Search Results

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.

Ask a specific question about this device

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:

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery 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 the femur.

The provided text is a 510(k) summary for the OrthoSensor VERASENSE™ Knee System, which describes a modification to an existing device. It focuses on regulatory approval for labeling changes and physical modifications to allow compatibility with another knee system.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its performance or effectiveness in the way an AI/ML device would be evaluated (e.g., accuracy, sensitivity, specificity).

The document states:

"The modifications to the Orthosensor VERASENSE™ Knee System were evaluated under design controls, and met the same performance criteria as the predicate device."

This indicates that the modified device was tested against the same performance criteria as the original predicate device, not that a new study was conducted to establish new acceptance criteria or to prove clinical effectiveness of the device's intended use (reducing instability from flexion gap asymmetry). The changes are primarily related to mechanical compatibility and labeling.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth, expert involvement, or MRMC studies for this specific submission, because that information is not present in the provided text.

The document discusses:

• Intended Use: For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.
• Device Description: An instrumented trial tibial insert with load sensors and angular positional information.
• Changes: Modification to package label to reflect use with Biomet Vanguard Knee System, changes to device surface contours and dimensions specific to the Biomet Vanguard Knee System, and addition of a new color of Polycarbonate.
• Design Control Activities: The modifications were evaluated under design controls and "met the same performance criteria as the predicate device."
• Substantial Equivalence: The submission claims substantial equivalence to the predicate device, stating it has the same intended use and technological characteristics that do not raise different questions of safety and effectiveness.

In summary, the provided text does not contain the specific information required to answer the prompt regarding acceptance criteria and performance study details for an AI/ML device.

Ask a specific question about this device

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

OrthoSensor Knee Balancer provides a means to dynamically balance the knee during knee replacement surgery 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 after insertion into the space between the tibia and the femur.

The provided text describes a Special 510(k) submission (K130380) for the OrthoSensor Knee Balancer. This submission is specifically for removing the "qualitative reference only" designation from the angular positional information previously associated with the device. It explicitly states that "This results in no change to the device itself as it has the same intended use, operating principles, and physical, operational specifications as compared to the predicate device." Therefore, the focus of this submission is not on demonstrating new performance criteria for the device as a whole, but rather on validating the angular positional data as quantitative without altering the fundamental scientific technology.

Given this, the provided document does not contain details about acceptance criteria or a study proving the device meets general performance criteria for its intended use as a whole. Instead, it refers to design control activities and verification/validation testing specifically for the change made.

However, based on the information provided, here's what can be extracted and inferred regarding the "study" related to the change:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: "cadaver lab setting" is mentioned for design validation and usability testing. This implies a prospective study using cadaveric tissue. The country of origin is not specified.

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

• Not specified. The document only mentions "design validation and usability testing performed in a cadaver lab setting," without detailing the involvement or qualifications of experts for establishing ground truth within that testing.

4. Adjudication method 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:

• No, a multi-reader multi-case comparative effectiveness study is not mentioned. The device is a physical intraoperative tool, not an AI diagnostic algorithm.

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

• Not applicable in the context of an intraoperative physical device. The device's "algorithm" (its measurement capabilities) is inherently used with a human (surgeon) who interprets the data. However, the benchtop and cadaveric testing would effectively be "standalone" in verifying the accuracy of the device's measurements themselves, independent of a surgeon's interpretation of those measurements for decision-making. The document states "bench top performance verification testing."

7. The type of ground truth used:

• For the cadaver lab testing, the "ground truth" would likely involve direct physical measurements or established anatomical references against which the device's angular positional information is compared. The document doesn't explicitly state the specific ground truth method.

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" of the device would be its initial design and calibration for which no sample size is provided.

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

• Not applicable for this type of device.

In summary, this 510(k) submission focuses on a minor change (redefining the status of existing angular data) and relies on prior validations and risk analysis, along with limited specific verification and validation testing for the change itself. It does not present a comprehensive study demonstrating new performance criteria for the device as a whole.

Ask a specific question about this device

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.

Orthosensor Intra-Operative Load Sensor (IOLS) system provides a means to dynamically balance the knee during knee replacement surgery intraoperatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface after insertion into the space between the tibia and the femur.

Here's a breakdown of the acceptance criteria and study information for the OrthoRex Intra-Operative Load Sensor, based on the provided document:

This 510(k) summary does not provide detailed acceptance criteria or extensive study data typical of a clinical trial. It primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • The document mentions "a series of bench testing which includes mechanical, engineering, and comparison studies." However, specific sample sizes (e.g., number of units tested, number of measurements taken) for these bench tests are not provided.
   • Data Provenance: The nature of "bench testing" implies the data was generated in a controlled laboratory environment, not from human subjects. The country of origin is not explicitly stated, but the company is based in Sunrise, FL, USA. The testing would be considered prospective for the device's development and regulatory submission.

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

   • Not applicable. As this was bench testing, there was no "ground truth" established by human experts in the way clinical studies requiring image interpretation or diagnosis would. The "ground truth" would be the known physical properties and performance of the test setups (e.g., applied forces, mechanical loads).

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

   • Not applicable. This concept is relevant for clinical studies involving multiple human readers and is not applicable to mechanical bench testing.

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 device is an intra-operative load sensor, not an AI-based diagnostic imaging tool. It does not involve human readers interpreting data, nor does it involve AI assistance in that context.

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

   • Not applicable in the typical AI sense. The device is a sensor and measurement system designed to provide real-time data during surgery for direct human interpretation and action. Its performance is inherent in its ability to accurately measure forces, which is what the bench testing would have evaluated. There isn't an "algorithm only" performance separate from its function as a measurement tool.

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

   • For the bench testing, the "ground truth" would have been established by precisely calibrated measurement instruments (e.g., load cells, force gauges) used in the mechanical and engineering studies. This would represent physical measurements under controlled conditions.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. Its "training" would be the engineering design, calibration, and manufacturing process.

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

   • Not applicable. (See point 7).

Ask a specific question about this device