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The Pectus Blu system is indicated for the treatment of Pectus Excavatum and other sternal deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The Pectus Blu Support Bar and Stabilizers (including Pectus Blu TruLink™ Stabilizers) are surgical implants intended to aid treatment of Pectus Excavatum deformity in adults and pediatric patients (children and adolescents) for which the rib cage across the sternum measures 7 inches (17.78 centimeters) or larger. The Pectus Blu Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient. These devices are offered in a generic pre-bent shape that can be further shaped intraoperatively. These devices are intended to be used in professional healthcare facilities.

This FDA 510(k) summary (K241709) describes the Pectus Blu Support Bar System, which is indicated for the treatment of Pectus Excavatum and other sternal deformities in pediatric and adult populations. The submission is for a line extension to the previously cleared Pectus Blu Support Bar System (K212841), with the addition of Pectus Blu TruLink™ Stabilizers. As such, the FDA has determined substantial equivalence based on a comparison to the predicate device, rather than requiring a new clinical study with specific acceptance criteria related to disease detection or diagnosis.

Here's an analysis of your questions based on the provided document:

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

Based on the provided FDA 510(k) summary, specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for the device are not applicable and not provided. The device is a surgical implant, not a diagnostic tool. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs as intended and is as safe and effective as the already cleared device.

The performance data mentioned (in section 8) refers to Verification and Validation attachments, which would typically include engineering tests, biocompatibility tests, mechanical strength tests, and other non-clinical performance characteristics to ensure the device meets its design specifications and performs as intended. These are not diagnostic accuracy metrics.

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

This information is not applicable and not provided in the FDA 510(k) summary. Since this is a submission for a surgical implant and not a diagnostic AI device, there isn't a "test set" in the context of diagnostic performance evaluation. The "performance data" refers to non-clinical testing of the device's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" in the context of expert review for a diagnostic test set is irrelevant for a surgical implant.

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

This information is not applicable and not provided. Adjudication methods are used in diagnostic studies to resolve discrepancies among expert readers, which is not relevant here.

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 and not provided. MRMC studies are conducted to evaluate the performance of diagnostic devices, particularly those involving AI assistance for human readers. This device is a surgical implant, not a diagnostic tool with AI assistance.

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

This information is not applicable and not provided. "Standalone" performance refers to the performance of a diagnostic algorithm without human intervention. This device is a physical surgical implant.

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

This information is not applicable and not provided. "Ground truth" typically refers to a definitive diagnosis or condition used to evaluate a diagnostic test. For a surgical implant, the "truth" is whether the device functions as intended, is biocompatible, and structurally sound, which is assessed through non-clinical testing and clinical experience (though a new clinical study wasn't required for this 510(k)).

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used in the development of AI algorithms. This device is a physical surgical implant.

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

This information is not applicable and not provided. This question is pertinent to AI algorithm development, which is not the subject of this 510(k) submission.

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The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Biomet Microfixation Twist Drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.

The provided text describes the submission of a medical device (2.1 x 255mm Drill, 22mm Stop) for FDA clearance. It details the performance testing conducted, but it does not represent a study involving AI, human readers, or ground truth establishment in the context of medical image analysis or similar diagnostic applications. Instead, it refers to the physical characteristics and usability of a surgical drill.

Therefore, many of the requested categories (e.g., sample size for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth) are not applicable to this type of device and the information provided.

However, I can extract the relevant information regarding the device's acceptance criteria and the study performed for its clearance.

Acceptance Criteria and Device Performance

Study Details (as applicable to a physical surgical instrument)

1. Sample size used for the test set and the data provenance: Not applicable. For the tolerance analysis, dimensional measurements of the drill were compared against the specified dimensions of neurosurgical stereotactic placement devices. For usability, a group of users (not specified in number) would have participated in the summative usability evaluation.

   • Provenance: Not specified, but likely conducted by the manufacturer or a contracted lab.
   • Retrospective/Prospective: The usability evaluation would have been prospective, while the tolerance analysis is a form of design verification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of establishing "ground truth" as it relates to diagnostic accuracy. For usability testing, healthcare professionals (e.g., neurosurgeons, surgical technicians) would have been involved, but their number and specific qualifications are not detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device. Usability testing typically involves observing user interactions and collecting feedback against predetermined criteria.

4. 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 study concerns the physical characteristics and usability of a surgical drill, not AI software or diagnostic image interpretation.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual surgical tool and does not involve an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in a diagnostic sense is not relevant here. The ground for the tolerance analysis was the dimensional specifications for compatibility, and for usability, it was the safe and effective operation of the device by users according to predefined usability criteria.

7. The sample size for the training set: Not applicable. No training set as this is not a machine learning model.

8. How the ground truth for the training set was established: Not applicable. No training set.

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The Biomet Microfixation SternaLock® System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation SternaLock® System is intended for use in patients with normal and poor bone quality.

The Biomet Microfixation SternaLock® System is composed of metallic locking bone plates and locking screws that provide stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

The provided text is a 510(k) summary for the Biomet Microfixation SternaLock® System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of medical device submission (AI/ML device evaluation) and not a mechanical fixation system.

However, I can extract information related to non-clinical testing performed and acceptance criteria met for the mechanical device:

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

2. Sample size used for the test set and the data provenance: Not applicable. The document states "Non-Clinical Performance Data: The following non-clinical testing has been performed and met all established acceptance criteria: Magnetic Resonance Testing per ASTM F2182-11." This is likely referring to a materials compatibility test, not a diagnostic accuracy study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the type of study described here.

4. Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. This device is a mechanical fixation system, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For the Magnetic Resonance Testing, the ground truth would be established by the specifications of the ASTM F2182-11 standard itself, which defines the acceptable magnetic properties of the material. There isn't a "ground truth" in the sense of a medical diagnosis.

8. The sample size for the training set: Not applicable. This document describes non-clinical testing for a device, not the training of an AI model.

9. How the ground truth for the training set was established: Not applicable.

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The Biomet Microfixation RibFix Blu Thoracic Fixation System is in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, rib fractures associated with flail chest, or planned osteotomies. The system may be used in normal and poor bone to promote union.

The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures and osteotomies of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

This document is a 510(k) Premarket Notification from the FDA regarding the Biomet Microfixation RibFix Blu Thoracic Fixation System. It confirms that the device is substantially equivalent to a legally marketed predicate device.

The document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of comparing device performance metrics like sensitivity, specificity, accuracy, etc.

Instead, the document focuses on demonstrating substantial equivalence through non-clinical performance data and showing that the technological characteristics are similar or do not raise new questions of safety and effectiveness compared to the predicate device.

Here's what can be extracted and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI-specific questions (2-9), this document does not refer to an AI/ML device. The Biomet Microfixation RibFix Blu Thoracic Fixation System is a physical metallic bone fixation system (plates and screws). Therefore, the following points are not applicable to this submission.

2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device.
4. Adjudication method for the test set: Not applicable, as this is not an AI/ML device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI/ML device. The "ground truth" for this device relates to its material properties and mechanical performance.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary for this specific medical device (Biomet Microfixation RibFix Blu Thoracic Fixation System):

This document describes the non-clinical testing performed to demonstrate that a physical medical device (bone fixation system) meets established acceptance criteria for mechanical performance and MR compatibility. It does not involve any AI/ML components, clinical trials, or the use of experts for ground truth in the context of diagnostic interpretation. The acceptance criteria are based on recognized standards (like ASTM F2182-11 for MR testing) and mechanical engineering principles.

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This device is intended for use in surgical procedures to repair Pectus Excavatum. It is intended to be used in pediatric (children and adolescents) populations.

The Pectus Support Bar and stabilizers are surgical implants intended to aid treatment of Pectus Excavatum deformity. The Pectus Support Bar provides the surgeon with a means to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shape deformity. The device should be removed when remodeling is evident. These devices are offered as flat (unbent) bars requiring intraoperative shaping, or alternatively may be prebent to patient anatomy. These devices are intended to be used in professional healthcare facilities.

The Pectus Support Bar are made of titanium alloy (ASTM F1472) or stainless steel (ASTM F138). The Pectus Stabilizers are made of stainless steel (ASTM F138) or titanium alloy (ASTM F136). The Pectus Support Bar system is provided non-sterilization by the end user.

The provided text is a 510(k) summary for a medical device called the "Pectus Support Bar System." This document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about AI/ML device performance, acceptance criteria, or a study proving it meets those criteria, as it's a structural implant and not an AI/ML diagnostic or prognostic device.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details as an AI/ML device. The document explicitly states:

• "Clinical data was not required for the determination of substantial equivalence."
• The performance testing described is focused on material properties, mechanical strength, MR compatibility, and biocompatibility, as relevant for an implantable device, not AI/ML performance.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the requested information.

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Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

This FDA 510(k) summary is for a medical device (Twist Drills), not an AI/ML algorithm. Therefore, many of the requested categories related to algorithm performance, training data, and expert review are not applicable.

Here's an analysis of the provided document based on the available information:

This document describes the FDA's decision to clear the Biomet Microfixation Twist Drills (K213208) as substantially equivalent to a predicate device (Twist Drills K062842).

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

The document states that "Design verification and validation testing were performed on the subject devices" and "The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not provided in this summary document. The performance is reported as meeting these unspecified criteria.

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

This document discusses performance testing for a physical medical device, not a data-driven AI/ML algorithm. Therefore, terms like "test set" and "data provenance" in the context of data analysis are not directly applicable. The document refers to "design verification and validation testing," which would involve physical samples of the drill. The sample size for these physical tests is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

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

This is not applicable for a physical medical device without a diagnostic component.

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 is not applicable as the document describes a physical medical device, not an AI-assisted diagnostic tool.

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

This is not applicable as the document describes a physical medical device.

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

For a physical medical device like a drill, "ground truth" generally refers to objective physical and mechanical properties. The validation would typically involve comparing the device's performance against predefined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. The document generally refers to "predetermined acceptance criteria" and "design verification and validation tests."

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as the document describes a physical medical device.

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The Biomet Microfixation OmniMax MMF System is indication of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks.

The OmniMax MMF system includes a fixation plate (also known as an arch bar) that has an in-plane bend to provide an initial approximation of mandibular and maxillary anatomy. The plate also features slots for locking screw fixation. These slots allow for a maximum of 12 fixation points in the bone as well as screw placement variation within the slot to avoid tooth roots. The OmniMax locking screws are 2.0mm in diameter and vary in length from 7mm to 11mm. The screw head also features a low-profile design to minimize irritation and palpability.

The document provides information about the Biomet Microfixation OmniMax MMF System, specifically for its 510(k) submission, K202969. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with diagnostic AI/ML device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, the non-clinical performance data section focuses on validation testing for the cleaning process and biocompatibility assessment as the primary acceptance criteria for this specific submission, which seems to be an update or modification rather than a completely new device that requires extensive clinical performance evaluation.

Here's a breakdown of the information available based on your request, highlighting what is present and what is explicitly stated as not necessary or not evaluated:

Acceptance Criteria and Device Performance

Study Details (Based on the provided document)

Since the submission primarily focuses on updates to the cleaning process and biocompatibility, and explicitly states that clinical testing was not necessary for substantial equivalence, many of the typical elements of a clinical performance study (like those involving AI/ML devices) are not applicable or not provided in this document.

1. Sample size used for the test set and the data provenance: This information is not provided as there wasn't a clinical performance study in the traditional sense for diagnostic accuracy. The "test set" here refers to the materials and controls used for cleaning validation and biocompatibility testing. The document does not specify their origins.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.

4. 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 is not applicable. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This is not an algorithm-based device.

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

   • For Cleaning Validation: The ground truth is established by the ability to meet the acceptance criteria derived from FDA guidance documents and industry standards for sterility/cleaning.
   • For Biocompatibility: The ground truth is established by meeting acceptance criteria based on ISO 10993-1 standards and predicate device performance, often involving laboratory tests for material safety and biological responses.

7. The sample size for the training set: This information is not provided as there was no AI/ML training set.

8. How the ground truth for the training set was established: This information is not applicable as there was no AI/ML training set.

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The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc) and accessories during general diagnostic procedures. The device is also intended to hold endoscopes during diagnostic and therapeutic neurologic procedures.

The WalterLorenz Surgical Assist Arm Scope Holder is a manually operated surgical instrument intended to hold scopes (such as endoscopes, etc) in a desired position during diagnostic, therapeutic, and surgical procedures (including neurologic procedures). The holder is manufactured from Stainless Steel and functions by the user manually tightening or loosening a knob, which opens and closes around a surgical scope. The device is intended to attach to the WalterLorenz Surgical Assist Arm, which is a Class 1, table-mounted, electromechanical holding arm that has many general surgical functions in addition to scope holding; it can also be used for instrument holding, retraction, and positioning.

This document is a 510(k) premarket notification for a medical device called the "WalterLorenz Surgical Assist Arm Scope Holder." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials. As such, the document explicitly states that "Clinical testing was not necessary for the determination of substantial equivalence."

Therefore, the following information, typically found in studies proving device effectiveness, is not applicable to this 510(k) submission:

• A table of acceptance criteria and the reported device performance: This submission relies on substantial equivalence to predicate devices based on non-clinical performance data and similar indications for use, not on specific performance metrics against pre-defined acceptance criteria from a clinical study.
• Sample size used for the test set and the data provenance: Clinical testing was not performed; hence, there is no test set or related data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no test set requiring ground truth establishment.
• Adjudication method for the test set: Not applicable as there was no test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical surgical assist arm, not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a mechanical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there were no clinical studies generating such data.
• The sample size for the training set: Not applicable as this is a mechanical device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable as this is a mechanical device, not an AI/ML algorithm.

However, the document does contain information about non-clinical performance data and acceptance criteria in a broader sense related to safety and effectiveness for substantial equivalence:

Acceptance Criteria and Device Performance (Non-Clinical):

The submission states: "Non-clinical testing met all established acceptance criteria." While the specific acceptance criteria and detailed performance metrics are not explicitly presented in this summary document, the FDA's clearance implies that the sponsor provided sufficient non-clinical data to demonstrate that the device performs as intended and is as safe and effective as the predicate devices. The non-clinical tests would typically address aspects like:

• Mechanical Integrity/Durability: Ability to securely hold scopes and accessories, withstand repeated use, and resist forces encountered during surgical procedures.
• Compatibility: Ability to attach to the WalterLorenz Surgical Assist Arm and hold a range of scope diameters.
• Sterilization Effectiveness: Validation that the recommended sterilization method (steam sterilization) is effective for the reusable device.
• Material Biocompatibility: Assurance that the stainless steel material is suitable for medical devices and does not pose undue risks.

Key Information from the Document:

• Device Name: WalterLorenz Surgical Assist Arm Scope Holder
• Indications for Use: The device is a manually operated surgical device intended to hold scopes (such as endoscopes, arthroscopes, etc.) and accessories during general diagnostic and therapeutic procedures, including neurologic procedures.
• Predicate Devices:
  • Primary Predicate: K990334, KSEA (Karl Storz) Endoscope Holder
  • Secondary Predicate: K070509, Fisso Holding Arm
• Similarities to Predicate Devices (basis for substantial equivalence):
  • Similar indications for use.
  • Similar range of scope diameters accepted.
  • Identical sterility (provided non-sterile, to be steam sterilized by end-user).
  • Similar material (Stainless Steel).
• Non-Clinical Performance Data: "Non-clinical testing met all established acceptance criteria." (Specific details of these tests and criteria are not in this summary, but would have been submitted to the FDA).
• Clinical Performance Data: "Clinical testing was not necessary for the determination of substantial equivalence."
• Training Set (for AI/ML): Not applicable for this mechanical device.

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The Biomet Microfixation RibFix Blu Thoracic Fixation System is indicated for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system may be used in normal and poor bone to promote union.

The Biomet Microfixation RibFix Blu Thoracic Fixation System is composed of metallic locking bone plates and locking screws that provide rigid fixation to fractures of the chest wall. These implants are available in multiple sizes and manufactured from Commercially Pure Titanium and Titanium Alloy (Ti-6Al-4V).

This document is a 510(k) Premarket Notification from the FDA for the Biomet Microfixation RibFix Blu Thoracic Fixation System. It grants substantial equivalence to a previously cleared device. As such, it does not contain the detailed study information typically found when a novel device is being introduced and rigorous performance criteria need to be established and proven.

Here's why the requested information cannot be fully provided:

• No new acceptance criteria or study: The document explicitly states: "Non-clinical testing was not necessary for the determination of substantial equivalence." and "Clinical testing was not necessary for the determination of substantial equivalence." This means there were no new studies conducted to prove the current device meets acceptance criteria distinct from its predicate. The device is considered substantially equivalent because its indications, design, sterilization, and materials are identical to the predicate device (K152253).
• Focus on substantial equivalence: The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically means it has the same intended use and technological characteristics, or if there are differences, they do not raise new questions of safety or effectiveness.

Therefore, the requested information elements (acceptance criteria, study details, sample size, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not present in this 510(k) summary because no new performance studies were required for this specific filing.

However, based on the principle of substantial equivalence, we can infer the acceptance criteria and performance are identical to the predicate device (K152253). Since this document doesn't provide those details, I cannot create the table or answer the specific questions about the study design.

If this were a new device requiring performance demonstration, the information would typically include:

1. A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative measures (e.g., tensile strength, fatigue life, bending stiffness, biocompatibility results) with their targets and the actual measured performance from testing.
2. Sample size used for the test set and the data provenance: Details on how many devices were tested, if it was an in-vitro, ex-vivo, or in-vivo study, and where the data originated.
3. Number of experts and qualifications: If human interpretation or evaluation was involved (e.g., in a clinical study or imaging study), details about the physicians or specialists involved in assessments.
4. Adjudication method: How disagreements among experts were resolved.
5. MRMC comparative effectiveness study: Not typically applicable for hardware like fixation systems, but if comparing diagnostic performance, this would quantify improvements with AI assistance.
6. Standalone performance: The performance of the algorithm itself, without human input, if AI was involved.
7. Type of ground truth used: What was considered the definitive truth (e.g., histopathology, surgical confirmation, long-term outcomes).
8. Sample size for the training set: If machine learning was used, the size of the dataset used to train the algorithm.
9. How the ground truth for the training set was established: How accurate labels were assigned to the training data.

In summary, the provided document indicates that the Biomet Microfixation RibFix Blu Thoracic Fixation System is substantially equivalent to a previously cleared device, and thus, no new non-clinical or clinical performance data were deemed necessary for this 510(k) submission.

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The SternaLock® 360 Sternal Closure System is intended for use in the stabilization and fixation of fractures of the sternum including sternal fixation following sternotomy and sternal reconstructive procedures, to promote fusion. The system is intended for use in patients with normal and/or poor bone quality.

The Biomet Microfixation Sternal Closure System is comprised of rigid fixation and cerclage technologies to approximate the sternal halves, provide bone compression, and rigidly fixate bone in one device. The cerclage aids in distributing forces around the sternal bone as well as reducing loss of fixation due to cut-through in bone. Implantable components include a metallic plate pre-assembled to a polymer-coated metallic band; the plate is rigidly fixated to bone through locking screws. The SternaLock® 360 plates are manufactured from Commercially Pure Titanium; the band is manufactured from Commercially Pure Titanium and coated with Parylene-C; the band locking mechanism is manufactured from Titanium Alloy (Ti-6Al-4V); the locking screws are manufactured from Titanium Alloy (Ti-6A1-4V); and the needle (not implantable) is manufactured from Stainless Steel.

The provided document is a 510(k) premarket notification for the Biomet Microfixation Sternalock® 360 Sternal Closure System. It is a submission to the FDA for a medical device and not a study proving a device meets acceptance criteria. Rather, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System) rather than performing new studies against specific performance acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable in the context of this 510(k) submission.

Here's why and what information can be extracted:

• No new performance studies were conducted or required to demonstrate substantial equivalence. The document explicitly states:
  • "Non-Clinical Performance Data: Non-clinical testing was not necessary for the determination of substantial equivalence."
  • "Clinical Performance Data: Clinical testing was not necessary for the determination of substantial equivalence."

This means there's no data available in this document to populate most of your requested fields directly, as the device's performance was not re-evaluated against new acceptance criteria. The FDA's substantial equivalence determination implies that the predicate device already met established safety and effectiveness criteria, and the new device is sufficiently similar.

However, to address your request based on the spirit of the question and the available information:

1. Table of acceptance criteria and the reported device performance:

Since no new performance studies were conducted, there are no specific new acceptance criteria and reported device performance from this submission. The acceptance criteria would conceptually align with the predicate device's demonstrated safety and effectiveness.

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

• Not applicable. No new test set was used as no new non-clinical or clinical studies were performed.

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. No new ground truth for a test set was established.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• Not applicable. This device is a mechanical sternal closure system, not an AI or imaging device.

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

• Not applicable. This device is a mechanical sternal closure system, not an algorithm.

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

• Not applicable. The submission relies on the established safety and effectiveness of the predicate device as a "ground truth" for substantial equivalence rather than generating new ground truth data for this specific submission.

8. The sample size for the training set

• Not applicable. No new training set was used.

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

• Not applicable.

Summary of what the submission does state:

The changes proposed in this 510(k) were primarily to update the Package Insert to provide additional information to users. The claim for substantial equivalence rests on the following similarities to the predicate device (K151019, also the Biomet Microfixation SternaLock® 360 Sternal Closure System):

• Identical indications for use and contraindications.
• Equivalent device design.
• Equivalent sterilization method (steam sterilization).
• Equivalent materials.

The FDA concluded that "any differences in technological characteristics of the predicates do not raise any new questions of safety and efficacy and (2) the proposed devices are at least as safe and effective as the predicates."

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