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510(k) Data Aggregation
(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed External Fixation Devices:
Acceptance Criteria and Device Performance Study for Reprocessed External Fixation Devices
Based on the provided 510(k) summary (K012623), the device in question is a reprocessed medical device, specifically external fixation devices. The regulatory approach for such devices often focuses on demonstrating that the reprocessed device performs identically to the original, new device, and that the reprocessing itself does not compromise the device's safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the types of tests conducted rather than explicit quantitative acceptance criteria with specific thresholds. However, the overarching acceptance criterion is substantial equivalence to the predicate devices. The reported performance is a qualitative statement that the device met this criterion.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Material Equivalence | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." (Stated as a characteristic of the reprocessed device, implying it performs equivalently to the original materials.) |
| Functional Equivalence | "The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." | "The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices..." (This implies that any functional tests performed would have shown equivalent performance to original devices, although specific functional performance data is not detailed in terms of measurable outcomes in this summary.) "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (This is the summary conclusion for the overall functional performance based on the specific tests mentioned below.) |
| Biocompatibility | Demonstrate that the reprocessed device remains biocompatible. | Listed as a conducted test: "Biocompatibility." The implication is that the reprocessed devices met biocompatibility standards equivalent to the original devices. (No specific data or numerical criteria provided in this summary.) |
| Reprocessing Validation | Demonstrate that the reprocessing methods are effective and do not degrade the device. | Listed as a conducted test: "Validation of reprocessing." The implication is that the reprocessing procedures effectively cleaned, sterilized, and restored the device to its original performance characteristics without damage. (No specific data or numerical criteria provided in this summary.) |
| Overall Safety & Effectiveness | Conclusion: device is safe, effective and substantially equivalent to predicate devices. | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." and "Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices as described herein." |
Note: This is a 510(k) Summary, which typically does not include the detailed raw data or specific quantitative acceptance thresholds. It provides a high-level overview of the testing and conclusions. The actual data would be in the full 510(k) submission.
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for the benchmark and laboratory testing. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that this is a reprocessed device, the "test set" would primarily refer to a batch of reprocessed devices subjected to various tests.
3. Number of Experts and Qualifications for Ground Truth
This type of study is a bench and laboratory testing of physical devices, not a study evaluating an AI algorithm's diagnostic performance against human experts. Therefore, the concepts of "number of experts," "ground truth establishment by experts," and their qualifications are not applicable to this submission. The "ground truth" would be the engineering and material science specifications of the original devices.
4. Adjudication Method for Test Set
As this is a physical device performance study and not an interpretation task done by experts, an adjudication method is not applicable. The test results would be quantitative (e.g., material strength, chemical residue levels) compared against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable. This type of study is used to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of medical cases. The submission describes testing of a physical medical device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study refers to the evaluation of an AI algorithm's performance without human intervention. This document describes the testing of a physical medical device, not an AI algorithm. Therefore, such a study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and performance data of the original, new devices, as well as established industry standards for biocompatibility and reprocessing. This is inferred from the statement: "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." The original intention and performance characteristics define the ground truth for the reprocessed device.
8. Sample Size for Training Set
The concept of a "training set" is relevant to machine learning or AI models. This submission is for a physical medical device (reprocessed external fixation devices). Therefore, a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable.
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