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The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device APTUS Elbow Dorsal Olecranon Plates are available in three (3) designs: Standard, Medium and Extended. The designs differ in the shape of the proximal ends of the Standard Plates are available in 6 lengths; The Medium Plates are available in 2 lenghts and the Extended Plates are available in 3 lenghts, each for left and right. All plates have appropriate for the olecranon. The subject device plates are compatible with screws and k-wires previously cleared in K051567, K09332, K112560, K232144 (for screws) and K092038 (for k-wires).

The subject device plates are manufactured from titanium alloy, conforming to ASTM F136. All plates are provided sterile and selected plates are provided non-sterile aswell.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Elbow Dorsal Olecranon Plates), which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance-based acceptance criteria through clinical studies or AI algorithm validation. Therefore, the information needed to answer many of your questions, particularly those related to AI performance, ground truth establishment, expert adjudication, and MRMC studies, is not present in this document.

However, I can extract information regarding non-clinical testing and general regulatory context, and then explain why other requested details are absent.

Here's a breakdown based on the provided text, and an explanation of what cannot be answered:

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

The document mentions non-clinical (mechanical) testing based on a specific ASTM standard and FDA guidance, but it does not provide a table of acceptance criteria and reported performance values. It only states a general conclusion:

• Acceptance Criteria Mentioned: Minimum requirements pointed out in the "FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)" and ASTM F382.
• Reported Device Performance: "The mechanical test results show that the bending structural stiffness of the Dorsal Olecranon Medartis APTUS Elbow Plates are higher than the acceptance values indicated in the relative FDA guidance..."
• Specific Values: No specific numerical acceptance criteria or reported device performance values (e.g., in N/mm or similar units) are provided in this regulatory letter.

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

• Sample Size: Not specified for non-clinical (mechanical) tests. For clinical studies, the document explicitly states: "Clinical data were not provided in this submission." This means there was no clinical test set for patient data.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable as no clinical data or patient test sets were used or provided.

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 information would be relevant for studies involving human interpretation or AI algorithm validation using expert-labeled data, which were not part of this 510(k) submission. No clinical ground truth was established from patient data.

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

• Not applicable. Adjudication methods are used to establish ground truth in clinical or imaging studies, which were not conducted for this 510(k) submission.

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. The document explicitly states: "Clinical data were not provided in this submission." An MRMC study, especially one involving AI assistance, would fall under clinical data. This submission is for a traditional medical device (bone plates), not an AI/ML-driven diagnostic or therapeutic device that would typically undergo such a study.

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

• No. This study type is for AI/ML algorithms. The device submitted is a mechanical orthopedic implant, not an algorithm.

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

• For the non-clinical mechanical testing, the "ground truth" or reference for evaluating performance was defined by the stated FDA guidance and ASTM standards for mechanical properties (e.g., bending stiffness). There was no "ground truth" concerning patient outcomes, pathology, or expert consensus on clinical imaging, as no clinical data was used.

8. The sample size for the training set

• Not applicable. This applies to AI/ML algorithms that require training data. This submission is for a physical medical device.

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

• Not applicable for the same reason as point 8.

Summary of Device Acceptance & Study

The acceptance of this device by the FDA (K240613) is based on its substantial equivalence to legally marketed predicate devices (K120070, K193633, K193639, K193554) and successful completion of non-clinical (mechanical) testing.

• Acceptance Criteria for Substantial Equivalence: Similar intended use, similar technological characteristics (design, principle of operation, material), and comparable safety and effectiveness, supported by non-clinical testing.
• Study Proving Acceptance:
  • Study Type: Non-clinical (mechanical) testing.
  • Objective: To demonstrate that the bending structural stiffness of the APTUS Elbow Dorsal Olecranon Plates is at least "higher than the acceptance values indicated in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)" and meets ASTM F382.
  • Results: The mechanical tests confirmed that the device's stiffness was higher than the specified acceptance values.
  • Clinical Data: No clinical data or studies were performed or submitted. The FDA 510(k) process for traditional devices like bone plates often relies on substantial equivalence and non-clinical data if the technological characteristics are well-understood.

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APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537.
The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires).
The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "APTUS Hand Scaphoid Plates." It outlines the regulatory review and states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/Software as a Medical Device (SaMD) product.

Instead, this document pertains to a physical medical device (bone fixation plates) and references mechanical testing to demonstrate performance and substantial equivalence to predicate devices, not AI performance.

Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/SaMD product, details of an AI performance study, number of experts, ground truth establishment, etc.) is absent from the provided text.

The document explicitly states: "Clinical data were not provided in this submission." and refers to "Mechanical fatigue and static testing" as the non-clinical testing performed.

To complete your request, I would need a regulatory submission document for an AI/SaMD product that discusses its performance characteristics, acceptance criteria, and the study conducted to demonstrate its capabilities.

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APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Ulna Plates, previously cleared under K 103332. The subject device APTUS Distal Ulna Plates is available in four (4) designs with 10 or 12 screw holes. All plates have anatomical designs that are appropriate for either the right ulna. The 10 and 12 hole plates have a length of 53 mm and 66 mm, respectively. The maximum thickness of the plates is 1.6 mm and the maximum width is 15 mm.

The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K051567 (TriLock), K103332 (cortical), and K092038 (K-wires).

The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67, and are provided non-sterile and sterile.

This FDA 510(k) summary for the APTUS 2.5 TriLock Distal Ulna Plates does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical implant device (bone fixation plates) and its equivalence to previously cleared predicate devices based on mechanical performance data.

Therefore, many of the requested details, such as those related to AI/ML device testing (e.g., test set sample size, ground truth establishment, MRMC studies, training set details), are not applicable to this document.

However, I can extract information relevant to the performance data provided for this specific type of device.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

For this type of device (bone fixation plates), the "acceptance criteria" and "device performance" are typically related to mechanical integrity and biocompatibility, not diagnostic accuracy.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size for the mechanical testing (e.g., how many plates were tested). It simply states that "Mechanical testing Fatigue Bending Test and Static Bench Testing" were performed.
• Data Provenance: The mechanical testing was "non-clinical testing data," meaning it was benchtop testing, not involving human subjects. The country of origin for this testing data is not explicitly stated, but the manufacturer (Medartis AG) is based in Switzerland. The data is retrospective in the sense that it supports a new device's clearance based on established methods and comparison to existing predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is not a diagnostic AI/ML device that requires expert review for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and standards.

4. Adjudication Method for Test Set

• Not Applicable. This is not a diagnostic AI/ML device study requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not Applicable. This is not a diagnostic AI/ML device. "Clinical data were not provided in this submission."

6. Standalone Performance (Algorithm only)

• Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• For mechanical testing: Engineering standards and established benchmarks (comparison to predicate device performance).
• For biocompatibility: Material standards and proven safety of identical materials used in cleared predicate devices.

8. Sample Size for Training Set

• Not Applicable. This is not an AI/ML device with a "training set."

9. How Ground Truth for Training Set was Established

• Not Applicable.

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APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

The subject device includes a total of seven (7) plates are to be applied using a dorsal surgical approach, and have an anatomical design appropriate for either the left or right wrist; two (2) plates are to be applied using a volar surgical approach, and are provided in versions designed specifically for the left and right wrist. The dorsal plates have overall lengths ranging from approximately 61 mm to 116 mm, and maximum widths of 13.5 mm. The volar plates have overall lengths ranging from approximately 39 mm to 42 mm, and overall widths ranging from approximately 16 mm to 26 mm. The plates from the subject device, the primary predicate device, and the reference devices have the same technological characteristics, and have similar design characteristics, include designs for dorsal or volar surgical placement, and include screw holes to accommodate locking and nonlocking screws. The plates from the subject device, the primary predicate device, and the reference devices encompass a similar range of physical dimensions (overall width, overall length, and thickness). The subject device and the primary predicate device K112169 both include plates with similar anatomic designs for dorsal surgical placement. Similarly, the subject device and the reference device K142906 both include plates with similar anatomic designs for volar surgical placement. The plates from the subject device, K112169, K142906, and K051567 are manufactured from identical unalloyed titanium material conforming to ASTM F67. The plates from the subject device, K112169, and K 142906 are compatible exclusively with previously cleared Medartis APTUS® screws, and also are compatible with previously cleared Medartis APTUS® K-Wires. All subject device final, finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared Medartis device components (K112169, K142906, and K051567) and, therefore, are substantially equivalent to these devices regarding biocompatibility. The subject device components and the Medartis device components cleared in K112169 and K142906 are packaged using the same materials, and are to be sterilized by the same methods.

The provided document is a 510(k) summary for a medical device (APTUS® Wrist Arthrodesis Plates), asserting its substantial equivalence to previously marketed predicate devices. This type of regulatory submission does not involve clinical studies to prove acceptance criteria in the way an AI/ML medical device would. Instead, it relies on non-clinical testing (e.g., mechanical, biocompatibility) and a comparison of technological characteristics to already cleared devices.

Therefore, most of the requested information regarding acceptance criteria and performance proven by a study (especially sample sizes, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training data details) is not applicable to this type of device submission.

However, I can extract the relevant information regarding the non-clinical testing and "acceptance criteria" (which in this context refers to demonstrating comparable performance to predicates), and present it in a modified format.

Based on the provided 510(k) summary for the APTUS® Wrist Arthrodesis Plates, the following information can be extracted regarding its "acceptance criteria" and "study" (non-clinical testing) that proves the device meets these criteria:

This submission is a 510(k) premarket notification for a bone fixation appliance, and as such, the "acceptance criteria" and "study" differ significantly from those for an AI/ML-driven medical device. The primary goal is to demonstrate substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics, rather than proving a specific diagnostic accuracy or clinical outcome through a traditional clinical trial.

1. Table of Acceptance Criteria and the Reported Device Performance

For this mechanical device, "acceptance criteria" are implicitly met if the device's performance is comparable or superior to its predicates in specified non-clinical tests, and its technological characteristics and intended use are substantially equivalent.

Results: "Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the reference devices K142906 and K051567." No specific quantitative performance metrics (e.g., force limits, cycles to failure) are provided in this summary, but the conclusion of substantial equivalence implies acceptable performance relative to the predicates. |
| Design Characteristics: Similar anatomical fit and functional features. | The device has similar design characteristics to predicates, including designs for dorsal or volar surgical placement, and screw holes to accommodate locking and non-locking screws. Minor differences in specific dimensions or screw hole placement for new plates were assessed not to impact safety or effectiveness. |
| Material Composition: Compatible and safe materials. | Plates are manufactured from identical unalloyed titanium material conforming to ASTM F67, as used in predicate devices K112169, K142906, and K051567. Screws are made of previously cleared Ti-6Al-4V alloy, ASTM F136. |
| Sterilization: User-level sterilization methods are effective and safe. | Packaged using the same materials and sterilized by the same methods as clear Medartis device components (K112169 and K142906). Provided non-sterile, with the end-user instructed to sterilize by moist heat. |
| Intended Use: Device performs its stated function. | The subject device and the primary predicate device (K112169) share identical Indications for Use: "APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis." Though other reference devices have broader indications (e.g., fractures, osteotomies), the core "internal fixation of the upper extremity" is shared across all, and these minor differences were deemed not to impact substantial equivalence. |

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

• Sample Size: Not specified in terms of human subjects or clinical data for performance evaluation. For mechanical testing, the "sample size" would refer to the number of physical device units tested according to ASTM standards. This information is typically detailed in the full test report, not usually in the 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for acceptance criteria. The data comes from non-clinical bench testing of the physical device and a comparison of engineering specifications and materials to predicate devices. No human subject data (retrospective or prospective) is mentioned for this type of submission.

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

• Not Applicable. As this is a mechanical device submission, there is no "ground truth" in the clinical sense established by human experts for a test set. Substantial equivalence is based on engineering principles, material science, and a comparison to already cleared devices.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "adjudication" in the context of human interpretation or clinical data for this type of device submission.

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

• Not Applicable. MRMC studies are typically performed for diagnostic imaging devices where human reader performance is being evaluated, particularly with AI assistance. This device is a passive implantable fixation plate.

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

• Not Applicable. This is a mechanical implant, not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance evaluation is established through recognized industry standards (e.g., ASTM F382) for mechanical testing and material specifications (e.g., ASTM F67, ASTM F136). The performance is compared to that of legally marketed predicate devices, implying that their demonstrated safety and effectiveness serve as benchmarks for the subject device.

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.

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

• Not Applicable. See point 8.

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The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.

The subject device plate has an anatomical design appropriate for both the left and right wrist. The plate has a uniform thickness of 1.3 mm and has overall dimensions of approximately 35 mm x 13 mm, before bending to conform to the hand anatomy. The screw holes of the plate are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared under K051567. The subject device plate is compatible with 2.0 mm diameter screws, and is used with TriLock locking screws and cortical (nonlocking) screws. The subject device plate is made of unalloyed titanium conforming to ASTM F67.

This document (K181009) is a 510(k) premarket notification for the Medartis AG APTUS® CMC-I Fusion Plate System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for software performance (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various tests.

The performance data primarily focuses on mechanical equivalence.

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

• Sample Size: The document does not specify the number of physical samples used for the mechanical tests (e.g., number of plates tested for four-point bend or dynamic testing). ASTM F382 and similar standards typically require a certain number of replicates, but this detail is not provided.
• Data Provenance: The tests are non-clinical, laboratory-based mechanical and biocompatibility tests. Product development and potentially the testing itself occurred in Switzerland (Medartis AG is based in Basel, Switzerland). The document does not specify if the testing was performed retrospectively or prospectively, although in a verification/validation context they are typically conducted prospectively.

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

This information is not applicable as the submission is for a physical medical device (bone plate) and relies on non-clinical engineering and material science testing, not on clinical data, image interpretation, or expert consensus on patient outcomes.

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

This information is not applicable for the reasons stated above (non-clinical, non-human-reader dependent 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 information is not applicable. This is a submission for a physical medical implant, not an AI/software device that assists human readers.

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

This information is not applicable. This refers to AI/software performance.

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

The "ground truth" in this context refers to the established standards and specifications for material properties and mechanical performance.

• For Biocompatibility: The "ground truth" is that the material (unalloyed titanium, ASTM F67) and manufacturing processes are identical to a previously cleared device (K051567), and thus are known to be biocompatible.
• For Mechanical Performance: The "ground truth" for mechanical testing is established by recognized standards such as ASTM F382 and by comparative performance against a legally marketed predicate device (K062498) known to be safe and effective for its intended use. The device's performance measurements (e.g., load to failure, fatigue life) are compared against the predicate's performance in similar test setups.

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical implant.

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

This information is not applicable for the reasons stated above.

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APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.

I am sorry, but the provided text is a 510(k) summary for a medical device (APTUS® Wrist 2.5 System), which describes its intended use, device description, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, study details for a diagnostic or AI-powered device, or any of the other specific points you requested (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size).

Therefore, I cannot provide the requested table and study description based on the information given.

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The Acumed Hand Plating System is intended for the management of fractures, fusions, and osteotomies of the distal, middle, and proximal phalanges and metacarpals and other bones of appropriate size for the devices.

The Hand Plating System consists of plates, locking screws, lag screws, and k-wires. Plates are available in a variety of shapes to accommodate varying fracture patterns and/or patient anatomy. The plates come in thicknesses of 0.8 mm to 1.3 mm. The locking screws and lag screws have major thread diameters of 1.5 mm to 2.3 mm, provided in lengths ranging from 5 mm to 20 mm. The lag screws and k-wires are used for fixation independent of the plates. The plates are made of titanium per ASTM F-67. The screws, lag screws, and the k-wires are made of titanium alloy per ASTM F136. All plates and screws are provided sterile and non-sterile.

The provided text describes a 510(k) submission for the Acumed Hand Plating System, which is a medical device for orthopedic fixation. It does not describe the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based device.

The document explicitly states: "The non-clinical testing enclosed in this submission includes static and cyclic performance testing and engineering analysis." This refers to mechanical and engineering tests, not studies related to algorithm performance or human-in-the-loop improvements.

Therefore, for your request regarding AI/algorithm acceptance criteria and studies, the provided text does not contain the necessary information. It is a traditional medical device submission focused on substantial equivalence to existing predicate devices based on design, materials, and mechanical performance.

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The APTUS® 1.5 TriLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

• Management of the fractures of the distal, middle and proximal phalanges and metacarpals
• Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodoses .

APTUS® Radius 2.5 group:

• . Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• . Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

The APTUS 1.5 TriLock consists of titanium TriLock plates and titanium TriLock screws with locking function. The system is intended to be used for internal fixation of small bones. The 1.5 TriLock plates may also be used with existing standard 1.2 mm (thread diameter) and 1.5 mm (thread diameter) cortical bone screws cleared under APTUS® Titanium Fixation System. K051567. The only modifications being made in this submission are the addition of eight (8) plates, all 0.8 mm in thickness, having various screw hole and design configurations, and the addition of ten (10) screws, all having a major thread diameter of 1.5 mm, all with a locking head design, provided in lengths ranging from 4 mm to 13 mm in 1 mm increments. The technological differences between the subject device and the predicate include a change in the thickness of the plates and the change in plate configurations and the change in screw head design to allow locking to the plates.

The provided document is a 510(k) Summary for a medical device (APTUS® 1.5 TriLock) and does not describe an AI/ML study. It details the device's intended use, description, and claims of substantial equivalence to a predicate device based on performance data that includes dimensional analysis, insertion, shear, and pullout testing of screws, and fatigue testing of plates.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML study, as the document pertains to a traditional medical device submission.

Here's why and what information is available:

• No AI/ML Component: The document does not mention any artificial intelligence, machine learning, software algorithm, or diagnostic aid. It describes a physical orthopedic fixation system (plates and screws).
• Performance Data Type: The "performance data" referred to is related to the mechanical properties of the implants (e.g., screw insertion/pullout strength, plate fatigue life), not diagnostic accuracy or AI model performance.
• Substantial Equivalence: The submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (APTUS® Titanium Fixation System, K051567), a common pathway for medical device clearance. This involves showing similar intended use, technological characteristics, materials, and mechanical performance.

Therefore, all requested points related to AI/ML study components (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone algorithm, training set, etc.) are NOT applicable to this document.

The "acceptance criteria" for this device would be the demonstration of substantial equivalence through meeting comparable mechanical performance benchmarks to the predicate device, which are implicitly accepted by the FDA clearance. The "study" proving this involves the specific mechanical tests mentioned:

• Detailed dimensional analysis of subject and predicate screw designs.
• Insertion, shear, and pullout testing of subject and predicate screws.
• Fatigue testing of subject and predicate plate designs.

Without the actual reports for these mechanical tests, specific numerical acceptance criteria and performance results cannot be extracted. The summary only states that these tests were "provided to demonstrate substantial equivalence."

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