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The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

This Special 510(k) submission is a line extension to address modifications made to the AxSOS™ Locking Plate System which was cleared in K061012. This line extension is to add four femoral long plates to the existing size range of the AxSOS™ Locking Plate System. These monoaxial long plates will be known as AxSOS™ Distal Lateral Femur TS (Threaded Shaft) Long Plates and will be available in two lengths in left and right configurations.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the "AxSOS™ Distal Lateral Femur TS Long Plates are substantially equivalent to the AxSOS™ Distal Lateral Femur TS Plates of the AxSOS™ Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device." The specific performance metrics for static and fatigue strength are stated as having "demonstrated the subject plates are substantially equivalent to the predicate devices" but no numerical acceptance ranges or specific values are provided in this summary.

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

The provided text only mentions "Static strength as well as fatigue strength testing" for the subject device. It does not specify a sample size for these tests, nor does it describe them as a "test set" in the context of clinical or image-based studies. The data provenance is also not mentioned (e.g., country of origin, retrospective/prospective), as these are in vitro mechanical tests, not human data studies.

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

This information is not applicable as the provided document describes a 510(k) submission for a medical device (bone fixation plates) based on mechanical testing and substantial equivalence, not a study involving human readers or image analysis requiring expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

An MRMC comparative effectiveness study was not conducted. This document describes a mechanical device substantially equivalent to a predicate, not an AI or imaging diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm was not done. This document pertains to a physical medical device.

7. The Type of Ground Truth Used

For the mechanical testing (static and fatigue strength), the "ground truth" would be established by standardized engineering testing protocols and measurement instruments. There is no mention of expert consensus, pathology, or outcomes data, as these are material science evaluations.

8. The Sample Size for the Training Set

There is no mention of a "training set" in this document. The submission relies on demonstrating substantial equivalence through design comparisons and mechanical testing, not a machine learning model.

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

This information is not applicable as there is no training set mentioned.

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The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshaft Plates are indicated for fixation of single, segmental and comminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.

The Variax Clavicle System consists of anatomically contoured Anterior and Superior Lateral Plates as well as Anterior and Superior Midshaft Plates. The plates are manufactured from Titanium alloy per ASTM F136 and Commercially Pure Titanium per ASTM F 67. The plates are fixed to the clavicle using 3.5mm or 2.7mm locking or non-locking screws.

This FDA 510(k) summary describes a medical device, the Variax Clavicle System, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML-driven device.

Therefore, I cannot populate the requested table and answer the study-related questions (2-9) because the provided document is a 510(k) summary for a traditional medical device (a bone fixation system) and explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

This device is not an AI/ML device, and its approval relies on demonstrating substantial equivalence to existing predicate devices through non-clinical testing (fatigue strength and pull-off testing) and comparison of technological characteristics.

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The VariAx® Distal Radius Plates are intended for use for internal fixation for fractures and reconstruction of the small bones, primarily including the distal radius. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for palmar, dorsal or orthogonal application.

This Special 510(k) submission is intended to add aiming blocks as an accessory to the VariAx® Distal Radius plate line which was cleared in K040022 and K100271. The aiming blocks are accessories used intra-operatively to guide the user in placement of the screws into the plate. There are 4 aiming blocks which correspond to the configurations of volar plates: Narrow Right, Narrow Left, Standard Right and Standard Left. The aiming blocks are used with a joystick tool which helps the user find the appropriate screw trajectory and is pinned in place once the desired alignment is obtained. Kirschner wires can also be used in conjunction with the aiming blocks to determine screw trajectory.

This document describes a Special 510(k) submission for the VariAx® Distal Radius Locked Plating System Line Extension, specifically for the addition of aiming blocks. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K040022 and K100271).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each benchtop test (torque to failure, lateral loads, biocompatibility, cleanability, sterility, corrosion resistance). It only mentions that these tests "were conducted." The data provenance is from non-clinical benchtop testing, performed by the manufacturer, Howmedica Osteonics Corp., in the USA (implied, given the company's address). This is a prospective test in the sense that it was conducted specifically for this submission.

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

Not applicable. This submission is for a medical device accessory and relies on benchtop mechanical and material testing, not clinical data or expert evaluation of images/data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical study involving human judgment or interpretation, therefore no adjudication method was used.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required for this submission."

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

Yes, in a conceptual sense. The "standalone" performance here refers to the device's intrinsic mechanical and material properties as assessed through benchtop testing, without human judgment playing a direct role in evaluating its primary function (guiding screw placement). The tests focused on the physical integrity and safety of the aiming blocks themselves.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on engineering specifications, material science standards, and established regulatory requirements for mechanical performance, biocompatibility, sterility, cleanability, and corrosion resistance for medical devices. The "acceptance" of the "failure loads" for torque and lateral tests implies a pre-defined threshold or range considered safe and effective based on industry standards for bone fixation devices.

8. The Sample Size for the Training Set

Not applicable. This submission is for a hardware accessory and involves benchtop testing, not machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this type of device submission.

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The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating System is indicated for fixation of long bone fractures including fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.

This Special 510(k) submission is intended to address modifications to the Device Description. This Special 510(k) backing Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 4mm Locking Inserts to which changes are being made to improve manufacturability. The locking inserts are made from stainless steel per ASTM F138 and ASTM F139. The AxSOS® Locked Plating 4.0mm Locking Inserts have similar or identical and material properties to the predicate 4.0mm Locking Inserts determined substantially equivalent via 510(k) K050512.

This document describes a Special 510(k) submission for a line extension of 4mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter its intended use or fundamental scientific technology. Therefore, the "study" conducted is primarily non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information 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

• Sample Size: Not explicitly stated for each test. The text mentions "non-clinical laboratory testing was performed," implying a sufficient number of samples were tested to generate reliable data for each mechanical test.
• Data Provenance: Not explicitly stated, but assumed to be laboratory-generated per standard non-clinical testing protocols for medical devices. There is no indication of country of origin for the data, but the manufacturer is based in New Jersey, USA. The testing is retrospective in the sense that it's performed on manufactured devices to compare them to an existing predicate.

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

• Not Applicable. This is a non-clinical, mechanical testing study for substantial equivalence, not a clinical study involving human patient data and expert interpretation. The "ground truth" is defined by established engineering and material science standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical testing, there is no need for an adjudication method in the context of expert consensus or dispute resolution. Test results are objective measurements against defined performance requirements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. The submission explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is a purely non-clinical submission.

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

• Not Applicable. This is a physical medical device (bone plating system), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on established engineering performance requirements and material standards (e.g., ASTM F138 and ASTM F139 for stainless steel), and the demonstrated performance of the legally marketed predicate device (K050512). The goal is to show the modified device performs "as safe and effective as their predicates."

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It is a physical product undergoing mechanical validation.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The VariAx™ Fibula Straight Plates are intended for use in internal fixation of the distal fibula.

This 510(k) submission is intended to add bone plates with a different geometry to the VariAx " fibular plate line which was cleared in K081284. The new plates are termed "Fibula Straight Plates" and consist of the shaft portion of the cleared plate plus an oblong screw hole in some configurations. Additionally, other fixation plates (predicates) have been cleared with the approximate plate length of the subject device, including the Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335).

The provided text is for a 510(k) summary for a medical device (VariAx™ Locked Plating System Line Extension for Addition of Fibula Straight Plates), which is a regulatory document to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe a study involving an algorithm or artificial intelligence, nor does it involve performance criteria typically associated with such technologies.

The acceptance criteria and "study" described here pertain to mechanical and material equivalence for a physical medical implant.

Here's a breakdown based on the provided text, heavily formatted to address your specific points even if they don't perfectly align with the nature of this submission:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context refer to demonstrating substantial equivalence in mechanical properties to predicate devices. The "reported device performance" indicates that these criteria were met.

Study Details (as applicable to a physical device equivalence study)

1. Sample size used for the test set and the data provenance:

   • The document does not specify the exact sample size (number of plates tested) for the fatigue and stiffness tests.
   • Data Provenance: The tests were performed to compare the subject device's mechanical properties to predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates (K001945) and Synthes One-Third Tubular Dynamic Compression Locking (DCL) (K011335)). This is laboratory-generated data, not patient data, and does not have a "country of origin" in the same sense as clinical data. It is a prospective test in that new plates were manufactured and tested for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable. For mechanical testing of medical devices, "ground truth" is established by standardized testing methods and measurements, not expert human interpretation. The "truth" is objective physical properties.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or clinical outcomes. This study involves objective mechanical measurements.

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:

   • No. This is a 510(k) for a physical bone plate, not an AI or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This is not an algorithm, but a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for this submission is based on objective mechanical properties and material composition, established through standardized physical testing (4-point bending test) to compare the subject device to existing predicate devices.

7. The sample size for the training set:

   • Not applicable. This submission describes mechanical testing of a physical device, not an AI algorithm requiring a training set.

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

   • Not applicable. See point 7.

Summary of the "Study" for this device:

The study was a benchtop mechanical comparison of the subject device (VariAx™ Fibula Straight Plates) against predicate devices (Synthes 3.5 mm LCP® Medial Distal Tibia Plates and Synthes One-Third Tubular Dynamic Compression Locking plates).

• Methods: Fatigue strength verification and stiffness analysis were evaluated using a 4-point bending test.
• Findings: The median fatigue limits and stiffness of the VariAx™ Fibula Straight Plates were found to be equivalent to the existing fibula plates in the predicate system.
• Conclusion: This data demonstrated substantial equivalence to the predicate devices, a key regulatory requirement for 510(k) clearance.

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The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

The Stryker® Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.

The provided text describes a Special 510(k) submission for the Stryker® Patient Specific Polymer Implant, focusing on sterilization and a change in manufacturing location. The study's purpose is to demonstrate equivalence to the predicate nonsterile devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the tests conducted (sterilization, pyrogenicity, bioburden, packaging validation). It also does not provide information on data provenance (country of origin, retrospective/prospective) beyond stating that "Testing has been performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies performed are primarily laboratory-based equivalency testing (sterilization, pyrogenicity, packaging), not studies that would typically involve expert-established ground truth in the context of device performance in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where expert review is needed to establish ground truth from ambiguous or complex cases. The tests described are objective laboratory analyses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on device modifications related to sterilization and manufacturing, not on the clinical effectiveness or performance of the implant compared to human readers or other devices in a diagnostic or clinical decision-making context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable to this device. The Stryker® Patient Specific Polymer Implant is a physical implant, not a software algorithm or AI system for diagnostic or clinical decision support. While the manufacturing process involves commercially available software (Materialise), the submission does not detail standalone performance of this software in a clinical context but rather its integration and validation within the manufacturing process.

7. The Type of Ground Truth Used

For the studies mentioned (sterilization, pyrogenicity, bioburden, packaging validation), the "ground truth" is established by adherence to recognized international and national standards (ISO 11137-2, ANSI/AAMI ST72:2002) and validated laboratory testing protocols. These are not clinical ground truths (e.g., pathology, outcomes data) but rather objective measures of manufacturing and product quality.

8. The Sample Size for the Training Set

This is not applicable and therefore not provided. The device is a physical implant, and the submission describes manufacturing and sterilization validation, not the development of an AI algorithm or model that would require a training set. The "Materialise software" is mentioned as a commercially available tool integrated into the manufacturing process, implying it's not a newly developed algorithm by Stryker for this specific submission that would require a training set.

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

This is not applicable for the same reasons as point 8.

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