Search Results
Found 8 results
510(k) Data Aggregation
(83 days)
Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions and management of comminuted intra-articular fractures of the distal radius.
SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods, articulating and telescoping components), and connection elements (rings, plates, and posts) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
The provided text describes a 510(k) premarket notification for a Reprocessed External Fixation Device, not an AI or imaging device, therefore many of the requested fields are not applicable. The device is a reprocessed medical device, and the focus of the submission is to demonstrate its substantial equivalence to an original, legally marketed predicate device (the Smith & Nephew Original Ilizarov® External Fixation System).
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for a reprocessed medical device like this external fixation device are generally focused on demonstrating that the reprocessed device performs functionally and safely to the same standards as the original device, and that the reprocessing itself is safe and effective (e.g., proper cleaning and sterilization).
| Acceptance Criteria Category | Reported Device Performance (as per submission) |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Process Validation (Cleaning) | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Smith & Nephew Original Ilizarov® external fixation devices based upon similarities in functional design (principle of operation), materials, indications for use, and methods of construction. |
Study Details
Given that this is a 510(k) for a reprocessed non-AI medical device, the typical "study" involves engineering and process validation testing rather than large-scale clinical trials or AI performance evaluations as would be expected for a diagnostic software device.
-
Sample size used for the test set and the data provenance:
- The document mentions "Representative samples of reprocessed external fixation constructs were tested." No specific numerical sample size is provided in the text.
- Data Provenance: Not explicitly stated, but implicitly from SterilMed, Inc.'s internal testing labs, likely in the USA. These tests would be prospective in the sense that they were conducted specifically for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device and the "ground truth" is defined by established engineering and medical device performance standards for the predicate device, not by expert interpretation of data like images. No expert consensus on performance is described beyond regulatory review.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to discrepancies in expert readings for diagnostic algorithms. For a physical device, performance is typically assessed against quantifiable engineering specifications derived from the predicate device.
-
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 type of study is for evaluating the impact of AI on human reader performance, which doesn't apply to a reprocessed external fixation device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, reprocessed medical device, not an algorithm. The standalone performance would refer to the device's functional integrity as tested in the lab, which was done ("Representative samples...were tested to demonstrate appropriate functional characteristics.").
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this type of device is the established functional and safety specifications of the original (predicate) device, and adherence to those specifications through engineering tests (e.g., mechanical strength, fatigue, material integrity) and process validation (e.g., cleaning efficacy, sterilization).
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. No training set is used for this type of device submission.
Ask a specific question about this device
(74 days)
This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation
SterilMed's reprocessed external fixation devices consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
The provided text describes a 510(k) submission for a Reprocessed External Fixation Device by SterilMed, Inc. It claims substantial equivalence to the Stryker Hoffman II® External Fixation System.
However, the document does not contain the kind of detailed information requested about acceptance criteria and a study proving device performance in the context of diagnostic accuracy, which is typical for AI/ML devices or those with measurable performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this submission focuses on the performance claims related to a reprocessed medical device, where the "performance" is more about functional integrity, sterility, and safety after reprocessing, rather than a diagnostic accuracy metric.
Here's a breakdown of what can be extracted based on the nature of this submission, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a reprocessed device, the "acceptance criteria" and "performance" are framed around maintaining the original device's functionality and safety after reprocessing. There are no specific numerical metrics like accuracy, sensitivity, or specificity.
| Aspect of Performance/Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Cleaning Procedure | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Stryker Hoffman® II external fixation devices in functional design (principle of operation), materials, indications for use and methods of construction. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Representative samples" were used for functional testing and cleaning procedure validation. Specific numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of data origin (e.g., country) as this pertains to the testing of the reprocessed physical device itself, not data collected from patients or diverse populations. The testing would have been conducted by SterilMed, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not present in the document. For device reprocessing, the "ground truth" would be established by validated engineering and quality control standards, rather than expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation or consensus is required to establish ground truth for a diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance (e.g., of an AI system vs. human readers) and is not applicable to the reprocessing of a surgical fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not an algorithm or AI device. Hence, a standalone performance study in that context is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device would be established by engineering specifications, regulatory standards, and validated testing protocols to ensure the reprocessed device meets the functional and safety requirements of the original device and regulatory guidelines for reprocessing. This is based on physical and mechanical testing, not expert consensus on medical cases, pathology, or outcomes data in the usual sense for diagnostic devices.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML algorithm requiring a training set mentioned in this document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
Conclusion on Document Suitability:
The provided document is a 510(k) summary for a reprocessed medical device. The information requested in points 2 through 9 (and parts of point 1) is typically relevant for evaluating diagnostic devices, especially those incorporating Artificial Intelligence or Machine Learning, which rely on large datasets, expert ground truth, and statistical performance metrics (e.g., sensitivity, specificity, ROC analysis). This document does not pertain to such a device, and therefore, most of the requested details are not present or applicable.
Ask a specific question about this device
(75 days)
Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
The TransFx" External Fixation System is a modular system. Device description: The system design is designed to provide options in frame construction, simplicity in frame components, and ease of transition from one frame size to another.
This document describes a 510(k) submission for Reprocessed External Fixation Devices. The acceptance criteria and supporting study information are derived from the "Performance data" and "Technological characteristics" sections.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safely reprocessed without introducing hazards. | "Validation of reprocessing" conducted. |
| Effectiveness: Device performs as originally intended. | "Function test(s)" conducted. "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Sterility: For sterile devices, sterility is maintained. | "Sterilization Validation (for sterile devices)" conducted. |
| Equivalence to Predicate: Design, materials, intended use, mechanism of action, claims, clinical applications, patient population, performance specifications, and method of operation are identical to predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action... is identical... 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." |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of a clinical study with human subjects. The performance testing appears to be primarily bench and laboratory-based. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical "test set" in the traditional sense. The testing was conducted on "Reprocessed External Fixation Devices," implying a sample of these reprocessed devices was tested.
- Data Provenance: The studies were "Bench and laboratory testing." No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the submitted data. The studies performed were bench and laboratory tests, not clinical evaluations requiring expert consensus for ground truth.
4. Adjudication method for the test set
This information is not applicable. No clinical test set or subjective evaluation requiring adjudication 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
No multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is a reprocessed medical device (external fixation devices), not an AI/imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical, reprocessed external fixation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench and laboratory testing:
- Ground Truth for performance: The performance of the predicate (original) devices serves as the functional "ground truth." The reprocessed devices are evaluated against the expectation that they perform "as originally intended," meaning identically to the new, non-reprocessed versions. This would involve comparing mechanical properties, material integrity, and functional operation to established standards for new devices.
- Ground Truth for sterility: Sterility validation would be against recognized sterility assurance levels (e.g., ISO standards) for medical devices.
- Ground Truth for reprocessing validation: This would be against established procedures and standards for effective cleaning, disinfection, and sterilization to remove contaminants and pathogens.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
Ask a specific question about this device
(102 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 bory 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 document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed External Fixation Devices. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for a novel AI/medical imaging device would.
Instead, the submission for these reprocessed devices focuses on demonstrating that they perform "as originally intended" and are substantially equivalent to the original predicate devices. This is a crucial distinction. For reprocessed devices, the "acceptance criteria" are primarily centered around ensuring the reprocessing does not compromise the device's functional integrity, sterility, and material properties compared to new devices.
Therefore, the information for some of your requested points is not present in this type of submission. I will answer based on the information provided and note when information is not available due to the nature of this 510(k) for reprocessed external fixation devices.
Description of Acceptance Criteria and Study
The acceptance criteria for the Reprocessed External Fixation Devices are implicit in demonstrating that the reprocessed devices are safe, effective, and substantially equivalent to the predicate devices and perform "as originally intended." The study conducted was a series of bench and laboratory tests designed to validate the reprocessing methods and ensure the device's original performance characteristics are maintained.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as originally intended, exhibiting the same mechanical design, materials, shapes, and sizes as predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. 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." "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Material Integrity: Reprocessing does not compromise the material properties. | Implied by the statement that "design, materials, and intended use... are identical to the predicate devices" and "performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (No specific material property tests mentioned beyond functional tests for reprocessing) |
| Sterility: If provided sterile, the reprocessed device meets sterility requirements. | "Sterilization Validation (for sterile devices)" was conducted. |
| Safety and Effectiveness: Reprocessed devices maintain safety and effectiveness comparable to predicate devices. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed External Fixation Devices. This included the following tests: Validation of reprocessing, Sterilization Validation (for sterile devices), Function test(s)." "Alliance Medical Corporation concludes that the modified devices (Reprocessed External Fixation Device) are safe, effective, and substantially equivalent to the predicate devices as described herein." |
| Reprocessing Validation: The reprocessing procedure effectively cleans and prepares the device for re-use without degradation. | "Validation of reprocessing" was conducted. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The 510(k) summary only states "Bench and laboratory testing was conducted," implying that a sample of reprocessed devices would have been tested, but the exact number is not disclosed.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a US submission, it's highly probable the testing occurred in the USA. The tests were likely conducted prospectively as part of the reprocessing validation process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. The "ground truth" for proving substantial equivalence of reprocessed mechanical devices primarily relies on objective engineering and scientific measurements from bench and laboratory tests, rather than expert clinical assessment of images or patient outcomes. The "ground truth" would be the engineering specifications and performance characteristics of the original predicate devices.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiologists, pathologists) where there might be inter-reader variability. For bench testing of mechanical properties, results are generally objective measurements that do not require clinical 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 information is not applicable and not provided. This device is a reprocessed external fixation device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. This device is a mechanical medical device, not an algorithm or AI system.
7. The type of ground truth used:
- The ground truth used for these tests would be the original manufacturer's specifications and performance data for the predicate (new) external fixation devices. The reprocessed devices are demonstrated to be substantially equivalent if their performance in the bench and lab tests meet these established specifications.
8. The sample size for the training set:
- This information is not applicable and not provided. There is no concept of a "training set" for a reprocessed mechanical device as there would be for an AI algorithm.
9. How the ground truth for the training set was established:
- This information is not applicable and not provided. As explained above, there is no training set for this type of device submission.
Ask a specific question about this device
(68 days)
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE: Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components are used for: Stabilization of soft tissues and fractures, Polytrauma/multiple orthopedic trauma, As treatment adjunct for vertically unstable pelvic fractures, Arthrodeses and osteotomies with soft tissue problems; failures of total joints, Treatment of fractures stabilized with limited internal fixation, Non-unions/septic non-unions, Intra-operative reductions/stabilization tool to assist with indirect reduction, Unilateral rectilinear bone segment transport or leg lengthening.
MEDIUM: Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL: Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, and foot. Specifically, the components can be used for: Preliminary fixation before ORIF, Unstable fractures of the distal radius (both intra and extra-articular), Open and/or comminuted bilateral fractures, Open and or combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement, Fracture dislocations, Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations), Pediatric open fractures with bone loss and osteotomies.
MINI: Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: Comminuted fractures of phalanges and metacarpals, Displaced intra-articular fractures, Segmental bone loss, Fractures that do not allow stable internal fixation, Fractures with associated complex soft tissue injuries, Tumor resections.
The Reprocessed External Fixation Device consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Anchorage elements are not included in the Reprocessed External Fixation Device.
The provided document describes a 510(k) premarket notification for a Reprocessed External Fixation Device. This is a regulatory filing for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
As such, the document does not contain the typical information regarding acceptance criteria and a study design that demonstrates the device meets those criteria in the way a new device would. Instead, the "study" described is primarily focused on demonstrating functional equivalence to existing devices through bench testing and process validation.
Here's an analysis of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Characteristics: Reprocessed devices must demonstrate appropriate functional characteristics. | "Functional and Representative samples of Reprocessed External Fixation Devices underwent bench testing to demonstrate appropriate functional characteristics." (No specific quantitative metrics or results are provided, simply that they "demonstrate appropriate functional characteristics.") |
| Cleaning Procedure Validation: The reprocessing cleaning procedure must be validated. | "Process validation testing was done to validate the cleaning procedure." (No specific validation criteria or results are provided.) |
| Visual and Functional Testing: All reprocessed products must pass visual and functional inspection prior to release. | "In addition, the manufacturing process includes visual and functional testing of all products prior to release." (This describes an internal quality control step rather than specific performance data from a study.) |
| Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, and indications for use. | "The External Fixation Device reprocessed by SterilMed is substantially equivalent to counterpart devices originally manufactured by Synthes. This conclusion is based upon the devices' similarities in functional design, materials and indications for use." (This is the overarching conclusion of the 510(k) submission, not a specific performance outcome against a metric.) The predicate devices are listed as Synthes Reprocessed External Fixation Devices (K033158), Synthes Large External Fixation Clamps MR Safe (K031428) and Synthes Medium External Fixation System MR Safe (K040258). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "Functional and Representative samples" were used for bench testing. The exact number of samples is not specified.
- Data Provenance: The data is likely from retrospective bench testing conducted by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. The country of origin of the data would therefore be the USA. This is not a clinical study involving patients.
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)
- The concept of "ground truth" as typically understood in AI/medical imaging studies (e.g., pathology, expert consensus on disease presence) does not apply directly here. The "ground truth" for this type of submission is the functional and material specifications of the original, new devices and established regulatory standards for reprocessing.
- The document does not mention any external experts establishing ground truth for the test set. The validation would have been performed by SterilMed's internal engineering and quality personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable here. Adjudication methods like 2+1 are used in clinical studies where conflicting expert opinions need to be resolved for ground truth labeling. This submission relies on objective bench test results and process validation.
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
- No MRMC comparative effectiveness study was done. This is a submission for a physical medical device (external fixation device, reprocessed), not an AI algorithm for diagnostic imaging. Therefore, the question of human readers improving with AI assistance is not relevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. Again, this is for a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional and material testing, the "ground truth" would be considered the established engineering specifications and performance characteristics of the originally manufactured (new) devices, as well as relevant industry standards for mechanical properties and material integrity, and regulatory requirements for device reprocessing and sterility. This is not ground truth in the sense of a medical diagnosis.
8. The sample size for the training set
- This device is a reprocessed physical medical device, not an AI model. Therefore, the concept of a "training set" for an algorithm is not applicable.
9. How the ground truth for the training set was established
- As mentioned above, there is no training set for an AI algorithm in this context.
In summary:
This 510(k) submission establishes substantial equivalence for a reprocessed external fixation device. The "study" involves bench testing of representative samples to confirm functional characteristics and process validation for the cleaning procedure. The core argument is that the reprocessed device performs comparably to the original, new device and other legally marketed reprocessed predicate devices. It does not involve clinical trials, expert consensus on patient data, or AI algorithm validation.
Ask a specific question about this device
(90 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.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Validation of Reprocessing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Function Testing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Substantial Equivalence to Predicate Devices | The design, materials, and intended use are identical to predicate devices. The mechanism of action is identical. There are no changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
-
Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and laboratory testing was conducted," but it does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not provided in the submitted text. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct performance testing of the reprocessed devices against their original intended performance. -
Adjudication Method for the Test Set:
Since no experts were mentioned in establishing ground truth, there was no adjudication method described. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the performance of the reprocessed devices themselves, not on human reader performance with or without AI assistance. -
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the performance testing described appears to be a standalone evaluation of the reprocessed external fixation devices. It assesses whether the devices, after reprocessing, perform as originally intended, without human-in-the-loop interaction in the context of an AI algorithm. However, this is a medical device, not an AI algorithm, so the term "standalone" here refers to the device's functional performance. -
Type of Ground Truth Used:
The ground truth used was implied to be the original performance specifications and functionality of new, non-reprocessed external fixation devices. The goal of the testing was to demonstrate that the reprocessed devices perform "as originally intended," suggesting comparison to the known performance of new devices. -
Sample Size for the Training Set:
This is a submission for a medical device (reprocessed external fixation devices), not an AI algorithm. Therefore, the concept of a "training set" is not applicable in this context. -
How the Ground Truth for the Training Set Was Established:
As this is not an AI algorithm, the concept of a "training set" and establishing its ground truth is not applicable.
Ask a specific question about this device
(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand 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 document (K012634) is a 510(k) Pre-Market Notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This type of submission is for "reprocessed" medical devices, meaning devices that were originally intended for single use but are being re-used after cleaning, sterilization, and sometimes repair. The testing described focuses on demonstrating that the reprocessed devices perform as intended, similar to their original, new counterparts, and that the reprocessing method is effective.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance (Safety and Effectiveness) | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness). |
| Biocompatibility | Validation of reprocessing included biocompatibility testing. |
| Validation of Reprocessing | Validation of reprocessing (methods for cleaning, sterilization, etc.) was performed. |
| Original Intended Performance Maintained | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
Note: The document states that the reprocessed devices are identical in design, materials, and intended use as the predicate devices, implying that the acceptance criteria are met if these characteristics and the performance benchmarks are maintained after reprocessing. The specific quantitative acceptance criteria values (e.g., specific tensile strength, fatigue life, or sterilization sterility assurance levels) are not detailed in this summary, but are generally part of the underlying bench and laboratory testing reports.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the test set in the performance, biocompatibility, or reprocessing validation studies. It only mentions "Bench and laboratory testing."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for reprocessed devices, the data would typically be derived from controlled laboratory studies and possibly prior clinical use data of the original devices or reprocessed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for reprocessed devices typically relies on engineering and scientific experts to establish test protocols, analyze performance, and validate reprocessing methods, rather than clinical experts establishing a "ground truth" for a diagnostic or AI device. The document does not specify the number or qualifications of such experts involved in establishing the testing parameters or reviewing the results.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (like 2+1, 3+1) is not applicable to this type of device submission. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved to establish ground truth. For reprocessed external fixation devices, performance is assessed through objective physical, mechanical, and chemical tests.
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 imaging devices where human readers interpret medical images. External fixation devices are physical medical instruments, and their effectiveness is not assessed through human reader interpretation of cases.
6. 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 concept applies to AI/ML algorithms that operate independently. The device here is a physical external fixation device.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by objective engineering specifications, material properties, and sterility standards for external fixation devices. For instance:
- Mechanical Integrity: The reprocessed devices must meet the same mechanical strength, fatigue, and other performance characteristics as new, predicate devices.
- Biocompatibility: The materials must remain biocompatible after reprocessing.
- Sterility: The reprocessing must render the devices sterile, typically validated to a Sterility Assurance Level (SAL) of 10^-6.
- Cleaning Effectiveness: The devices must be effectively cleaned to remove biological and other foreign material.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning for AI algorithms. This submission is for reprocessed physical medical devices, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" is not applicable to this device.
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 1