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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

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The KLS Martin Pure Pectus System is indicated for use in surgical procedures to repair pectus excavatum. It is indicated for use in adult and pediatric (children and adolescents) populations.

The KLS Martin LP Pure Pectus system consists of metallic implants comprised of straight and angled pectus bars and connector bars that provide support to the thoracic cavity undergoing repair for pectus excavatum. The implants are provided non-sterile in multiple sizes and are manufactured using tradition methods. Pectus bars are manufactured from CP Titanium. Connector bars are manufactured from Ti-6Al-4V. The system also instruments to facilitate placement of the implants.

The KLS Martin Pure Pectus System is a metallic implant system designed for surgical repair of pectus excavatum in both adult and pediatric populations. The submission K221938 received FDA clearance. Given the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a standalone algorithm, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or AUC, as would be the case for an AI/ML device. Instead, the acceptance criteria are related to mechanical and biological performance designed to demonstrate substantial equivalence to an existing predicate device.

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

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" because this was bench testing on physical devices, not a clinical trial or algorithm evaluation with data. The sample size would refer to the number of bars tested for each mechanical test (static and dynamic bending). While not specified, these types of tests typically involve a statistically significant number of samples per variant (e.g., 5-10 samples per size/configuration for fatigue, 3-5 for static).
• Data Provenance: The data provenance is from non-clinical "bench testing" conducted by the manufacturer, KLS Martin L.P. This is not patient data; it's laboratory test data.

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

Not applicable. For this type of submission (mechanical and biocompatibility testing for a medical device), "ground truth" is not established by human experts in the way it would be for an AI diagnostic algorithm. Ground truth is established by validated laboratory testing procedures and international standards.

4. Adjudication Method for the Test Set

Not applicable. This was not an expert review/adjudication of clinical images or patient cases. The "adjudication" in this context is the comparison of test results against pre-defined acceptance criteria per established test protocols and 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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers in interpreting medical images or data. The KLS Martin Pure Pectus System is a metallic implant; its evaluation focused on its physical and biological performance, not its interpretive capabilities.

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

No, a standalone performance evaluation was not done. This is also not relevant for an implantable medical device. Standalone performance is assessed for algorithms that provide diagnostic or prognostic outputs without human oversight.

7. The Type of Ground Truth Used

For the mechanical testing, the "ground truth" is the measured physical properties and performance of the subject device compared against the measured physical properties and performance of the predicate device, with both tested under standardized conditions. The benchmark for "ground truth" for biocompatibility is conformance to ISO 10993-1:2018 standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. This device is not an AI/ML algorithm that requires a "training set" or ground truth for training.

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KLS Martin IPS Distraction 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, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction of maxillofacial / midface and mandibular bones. 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 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 personnel 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 sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

This document describes the 510(k) summary for the KLS Martin IPS Distraction device. It provides information regarding the device's indications for use, technological characteristics, and a comparison to predicate and reference devices to support a claim of substantial equivalence.

Based on the provided text, the device in question is a medical implant (bone plates) designed for cranial and facial bone distraction. Therefore, the acceptance criteria and study proving its performance will relate to its mechanical properties, biocompatibility, sterilization, software validation, and clinical safety and effectiveness for its intended patient population.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and their outcomes in narrative form to demonstrate substantial equivalence. I will infer the "acceptance criteria" from the types of tests conducted and the "reported device performance" from the stated results.

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

• Mechanical Testing (Weld Strength): The document does not specify the exact sample size for the weld strength test. It states "A direct comparison weld strength test was performed," implying sufficient samples for a comparative analysis, but no number is given.
• Biocompatibility, Sterilization, Pyrogenicity: These tests leveraged data from a previously cleared device (K191028). No new sample sizes are explicitly mentioned for these, as the substantial equivalence hinges on the similarity to the already-tested reference device. If new samples were tested for verification, their numbers are not stated.
• Software V&V: No specific sample size (e.g., number of cases or simulations) is mentioned for software testing. It refers to "all software requirements and specifications" and "on-site user acceptance testing."
• Clinical Performance (Pediatric): 5 clinical studies were analyzed to support the pediatric indications. The document lists the studies, but does not state how many patients were in the "test set" for the KLS Martin device specifically. These appear to be literature reviews, not new clinical trials conducted for this device clearance.
  • Data Provenance: The provenance of the data for the 5 analyzed clinical studies is implied to be from published literature ("Based on published literature findings"). Specific country of origin is not mentioned, nor is whether the studies were retrospective or prospective, though typical clinical trials are prospective, and reviews can be of either.

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

• Mechanical, Biocompatibility, Sterilization, Pyrogenicity, Software V&V: The document does not mention the use of external "experts" to establish ground truth for these non-clinical performance tests. These are typically assessed against pre-defined engineering and biological standards by internal or contract testing labs.
• Clinical Performance (Pediatric): The "ground truth" for the pediatric clinical performance is based on "published literature findings" and risk assessments performed based on FDA guidance. There is no mention of a specific number of experts used to establish a new ground truth for this 510(k) submission's test set. The experts are implicitly the authors of the peer-reviewed clinical literature analyzed and the regulatory/clinical affairs personnel conducting the risk assessment. Qualifications of these implied experts are not detailed in this document.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is described for any of the tests, as these are technical performance tests or literature reviews, not studies involving human interpretation of medical images or data requiring reader consensus.

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 comparative effectiveness study was mentioned or performed. This device is a passive implantable device, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a surgical implant, not a software algorithm. The software mentioned (for planning and design) is a tool for manufacturing patient-specific implants, not a diagnostic algorithm in itself that would have standalone performance.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is implicitly defined by engineering standards for tensile strength and material properties.
• Biocompatibility: Ground truth is established by the accepted international standard ISO 10993 series.
• Sterilization: Ground truth is defined by the accepted international standard ISO 17665-1:2006 and a target SAL of 10^-6.
• Pyrogenicity: Ground truth is defined by AAMI ANSI ST72:2019 and USP allowed limits for endotoxins.
• Software V&V: Ground truth is established by pre-defined software requirements, specifications, and risk assessment outcomes.
• Clinical Performance (Pediatric): Ground truth for the safety and effectiveness in pediatric applications is based on peer-reviewed clinical literature and FDA guidance on pediatric medical devices, interpreted through a risk assessment. This is a form of outcomes data and expert consensus derived from previous studies, rather than a new "ground truth" adjudicated for this submission.

8. The Sample Size for the Training Set

• This question is not applicable to an implantable device like KLS Martin IPS Distraction. "Training set" usually refers to data used to train a machine learning algorithm.
• For the patient-specific design, the "training" data is the individual patient's CT scan. Each device's design is unique to the patient's anatomy. The "training" for the process comes from accumulated experience, validated software, and adherence to design specifications described in the section about patient-specific manufacturing.

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

• This question is not applicable for the reasons stated above. For the individual patient design process, the "ground truth" (the patient's anatomy for which the device is being designed) is established directly from the patient's CT scan data. The "virtual planning" involves interactions between the physician and trained KLS Martin personnel to refine the design, with "verification" performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure adequate fit.

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The KLS Martin LSS Plating System is to be used in conjunction with sternal closure wire for use in primary or secondary closure/repair of the sternum following sternotomy and is intended to reinforce the sternal halves and distribute wire tension.

The KLS Martin LSS Plating System includes plates and screws that are intended to be used in conjunction with stainless steel suture wire for midline sternal closure. The LSS plates, where applied, are used to reinforce the sternal halves and mitigate the chance of sternal wire pulling through bone. The plates are manufactured from PEEK and offered in one size. The thickness of each plate ranges from 2.1 mm – 2.5 mm (minimum – maximum dimensions) and are fixated using 2.3mm titanium screws. Once the sternum is reapproximated, the midline is closed using circumferentially wrapped stainless steel suture wires. Emergent re-entry is accomplished by cutting the stainless steel suture wire.

This document is a 510(k) premarket notification for the KLS Martin LSS Plating System, a medical device for sternal closure. The document states that clinical testing was not necessary to support substantial equivalence (page 4). Therefore, the information typically requested regarding acceptance criteria based on clinical studies, sample sizes, expert involvement, and ground truth establishment is not available in this filing.

However, the document does describe non-clinical mechanical testing performed to demonstrate that the device met performance standards. Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria", I will extract the information related to the mechanical testing, which serves as the "study" in this case for demonstrating safety and effectiveness for substantial equivalence.

Here's a summary of the non-clinical testing:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document doesn't explicitly state numerical acceptance criteria values. The implied acceptance criterion for each test is to perform "equivalently or better" than the predicate devices or to demonstrate acceptable mechanical behavior for its intended use.

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 exact number of samples (e.g., number of plates or screws) used for each mechanical test. It mentions "various apparatus set-ups" and "a series of tensile tests."
• Data Provenance: Not applicable in the context of mechanical, non-clinical testing. This was laboratory testing, not human-subject data.

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

• Not applicable. This was non-clinical mechanical testing.

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

• Not applicable. This was non-clinical mechanical 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:

• No. This was non-clinical mechanical testing of a physical device, not an AI-assisted diagnostic device.

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

• No. This was non-clinical mechanical testing of a physical device.

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

• Ground Truth: For mechanical testing, the "ground truth" is established by engineering principles, accepted testing standards, and comparison with the known performance of legally marketed predicate devices, as well as general expectations for structural integrity and durability.

8. The sample size for the training set:

• Not applicable. This was non-clinical mechanical testing, not a machine learning study.

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

• Not applicable. This was non-clinical mechanical testing, not a machine learning study.

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The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
The purpose of this premarket notification is to offer the implants sterile.

This document is a 510(k) premarket notification for the KLS Martin L.P. Patient Contoured Implant - PEEK (PCI-PEEK). However, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Patient Contoured Mesh - PEEK (PCM-P) [K072707]). This means the submission argues that the new device is as safe and effective as the predicate device because it shares similar characteristics and intended use.

Here's a breakdown of the information provided, specifically addressing your request:

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

• Not provided. This document does not specify performance acceptance criteria in terms of metrics like accuracy, reliability, or specific functional outputs. The focus is on demonstrating equivalence in design, materials, and intended use.

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 for performance testing. There is no "test set" in the context of typical AI/software performance evaluation. The substantial equivalence argument relies on comparing the characteristics of the new device to the predicate.
• Biocompatibility testing: The document mentions LAL endotoxin testing. While a "sample size" isn't explicitly stated for this, it's typically performed on batches of devices. Data provenance is not specified beyond "LAL endotoxin testing demonstrates...".

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. There is no "test set" requiring ground truth established by experts for performance evaluation in this type of submission.

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

• Not applicable. See point 3.

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 implant, not an AI or software device. Therefore, no MRMC study or AI-related effectiveness study was conducted or is applicable.

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

• No. This is a hardware implant, not an algorithm.

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

• Not applicable. See point 3. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate device, and the biocompatibility of the material.

8. The sample size for the training set

• Not applicable. This is a hardware implant, not an AI/machine learning model that requires a training set.

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

• Not applicable. See point 8.

Information provided related to "acceptance criteria" and "study" (in the context of substantial equivalence):

The document primarily discusses biocompatibility testing as the relevant "study" for the new device.

• Biocompatibility Testing:

  • The evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
  • The patient-contacting material (PEEK) is the same as the predicate device (K072707), with identical chemical composition, manufacturing processes, and permanent body contact duration.
  • Specific performance finding: LAL endotoxin testing demonstrated that the sterile PEEK implant conforms to the required < 2.15 EU/device endotoxin lot release specification. This is the closest thing to an "acceptance criterion" and "reported performance" for the sterile aspect of the device.

• Clinical Studies:

  • "Clinical testing was not necessary for the determination of substantial equivalence." This explicitly states that no clinical studies were performed for this submission.

Conclusion from the document:

The KLS Martin L.P. Patient Contoured Implant - PEEK (PCI-PEEK) is deemed substantially equivalent to its predicate because it has the same intended use, design, function, and material composition. The only difference is that the new device will be offered in sterile packaging. The manufacturer argues that these similarities do not raise new safety or effectiveness issues.

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The RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.

The RxG Distraction System consists of implantable devices used to lengthen or increase the dimension of cranial bones through distraction osteogenesis. It is composed of multiple sizes and shapes of RxG footplates and a threaded drive screw connected to an activation arm. The device is positioned internally with the connected activation arm extending through the soft tissue for external activation. The RxG footplates are secured to the bone on either side of the osteotomy with SonicPins RxG. Distraction is achieved by turning the activation arm with the patient activation driver, causing the plates to separate. Various lengths of drive screws are available to achieve up to 40 mm of distraction. Upon completion of distraction and consolidation of the bone, the drive screw is detached from the RxG footplates and removed, while the RxG footplates and SonicPins RxG remain implanted and are resorbed in 12-14 months.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document only describes non-clinical testing.

• Performance Bench: The test involved comparing the RxG distractor to the LactoSorb distractor. The sample size for this comparative mechanical testing is not specified in the provided text.
• Data Provenance: The tests are described as non-clinical (bench testing), so there's no patient data or country of origin to report.

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

Not applicable. The tests are non-clinical (bench testing) and do not involve human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests are non-clinical (bench testing) and do not involve human 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 device is a medical implant system, not an AI-powered diagnostic tool. No MRMC study was performed.

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

Not applicable. This device is a medical implant system, not an algorithm. No standalone performance study (in the context of AI) was done.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was based on:

• Performance Bench: Direct measurements of deformation and distraction distance during simulated osteotomy in a controlled laboratory setting.
• Biocompatibility: Adherence to FDA-recognized international standards (ISO 10993).
• Sterility: Adherence to international standards for sterilization validation (ISO 11137, ISO 11737).
• Packaging & Shelf-Life: Adherence to international standards for packaging integrity (ISO 11607) and real-time stability testing.

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant system, not an AI model that requires a training set.

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

Not applicable. This device is a medical implant system, not an AI model.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The KLS-Martin RxG Distraction System demonstrated substantial equivalence through a series of non-clinical laboratory tests. These tests compared the subject device to its primary predicate (LactoSorb Distraction, K002083) and referenced other cleared devices (RxG Distraction System, K133304; Resorb-X G, K121606) to demonstrate that the new device does not raise new issues of safety or effectiveness.

The key studies and their findings were:

• Performance Bench Testing: Comparative mechanical testing was conducted between the RxG distractor and the LactoSorb distractor. The devices were affixed to sawbone blocks, simulating an osteotomy, and placed in a Ringer's solution waterbath. After a 48-hour latency period, distraction and consolidation were simulated over 52 days, with deformation measurements taken at regular intervals. The RxG Distraction System met the acceptance criterion by exhibiting less deformation and achieving greater distraction distance than the predicate device.
• Biocompatibility Testing: The biocompatibility of the materials (Resorb xG, Ti-6Al-4V, and Stainless Steel) was assessed according to FDA Blue Book Memorandum #G95-1, encompassing toxicology, cytotoxicity, and chemical analysis. The materials in the subject device were deemed to have met biocompatibility requirements as they are identical to those previously cleared in reference devices, with the same chemical composition, manufacturing processes, body contact, and sterilization methods.
• Sterility Testing: Validation of the gamma sterilization process was performed in accordance with ISO 11137-1, -2, and ISO 11737-1, -2. The tests included bioburden assessment and dose verification. The sterilization methods achieved an SAL of 10⁻⁶, meeting the acceptance criteria.
• Packaging & Shelf-Life Testing: Validation of package integrity was conducted per ISO 11607-1, -2, and real-time stability testing was performed for the Resorb xG implants. The packaging and shelf-life were found to be identical to a reference device, confirming its suitability for sterilization and maintenance of sterility for a 5-year shelf life.

Clinical testing was explicitly stated as "not necessary for the determination of substantial equivalence." This indicates that the non-clinical data was considered sufficient by the FDA to demonstrate that the RxG Distraction System is as safe and effective as existing legally marketed devices.

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

The LINOS MOH Hand Plating System consists of plates of various shapes and thicknesses for bone fixation. Plate features include a low profile with angulated-locking threaded screw holes. The system also includes locking and non-locking screws of various lengths and diameters and the necessary instruments to facilitate placement of the implants. The purpose of the Special 510(k) submission is to gain marketing clearance for modifications to the existing plates and screws in the previously cleared KLS Martin Hand Plating System.

Here's a breakdown of the acceptance criteria and the study details for the LINOS MOH Hand Plating System, based on the provided documents:

The provided documents describe a Special 510(k) submission for the LINOS MOH Hand Plating System, where the device is considered substantially equivalent to a previously cleared predicate device (KLS Martin Hand Plating System, K040598). This type of submission focuses on demonstrating equivalence to an existing device rather than proving de novo performance against a new set of clinical acceptance criteria. Therefore, the "acceptance criteria" discussed here relate to the device meeting performance requirements comparable to its predicate, rather than independently established goals for a new kind of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The documents do not specify a "test set" in the context of clinical data. The evaluation was primarily based on nonclinical mechanical testing and comparison of technological characteristics to a predicate device.
• Data Provenance: The nonclinical mechanical testing was performed in accordance with ASTM (American Society for Testing and Materials) standards. The results from these tests are generally from laboratory settings, not patient data. No "country of origin of the data" or "retrospective/prospective" study design is applicable as this was not a human clinical study.

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

• This information is not applicable as there was no clinical test set requiring expert ground truth or human readers. The evaluation was based on engineering and performance specifications and comparison to a predicate device.

4. Adjudication Method for the Test Set

• This information is not applicable as there was no clinical test set requiring adjudication.

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

• No MRMC comparative effectiveness study was done. This submission is for a medical implant (bone plating system) and its modifications, not a diagnostic imaging or AI-assisted device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

• No standalone algorithm performance study was done. This device is a physical medical implant, not an algorithm or software-based device.

7. Type of Ground Truth Used

• The "ground truth" for the nonclinical testing was defined by the performance requirements outlined in ASTM F382-99 and ASTM F543-13, demonstrating that the device meets safety and efficacy standards by performing comparably to the predicate device under mechanical stress. For the substantial equivalence claim, the ground truth was the established characteristics and performance of the legally marketed predicate device.

8. Sample Size for the Training Set

• This information is not applicable. "Training set" typically refers to data used to train machine learning models. This submission is for a physical medical device, not an AI/ML product.

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

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

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The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0 mm to 3.0 mm and screw diameter ranges from 2.3 mm to 3.2 mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stabilized fixation. The device has a three position screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.

The KLS Martin Recon Talon is a bone fixation appliance intended for stabilization and fixation of anterior chest wall fractures, including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implied by the reporting structure of the performance testing results. For instance, for fatigue testing, "no device failures" is the explicit outcome that validates the device meets an inherent requirement for durability. Similarly, for system testing, the phrase "method of failure in all system testing was either pullout at the screw/Sawbone interface or Sawbone failure. No device failures were noted in system testing" indicates that the device itself did not fail, meeting the intended performance.

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

• Sample Size: Not explicitly stated for each test. The wording "individual Recon Talons" for fatigue and tensile tests, and "Sawbones" for system testing, suggests multiple units/specimens were used, but the exact number isn't quantified.
• Data Provenance: The studies were conducted by KLS Martin, L.P. The type of study is prospective, laboratory-based physical testing of the device. The data is from in-vitro testing using mechanical forces and Sawbones, not from human or animal subjects, so country of origin of patient data is not applicable.

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

• Not applicable. The "ground truth" for this device is based on engineering performance specifications and objective physical measurements rather than expert interpretation of medical images or clinical outcomes. The tests evaluate the mechanical integrity and strength of the device itself.

4. Adjudication Method for the Test Set

• Not applicable. This involves objective physical testing with measurable outcomes (e.g., force at failure, number of cycles without failure), which typically does not require expert adjudication in the same way clinical data or image interpretation would.

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

• No. This type of study (MRMC) is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images with or without AI assistance). The Recon Talon is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not human reader interpretation.

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

• Yes, effectively. The performance testing described (fatigue, tensile, system testing) evaluates the device's inherent mechanical properties and behavior directly, without human intervention during the test itself. While humans set up and observe the tests, the performance criteria are machine-measured and objective.

7. The Type of Ground Truth Used

• The ground truth is based on engineering specifications and established mechanical testing protocols. For example, "no device failures after 5 million cycles" is the ground truth for fatigue performance. "Maximum load was 1.06 kN" is the ground truth for tensile strength. These are objective, quantitative measures of the physical device's performance.

8. The Sample Size for the Training Set

• Not applicable. The Recon Talon is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing processes are iterative but do not involve 'training' in this sense.

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

• Not applicable. As a physical medical device, the concept of a training set and its associated ground truth establishment does not apply. Performance is validated through the tests described in point 1.

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The Drill Free MMF Screw is intended for use in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both.

The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture.

I am sorry but this document does not contain the information you are requesting. This document is a 510(k) summary for a medical device called "Drill Free MMF Screw". It focuses on establishing substantial equivalence to previously marketed predicate devices, rather than detailing a specific study with acceptance criteria and performance metrics in the way you described.

Specifically, the document primarily discusses:

• Intended Use: Maxillomandibular fixation for stabilization of fractures.
• Technological Characteristics: Similarities and differences to predicate devices (mainly material composition).
• Substantial Equivalence: Arguing that the new device is equivalent to existing ones based on intended use, manufacturing, quality systems, and material.

It does not include information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot extract the information requested from the provided text.

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KLS Martin Xternal Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

The KLS Martin Xternal Fixator consists of 3.2mm titanium pins in various lengths that are fixated to the bone. The titanium pins are held in place with titanium pin clamps and a 4mm titanium rod or can be held in place with an acrylic bar and titanium screw caps.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the KLS Martin Xternal Fixator, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and study results in the manner you've requested.

Therefore, I cannot fulfill your request for the following information based on the input:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This document primarily describes the device, its intended use, and its similarities and differences to predicate devices to establish substantial equivalence for regulatory clearance. It does not include specific performance studies or acceptance criteria typically found for diagnostic or AI-driven devices.

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