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The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.

The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.

The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.

The provided document describes a 510(k) premarket notification for the "ACTIVE™ Screw Bone Screw" and contains information about its performance testing. However, it does not present acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes general compliance with existing standards and acceptable results.

Here's a breakdown of the information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not explicitly stated in the document, I will infer them from the reported testing methods and positive outcomes.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of screws or tests conducted for each performance evaluation (torsion, pullout, torque in/out, bone interaction). It refers to "testing" as a general activity.
• Data Provenance: The studies were pre-clinical bench tests. The data is generated from laboratory testing of the device itself, not from human subjects or retrospective/prospective clinical data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense; the tests were conducted by the manufacturer, Intelligent Implant Systems, LLC.

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

This question is not applicable to the type of safety and effectiveness testing described in the document. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F543-07) and objective physical measurements rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation) require reconciliation; this document describes objective mechanical performance testing.

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 question is not applicable. The device described is a bone screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical bone screw, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on:

• Engineering Standards: Specifically, ASTM F543-07 for bone screw testing methods.
• Physical Measurements: Objective measurements of torsional strength, breaking angle, axial pullout strength, and force exerted.
• Comparative Performance to Predicate Devices: Damage from removal was compared directly to that of "traditional (predicate) bone screw[s]."

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device (bone screw), there is no "training set" in the context of machine learning or AI models. Performance is evaluated through physical testing.

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

This question is not applicable, as there is no training set for this device.

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Wright's ORTHOLOC™ 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.

ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

ORTHOLOC™ 3Di Ankle Fusion Plating System: The ORTHOLOC™ 3Di Ankle Fusion Plating System contains 22 plates belonging to 1 of 3 general categories based on the contouring of each plate and intended surgical approach. All plates feature poly-axial locking screw holes and one or two compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 4.5mm and 5.5mm ORTHOLOC™ 3Di locking screws, 4.5mm and 5.5mm ORTHOLOC™ Fully Threaded Bone Screws, and 5.5mm ORTHOLOC™ Partially-Threaded Bone Screws. Washers of the same material are also available for use with the ORTHOLOC™ Bone Screws.

ORTHOLOC™ Bone Screws: ORTHOLOCTM Bone Screws are cancellous or cortical, partially or fully threaded non-locking screws offered in various diameters and lengths. All screws are manufactured from ASTM F136 or ISO 5832-3 titanium alloy and intended for single use only. These screws are intended to be used with the appropriately sized washers to prevent the screw head from breaking through the cortex of the bone by distributing the forces/loads over a large area.

The provided document, K121425 for the ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOCTM Bone Screws, describes non-clinical evidence for substantial equivalence, primarily focusing on mechanical testing rather than a clinical study or AI-based performance. Therefore, many of the requested elements for AI-based device evaluation (like sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with AI) are not applicable or not explicitly detailed in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated as this was mechanical testing of device components, not a clinical study on patient data.
• Data Provenance: The data is generated from in vitro mechanical testing of the physical device components (plates and screws). There is no patient data involved from specific countries or retrospective/prospective studies.

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

• Not Applicable. This submission relies on engineering and mechanical testing, not a ground truth established by human experts interpreting clinical data for diagnosis or treatment decisions. The "ground truth" or acceptance criteria for mechanical properties would be established by engineering standards and internal specifications, likely vetted by qualified engineers.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is mechanical testing, there is no human interpretation of images or clinical data that would require an adjudication method. The results are quantitative measurements against pre-defined engineering thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not done. This submission is for a medical implant (bone plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not on the interpretation capabilities of human readers, with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is not an AI algorithm. The device is a physical surgical implant.

7. The Type of Ground Truth Used:

• The "ground truth" for the mechanical performance testing would be the established engineering specifications, ASTM or ISO standards, and internal design requirements for strength, locking mechanism efficacy, and pullout resistance for bone plates and screws. These are quantifiable, objective physical properties.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

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The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:

• First metatarsal osteotomies for hallux valgus correction including:
  • Opening base wedge osteotomy
  • Closing base wedge osteotomy
  • Crescentic osteotomy
  • Proximal Chevron osteotomy
  • Distal Chevron osteotomy (Austin)
• First metatarsal fracture fixation
• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Arthrodesis of the first metatarsophalangeal joint (MTP) including:
  • Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
  • Revision MTP Fusion
  • Revision of failed first MTP Arthroplasty implant

Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. The subject plates are modified from the DARCO Locking Bone Plate System (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.

This document describes the ORTHOLOC™ 3Di Hallux System, a bone plate system intended for stabilization and fixation of bones in the feet and toes. The device is a Class II medical device.

1. Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device (K061808 - DARCO Locking Bone Plate System) rather than defining specific quantifiable acceptance criteria related to clinical endpoints (like success rates in fracture healing). Instead, the acceptance criteria are implicitly met by demonstrating that the new design features perform at least as well as, or better than, the predicate device in relevant mechanical tests, and do not introduce new safety or effectiveness concerns.

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

• Sample Size: The document does not specify the exact sample sizes (number of plates or screws tested). It refers to "performance testing" and "torque testing" but doesn't quantify the number of units tested.
• Data Provenance: The data is generated from non-clinical (bench) testing performed by Wright Medical Technology, Inc. The country of origin for the data is not explicitly stated but is implied to be internal testing by the
  US-based manufacturer. The testing is prospective for the purpose of this submission, designed to demonstrate substantial equivalence of the new device.

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

• This device is a bone plate system demonstrating substantial equivalence primarily through mechanical engineering tests and computational analysis (FEA), not through a diagnostic algorithm interpreting images or clinical data where human expert ground truth would be established.
• Therefore, the concept of "experts establishing ground truth for the test set" (as would be applicable for an AI device) is not relevant in this context. The "ground truth" here is derived from established engineering principles and measurements.

4. Adjudication Method for the Test Set:

• This question is not applicable as the study described is a non-clinical, mechanical performance study, not a study involving human readers or expert consensus on clinical findings.

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 mechanical implant device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No standalone algorithm performance study was done.
• This is a mechanical implant device, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used:

• The "ground truth" for this submission is based on mechanical performance metrics and engineering standards. This includes:
  • Quantifiable measurements of screw locking strength (e.g., torque values).
  • Analysis of bending properties of plates.
  • Comparison against established performance of the predicate device.
  • Compliance with ASTM F136 or ISO 5832-3 standards for titanium alloy.
  • Results from mechanically validated Finite Element Analysis (FEA).

8. The Sample Size for the Training Set:

• This question is not applicable. This is a mechanical device, not an AI or machine learning model that requires a "training set." The design and validation relied on engineering principles, materials science, and mechanical testing.

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

• This question is not applicable for the same reason as #8. There is no training set in the context of this device's validation.

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