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510(k) Data Aggregation
(43 days)
The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
The R&R Ring Fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Ring Fixator design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.
Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.
The R&R Unilateral Mini Fixator is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression / distraction and early weight bearing, The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.
The provided text is a 510(k) summary for the R&R External Fixation System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria and device performance results as would be typical for a software or AI/ML device.
Therefore, many of the requested categories for describing acceptance criteria and study details are not directly applicable to this type of regulatory submission. The 510(k) process for this device relies on demonstrating that the new device has "the same intended use as legally marketed predicate device(s) and the same technological characteristics as the predicate device(s), OR the same intended use as legally marketed predicate device(s) and different technological characteristics than the predicate device(s) and information submitted by the 510(k) submitter does not raise new questions of safety and effectiveness." It is not about meeting specific performance metrics from a controlled study with predefined acceptance criteria in the manner of an AI/ML device.
Here's an attempt to address the request based on the available information, noting where the information is absent due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to predicate devices, not on presenting specific performance data against predefined acceptance criteria for a study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. The 510(k) summary does not describe a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present. No such ground truth establishment process for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. No adjudication method for a test set is described.
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
This information is not present. The R&R External Fixation System is a physical medical device (an external fixator), not an AI/ML device, so an MRMC study related to "human readers improving with AI" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. As it's a physical device, this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. No ground truth for a study is described. Regulatory clearance for this type of device often relies on mechanical testing, biocompatibility testing, and comparison to predicate devices, rather than clinical studies requiring "ground truth" as might be understood for diagnostic AI.
8. The sample size for the training set
This information is not present. No training set is described as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not present. No training set or associated ground truth establishment is described.
Summary of Relevant Information from the K052005 510(k) Summary:
While the detailed study information you're asking for isn't in this document, here's what the 510(k) does provide regarding the device and its regulatory clearance:
- Device: R&R External Fixation System (Ring Fixator and Unilateral Mini Fixator)
- Intended Use: For various orthopedic applications including fracture fixation, limb lengthening, and deformity correction of long bones (tibia, fibula, femur, humerus, radius, ulna) and small bones (metacarpal, metatarsal, ulnar, calcaneal).
- Classification: Class II, Product Code KTT (Single/multiple component metallic bone fixation appliances and accessories).
- Equivalent Devices (Predicates):
- Regulatory Basis: The FDA reviewed the 510(k) submission and determined the device is "substantially equivalent" to the predicate devices for its stated indications for use. This determination means the device does not raise new questions of safety and effectiveness compared to existing, legally marketed devices.
- Approval Date: September 6, 2005.
The 510(k) process for this type of device typically involves demonstrating that the new device has similar design, materials, and mechanical properties to predicates, and that any differences do not raise new safety or effectiveness concerns, often supported by design comparisons, risk analysis, and non-clinical performance testing (e.g., fatigue, static strength, and biocompatibility testing) rather than clinical studies with "test sets" and "ground truths" as described for AI devices.
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(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) submission for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to predicate devices, not on a new, AI-powered diagnostic or therapeutic device. As such, many of the requested criteria (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI improvement effect size) are not applicable to this type of submission.
The core of this submission is about proving that reprocessing existing external fixation devices does not alter their safety and effectiveness compared to new, predicate devices.
Here's an analysis of the available information based on your request:
Description of Acceptance Criteria and Study to Prove Device Meets Them
The acceptance criteria for the "Reprocessed External Fixation Devices" are implicitly tied to demonstrating that the reprocessed devices perform identically to their original, new counterparts, and to the predicate devices, in terms of safety and effectiveness. The study described focuses on proving that the reprocessing procedure maintains these critical performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Reprocessed devices must perform functionally equivalent to new devices. | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." "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." |
| Biocompatibility: Reprocessing must not introduce unacceptable biocompatibility risks. | "Biocompatibility Validation of reprocessing" (mentioned as conducted to demonstrate performance). |
| Sterility/Cleanliness: Reprocessing must ensure proper sterilization and removal of contaminants. | While not explicitly detailed in the provided text, "Biocompatibility Validation of reprocessing" would inherently include aspects of cleanliness and sterilization efficacy to ensure patient safety. |
| Material Integrity: Reprocessing must not degrade the materials of the device. | "The design, materials, and intended use of the Reprocessed External Fixation Device s are identical to the predicate devices." Implies that reprocessing does not fundamentally alter these. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the devices tested as part of the "bench and laboratory testing."
- Data Provenance: The data comes from "bench and laboratory testing" conducted by Alliance Medical Corporation. No country of origin is specified for the data itself, but the submitter is based in Phoenix, Arizona, USA. The testing is retrospective in the sense that it evaluates the performance of reprocessed versions of already existing devices. It is not prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission does not involve a diagnostic device or a study requiring expert readers to establish ground truth for a test set in the traditional sense (e.g., radiology interpretation). The "ground truth" here is the established performance and safety of the original, new devices and the predicate devices. The study aims to show the reprocessed device meets these existing standards, rather than defining a new ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There is no mention of an adjudication method as it relates to expert reader interpretation. The testing is bench and laboratory-based.
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 is not an AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device or algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is implicitly the established performance specifications, material properties, biocompatibility, and intended use of the original, new, and predicate external fixation devices. The study aims to demonstrate that the reprocessed devices meet these existing, well-defined standards. This is akin to using established engineering standards and material science data as a basis for comparison.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is not a machine learning or AI device.
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