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510(k) Data Aggregation
(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand 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.
The provided text describes a 510(k) premarket notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. The focus of this submission is to demonstrate substantial equivalence to predicate devices, primarily through the assertion that the reprocessed devices maintain identical characteristics and performance to new, legally marketed devices.
Based on the information provided, it's important to note that the acceptance criteria and study detailed are not typical performance metrics for a novel medical device. Instead, they center on demonstrating that the reprocessing process does not compromise the original device's safety and effectiveness. There are no specific AI components or human-in-the-loop performance studies described.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Design | Identical to predicate devices (original, new external fixation devices). | "The design...of the Reprocessed External Fixation Device s are identical to the predicate devices." |
| Materials | Identical to predicate devices. | "The...materials...of the Reprocessed External Fixation Device s are identical to the predicate devices." |
| Intended Use | Identical to predicate devices. | "The...intended use...of the Reprocessed External Fixation Device s are identical to the predicate devices." (Also, "There are no changes to the claims, intended use...") |
| Mechanism of Action | Identical to predicate devices, utilizing the same standard mechanical design, materials, shapes, and sizes. | "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." |
| Claims | No changes from predicate devices. | "There are no changes to the claims..." |
| Clinical Applications | No changes from predicate devices. | "There are no changes to the clinical applications..." |
| Patient Population | No changes from predicate devices. | "There are no changes to the patient population..." |
| Performance Specifications | No changes from predicate devices. | "There are no changes to the performance specifications..." |
| Method of Operation | No changes from predicate devices. | "There are no changes to the...method of operation." |
| Biocompatibility | Maintained post-reprocessing. | Biocompatibility testing was conducted. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Performance (Safety & Effectiveness) | Reprocessed devices perform as originally intended (i.e., equivalent to new devices). | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." and "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Validation of Reprocessing | Reprocessing method is valid and consistently achieves desired outcomes. | "Validation of reprocessing" was performed. (Specific details of validation criteria and results are not provided but are implied to be sufficient for substantial equivalence). |
Study Details:
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Sample size used for the test set and the data provenance:
The document states "Bench and laboratory testing was conducted." It does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing would involve a subset of the reprocessed devices mentioned in the list (e.g., specific models of clamps, rods, etc.). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. Given the nature of a reprocessing submission, the "ground truth" would likely be defined by established engineering standards, material specifications, and performance benchmarks for new, equivalent devices, rather than expert interpretation of clinical data in the same way an AI diagnostic would require. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving expert readers, which is not the type of study described here. -
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 was not done. This device is a reprocessed external fixation device, not an AI or diagnostic tool that assists human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this submission is implicitly defined by the performance specifications and characteristics of the new, legally marketed predicate devices. The reprocessing validation and performance testing aim to demonstrate that the reprocessed devices meet these pre-established new device standards. This would involve objective measurements against engineering specifications for strength, fatigue, material integrity, sterility, biocompatibility, etc. -
The sample size for the training set:
This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set. -
How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.
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