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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).

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.").

6. 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).

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is used for this type of device submission.

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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.

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.

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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

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.

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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

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.

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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used noninvasive orthopedic devices that have been cleaned, inspected, tested, and packaged by Vanguard Medical Concepts, Inc. External Fixation Device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation. External fixation elements consist of components such as straight rods, telescoping rods, rod-to-rod and pin-to-rod couplings and clamps. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

The provided document is a 510(k) Summary of Safety & Effectiveness for Vanguard Reprocessed External Fixation Devices. It declares substantial equivalence to predicate devices but does not contain specific acceptance criteria or a study proving that the device meets such criteria.

The document states:
"Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."
"Vanguard Reprocessed External Fixation Devices are essentially identical to the Original Equipment Manufacturer (OEM) devices. No changes are made to the currently marketed OEM device specifications and the Reprocessed External Fixation Devices possess identical technological characteristics."

Based on the provided text, I cannot complete the requested table and details because the information is not present. The document focuses on demonstrating substantial equivalence based on the identical technological characteristics and intended performance to predicate devices rather than providing detailed acceptance criteria and a study with specific performance metrics.

Therefore, the questions cannot be answered from the provided text.

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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

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.

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Reprocessed External Fixation Devices are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery.

Vanguard Reprocessed External Fixation Devices are previously used non-Device invasive orthopedic devices that have been cleaned, inspected, tested, and Description packaged by Vanguard Medical Concepts, Inc. External fixation device systems are comprised of various elements that, when used in conjunction with one another, form bridge constructs to which anchoring screws, wires and/or pins may be attached. Bridge elements are designed to provide a framework for stabilization of bone fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casting or other means of internal fixation.

External fixation elements consist of components such as rails and modular rails, rail-to-rail couplings, rail-to-screw clamps, rail-to-clamp couplings, rail-to-clamp couplings, and clamp-to-clamp couplings. These components are provided in bulk, packaged in nylon pouches, non-sterile, with instructions for steam sterilization by the health care facility.

Rods. Rails and Modular Rails ~ Straight rods and rails are external fixation devices of varying lengths (adjustable in the case of modular rods and rails) and dimensions that are used with rail-to-rail, rod-to-rail, rod/rail-to-ring, and rail-to-screw clamps by the surgeon to connect anchoring pins and screws together to form a rigid structure that immobilizes the affected bone or Differences in the dimensions of the rods and rails allow structures. accommodation of a broad range of fracture scenarios and applied loads. All rods and rails have a straight, solid design. These devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel.

Rings and Ring Segments ~ Rings and ring segments are circular or semicircular segments manufactured to surround the area of attachment to bone located centrally in the ring. Various attachments are made to the rings or ring segments to stabilize bone fractures or to reduce or extend the length of Tensioned wires or pins are commonly attached to rings and ring bones. segments using clamps designed for this purpose. Multiple ring or ring segment constructs are used to stabilize and structurally support the anatomical structures being treated using a range of configurations and attachments and connectors. The rings and ring segments are manufactured in a range of diameters to allow selection of a size most appropriate to the anatomy and application needed. Rings and ring segments are typically manufactured from one or more of the following materials: anodized aluminum alloys, steel and stainless steel alloys or carbon fiber composites.

Ring-to-Rod/Rail Clamps ~ Ring-to-rod/rail clamps are utilized to connect a Ring-to-KourKail Claimps - Iting to today in these attachments are made to form an ring of Ting segment to a routine as required for the particular biomechanical external fixator frame construct us requence to requence typically constructed from needs of the procedure. Italy to rearmials: anodized aluminum alloys, steel and/or stainless steel alloys and titanium alloys.

Ring-to-Pin or Ring-to-Wire Clamps ~ Ring-to-pin or ring-to-wire clamps u Ring-to-Fin of Ring-to-Wire Or ring or ring or ring segment to a pin or wire that is normally attached on one side of the ring, passed through the bone, wire that is normally attachment point on the opposite side of the ring where and continue to an attacimient point on another ring to wire clamp. Ring-to-pin or wire clamps are used to secure the ring to a pin, wire or set of pins and wires wire clamps are used to seears assing centrally through the external fixation that are anchored in the octor pare clamps are typically constructed from one Inig. King-to-pin and ring to wire claims alloys, steel and/or stainless steel alloys and titanium alloys.

Rod/Rail-to-Screw Clamps ~ Rod/Rail-to-screw clamps are utilized to 8 Rour Ran-to-Screw - Califfer - Califfer - Station raily affixed to the bone. connect an excential rination fail to a proscrews that are anchored in the bone.

DFS System rod/rail-to-screw clamps are V-shaped to provide tri-planar DPS System Todaran to seren. Distraction components are affixed to certain compression of DFS Distal Radius Fixator rod/rail-to-screw clamps to provide Houcis of Dro Distal Rather distal fixator rail. The devices are typically clistiacted from one of the following materials: anodized aluminum and stainless steel.

Rail-to-Rail Couplings ~ Rail-to-Rail couplings are multi-element . Components used to connect one rail to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a by the individual blanks of rails. These devices are typically constructed specific size of railge of the following materials: anodized aluminum and stainless steel.

Rod-to-Rail Couplings ~ Rod-to-Rail couplings are multi-element . Kou-to-Kan - Couplines
components used to connect one rod to a rail in a range of positions defined by the individual clamp configuration. They are designed to interconnect a the individual olanip connigation of rods and rails. These devices are typically specific size or a rangor more of the following materials: anodized aluminum and stainless steel.

Rod-to-Rod Couplings ~ Rod-to-Rod couplings are multi-element 제 Device components used to connect one rod to another in a range of positions Description defined by the individual clamp configuration. They are designed to (continued) denned by and meetific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rail-to-Clamp Couplings ~ Rail-to-clamp couplings are multi-element 트 components used to connect one rail to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rails. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Rod-to-Clamp Couplings ~ Rod-to-clamp couplings are multi-clement 8 components used to connect one rod to a clamp in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of rods. The devices are typically constructed from one or more of the following materials: anodized aluminum and stainless steel. Clamp-to-Clamp Couplings ~ Clamp-to-clamp couplings are multi-element 해 components used to connect one clamp to another in a range of positions defined by the individual clamp configuration. They are designed to interconnect a specific size or range of sizes of clamps. The devices are typically constructed from one or more of the following materials: anodized aluminum or stainless steel.

The provided text is a 510(k) summary for Vanguard Reprocessed External Fixation Devices. It describes the devices, their indications for use, and declares substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily focuses on:

• Device Identification: Trade Name, Common Name, Classification, Product Codes.
• Predicate Devices: Listing the original equipment manufacturers and their trade names.
• Indications for Use: What the reprocessed devices are intended for.
• Contraindications: When the devices should not be used.
• Device Description: Detailed breakdown of components like rods, rings, clamps, and couplings, including materials (anodized aluminum, stainless steel, carbon fiber).
• Technological Characteristics: Stating that the reprocessed devices are essentially identical to OEM devices and perform as intended after cleaning, packaging, and performance testing.
• Conclusion: A declaration of substantial equivalence to predicate devices.
• FDA Approval Letter: Confirming the 510(k) clearance.
• Catalog Pages: Listing specific models, their descriptions, and materials.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement based on the provided text.

The statement "Cleaning, packaging, and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective" is a summary conclusion, but the actual data, methods, acceptance criteria, or results of these tests are not present in this document. This kind of detailed study information is often found in the full 510(k) submission, which is typically much more extensive than the public summary.

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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:

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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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

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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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

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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