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The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

3. Number of experts used to establish the ground truth... and qualifications of those experts:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

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

• Not applicable, as this is not an AI/machine learning device.

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The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:

In Adults:

• 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal humerus, clavicle
• 4mm Locking Insert
• 4mm Locking Screws
• 3.5mm Cortical Screws
• 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals
• 4mm Reconstruction Plate - humerus, pelvis

In Pediatrics:

• 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, clavicle
• 4mm Locking Insert
• 4mm Locking Screws
• 3.5mm Cortical Screws

The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:

In Adults:

• 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis
• 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
• 5mm Locking Insert
• 5mm Locking Screws
• 4.5mm Cortical Screws
• 5mm Reconstruction Plate - femur, tibia, humerus, pelvis

In Pediatrics:

• 5mm Waisted Compression Plate -- Broad -femur, tibia, humerus
• 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus
• 5mm Locking Insert
• 5mm Locking Screws
• 4.5mm Cortical Screws

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to add the pediatric indication to a specific subset of plates, screws and inserts of the previously cleared Stryker Plating System (K060514). The components from the previously cleared system, some of which carry the pediatric indication, will make-up the system to be marketed as the AxSOS™ Locking Plate System. The indications for use will clarify which components will include the pediatric indication.

The provided text describes a 510(k) submission for the AxSOS™ Locking Plate System. This is a traditional 510(k) to add a pediatric indication to a previously cleared system, making it a medical device submission, not a study of a device employing AI. Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth, MRMC study, AI improvement effect size, training set, etc.) is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an breakdown of the relevant information provided:

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):

• Not applicable. This submission relies on non-clinical (laboratory) testing, not clinical data or a test set in the context of an AI/algorithm study.

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):

• Not applicable. This is a mechanical device submission, not an AI/algorithm study.

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

• Not applicable.

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 a medical device submission, not an AI/algorithm study. There is no AI component.

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

• Not applicable. There is no algorithm.

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

• Not applicable. The "ground truth" equivalent for this type of device submission is the established performance benchmarks and regulatory requirements for similar predicate devices, particularly regarding mechanical integrity and fatigue resistance.

8. The sample size for the training set:

• Not applicable. This is a medical device submission, not an AI/algorithm study.

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

• Not applicable. This is a medical device submission, not an AI/algorithm study.

Summary of the study/submission:

The submission focuses on demonstrating substantial equivalence of the AxSOS™ Locking Plate System to previously cleared predicate devices (K082807- Synthes 3.5 and 4.5mm Locking Compression Plate (LCP) System and K060514- Stryker Locked Plating System) to add a pediatric indication.

• Non-Clinical Testing:
  • Study performed: An additional compression fatigue testing was conducted for the subject plates, screws, and inserts.
  • Purpose: To evaluate the fatigue resistance in long-term pediatric use.
  • Conclusion: The testing demonstrated that the AxSOS™ Locking Plate Systems are substantially equivalent to devices currently cleared for market with pediatric indications.
• Clinical Testing: Not required for this submission.

Therefore, the "study" described is a non-clinical laboratory test specifically for compression fatigue, aimed at showing the new pediatric indications for the AxSOS™ Locking Plate System are as safe and effective as existing legally marketed predicate devices for pediatric use.

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The SPS Monoaxial Locking Plates in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The SPS Monoaxial Locking Plates are 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 predicate Stryker Locking Inserts. The AxSOS® Locking Insert is being modified as part of a line extension of the AxSOS® Locked Plating System. The AxSOS® Locked Plating System contains 3mm Locking Inserts to which changes are being made.

The provided text describes a Special 510(k) submission for a line extension of 3mm locking inserts for the AxSOS® Locked Plating System. This type of submission is for modifications to a legally marketed device that do not alter the intended use or fundamental scientific technology. Therefore, the "study" conducted is a demonstration of comparable mechanical and functional properties to predicate devices, rather than a clinical study involving human subjects or AI performance.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for the modified device in terms of specific performance thresholds (e.g., minimum tensile strength, fatigue life). Instead, the performance is evaluated in comparison to predicate devices. The implicit acceptance criterion is that the modified device demonstrates comparable mechanical and functional properties to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the mechanical and functional testing. It also does not provide details on data provenance (e.g., country of origin) or whether it was retrospective or prospective, as it pertains to engineering bench testing rather than clinical study data.

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)

This question is not applicable to this type of submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices, particularly those involving image analysis or clinical assessments. This submission is for a medical implant (bone plates and screws), and the evaluation is based on engineering principles and mechanical testing, not expert interpretation of clinical data.

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

This question is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, typically in clinical ground truth establishment. For mechanical testing, the results are typically quantitative and objective, and do not involve human adjudication in the same way.

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 such study was done. MRMC studies are used to evaluate diagnostic systems, especially those assisted by AI, by comparing the performance of multiple human readers on multiple cases. This submission is for a mechanical medical device, not an AI-powered diagnostic tool.

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

No standalone algorithm performance study was done for the same reasons as above. This is not an AI/algorithm-based device.

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

As discussed, "ground truth" in the clinical sense is not directly applicable. The "ground truth" for the assessment of this device is based on established engineering standards and direct physical measurements from mechanical and functional testing. The comparable performance to predicate devices serves as the benchmark.

8. The sample size for the training set

This question is not applicable. Training sets are used for machine learning models (AI). This device is a mechanical implant and does not involve any AI components or machine learning.

9. How the ground truth for the training set was established

This question is not applicable, as there is no training set for an AI model.

In summary:

This 510(k) submission is for a modification to a mechanical implant. The "study" involved mechanical and functional bench testing to demonstrate the modified device's performance is comparable to its predicate devices. Details regarding specific test parameters, sample sizes for testing, or objective acceptance criteria are not provided in this summary, but the overarching conclusion is that comparable performance was demonstrated. The concepts of expert ground truth, adjudication, MRMC studies, or AI algorithm performance are not relevant to this type of device and submission.

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