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The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced.

For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use.

The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.

The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery.

The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure.

The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion.

The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.

The provided text describes the regulatory clearance for the QUADSENSE device and includes some performance data, but it does not contain the specific information requested in your prompt regarding detailed acceptance criteria, the study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, or training set details.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (VERASENSE for Zimmer Biomet Persona) for FDA clearance (K241298). It mentions several types of testing performed to ensure safety and performance, but these are general categories rather than specific performance studies with detailed outcomes against acceptance criteria.

Here's an breakdown of the information that is available and what is missing based on your request:

Information available in the document:

• 1. A table of acceptance criteria and the reported device performance: A direct table is not provided. However, some performance aspects are mentioned:

  • Applied Force of Load Sensing - Load Range and Accuracy:
    • Predicate (VERASENSE): 5-40 lbf ≤ 3.5 lbf; 41-70 lbf for reference only
    • Subject Device (QUADSENSE): Sensor is calibrated at 70 Newtons (15.7 lbf) with 10% error
  • Maximum Safe Load:
    • Predicate (VERASENSE): 70 lbf
    • Subject Device (QUADSENSE): 16.8kg (37.0 lbf)
  • Biocompatibility: Meets requirements of ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Material mediated pyrogenicity).
  • Electrical Safety: Complies with IEC 60601-1.
  • Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2.
  • Software Verification and Validation: Conducted, documentation provided as per FDA guidance.
  • Cybersecurity: Threat modeling, risk management, and mitigation measures performed.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "The QUADSENSE software application does not directly drive a decision regarding treatment or therapy." It's a "comparative tool to measure patellofemoral joint force." This implies a standalone measurement capability to provide data to the surgeon, so in that sense, its basic functionality is standalone.

• 7. The type of ground truth used: Not explicitly stated for performance validation beyond compliance with standards (e.g., electrical safety, biocompatibility). For force measurement, the "ground truth" would implicitly be the calibrated reference loads used during testing.

Information NOT available in the document:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample sizes for any performance testing, nor on data provenance (country, retrospective/prospective).
• 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 or not specified, as the device doesn't make a diagnosis but rather measures force. The "experts" would be the engineers validating the force measurement.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the nature of the device (a measurement tool, not a diagnostic imaging AI).
• 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 surgical tool that measures force, not an AI for interpreting medical images by human readers.
• 8. The sample size for the training set: The document does not describe any machine learning/AI training sets for the device.
• 9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the document demonstrates that QUADSENSE has undergone various engineering and safety tests to meet medical device standards and establish substantial equivalence. However, it does not detail a clinical performance study with defined acceptance criteria for diagnostic accuracy, nor does it describe an AI component with associated training or test data specifics as often found for AI/ML-based diagnostic devices.

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Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The surgeon in controlling leg length and offset discrepancies.

The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.

The Lantern® Hip (modified device) utilizes a palm- sized computer module and reference sensor to generate positional information in orthopedic procedures, providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

The Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies

The Lantern® Hip consists of the sterile, single-use Lantern® Hip navigation unit (packaging includes reference sensor, CR2 battery and femur sensor battery), the non-sterile reusable reference sensor, the non-sterile reusable femur sensor, and associated non-sterile reusable instrumentation. The Lantern® Hip unit is sterile unless the sterile packaging is opened or damaged.

Here's a breakdown of the acceptance criteria and study information for the Lantern® Hip device, based on the provided FDA 510(k) summary:

The provided document is a 510(k) clearance letter and summary for a device modification, not a primary submission for a novel device. Therefore, the depth of performance study details typically found in an original PMA or De Novo submission is not present. The focus here is on demonstrating substantial equivalence to a predicate device rather than exhaustive standalone performance evaluation against a set of independent acceptance criteria for a new clinical use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a Special 510(k) for a device modification, the "acceptance criteria" primarily revolve around demonstrating that the modified device is as safe, as effective, and performs as well as the existing predicate device. The document doesn't explicitly list quantitative clinical acceptance criteria like sensitivity, specificity, or accuracy targets. Instead, the acceptance criteria are met by comprehensive verification and validation testing, confirming that the changes do not adversely affect performance or safety.

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

The document describes "performance testing" and "verification and validation" but does not specify a sample size for a test set in the traditional sense of a clinical study with patient data. The testing appears to be primarily bench testing and software validation, focused on the technical performance of the device itself rather than its performance on a dataset of patient images or clinical cases.

There is no mention of patient data (e.g., retrospective or prospective, country of origin) being used for this particular submission, as the changes are related to software operating system and hardware materials, not a change in the underlying algorithms that process patient-specific data or interact with patient anatomy directly (beyond what was already established for the predicate).

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

Not applicable for this submission as it's a software and material modification. This type of information would be relevant for devices that interpret medical images or physiological signals where expert review is needed for ground truth. The testing described focuses on the device's functional integrity rather than diagnostic accuracy against a ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of expert review of cases or patient data for ground truth establishment, there is no adjudication method described.

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

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study would be relevant if the AI (or computer-assisted) component was new or significantly changed in a way that might impact a human reader's performance. The Lantern® Hip is a computer-controlled system to assist surgery, not a diagnostic AI that assists in image interpretation for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, implicitly. The "Performance Data" section states: "Device performance testing confirms that the Lantern® Hip can be used according to its intended use. The Lantern® Hip has been verified and validated according to OrthAlign's procedures for product design and development." This type of testing of a computer-controlled system for surgical assistance would primarily involve standalone algorithm performance (accuracy of measurements, positional data, calculations) within simulated or laboratory environments, independent of a human surgeon's interaction, to ensure correctness of the system's outputs.

While not explicitly called a "standalone study," the software verification and validation, and general performance testing, would assess the device's technical capabilities without a human in the loop for the core computations.

7. The Type of Ground Truth Used

The ground truth for the device's performance validation would likely be based on engineering specifications, known physical principles, and established measurement standards. For example:

• For software calculations of mechanical axes, the ground truth would be the mathematically correct axes based on defined anatomical landmarks.
• For positional accuracy, the ground truth would be established by high-precision measurement systems (e.g., optical trackers, coordinate measuring machines) to verify the device's reported positions against known physical positions.
• For material biocompatibility, the ground truth would be established by industry standards like ISO 10993.

It is not based on expert consensus, pathology, or outcomes data in this context, as those relate more to clinical diagnosis or patient treatment effectiveness, which is beyond the scope of a modification focusing on software and material changes for a surgical guidance system.

8. The Sample Size for the Training Set

Not applicable. The Lantern® Hip is a computer-controlled stereotaxic instrument that provides positional information and assists with alignment. While it uses algorithms, the document describes it as "determining reference alignment axes" and "facilitates accurate positioning." This suggests algorithms based on geometric calculations and sensor data processing rather than machine learning algorithms that require large training sets of labeled data (like for image recognition or predictive models). Therefore, a "training set" in the context of machine learning is not mentioned or implied.

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

Not applicable. As no machine learning training set is mentioned, this question is not relevant to the information provided.

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TrueBalance™ Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.

TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

TrueBalance™ Surgical System consists of seven components and one optional component:

• Electronic Module, 1.
• 2. Ultra-Thin Force Sensor,
• Multifunction Alignment Handle, 3.
• 4. Sensor Covers (8 sizes),
• 5. Alignment Rod,
• Sterilization Tray, and 6.
• 7. TrueBalance™ Software Application (TSA) and Display (iPad)
• 8. (Optional) Off-the-shelf Tablet Floor Stand for iPad

The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches.

TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.

Here's a breakdown of the acceptance criteria and study information for the TrueBalance™ Surgical System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific performance specifications for Load/Force and Alignment, comparing them to previous predicate devices (K193580 and K180459). The acceptance criteria are implicit in these reported performance specifications, as stated "with results demonstrating that acceptance criteria were met."

2. Sample Size for the Test Set and Data Provenance

The document states that "Load/Force Performance Testing" and "Alignment Performance Testing" were conducted using "Internal Protocol." However, specific sample sizes for the test sets are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not explicitly stated beyond being "Internal Protocol." Given the nature of the device (surgical system), it is likely that these tests were conducted in a laboratory setting or on cadaver models, but this is not explicitly detailed.

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

The document mentions "Usability Engineering / Cadaver Labs" as a safety and performance test. While this implies involvement of surgical experts, the number of experts and their qualifications (e.g., radiologist with 10 years of experience) are not specified.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1, none) for the test set results. The internal protocols for Load/Force and Alignment performance testing would typically detail how results are evaluated and confirmed, but these details are not provided in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned. The document explicitly states:

• "Performance Testing - Animal: N/A (Animal performance testing was not required to demonstrate substantial equivalence)"
• "Performance Testing - Clinical: N/A (Clinical performance testing was not required to demonstrate substantial equivalence)"

Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document as it's not an AI-assisted diagnostic device in the traditional sense, but a measurement tool.

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

The device is described as a "measurement tool to provide the surgeon with quantifiable data." It relies on "Electronics and sensors to measure load/force pressure" and an "accelerometer to measure coronal plane alignment." The "TrueBalance™ Software Application (TSA)" processes this data and "displays both numerically and pictorially load data along with angular measurements (alignment data)."

This indicates that the algorithm operates in a standalone capacity to process sensor input and generate measurements, which are then presented to the human user (surgeon). The performance specifications listed in the table (Load Accuracy, Tibia Varus/Valgus, etc.) are a direct measure of this standalone algorithmic performance.

7. The Type of Ground Truth Used

For the Load/Force and Alignment Performance Testing, the ground truth would have been established through highly precise mechanical measurement systems and/or calibrated physical models/phantoms designed to simulate the knee joint under various loading and alignment conditions. This is implied by the nature of the reported accuracy metrics (e.g., LBF, degrees). For the Usability Testing Cadaver Labs, the ground truth would likely be established by observing surgical procedures, expert assessment of outcomes, and possibly comparative measurements against established surgical references.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is common for devices that rely on established physical principles and calibrated sensors for measurement, rather than machine learning models that require extensive training data.

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

Since no training set is mentioned for a machine learning model, this information is not applicable/provided. The device operates based on sensor readings and algorithms derived from engineering principles.

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The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated.

For use as a tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.

The VERASENSE for Exactech Equinoxe is sterile, for single patient use.

The VERASENSE for Exactech Equinoxe device is an intelligent disposable humeral insert trial that measures dynamic loads on the humeral insert and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application for Shoulder (VSA-S). The VSA-S provides the surgeon with a graphical and numerical presentation of the glenohumeral load magnitude and center of load (COL) location (weighted average) from the humeral to glenoid components. Individual VERASENSE for Exactech Equinoxe devices are packaged sterile, for single patient use with a shim set for thickness adjustments.

The provided text describes the VERASENSE for Exactech Equinoxe device, but it does not contain information about a study proving the device meets acceptance criteria related to an AI/ML algorithm's performance.

Instead, the document primarily focuses on demonstrating the substantial equivalence of the VERASENSE for Exactech Equinoxe to a predicate device (VERASENSE for Zimmer Biomet Persona) for regulatory clearance. This involves a comparison of technological characteristics, mechanical and functional features, electrical properties, environmental conditions, and materials.

The performance data section mentions:

• Biocompatibility testing: Conducted according to ISO 10993-1.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: For sensor firmware and software application accessory, categorized as "minor" level of concern.
• Performance Testing (Bench): Covering usability, sterilization, packaging integrity, shelf life, biocompatibility, electrical safety, software V&V, and EMC.

Crucially, it explicitly states:

• Performance Testing Animal: "This submission does not include any animal performance testing. We determined that no such testing was required to demonstrate substantial equivalence."
• Performance Testing Clinical: "This submission does not include any clinical performance testing. We determined that no such testing was required to demonstrate substantial equivalence."

Therefore, based on the provided text, I cannot describe acceptance criteria and a study that proves the device meets those criteria for an AI/ML algorithm's performance, as no such study is detailed.

The device, VERASENSE for Exactech Equinoxe, is described as a tool for "measuring load magnitude and displaying center of load (COL) location (weighted average) of the humeral component on the glenosphere component during a reverse total shoulder arthroplasty (rTSA)." This describes a sensor-based measurement device rather than an AI/ML diagnostic or assistive algorithm.

The closest information available regarding "performance" that could be interpreted as "acceptance criteria" related to the device's core function (load and COL measurement) is in the comparison table:

Table of Acceptance Criteria and Reported Device Performance (as inferred from comparison with predicate and functional specifications)

None of the other requested information (sample size for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is present in the provided document, as it pertains to AI/ML algorithm validation, which is not described for this device.

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VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.

VERASENSE is sterile, for single patient use.

The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.

This document describes a 510(k) premarket notification for the VERASENSE for Stryker Triathlon device. It is a re-submission for a device that has previously been cleared for other implant systems (VERASENSE for Zimmer Biomet Persona, K180459). Therefore, the provided text focuses on demonstrating substantial equivalence to existing predicate devices, rather than a full de novo acceptance criteria and performance study for a novel device.

As a result, many of the typical elements of an acceptance criteria and performance study (like specific performance metrics from a clinical study, sample size for testing, expert validation process, MRMC studies) are not present in this document, as the primary goal is to show that the modified device functions similarly and safely to already-cleared devices.

However, I can extract the information that is present and highlight what is not available based on the request.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria for this 510(k) submission are not expressed as specific performance thresholds for a new clinical trial, but rather as demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device meets the same specifications and standards as the predicate devices, despite minor technological differences.

Table of Acceptance Criteria (vs. Predicate Device) and Reported Device Performance:

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The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.

VERASENSE for Zimmer Biomet Persona provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE for Zimmer Biomet Persona consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE for Zimmer Biomet Persona parent device. Individual VERASENSE for Zimmer Biomet Persona devices are packaged sterile, for single patient use with a shim set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

VERASENSE for Zimmer Biomet Persona devices are implant system specific due to variations in implant design and is compatible with the Zimmer Biomet Persona Knee System.

The VERASENSE for Zimmer Biomet Persona is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and angular velocity and acceleration for the alignment functionality. The data from the sensor is wirelessly transmitted to the LinkStation MINI or LinkStation MINI Evaluation Kit which runs the VSA and is located outside the sterile field in the operating room. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee, center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only, static measurement of the coronal alignment of the tibial resection relative to the patient specific tibial reference axis defined by the system registered anatomical landmarks, and numerical value of the varus/valgus tibial mechanical alignment.

The provided text describes the VERASENSE for Zimmer Biomet Persona device, an intraoperative tool for Total Knee Arthroplasty (TKA), and specifically focuses on a 510(k) submission (K193580) for a modified version of the device. This modification primarily involves an updated firmware and software application to enable and utilize an IMU (inertial measurement unit) chip for measuring tibial implant coronal alignment.

The document states that performance studies were conducted to demonstrate that the product meets established acceptance criteria. However, it does not provide a detailed table of acceptance criteria and reported device performance for the alignment functionality. Instead, it broadly states that "Performance studies demonstrated the product meets established acceptance criteria."

Based on the information provided, here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table listing specific numerical acceptance criteria alongside
corresponding reported device performance for the alignment function. The only specific performance metric mentioned for the alignment function is:

• Tibial Mechanical Alignment Range: varus/valgus ± 7°
• Accuracy: ± 3°

However, it does not state the actual measured performance against this accuracy or range in a reportable format beyond "performance studies demonstrated the product meets established acceptance criteria."

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Performance Testing Bench" including "Benchtop Design, Cadaver Design, Benchtop Sensitivity analysis, Usability, Software Verification." It also states, "The method for calculating alignment was verified through sensitivity analysis and a mathematical simulation." While these imply testing, the sample sizes (e.g., number of cadavers, number of benchtop tests) are not provided.
• Data Provenance: The studies appear to be benchtop and cadaver-based. The country of origin is not specified, but the device manufacturer is OrthoSensor, Inc., located in Dania Beach, Florida, USA. The studies seem to be retrospective or laboratory-based, as it explicitly states, "This submission does not include any clinical testing."

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role of Experts: Given the nature of a medical device submission without clinical trials for the specific modification, it's highly likely that engineering or testing personnel established the "ground truth" for the benchtop and cadaver studies. However, this is not detailed.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Given that no clinical studies with human readers or experts are described for the performance evaluation of the alignment function, an adjudication method for a test set is not relevant.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "This submission does not include any clinical testing. We determined that no such testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI assistance vs. without AI assistance can be reported. The device is a measurement tool, not an AI-assisted diagnostic tool for image interpretation by clinicians.

6. Standalone Performance (Algorithm Only)

Yes, standalone performance was assessed. The "Performance Testing Bench" section describes how the "Alignment function calculation" was tested and verified through "sensitivity analysis and a mathematical simulation." This implies testing of the algorithm's performance in a controlled, non-human-in-the-loop environment. The device itself (VERASENSE for Zimmer Biomet Persona) with its integrated IMU and associated software (VSA) acts as the "algorithm only" system in the context of this specific regulatory submission for its alignment measurement capability.

7. Type of Ground Truth Used

The ground truth used for the benchtop and cadaver studies was established through:

• Experimental/Physical Measurement: For benchtop design and cadaver studies, the ground truth for alignment would have been established using highly accurate physical measurement tools (e.g., optical tracking systems, precise goniometers, or reference jigs) against which the device's measurements were compared.
• Mathematical/Simulated Ground Truth: For the "sensitivity analysis and a mathematical simulation," the ground truth would have been derived from theoretical models or known inputs within the simulation environment.

The document does not explicitly state these methods but they are implied by the nature of benchtop and simulation testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The document describes a "510(k) premarket notification" for a hardware/firmware/software modification to an existing device. It does not describe the development or training of a de novo AI/ML model for which a training set would typically be referenced. The "software accessory" is stated as a "minor" level of concern and primarily reports calculated values, not predictions from a data-driven learning model.

9. How Ground Truth for Training Set was Established

Not applicable, as a training set for an AI/ML model is not described as being part of this submission for this specific modification. The "Software Verification and Validation Testing" section refers to standard software testing procedures, not AI model training.

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The VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

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

VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).

The VERASENSE consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE parent device. The LinkStation MINI / LinkStation MINI Evaluation Kit is capable of running the VSA and communicating wirelessly with the VERASENSE from outside the sterile field in the operating room. Individual VERASENSE devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments. The required accessories are not packaged sterile and are reusable.

The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI Evaluation Kit. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. The VSA also provides location of the center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments for reference only.

VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems:

• VERASENSE for Biomet Vanguard
• VERASENSE for Stryker Triathlon
• VERASENSE for Zimmer NexGen
• VERASENSE for Smith & Nephew Legion
• VERASENSE for Smith & Nephew Journey II
• VERASENSE for Zimmer Biomet Persona

The provided text describes the VERASENSE for Zimmer Biomet Persona device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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

The text primarily focuses on bench testing and software verification. There are no specific "test set" sample sizes mentioned for clinical or animal studies, as they were not deemed necessary for this submission. The performance data is derived from:

• Bench Performance Testing: The specific sample sizes for these tests (e.g., number of devices tested for load accuracy or operating range) are not explicitly stated in the document.
• Biocompatibility Testing: Conducted on the final VERASENSE for Zimmer Biomet Persona and its raw materials. The sample size for these tests is not specified.
• Electrical Safety and EMC Testing: Conducted on the VERASENSE for Zimmer Biomet Persona and required accessories. The sample size for these tests is not specified.
• Software Verification and Validation Testing: Documentation provided.

The provenance (country of origin, retrospective/prospective) of this data is not explicitly stated, but it would have been generated internally by OrthoSensor, Inc. through their product design and development procedures.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert review for ground truth. The acceptance criteria relate to physical performance, electrical safety, biocompatibility, and software functionality, which are typically assessed through objective measurements and established standards, rather than expert consensus on diagnostic interpretations.

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

Not applicable, as this is not an AI/ML diagnostic tool requiring human adjudication for ground truth.

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. The VERASENSE is an intraoperative orthopedic joint assessment aid that measures dynamic loads; it is not an AI-assisted diagnostic tool that would involve human readers.

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

This refers to the performance of the device itself (the VERASENSE sensor and its software application) without direct human intervention in its measurement process, though it is a tool for human use in surgery. All performance testing (bench, biocompatibility, electrical safety, software) described can be considered "standalone" in this context, in that it assesses the device's inherent characteristics and compliance with standards. The device is intended to provide real-time data to a surgeon, who then uses that information for adjustment during TKA.

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

The "ground truth" for this device's performance is based on:

• Physical measurements and established engineering standards: For operating range, load accuracy, maximum safe load, usability, sterilization, packaging integrity, and shelf life, the ground truth is determined by precise measurements and adherence to predefined engineering specifications and internal procedures.
• International standards and guidance documents: For electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1), the ground truth is compliance with these recognized standards.
• Software verification and validation documentation: For software, the ground truth is adherence to the documented requirements and design specifications as per FDA guidance.

8. The sample size for the training set

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

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

Not applicable. As there is no training set for an AI/ML algorithm.

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The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.

Not Found

This FDA letter, K162237, for the XO1 Knee Balancing System, does not contain the detailed acceptance criteria or the study data proving the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device already on the market. It outlines the indications for use but does not delve into the specific performance studies, acceptance criteria, or the methodology of such studies.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided document. The document primarily focuses on regulatory clearance rather than detailed performance study reports.

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The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.

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

The VERASENSE Knee System provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA) intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior, and anterior slope positioning, etc.) after insertion into the space between the tibia and femur.

The VERASENSE™ Knee System is an intra-operative device for use in primary or revision total knee arthroplasty (TKA), where all patient contacting components are made of biocompatible polycarbonate and adhesive.

The VERASENSE™ Knee System is an intelligent disposable tibial insert that wirelessly transmits the measured data to the OrthoSensor LinkStation for surgeon visualization. Individual VERASENSE™ devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments.

The OrthoSensor LinkStation and VERASENSE™ Knee System Software Application are required for use of the VERASENSE™ Knee System device. The LinkStation contains a computer and all peripheral equipment required to display the measured data by providing a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. VERASENSE™ Knee System devices are implant system specific due to variations in implant design.

This submission (K150372) is a Traditional 510(k) for the VERASENSE Knee System, which is an intra-operative device used in Total Knee Arthroplasty (TKA). The primary purpose of this submission is to update the intended use statement for the device. Therefore, it does not include new performance data or clinical studies for acceptance criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states "Performance Data: N/A" and "Clinical Data: N/A". This 510(k) is for an update to the intended use statement of an already cleared device. Therefore, no new acceptance criteria or device performance data are presented in this specific submission. The substantial equivalence is based on the previously cleared predicate devices.

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. No new test set data is presented in this submission.

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 test set data is presented in this submission.

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

Not applicable. No new test set data is presented in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-based diagnostic or assistive reading tool. It is an intra-operative tool for surgeons.

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

Not applicable. This device is an intra-operative tool that provides real-time data to a surgeon, rather than a standalone algorithm.

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

Not applicable. No new performance studies requiring ground truth are presented.

8. The sample size for the training set:

Not applicable. No new algorithm training data is presented.

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

Not applicable. No new algorithm training data is presented.

Summary of what the document does provide regarding the device's meeting of criteria:

The document emphasizes Substantial Equivalence to previously cleared predicate devices (K131767, K130380, and K090474). The claim is that the VERASENSE™ Knee System has equivalent manufacturing materials, operating principles, and physical/operational specifications as compared to the predicate devices. The changes in this submission, primarily an update to the intended use statement, are determined to have no impact on safety or effectiveness. Therefore, the device meets the regulatory acceptance criterion of substantial equivalence rather than new performance criteria.

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