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510(k) Data Aggregation
(120 days)
The IFS Fixation Scaffold is indicated for small bone fixation, reconstruction and fusion such as inter-digital fusion of fingers and toes.
The IFS is a hollow fenestrated cylinder fabricated from nitinol with a section that increases the implants diameter to lock into the medullary compartment of bone while shortening its length. The nitinol's transition temperatures are set so that the material is in the austenitic state when released at room temperature. Features on the cylinder's surface, such as bulges and prongs, lock into bone.
The IFS is pre-loaded onto an insertion instrument and held elongated in position by a lock plate. During insertion, the IFS is released by turning a knob on its instrument while the lock plate both releases the IFS and limits the depth of implant insertion.
The IFS implants range in diameter from 2.5 to 4.5 mm and up to 9.3 mm when expanded and range in length from 21 to 27 mm depending on size and extent of contraction.
The provided document is a 510(k) premarket notification for the Intramedullary Fixation Scaffold (IFS) System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be done for a software or AI/ML-driven device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not relevant or available in this type of submission.
However, I can extract the relevant performance data that serves as the "acceptance criteria" and the "study" demonstrating the device meets these in the context of a 510(k) submission, which focuses on comparison to predicate devices.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
In a 510(k), "acceptance criteria" are often implicitly defined by the performance of the predicate device, with the new device needing to perform "equivalently or better."
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (IFS Fixation Scaffold) |
|---|---|
| Corrosion Susceptibility (equivalent or better than predicate per ASTM F2129) | "The corrosion behavior of the IFS was equivalent or better than the predicate device to which it was compared and presented high corrosion breakdown potentials for all IFS devices tested." |
| Contraction Force (equivalent to or less than predicate bone staple implants K123363 9x9 mm and 11x10 mm) | "Contraction tests showed that the IFS contraction force causing bone segments to be put into compression was equivalent to or less than the 9x9 mm and 11x10 mm bone staple implants of K123363." |
| Expansion Force (equivalent or superior to predicate K133520) | "...the expansion force causing retention in the medullary canal was equivalent or superior to the K133520 predicate device." |
| Ultimate Strength in Bending (equivalent or superior to predicates K133520 and K863734) | "Ultimate strength in bending was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior in strength to the predicate devices tested." |
| Bone Fixation Strength (equivalent or superior to predicates K133520 and K863734) | "Bone fixation strength was measured for the IFS, K133520 and K863734 and the IFS was found equivalent or superior to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or "test set" size. The document refers to "all IFS devices tested" for corrosion and "the IFS" (implying a set of IFS devices) for mechanical tests. For the predicates, it refers to specific models (e.g., "9x9 mm and 11x10 mm bone staple implants of K123363"). The exact number of units tested for each metric is not disclosed.
- Data Provenance: The studies are described as "Corrosion testing per ASTM F2129" and various mechanical tests conducted on the IFS and predicate devices. No information on country of origin of data or retrospective/prospective nature is provided, as these are in vitro engineering tests of the device itself, not clinical trial data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This relates to clinical data interpretation or ground truth establishment for AI/ML algorithms, which is not the subject of this 510(k) for a physical medical device. The "ground truth" here is the physical measurement of the device's mechanical and material properties.
4. Adjudication method for the test set
- Not applicable. This is for clinical data review or AI/ML ground truth, not for in vitro material and mechanical testing. The results are from direct physical measurements.
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 physical scaffold, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical scaffold, not an AI/ML algorithm.
7. The type of ground truth used
- For the performance data mentioned (corrosion, contraction/expansion force, ultimate strength, bone fixation strength), the "ground truth" is established through objective, standardized engineering and material science measurements according to recognized ASTM standards (e.g., ASTM F2129 for corrosion) or similar biomechanical testing protocols. These are direct physical properties of the device and its interaction with simulated bone.
8. The sample size for the training set
- Not applicable. This refers to AI/ML algorithms. The IFS System is a physical device.
9. How the ground truth for the training set was established
- Not applicable. This refers to AI/ML algorithms.
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