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510(k) Data Aggregation
(109 days)
The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are 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 pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants. Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. 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 resterilized. Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.
The provided text describes a 510(k) summary for the Inion FreedomPin™. It details the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a statistical analysis plan for an AI/ML device.
Therefore, many of the requested categories cannot be fully addressed. The information below reflects what is available in the provided text.
Acceptance Criteria and Study Details for Inion FreedomPin™
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Inion FreedomPin™ does not explicitly state numerical acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to demonstrate "substantial equivalence" to a predicate device in terms of mechanical properties and degradation profile.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical thresholds for AI/ML) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | "Sufficient strength to fulfil their intended function during the healing period." | "Mechanical testing in shear, bending, pull-out and torsion was performed to verify the strength and fixation properties of Inion FreedomPin™ and to compare them to the predicate devices." |
| "The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomPin™ are substantially equivalent with the predicate device Inion OTPS Biodegradable Pin (K050275)." | ||
| Degradation Profile | "Degrade gradually thereafter. Bioresorption takes place within two to four years." | "In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in vitro degradation and to ensure the degradation of the Inion FreedomPin™." |
| "The data demonstrates that... degradation profile... of Inion FreedomPin™ are substantially equivalent with the predicate device." | ||
| Functionality & Handling | "Functioning together as intended, and conform to the defined user needs and intended uses." | "Functional and handling test and simulated clinical use test were performed... The devices have passed the tests for functionality and handling in simulated clinical use settings." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes mechanical and in vitro degradation testing, as well as functional and handling tests and simulated clinical use tests. These are not clinical studies with "test sets" in the context of an AI/ML device's performance evaluation on patient data.
- Sample Size for Testing: Not specified in terms of number of pins, but implied to be sufficient for mechanical and degradation tests. It does not refer to patient samples.
- Data Provenance: The tests are described as in vitro and simulated clinical use, meaning they were conducted in a laboratory setting. There is no mention of patient data, geographical origin, or retrospective/prospective nature as this is a physical medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical bone fixation pin, not an AI/ML diagnostic or predictive system that requires expert-established ground truth from medical images or patient records. The "ground truth" for this device would be its physical properties and degradation characteristics, measured through established engineering and chemical testing methods.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation of data for "adjudication" in the context of the described physical and mechanical tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. An MRMC study is relevant for AI-powered diagnostic or screening tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Inion FreedomPin™ is a physical implant, not a diagnostic or image-analysis device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Inion FreedomPin™ is a physical medical device that is implanted surgically and supports bone healing. It does not involve an algorithm that operates "standalone" in the typical sense of AI/ML performance evaluation. Its "performance" is its mechanical integrity and biodegradation profile.
7. The Type of Ground Truth Used
For the Inion FreedomPin™, the "ground truth" for the performance testing refers to:
- Standardized Mechanical Test Results: Measurements of shear strength, bending strength, pull-out strength, and torsion using established engineering test methods.
- In Vitro Degradation Data: Measurements of material and mechanical property changes over time in a controlled laboratory environment mimicking physiological conditions.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence was the known and accepted performance of the predicate device (Inion OTPS Biodegradable Pin K050275), against which the new device's performance was compared.
8. The Sample Size for the Training Set
Not applicable. The Inion FreedomPin™ is a physical device, and its development and testing did not involve a "training set" in the context of AI/ML model development.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reasons as point 8.
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