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The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:

• A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
• A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
  ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.

The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.

This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).

Here's what can be extracted and what cannot:

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

Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.

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

• Not applicable / Not provided. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.

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 / Not provided. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.

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

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical 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 / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.

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

• Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.

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

• For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
• For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.

8. The sample size for the training set

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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

• Not applicable / Not provided. This is relevant for AI/ML algorithms.

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The Stryker Fixos Screw System is a single use device intended for the fixation, correction or stabilization of small and long bones in adult and adolescent patients. Indications include:

Ø4.0mm Headless Screw:

• · Fractures of the tarsals and metatarsals
• · Fractures of the olecranon, distal humerus
• Fractures of the radius and ulna
• · Patella fractures
• · Distal tibia and pilon fractures
• Fractures of the fibula, medial malleolus, os calcis
• · Tarso-metatarsal and metatarsophalangeal arthrodesis
• · Metatarsal and phalangeal osteotomies
• · Osteochondritis dissecans
• · Fractures of the pelvic ring
• · Small cancellous fragments of the small and long bones

05.0mm Headless Screw:

• · Medial and lateral malleolar and pilon fractures
• · Proximal and distal humerus fractures
• · Fractures of the olecranon process
• · Tibial plateau fractures
• Os calcis, talar and patellar fractures
• Fractures of the pelvis and acetabulum
• · Arthrodesis of the tarsals

07.0mm Headless Screw:

• · Tibial plateau fractures
• · Ankle arthrodesis
• · Calcaneus osteotomies

The Fixos Screw System is an internal fixation device that consists of various types of screws to treat a number of different types of fractures in small and long bones. The subject components will be available sterile and non-sterile.

This submission is for the Fixos Screw System, a bone fixation device, and does not involve AI or algorithms that would require a study with acceptance criteria as typically defined for AI/ML devices. Therefore, a table of acceptance criteria and reported device performance related to AI/ML is not applicable. Similarly, most of the requested points are not relevant to this type of medical device submission.

Here's an analysis based on the provided text, highlighting why most points are not pertinent:

1. Table of Acceptance Criteria and Reported Device Performance (AI/ML specific): Not Applicable
This product is a traditional medical device (bone screws), not an AI/ML diagnostic or therapeutic device. Acceptance criteria for such devices typically relate to engineering specifications, material properties, and mechanical performance, not AI-driven metrics like sensitivity, specificity, or F1-score. The document states "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing." This implies that the performance met the expected standards for a bone screw, which would be based on mechanical tests, not AI-specific metrics.

2. Sample Size for the Test Set and Data Provenance (AI/ML specific): Not Applicable
No "test set" in the context of AI/ML models was used. The non-clinical testing involved mechanical tests on the device components themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications (AI/ML specific): Not Applicable
Ground truth established by experts is a concept relevant to AI model training and evaluation, particularly for image analysis or diagnostic tasks. This device is a physical implant, not a diagnostic tool requiring expert ground truth for its performance assessment.

4. Adjudication Method (AI/ML specific): Not Applicable
Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert labeling or diagnoses, which is a process specific to establishing ground truth for AI model development and validation. This is not relevant to the mechanical testing of a bone screw.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (AI/ML specific): No
The document explicitly states "Clinical testing was not required for this submission." MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic tasks. Since this is a physical device and no clinical testing was performed, an MRMC study was not conducted.

6. Standalone (Algorithm Only) Performance (AI/ML specific): Not Applicable
This is a physical device, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used (AI/ML specific): Not Applicable
Ground truth (expert consensus, pathology, outcomes data) is used to validate AI systems. For a bone screw, the "ground truth" for its performance would be its mechanical integrity and biocompatibility, assessed through laboratory testing and material science, not through these types of data.

8. Sample Size for the Training Set (AI/ML specific): Not Applicable
There is no "training set" for an AI model as this is a physical device.

9. How the Ground Truth for the Training Set Was Established (AI/ML specific): Not Applicable
Again, this product is a physical device, not an AI model, so there is no training set or ground truth in that context.

Summary Relevant to the Provided Document:

• Acceptance Criteria: For the Fixos Screw System, acceptance criteria were based on non-clinical laboratory testing demonstrating substantial equivalence to predicate devices in terms of mechanical performance. These tests included:

  • Insertion Torque Testing
  • Shear-off Testing
  • Pull-out Testing
    The success criteria for these tests would typically be that the new device's performance falls within a predefined range that is equivalent to or better than the predicate devices, ensuring its mechanical integrity and strength for its intended use. The document confirms that "Testing demonstrated that Fixos Screw System is substantially equivalent to the predicate device currently cleared for marketing."

• Study Proving Acceptance: The study involved non-clinical laboratory testing of the Fixos Screw System components. The study's conclusion was that the device is "substantially equivalent to the predicate device identified in this premarket notification." The specific details of the exact values or thresholds for "substantial equivalence" are not provided in this summary but would be part of the full 510(k) submission.

In essence, the Fixos Screw System is a traditional medical device, and its evaluation for market clearance followed the standard path for such devices by demonstrating substantial equivalence through non-clinical mechanical testing when compared to already cleared predicate devices. AI/ML-specific validation criteria and studies are not applicable here.

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APTUS® Cannulated Compression Screws 5.0, 7.0 are intended for the treatment of fractures, osteotomies and arthrodeses of bones with the appropriate screw size.

APTUS® Cannulated Compression Screws 5.0, 7.0 are headless screws intended for the treatment of fractures, osteotomies and arthrodeses of bones. The design of the screw, incorporating various diameters, threads on the head and tip, provides compression of the bone segments upon insertion of the screw. The submission includes the associated Kwires, intended to be used for internal fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of the implants.

APTUS Cannulated Compression Screws 5.0, 7.0 are available in two diameters (5.0 mm and 7.0 mm) and come in partially-threaded or fully-threaded designs. The 5.0 mm screws are provided in overall lengths ranging from 30 to 70 mm. The 7.0 mm screws are provided in overall lengths ranging from 40 to 140 mm. The 5.0 and 7.0 mm screws are used with the 1.6 and 2.2 mm diameter K-wires, respectively.

APTUS® Cannulated Compression Screws 5.0, 7.0 are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and the K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and study proving device performance:

This 510(k) summary is for a medical device (APTUS® Cannulated Compression Screws 5.0, 7.0), not an AI/software device. Therefore, many of the typical acceptance criteria and study aspects related to AI (e.g., sample size for test set, data provenance, ground truth experts, MRMC studies, standalone performance, training set) are not applicable.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical data, primarily engineering and mechanical testing. Clinical data was explicitly not submitted.

1. Table of Acceptance Criteria and Reported Device Performance

Note: Since this is a hardware device submission, the "acceptance criteria" are related to mechanical performance and regulatory standards, not diagnostic accuracy or AI model performance.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable in the context of AI/software performance. For mechanical testing, the specific number of screws tested is not detailed in this summary, but it would typically involve a statistically relevant number of samples to demonstrate compliance with ASTM F543.
• Data provenance: Not applicable in the context of data used for AI training/testing. The tests were performed on the physical device.

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 (e.g., expert consensus on medical images) is not relevant for mechanical testing of bone screws. The "ground truth" here is compliance with established engineering and material standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication process as understood in AI performance evaluations. Mechanical tests have pass/fail criteria based on standards.

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. This is a hardware device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used

• Engineering and material standards compliance: The "ground truth" for this device revolves around its conformance to established material specifications (e.g., ASTM F136 for titanium alloy, ASTM F138 for stainless steel) and mechanical performance standards (ASTM F543 for metallic bone screws). The tests demonstrated that the device performs equivalently to previously cleared predicate devices when subjected to these standards.

8. The sample size for the training set

• Not applicable. This is a hardware device; there is no "training set" in the AI sense.

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

• Not applicable. This is a hardware device.

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