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The KLS Martin L1 MMF System is intended for temporary stabilization of mandibular and maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metallic archbars with sliding locking plates that attach to the dental arches with self-drilling locking screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoperative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67:2013), are available in either a 7-hole or 9-hole sliding plate configuration with two different lengths, and are 0.5 mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm or 2.0 x 8 mm self-drilling locking screws manufactured from Ti-6Al-4V (ASTM F136:2013). Implants are available both sterile and non-sterile. The system also includes the necessary instruments to facilitate placement of the implants.

The provided text describes the KLS Martin L1 MMF System, a medical device for temporary stabilization of mandibular and maxillary fractures. It includes information about its indications for use, technological characteristics, and comparison to predicate devices, but it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the particular information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established).

The document primarily focuses on establishing substantial equivalence for regulatory approval, which often relies on comparison to existing legally marketed devices rather than extensive new clinical trials with detailed statistical endpoints.

Based on the provided text, here's what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for mechanical or pyrogenicity testing.
• Data Provenance: Not specified (e.g., country of origin). The testing was non-clinical.

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

• Not applicable as this was non-clinical mechanical and pyrogenicity testing, not an expert-based clinical review or ground truth labeling study.

4. Adjudication method 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

• No. This device is a physical bone fixation system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant and was not performed.

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

• Not applicable for this type of medical device.

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

• For mechanical properties: Engineering specifications, stress/strain measurements, and comparison to predicate device performance.
• For pyrogenicity: LAL endotoxin testing against predefined regulatory limits (USP allowed limit).

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model.

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

• Not applicable.

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KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.

KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of mandibular bone. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit. Implants are provided non-sterile, range in thickness from 1.0 - 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

Here's a summary of the acceptance criteria and study information for the KLS Martin Individual Patient Solutions device, based on the provided document:

This document focuses on the mechanical and material performance of the device rather than the performance of an AI algorithm in a diagnostic or clinical decision support context. Therefore, many of the typical AI/ML study questions (like effect size of human readers with/without AI, standalone algorithm performance, number of experts for ground truth, etc.) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in terms of number of physical devices or specific data points for performance testing. The document refers to "the subject plates" for mechanical testing, implying a representative sample was tested.
• Data Provenance: The studies are non-clinical bench tests and conducted by the manufacturer, KLS Martin LP. The data originates from these laboratory tests, not from patient data or clinical settings. It is a retrospective analysis of device performance against established standards.

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

• This device is a medical implant, not a diagnostic AI device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation for its performance testing. The "ground truth" for its performance is derived from established engineering and materials science standards (ASTM, ISO, etc.).

4. Adjudication Method for the Test Set

• Not applicable. The performance tests are objective measurements against engineering standards, not subjective interpretations requiring adjudication.

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 implant, not an AI diagnostic or decision support tool. No human reader studies with or without AI assistance were conducted or are relevant.

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

• Not applicable. This is a medical implant. The "algorithm" in this context refers to the manufacturing process driven by patient CT data and physician input for design, not an AI algorithm for diagnosis or interpretation. The device itself is "standalone" in that it performs its mechanical function once implanted, but its pre-market testing does not involve "algorithm-only performance" as would be understood for an AI/ML product.

7. The Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for this device's performance is derived from compliance with established international standards for medical devices and materials, specifically:
  • ASTM F382 (Standard Specification for Metallic Bone Plates) for mechanical performance.
  • ISO 17665-1:2006 (Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices) for sterilization.
  • ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
• For the patient-specific design process, the "ground truth" for dimensional fit is a virtual fitting against a 3D model of the patient's anatomy derived from a CT scan.

8. The Sample Size for the Training Set

• Although the device design is patient-specific and involves a "virtual planning" phase, this is not an AI/ML product that learns from a "training set" in the conventional sense. Each device is unique to a patient based on their CT scan. The "training" for the manufacturing process (both traditional and additive) happens through engineering validation and quality control procedures, not through a data-driven training set for an algorithm.

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

• Not applicable, as there is no traditional "training set" for an AI/ML algorithm. The "ground truth" for the device's manufacturing and material properties is established through adherence to design specifications, material standards (ASTM F67, ASTM F136), and manufacturing quality control processes. The patient's CT scan provides the anatomical data for each individual device's design.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document is a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the "Zurich Distraction System (K010139)".

Here's a breakdown of the requested information:

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

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

The document primarily relies on non-clinical performance data (bench testing) and comparison to the predicate device.

• Biocompatibility: No new testing was performed; it relied on the predicate device's clearance.
• Pyrogenicity: The sample size for Bacterial Endotoxins testing is not specified.
• Mechanical Performance: The sample size for axial load, bending torsion, axial-torsion, and transverse shear testing is not specified. This was bench testing, not clinical data, so provenance like "country of origin" or "retrospective/prospective" is not applicable in the typical sense for patient 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)

Not applicable. The study is a 510(k) submission based on non-clinical bench testing and demonstration of substantial equivalence to a predicate device. There was no test set requiring expert ground truth for clinical cases.

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

Not applicable. No clinical test set or adjudication for diagnostic ground truth was performed or required.

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 device is a medical implant (internal distraction system), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance does not apply.

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

Not applicable in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission is based on:

• Predicate Device Equivalence: The safety and effectiveness profile of the legally marketed predicate device (Zurich Distraction System, K010139).
• Engineering Standards: Compliance with recognized standards for biocompatibility (ISO 10993-1), pyrogenicity (ANSI/AAMI ST72:2011, USP , EP 2.6.14), and mechanical performance through bench testing against design requirements.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI model. There is no concept of a "training set" for the device itself.

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

Not applicable. See point 8.

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The Level One Hand Plating System is used for stabilization of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

The Level One (L1) Hand Plating System includes metallic plates, washers, and screws intended for small bone fixation. Plates are pre-contoured to accommodate patient anatomy, available in various shapes and range in thickness from 0.6mm - 3.0mm, and are compatible with the standard and multidirectional locking screws offered in the system. Screws are self-tapping, available in a standard or multidirectional locking configuration and range in diameter from 1.0mm - 2.7mm with lengths from 2mm - 32mm. Standard screws may be used alone or in conjunction with the washers or plates for small fragment osteosynthesis. Implants are manufactured from CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136). The system includes the necessary instrumentation to facilitate implantation. The purpose of this submission is to offer the previously cleared non-sterile device system in K141489 in sterile packaging via gamma irradiation.

This document does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of device performance, as it is a 510(k) summary for a medical device (Level One Hand Plating System).

The primary purpose of this document is to demonstrate substantial equivalence to a predicate device, focusing on material, design, intended use, and a change in sterilization method (from non-sterile to sterile via gamma irradiation).

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this submission.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This indicates that no clinical performance study, as might be required for new or high-risk devices, was performed or presented.
• The non-clinical performance data section focuses on biocompatibility and bacterial endotoxin testing to support the change to sterile packaging, rather than demonstrating performance against specific clinical or diagnostic acceptance criteria.

In summary, this document is concerned with regulatory approval based on equivalence, not with proving new performance claims against defined acceptance criteria.

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KLS Martin Cannulated Headless Screws are intended for the treatment of fractures, osteotomies, and nonunions of small bones in the hand, wrist, foot, and ankle.

The KLS Martin Cannulated Headless Screws (CHS) system is comprised of headless cannulated screws intended for bone fixation in the treatment of fractures, non-unions, osteotomies, or to aid in small joint fusions of the hand, wrist, foot, and ankle. Bone fixation is achieved by proximal and distal threads designed with different pitches that, when inserted into the bone, cause compression of the bone fragments for bone reduction, stability, and healing. Cannulation of the screws is designed to allow the user to insert the screw over the guide wire for proper placement prior to compression. The CHS system offers screws in various diameters, overall lengths, and thread lengths to accommodate different sizes and types of bone reduction, such as scaphoid fractures and non-unions. The screws are self-drilling and self-tapping to eliminate the need for drilling a pilot hole prior to implantation. All screws are manufactured from Ti-6Al-4V (ASTM F136:2013). This system also includes the necessary and appropriate instrumentation to facilitate implantation of the screws by qualified and trained physicians.

The provided text describes a 510(k) premarket notification for a medical device, the KLS Martin Cannulated Headless Screws. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data, primarily mechanical and pyrogenicity testing.

Therefore, the requested information regarding acceptance criteria and studies focused on AI/algorithm performance, human reader studies, and training/test set details is not applicable to this document. This is a traditional medical device approval, not an AI/software as a medical device (SaMD) submission.

Here's a breakdown of the parts that are directly addressed by the provided text, and clarification for those that are not applicable:

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

The document does not provide a formal table of acceptance criteria with reported performance in a pass/fail format, as might be seen for a software algorithm. Instead, it describes mechanical property tests and pyrogenicity testing, stating they were "successfully completed without any signs of device failure" and that "endotoxin levels [are] below the USP allowed limit."

• Mechanical Properties Testing:
  • Acceptance Criteria Implied: Meeting the requirements of ASTM F543-13:2013 for torsional properties, driving torque, and axial pullout strength.
  • Reported Device Performance: Tests were "successfully completed without any signs of device failure." Comparative testing to the Synthes 3.0 mm cannulated screw "demonstrates substantial equivalence in performance testing."
• Pyrogenicity Testing:
  • Acceptance Criteria Implied: Endotoxin levels below the USP allowed limit for medical devices and meeting pyrogen limit specifications, as per AAMI ANSI ST72.
  • Reported Device Performance: "Endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications."

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 for the mechanical and pyrogenicity tests. Data provenance (country, retrospective/prospective) is not mentioned as these are laboratory tests of the physical device, not human 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)

Not applicable. Ground truth in this context refers to defined physical standards outlined in ASTM F543-13:2013 and AAMI ANSI ST72, not expert human interpretation.

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

Not applicable. Adjudication methods are relevant for human-interpreted data, not for laboratory physical property 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

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

The "ground truth" for this device's performance is based on established industry standards and test methods:

• For mechanical properties: ASTM F543-13:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws.
• For pyrogenicity: AAMI ANSI ST72.

8. The sample size for the training set

Not applicable. There is no training set for this type of medical device assessment.

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

Not applicable.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis) and mid-face bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of the mandible and mid-face bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document describes a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by indicating that the new device is a sterile version of existing non-sterile devices.

Based on the provided document, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study. Instead, it describes general design requirements and performance evaluations for mechanical properties and biocompatibility. The "reported device performance" indicates that these requirements were met.

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 for the test set: Not applicable (N/A). This submission did not involve a clinical study with a "test set" of patients. The performance data presented is from non-clinical bench testing and biocompatibility assessments of the device materials.
• Data provenance: N/A. The data provenance described is related to bench testing, not patient 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)

• Number of experts: N/A. No clinical test set with ground truth established by experts was used.

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

• Adjudication method: N/A. No clinical test set to adjudicate was utilized.

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

• MRMC study done: No. This is a medical device (bone plate/distractor) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study would not be relevant in this context.
• Effect size: N/A.

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

• Standalone done: No. This submission is for a physical medical device.

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

• Type of ground truth: N/A. For the mechanical and biocompatibility testing, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., design requirements, ANSI/AAMI ST72:2011, USP , EP 2.6.14 for endotoxins). No clinical ground truth (like expert consensus or pathology) was used as there was no clinical study.

8. The sample size for the training set

• Sample size for the training set: N/A. There was no "training set" in the context of an algorithm or AI. The design and manufacturing processes for the device are well-established based on existing predicate devices.

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

• How ground truth was established for the training set: N/A. This concept is not applicable to the type of device and submission described.

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