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The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.

The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula. The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Activmotion S DTO range." This document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, this document does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

Here's a breakdown of what can be gleaned from the text regarding the required information:

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

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performance metrics in the provided text. The document generally implies equivalence to predicate devices.
• Reported Device Performance:
  • "Engineering analysis and comparative 4-point-bending tests in static and dynamic condition were conducted to compare the bending strength of the subject device plates to the predicates."
  • "Static and dynamic tests were conducted according to according to ASTM F382."
  • "Engineering analysis: torsional, driving torque, and pullout tests according to ASTM F543 were performed on the subject screws."
  • "Endotoxin testing is performed using LAL quantitative kinetic chromogenic method."
  • "The analysis showed that the Activmotion S DTO range is as safe and as effective as the predicates."

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

• The sample sizes for the engineering tests (e.g., number of plates, screws tested) are not specified in this document.
• The data provenance is not explicitly stated as country of origin or retrospective/prospective. These were non-clinical, lab-based engineering tests.

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 is not applicable as the study involved non-clinical engineering tests, not clinical data requiring expert review for ground truth.

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

• This is not applicable as the studies were non-clinical engineering tests.

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 study was done. The document explicitly states "No clinical studies were performed."

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

• This is not applicable as the device is a metallic bone fixation appliance, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by engineering standards and measurements, as defined by ASTM F382 and ASTM F543, and the LAL quantitative kinetic chromogenic method for endotoxin testing. There is no expert consensus, pathology, or outcomes data involved.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device, not an AI/machine learning model that requires a training set.

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

• This is not applicable for the same reason as point 8.

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The Large Screws range is indicated for the fixation of bone fractures, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The Large Screws range consists of screws and washers designed for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults. The implants of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Large Screws Range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial S) containing implants and/or instruments will be provided sterile by gamma sterilization. Additional sterile instruments will also be provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F136 and ISO 5832-3). Function: The implants of the Large Screws range are indicated for the fixation of bone fractures, pseudarthroses, fusions and osteotomies of foot and ankle as well as medium and large bone fragments including radius, humerus, femur, tibia in adults.

The provided document is a 510(k) premarket notification letter and summary for the "Large Screws Range" by Newclip Technics. It details the device's substantial equivalence to predicate devices and provides information on non-clinical testing. However, it explicitly states that no clinical studies were performed.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as no such study is presented in this document.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

• Cannot be provided based on this document. The document does not define specific acceptance criteria for performance endpoints, nor does it report device performance from a clinical study.

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

• Cannot be provided based on this document. Since no clinical studies were performed, there is no test set, sample size, or data provenance to report.

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):

• Cannot be provided based on this document. As no clinical studies were performed, there was no test set requiring ground truth established by experts.

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

• Cannot be provided based on this document. No clinical studies, no adjudication method.

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:

• Cannot be provided based on this document. This device is a bone fixation screw, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is relevant here.

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

• Cannot be provided based on this document. This device is a physical medical implant, not an algorithm.

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

• Cannot be provided based on this document. No clinical studies were conducted, so no ground truth for performance evaluation was established using these methods.

8. The sample size for the training set:

• Cannot be provided based on this document. No clinical studies were performed, and this is not an AI/algorithm-based device that would typically have a "training set" in that context.

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

• Cannot be provided based on this document. (See #8).

What was reported in terms of testing:

The document explicitly states:

• "No clinical studies were performed." (Page 5)
• "Engineering analyses have been conducted in comparison with Large Screws Range of Newclip Technics (K160617)." (Page 5) - This refers to non-clinical, mechanical testing to show equivalence to a predicate device. The specifics of these analyses (e.g., sample size for mechanical tests, specific criteria) are not detailed in this summary.
• **"LAL testing was performed to demonstrate that the subject device meets the endotoxin limit of

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The implants of the Alians Clavicle range are dedicated to the fixation of fractures, mal-unions and osteotomies of the clavicle in adults.

The Alians Clavicle range consists of plates and screws designed for fixation of fractures, mal-unions, non-unions and osteotomies of the clavicle in adults.

The implants of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Alians Clavicle range will be provided non sterile for sterilization by health care professionals prior to use. Single use kits (Initial C) contain implants and instruments provided sterile by gamma sterilization. The Initial C kits contain implants (1 plate + screws), and instrumentation.

The provided document is a 510(k) summary for the "Alians Clavicle range" device. This type of regulatory submission is for medical devices that are substantially equivalent to legally marketed predicate devices, not for novel AI/software devices requiring the kind of extensive performance criteria and studies outlined in your request.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission. This document describes a traditional orthopaedic medical device (bone fixation plates and screws), not an AI/ML algorithm.

However, I can extract the acceptance criteria and study information that is relevant to this type of device and present it in your requested format.

Acceptance Criteria and Device Performance for Alians Clavicle Range

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The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults.

The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The plates and screws are manufactured from titanium alloy and are color anodized.

The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.

I am sorry, but based on the provided text, there is no information about an AI/ML-driven device or study parameters that would allow me to populate the requested table and describe the study proving the device meets acceptance criteria.

The document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System," which is a metallic bone fixation appliance. It discusses the regulatory review process, device description, indications for use, and a comparison to predicate devices, including mechanical testing (non-clinical tests).

There is no mention of:

• Acceptance criteria for an AI/ML device
• Device performance reported for an AI/ML device
• Test set sample sizes, data provenance, or the number/qualifications of experts involved in establishing ground truth for AI/ML
• Adjudication methods, MRMC studies, standalone AI performance, or types of ground truth for an AI/ML system
• Training set sample size or how ground truth for a training set was established for an AI/ML system

Therefore, I cannot fulfill your request for this specific document.

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