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510(k) Data Aggregation
(27 days)
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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.
The provided text describes an FDA 510(k) summary for Reprocessed External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove performance against specific metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or present in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (as originally intended for predicate device) | Bench and laboratory testing was conducted to demonstrate performance. |
| Functional Equivalence to Predicate Device | Validation of reprocessing function testing performed. |
| Performance Equivalence to Predicate Device | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Design, Materials, Intended Use, Mechanism of Action, Claims, Clinical Applications, Patient Population, Performance Specifications, Method of Operation identical to predicate device | The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action is identical. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Sterility (after reprocessing) | Modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use. (This is a change, but implies the expectation for pre-use sterility.) |
Explanation: The "acceptance criteria" for a reprocessed device in a 510(k) submission are primarily centered around demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device(s) and performs "as originally intended" after reprocessing. Specific quantitative, measurable acceptance criteria in the sense of an algorithm performance are not typically included in such submissions for mechanical devices.
Missing Information/Not Applicable to this Device/Submission Type:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device undergoing a diagnostic performance test. The "test set" here refers to the actual reprocessed devices that underwent bench and laboratory testing. The submission does not specify the number of individual reprocessed units tested. Data provenance is also not relevant in the context of device reprocessing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on medical images) does not apply here. The "ground truth" for a reprocessed device's performance is its original specifications and how untouched, new versions of the device perform.
- 4. Adjudication method for the test set: Not applicable for a reprocessed mechanical device.
- 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-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device is its performance against the original device's specifications and intended function. The benchmark is the performance of the new, original (predicate) fixation devices.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable.
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(27 days)
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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.
The provided text describes the 510(k) summary for a reprocessed external fixation device (K052064). This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical trials with human subjects. Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
Here's an analysis of the provided information in relation to the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Validation of reprocessing | Not explicitly detailed, but implied to be sufficient to ensure devices are safe and effective after reprocessing. |
| Function Testing (mechanical performance) | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (Implies meeting original specs) |
| Safety & Effectiveness (overall) | Concluded to be "safe, effective and substantially equivalent to the predicate devices." |
Explanation: The acceptance criteria for a reprocessed device primarily revolve around demonstrating that the reprocessing does not degrade the device's original performance characteristics or safety. The performance data provided is high-level, stating that testing was conducted and that the reprocessed devices perform as originally intended. Specific pass/fail thresholds for individual tests are not detailed in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable to this 510(k) submission. No test set involving human data or images was used. The evaluation was based on bench and laboratory testing of the reprocessed devices themselves.
The data provenance is from laboratory and bench testing, presumably conducted by Alliance Medical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. The "ground truth" for a reprocessed medical device in this context is its ability to perform identically to virgin devices according to established mechanical and functional standards. This is determined through engineering tests directly on the devices, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" in the sense of clinical data requiring adjudication.
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 is not applicable. This submission is for a reprocessed physical medical device, not an AI/ML-powered diagnostic tool. Therefore, no MRMC studies or human reader performance analyses were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For this device, the "ground truth" for performance is established by the original design specifications and performance characteristics of the predicate (virgin) external fixation devices. The reprocessed devices are compared against these established standards through defined bench and laboratory tests to ensure they function equivalently. The "ground truth" is therefore established through engineering specifications and validated testing methods.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm that requires a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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(24 days)
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically "Reprocessed External Fixation Devices."
For such devices, the "acceptance criteria" and "study" typically focus on demonstrating that the reprocessed device performs equivalently to the original, new device and the predicate device, especially after the reprocessing procedures (cleaning, disinfection/sterilization, functional testing).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance and Evidence |
|---|---|---|
| Functional Equivalence | Reprocessed devices must perform functionally as originally intended, comparable to new devices and predicate 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." | ||
| "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." | ||
| Material/Design Identity | Materials, design, shapes, and sizes of the reprocessed devices must remain identical to the original and predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." |
| Intended Use Identity | The intended use and indications for use of the reprocessed devices must be identical to the original and predicate devices. | "Intended use: External Fixation Devices are intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a quide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system." |
| "The only change is the modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use." (Note: this is a change in sterilization delivery, not intended use). | ||
| Safety and Effectiveness | The reprocessed devices must be safe and effective for their intended use. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." |
| "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." | ||
| No change in claims | There should be no changes to claims, clinical applications, patient population, or performance specifications. | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Reprocessing Validation | The reprocessing procedures themselves must be validated to ensure the device performs as intended after reprocessing. | "Validation of reprocessing Function Testing" (This implicitly means the reprocessing process was validated such that the device maintains its function). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "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."
- Sample Size: The specific sample size for the "bench and laboratory testing" is not explicitly mentioned in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's pre-market testing for a reprocessed device, it would be prospective testing conducted by Alliance Medical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of submission. For medical devices like reprocessed External Fixation Devices, the "ground truth" is typically defined by engineering specifications, material properties, and mechanical performance standards, not by expert clinical consensus on diagnostic accuracy. The testing involves physical and mechanical properties, not interpretation of clinical data by experts.
4. Adjudication Method for the Test Set
- This information is not applicable to this type of submission. Adjudication methods (like 2+1, 3+1) are used when establishing ground truth from multiple expert readings of diagnostic images or clinical assessments. For mechanical performance testing of a device, the results are typically quantitative measurements against predefined specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and their performance with and without AI assistance is compared. This submission is for a reprocessed surgical implant (external fixation device), not a diagnostic tool requiring human interpretation of data where AI assistance would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For this device, the "ground truth" for performance testing is generally based on mechanical and material specifications derived from the original device design, relevant ASTM/ISO standards, and engineering performance requirements for external fixation devices. It involves quantifiable measurements of properties like strength, fatigue resistance, torsional stability, and material integrity, ensuring they meet the same standards as new, original devices. It's not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather established engineering benchmarks.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical reprocessed medical device, there is no "training set" in the context of machine learning. The "training" for the reprocessing process would involve establishing and validating specific cleaning, disinfection, and functional testing protocols based on engineering principles and regulatory guidelines.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, there's no "training set" in the AI/ML sense. The "ground truth" for the reprocessing process (which ensures the device meets performance criteria post-reprocessing) is established through rigorous validation protocols that demonstrate the ability to consistently clean, sterilize, and restore functional performance to predefined engineering specifications for external fixation devices. This involves chemistry, microbiology, and mechanical engineering testing rather than expert-derived ground truth.
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(16 days)
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
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.
The provided text describes the reprocessed external fixation devices, their intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or comparative effectiveness studies involving human readers or standalone algorithm performance.
Instead, the document details "bench and laboratory testing" to demonstrate performance (safety and effectiveness) and that the "Reprocessed External Fixation Devices perform as originally intended." However, it does not provide specific metrics, sample sizes, or methodologies for this testing beyond "Validation of reprocessing" and "Function Testing."
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory approval (510(k) summary) based on substantial equivalence, rather than a detailed performance study with quantifiable acceptance criteria.
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