(90 days)
The Inion CompressOn™ products are intended for maintenance of alignment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodeses or bone grafts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).
In addition, the Inion CompressOn™ Ø 3.5/4.0/4.5/5.0/6.0 mm products are specifically intended for use in following indications:
A. General indication: maintenance of reduction of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization.
B. Specific indications: fractures and osteotomies of the malleoli, and ankle fractures.
Inion CompressOn™ Screws are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be re-used or re-sterilized.
Inion CompressOn™ Screws have nominal dimensions ranging from 2.7-6.0 mm in diameter and 12-90 mm in length. They are designed to be inserted using Inion® instrumentation: drill bits, bone taps, drill taps, screwdriver shafts, drill sleeves, K-wires and depth gauges. The screws can be inserted over a guide wire.
Inion CompressOn™ Screws provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
This is a 510(k) premarket notification for the Inion CompressOn™ Screw, a medical device for bone fixation. The document focuses on demonstrating substantial equivalence to a predicate device (Inion FreedomScrew™). As such, it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the way typically expected for such products.
The primary method for demonstrating substantial equivalence here is through mechanical performance testing and in vitro degradation testing, comparing the new device to a predicate device. There is no mention of an algorithm or AI model.
Therefore, many of the requested sections regarding AI/ML device performance (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this document.
However, I can extract information related to the performance testing conducted for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI/ML device, the acceptance criteria are not typically expressed as performance metrics like sensitivity/specificity. Instead, they relate to meeting specified mechanical and degradation properties, and being substantially equivalent to the predicate device.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Torsion | Sufficient mechanical properties for insertion | Determined and verified as sufficient for insertion. |
| Mechanical Pull-out (Initial) | Substantially equivalent to the predicate device (Inion FreedomScrew™) | Verified to be substantially equivalent to the predicate device. |
| In vitro Degradation & Pull-out | Degradation rate and pull-out properties substantially equivalent to predicate device (Inion FreedomScrew™) initially and over healing period | Verified to be substantially equivalent to the predicate device initially and over the healing period. |
| Functional and Handling Test | Implants, instruments, packaging, and IFU function as intended and conform to user needs | Performed, and devices passed tests for functionality and handling in simulated clinical use settings. |
| Simulated Clinical Use Test | Implants, instruments, packaging, and IFU function as intended and conform to user needs | Performed, and devices passed tests for functionality and handling in simulated clinical use settings. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to standard ASTM and ISO tests but does not specify the number of screws or test specimens used for each mechanical and degradation test. Data provenance is not relevant in the context of mechanical property testing of a fabricated device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as this is a non-AI/ML device and ground truth is not established by expert review in this context. The "ground truth" for mechanical testing is derived from the physical properties and performance metrics defined in consensus standards.
4. Adjudication Method for the Test Set
Not applicable, as this is a non-AI/ML device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable, as this is a non-AI/ML device.
6. If a Standalone Performance Study (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a non-AI/ML device. The "standalone" performance here refers to the device's inherent mechanical and degradation properties.
7. The Type of Ground Truth Used
For mechanical and degradation testing, the "ground truth" is defined by adherence to established consensus standards (ASTM F2502-11, ISO 13781:2017, ASTM F1635-16, ASTM F1839-08). The testing seeks to demonstrate that the device's physical properties meet these standards or are substantially equivalent to a predicate device that meets these standards.
8. The Sample Size for the Training Set
Not applicable, as this is a non-AI/ML device. There is no concept of a "training set" for mechanical performance testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is a non-AI/ML device.
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets its "acceptance criteria" (i.e., demonstrating substantial equivalence and sufficient mechanical/degradation properties) consists of the following pre-clinical bench testing:
- Mechanical Torsion Testing: Conducted to determine and verify sufficient mechanical properties for insertion.
- Mechanical Pull-out Test: Conducted to verify that the pull-out properties are substantially equivalent to the predicate device (Inion FreedomScrew™).
- In vitro Degradation Test: Conducted in accordance with ISO 13781:2017 and ASTM F1635-16 to verify that the degradation rate and pull-out properties are substantially equivalent to the predicate device, both initially and over the specified healing period.
- Functional and Handling Test: Performed to verify that the implants, accessory instruments, packaging, and instructions for use function together as intended and conform to user needs.
- Simulated Clinical Use Test: Performed for the same purpose as the functional and handling test, in a simulated environment.
These tests were conducted according to FDA recognized consensus standards, indicating a standardized and accepted methodology for evaluating such devices. The conclusion states that "The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CompressOn™ Screws are substantially equivalent with the predicate device Inion FreedomScrew™ (K123672). The devices have passed the tests for functionality and handling in simulated clinical use settings."
§ 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.