in-the-loop or standalone performance studies with detailed acceptance criteria that are characteristic of, for example, diagnostic imaging AI.
Here's a breakdown of what can be extracted or inferred, and what is explicitly unobtainable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided documents, explicit acceptance criteria and corresponding reported device performance as numerical metrics (e.g., sensitivity, specificity, accuracy) are NOT available.
For a device like a bone screw, "acceptance criteria" in the context of a 510(k) are typically met by demonstrating:
- Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device. This is the primary "acceptance criterion" for 510(k) clearance.
- Biocompatibility: The materials used are biologically safe.
- Mechanical Performance: The device meets certain strength, fatigue, and other engineering specifications (often tested in-vitro).
- Sterility: The device can be sterilized and maintained as sterile.
- Labeling: Clear instructions for use and warnings are provided.
The provided text focuses on the conclusion of substantial equivalence, not the detailed test results against specific criteria.
| Acceptance Criteria (Inferred from 510(k) process for bone screws) | Reported Device Performance (Inferred from FDA Clearance) |
|---|---|
| Substantial Equivalence to Predicate Devices | Achieved: FDA determined the device is substantially equivalent to legally marketed predicate devices (K021932, K000080, K862157, K903810). |
| Material Composition (6-4 ELI Titanium alloy with Tiodize, Type II surface) | Meets Specifications: Explicitly stated material composition. Implied to be equivalent to predicate materials. |
| Intended Use (Specific fracture fixations, not spinal use) | Meets Specifications: The stated intended use aligns with the FDA's acceptance for the device. |
| Design Characteristics (Self-tapping, self-drilling, cannulated, screw lengths) | Meets Specifications: Device description provided and implied to be equivalent to predicate designs. |
| Biocompatibility, Mechanical Strength, Sterility, Shelf Life, etc. | Implied to be met: These are fundamental requirements for medical devices, and their successful assessment is prerequisite for 510(k) clearance, even if not explicitly detailed in the summary. |
Study Details (Based on the provided documents)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable/not provided. This type of 510(k) submission for a bone screw does not typically involve a patient "test set" in the way a diagnostic AI device would. Performance is demonstrated through engineering tests (which are not detailed here) and comparison to predicate devices.
- Data Provenance: Not applicable/not provided.
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/not provided. Ground truth establishment with experts is not part of this type of 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/not provided.
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
- No. An MRMC comparative effectiveness study is not relevant or performed for a bone screw. This type of study is typically for diagnostic devices or AI applications where human interpretation is a factor.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical bone screw, not an algorithm. Standalone performance studies are not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of a "ground truth" for a patient test set. The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science, clinical consensus for predicate devices, and in-vitro testing for mechanical properties (not detailed here).
8. The sample size for the training set
- Not applicable/not provided. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/not provided.
Summary of what the documents do provide:
- Device Name: Epiphysis Screw
- Manufacturer: I.T.S. Implantat-Technologie-Systeme GmbH. (AUSTRIA)
- Device Description: Self-tapping, self-drilling, cannulated bone screw from 6-4 ELI Titanium alloy with Tiodize, Type II surface. Available in lengths 50mm-120mm.
- Intended Use: Stabilize slipped capital femoral epiphysis and fracture fixation in the pelvis of large bones and large bone fragments. Specific indications include: femoral neck fractures; slipped capital femoral epiphysis; tibial plateau fractures; pediatric femoral neck fractures; intercondylar femur fractures; and subtalar arthrodeses. Not intended for spinal use.
- Predicate Devices: Synthes 6.5mm Cannulated Screw (K021932), Howmedica Osteonics ASNIS III Cannulated Screw (K000080), Orthomet/Wright Medical Cannulated Screw (K862157), Ace/Depuy Cannulated Self Tapping Cancellous Bone Screw (K903810), Zimmer MAGNA-Fx Cannulated Screw Fixation system, Richards/Smith Nephew Universal Cannulated Screw, DePuyAce ACE SCFE Screw.
- Regulatory Conclusion: FDA found the device "substantially equivalent" to the predicate devices and cleared it for marketing.
§ 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.