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The eLIBRA® Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.

The device consists of two units, the force sensing unit and an electronic display. The eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee Replacement is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The eLIBRA Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Force Sensing Unit. The unit displays a number from 0-19 for both the for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). Each number is equivalent to 0.5 pounds of force.

The provided 510(k) summary for the eLibra® Uni Soft Tissue Force Sensor (K093046) describes the device, its intended use, and claims substantial equivalence to a predicate device (K070108 eLibra Dynamic Knee Balancer). However, it does not contain the detailed performance study information typically required to fully answer all aspects of your request regarding acceptance criteria and a study demonstrating performance against those criteria.

The summary states: "Performance: Both bench and test laboratory testing was performed. Bench testing included mechanical testing, radio frequency, and sterility testing, including EO residues. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

This statement indicates that performance testing was conducted, but it does not provide specific acceptance criteria, reported performance metrics, sample sizes, ground truth establishment, or details about the study design (e.g., MRMC, standalone). The focus of the summary is on demonstrating substantial equivalence rather than presenting detailed performance validation against specific, quantified acceptance criteria.

Therefore, for many of your questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• Note: The document states that "Each number [displayed on the unit] is equivalent to 0.5 pounds of force." This is a functional specification, but not an acceptance criterion against which performance was directly measured and reported in terms of accuracy or precision.

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

• Not specified. The document mentions "bench and test laboratory testing" but does not give sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

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

• Not specified. The document does not describe any study involving human experts establishing ground truth for a test set. The validation seems to be primarily through engineering and comparative testing.

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

• Not applicable/Not specified. This type of adjudication method is typically used in clinical studies with human readers interpreting data, which is not described 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

• No. An MRMC study was not described, nor is this device an "AI" device in the conventional sense (it's a force sensor and display). The device directly aids the surgeon with a display of force, not by processing complex imaging or clinical data.

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

• Not applicable/Not explicitly detailed as such. The device itself is designed to provide real-time information to a surgeon. The "performance" described is the device's ability to measure and display force. Bench testing would inherently be "standalone" in that it tests the device's intrinsic functions, but the details are not provided.

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

• Not explicitly stated. For mechanical and RF testing, ground truth would likely be established using calibrated reference instruments (e.g., highly accurate force gauges, RF measurement equipment). For "sterility testing," the ground truth would be the absence of viable microorganisms as per validated sterilization methods.

8. The sample size for the training set

• Not applicable/Not specified. This device does not appear to be an AI/machine learning device that requires a "training set." It's a sensor and display unit.

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

• Not applicable. As above, a training set is not relevant for this type of device.

In summary, the 510(k) process for this device focused on demonstrating substantial equivalence through bench and laboratory testing without providing detailed quantitative performance metrics or descriptions of clinical studies in the summary document. The information provided is insufficient to answer most of your detailed questions about acceptance criteria and study particulars.

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For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.

The device consists of two units, the force sensing unit and an electronic display. The eLIBRATM Force Sensing Tibial Unit is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The electronic signal represents the relative medial and lateral compartment forces generated from the soft tissue structures surrounding the knee joint during a total knee arthroplasty (TKA). The LIBRA Dynamic Knee Balancer eLIBRATM Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRATM Force Sensing Tibial Unit. The unit displays a number from 0-19 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).

The provided text describes the eLibra Dynamic Knee Balancer, an orthopedic manual surgical instrument used in total knee arthroplasty (TKA). It outlines the device's description, intended use, and technological characteristics. However, it does not contain specific acceptance criteria, detailed performance metrics, or a comprehensive study plan with the information requested.

Here's an analysis of what can be extracted and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the provided text. The submission mentions "results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices," but this is a general statement, not quantified acceptance criteria.
• Reported Device Performance:
  • Bench Testing: Included "mechanical testing, radio frequency, and sterility testing, including EO residues." The results were deemed "satisfactory."
  • Clinical Testing: Performed to determine "adequacy of instructions for use, the range of patient population, performance characteristics, and reliability." The results were "satisfactory."
  • Conclusion: "The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."

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

• Sample Size for Test Set: Not specified. The text only mentions "clinical tests were performed" without detailing the number of patients or cases.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only states "clinical testing was performed."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It only mentions aiding "the surgeon in balancing soft tissue structures."

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

• Not specified.

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: Not applicable. The device is a force-sensing instrument for surgical assistance, not an imaging or diagnostic AI tool that would involve human readers.
• Effect Size: N/A.

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

• Not applicable in the typical sense for an AI algorithm. The device itself (eLibra Dynamic Knee Balancer) provides a direct reading (numbers 0-19) for the surgeon to interpret and act upon. It's an instrument providing information to a human operator, not a standalone diagnostic or assistive AI system. Its "standalone" performance would be its accuracy and reliability in measuring force and displaying it. However, no specific details on this are provided beyond "satisfactory."

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

• Ground Truth: Not explicitly stated or defined. For a force-sensing device, the "ground truth" would likely involve comparison to established methods or calibrated force measurement systems in bench testing, and potentially clinical outcomes or successful soft tissue balancing assessed intra-operatively by surgeons in clinical testing. However, the document does not specify how this "ground truth" was established or measured for the clinical tests.

8. The sample size for the training set

• Not applicable. The device is a hardware instrument with a display, not a machine learning model that undergoes a "training set" in the context of AI.

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

• Not applicable (see point 8).

Summary of Missing Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as well as general safety and effectiveness through satisfactory bench and clinical testing. It lacks detailed quantitative performance data, specific acceptance criteria, sample sizes for testing, and methodologies for ground truth establishment or expert involvement, which are typically found in more comprehensive study reports for AI/diagnostic devices. This is common for predicate-based medical devices that are not complex AI systems.

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Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.

The subject devices (surgical burs and surgical drill bits) are stainless steel and/or tungsten carbide devices which may be coated with abrasion resistant coatings in order to increase cutting efficiency. They will be supplied as both sterile and non-sterile devices and will be labeled for single use.

The provided text is a 510(k) summary for surgical burs and surgical drill bits. It discusses the device's description, intended use, and substantial equivalence to legally marketed predicate devices. However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Specifically, the document states: "Safety and Effectiveness Testing: All materials used in the surgical bur and surgical drill bit devices conform with industry specifications for medical device use. Material specifications are tested on a design basis." This indicates that safety and effectiveness were assessed through material specification conformity and design-based testing, but it does not provide any quantitative results, specific acceptance criteria, or details of a study that would allow for the completion of the requested table and sections.

Therefore, I cannot provide the requested information from the given text.

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The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.

This document, K961522, is a 510(k) summary for Kirschner Wires (K-Wires) and Steinmann Pins. It describes the product, its intended use, and claims substantial equivalence to predicate devices.

However, the provided text DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details related to AI/algorithm performance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily a regulatory submission for a medical device and lacks the scientific study details you are asking for.

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