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Repair of long bone fractures due to trauma or reconstruction o
Reattachment of the greater trochanter in total hip arthroplasty, surface replacement の arthroplasty, or other procedures involving trochanteric osteotomy
Sternotomy closure の
Sublaminar and intrafacet wiring of the spinal column 0

The Metagen ActiveLock™ Wire Cerclage System is used in the management of orthopedic trauma and total joint reconstruction to secure and stabilize segments of bone. There are two versions of the device disclosed in this submission. The fundamental components of each device are a straight, annealed CoCr alloy wire and a novel Clamp device to secure the wire is 16.5 gage (.048 inch) fully annealed CoCr alloy. (ASTM F-799). A Clamp is provided to secure the wire after tensioning. The Clamp is offered in a "Single" configuration, which secures opposing ends of a single wire, and a "Double" configuration, which secures the free ends of two adjacent wires.

The provided 510(k) summary for the Metagen ActiveLock™ Wire Cerclage System does not contain information about a study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device submission. This document is from 1998 for a mechanical medical device, not an AI/ML device, and therefore the structure and content of the submission are vastly different.

Here's an attempt to extract and reframe the information based on your requested categories, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of this submission.

Acceptance Criteria and Device Performance for Metagen ActiveLock™ Wire Cerclage System

This submission pertains to a mechanical wire cerclage system, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "reported device performance" typically associated with diagnostic AI algorithms (e.g., sensitivity, specificity, AUC) is not directly applicable. Instead, the submission focuses on mechanical testing to demonstrate performance against established benchmarks of predicate devices or existing standards. The primary criterion is demonstrating substantial equivalence in mechanical properties, particularly tensile strength, to already accepted devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Repair of long bone fractures
• Reattachment of greater trochanter
• Sternotomy closure
• Sublaminar/intrafacet wiring of spinal column | YES - Intended uses are the same as predicate devices. |
  | Design Principles | Fundamentally the same as Metagen ActiveLock™ Cerclage Band system and comparable to pre-amendment stainless steel suture wire and cerclage cable systems. | System features a novel locking Clamp (similar to ActiveLock™ Band). Manual tightening instrument used for reduction/consolidation (similar to ActiveLock™ Band). Clamping methods similar to predicate cable systems (e.g., crimp, swage, sleeve). |
  | Material Composition | Wire: CoCr alloy (ASTM F-799) Clamp: Nitinol (superelastic effect utilized) | Wire: CoCr alloy conforming to ASTM F-799.
  Clamp: Nitinol, utilizing its superelastic effect for clamping force. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The submission mentions "Mechanical Testing" was performed and "data demonstrate" equivalence, but the number of samples tested is not quantified in this summary.
• Data Provenance: Not explicitly stated, but it would be from in-vitro mechanical testing conducted by the manufacturer, Metagen, LLC. It is prospective testing designed to characterize the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This is a mechanical device, not an AI/ML diagnostic. Ground truth would be based on engineering measurements and material science standards (e.g., ASTM F-799) rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Mechanical tests typically involve direct measurement against defined standards, not human adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. This is not an AI/ML device, so a MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study (Algorithm Only)

• Not applicable. This is a mechanical device. The "standalone performance" is its mechanical properties (tensile strength), which were evaluated through direct testing without any human-in-the-loop component in the assessment itself.

7. Type of Ground Truth Used

• Engineering Standards and Benchmarks: The "ground truth" for this device's performance is based on established engineering standards for materials (e.g., ASTM F-799 for CoCr alloy) and the performance characteristics (e.g., tensile strength) of predicate devices (like 16 gauge stainless steel wire, DePuy Control Cable System, Howmedica Dall-Miles Stainless Steel Cable) that are already clinically accepted. The "ground truth" is therefore comparative performance against accepted mechanical properties.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is designed and manufactured based on established engineering principles and material science.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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The Segmental Defect Replacement System, when used with bone cement, is intended for reconstruction of the humeral diaphysis with an extensive bone lesion due to metastatic disease, myeloma, or lymphoma, that places the humerus at risk for pathologic fracture.

The Clinical Indication for Use is:

"The Segmental Defect Replacement System, when used with bone cement, is indicated for pathologic fractures or impending pathologic fractures of the diaphysis of the humerus secondary to metastatic bone disease and hematologic malignancies."

The Segmental Defect Replacement System is an array of proximal and distal intramedullary rods which, when locked together, replace the resected diseased segment and fixation in the remaining humeral bone The system includes a locking device to secure the rod components, and instrumentation to facilitate stock. insertion.

Modular bistemmed intramedullary rod system with rigid cam locking mechanism designed to provide intraoperative adjustment after cementing components into the proximal and distal segments of the resected humerus.

Materials: Ti-6Al-4V NiTi alloy (locking system)

The provided text describes a 510(k) summary for a "Segmental Defect Replacement System." This document is a premarket notification for a medical device aiming to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, the specific information requested regarding acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies is not present in the provided text.

The document focuses on comparing the proposed device to existing predicate devices based on:

• Intended Use: Reconstruction of the humeral diaphysis with extensive bone lesions due to metastatic disease, myeloma, or lymphoma, placing the humerus at risk for pathologic fracture.
• Design: Modular bistemmed intramedullary rod system with a rigid cam locking mechanism for intraoperative adjustment after cementing components.
• Materials: Ti-6Al-4V, NiTi alloy (locking system).

The document states: "The Segmental Defect Replacement System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices." However, it does not provide details about the specific acceptance criteria for these tests, the performance metrics achieved, or the study design/results for demonstrating this substantial equivalence beyond this general statement.

In summary, the provided content is a regulatory submission for substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria and study results.

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The ActiveLock Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The ActiveLock M Modular Femoral Hip System is a matrix of interchangeable components (STEM, BODY, ACTUATOR, FEMORAL HEAD) that can be locked together to form a single femoral hip prosthesis.

The provided text is a 510(k) summary for the ActiveLock™ Modular Femoral Hip System, which is a medical device for hip replacement. It outlines the device's design, materials, and substantial equivalence to previously marketed devices. However, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.

The document focuses on:

• Substantial Equivalence: Comparing the new device's design, materials, and intended use to existing devices (predicates). This is a regulatory pathway for approval, not a clinical performance study.
• Mechanical Characterization and Corrosion Testing: These are mentioned as having been performed to show substantial equivalence to the predicate devices, indicating engineering performance rather than clinical outcome. The document states, "The ActiveLock Modular Hip System has been evaluated by use of the static and fatigue tests. It has been shown to be substantially equivalent to the predicate devices. [...] The components and materials of the ActiveLock™ Modular Hip System have been tested in corrosion. It has been shown that the materials of the system are resistant to corrosion." No specific acceptance criteria or study details (like sample size, methodology, or results) for these tests are provided.
• Intended Use and Indications: These describe what the device is for, not how well it performs clinically.
• FDA Clearance Letter: This letter confirms the FDA's finding of substantial equivalence but explicitly states a limitation regarding claims for HA-coated versions: "You may not label or in any way promote the HA coated versions of these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only)." This indicates that the 510(k) submission did not include data supporting enhanced clinical performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating the device meets those criteria because it is not present in the provided 510(k) summary. The document is typical of a 510(k) submission where the primary objective is to demonstrate substantial equivalence to existing devices based on design, materials, and intended use, rather than presenting a detailed clinical performance study with specific acceptance criteria.

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The Metagen All Poly Acetabular Cup consists of single use devices, intended for cemented replacement of the acetabular portion of the hip joint in primary and revision total hip arthroplasty.

The Metagen All Poly Acetabular Cup System is a family of acetabular components designed for use in total hip arthroplasty, that are manufactured using medical grade biocompatible materials. The basic design and materials are the same as those used in the predicate devices.

This document, K96403, is a 510(k) summary for the "Metagen All Poly Acetabular Cup System." It describes a medical device, its intended use, and argues for its substantial equivalence to previously marketed devices.

However, this document *does not contain any information regarding:

• Acceptance criteria for a study.
• A study that proves the device meets acceptance criteria.
• Device performance metrics (like sensitivity, specificity, AUC).
• Sample sizes for test or training sets.
• Data provenance (country, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
• Type of ground truth used.
• How ground truth was established.

This K96403 document is a regulatory submission for a physical medical device (an acetabular cup for hip replacement), not an AI/ML-based diagnostic or imaging device. Therefore, the questions you've asked, which are typically relevant to the validation of AI/ML algorithms, are not applicable to the content provided in this specific K96403 summary.

The document primarily focuses on demonstrating substantial equivalence in terms of design, materials, and intended use to predicate devices, rather than presenting a performance study against specific acceptance criteria.

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The Metagen High Tibial Osteotomy System consists of single use devices, intended to be used for the fixation of fractures of the proximal or distal end of long bones, or to stabilize the fracture site during the healing process following surgical procedures that involve cutting the bone, such as tibial osteotomies.

Tibial osteotomy is indicated in young, active patients with painful unicompartmental osteoarthritis associated with varus deformity of no more than 11 degrees, and for deformity incident to rheumatoid arthritis and trauma in selected cases.

The High Tibial Osteotomy System is a fracture fixation system used to perform closing wedge osteotomies. It consists of L-plates, cortical and cancellous bone screws, and offset staples.

Materials: The devices are manufactured from CoCrMo ( cast or Wrought ), Ti-6A1-V, and 316 LVM stainless steel per ASTM standards.

Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following osteotomy.

This looks like a 510(k) premarket notification for a medical device. The provided text is a "Summary of Safety and Effectiveness" which is a high-level overview. It does not contain the detailed information required to describe acceptance criteria and associated study results for AI/ML device performance.

This document specifically states: "Fracture Fixation System" and then describes components like L-plates, bone screws, and staples made from CoCrMo, Ti-6A1-V, and 316 LVM stainless steel. This is clearly a surgical implant/instrument system, not a software or AI/ML-driven diagnostic or therapeutic device.

Therefore, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/ML performance metrics (like sample size for test sets, data provenance, ground truth, MRMC studies, standalone performance, training set details) is not applicable to this specific K963700 submission.

Explanation of why the requested information is not present and cannot be inferred:

• Device Type: The Metagen High Tibial Osteotomy System is a mechanical orthopedic implant and surgical instrument system. Its safety and effectiveness are established through material testing, mechanical testing (e.g., fatigue, static strength), biocompatibility testing, and comparison to existing predicate devices based on design, materials, and intended use.
• No AI/ML Component: There is no mention of any artificial intelligence, machine learning, software algorithm, imaging analysis, or diagnostic function in the provided summary.
• Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to predicate devices. For mechanical devices, this typically involves comparing design specifications, materials, manufacturing processes, and sometimes bench testing results to show similar performance characteristics. It does not involve clinical studies with AI performance metrics.
• Missing Information: All bullet points in your request (acceptance criteria table, sample sizes, ground truth, expert adjudication, MRMC, standalone performance, training set details) are relevant to the evaluation of AI/ML-driven devices. Since this is not an AI/ML device, such information would not be part of its submission or evaluation.

In summary, the provided document K963700 does not describe an AI/ML device, and thus cannot fulfill the request for information pertaining to AI/ML device acceptance criteria and study details.

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