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The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.

The TCAT THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System instruments, tools and accessories. These trays are used to enclose and hold the instruments, tools, and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation, and drying. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. The trays have the same size and same basic configuration: a rectangular base with latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool, and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removing from the tray.

The presented document describes the non-clinical testing performed on the TCAT® THA Instrument Tray Set to demonstrate its safety and effectiveness.

Here's an analysis 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:

• Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., number of trays tested for sterilization efficacy). However, it consistently refers to "both devices" or "both trays" in the results, implying that at least one of each of the two different tray types (TCAT® Base Instrument Tray and TCAT® THA Instrument Tray) were tested for each criterion where applicable. For "maximum inoculated load" and "maximum load," it implies that the trays were loaded to their full capacity when tested.
• Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a controlled, laboratory environment. The provenance is internal to the manufacturer or a contracted testing facility, following established international (ISO, ASTM) and FDA guidance standards. This is prospective testing to validate the device's design and performance. There is no mention of country of origin for the data beyond the standards applied.

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

• This information is not applicable as the document describes non-clinical performance testing (e.g., sterilization efficacy, packaging, cleaning, biocompatibility). These tests do not involve human interpretation of medical images or diagnoses, and, therefore, do not require medical experts to establish a "ground truth" in that context. The "ground truth" for these tests comes from objective laboratory measurements and adherence to specified scientific standards (e.g., absence of microbial growth, meeting packaging integrity metrics, non-cytotoxicity).

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

• This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human reviewers provide initial assessments, and a consensus or tie-breaking mechanism is needed to establish a definitive ground truth, typically in image interpretation or clinical trial settings. The non-clinical tests described here rely on objective, quantifiable results from laboratory procedures.

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

• This information is not applicable. The device under review is an instrument tray set for sterilization, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant to its evaluation.

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

• This information is not applicable. The device is a physical medical device (sterilization tray), not an algorithm or software. Its performance is evaluated through physical and biological tests described, not through standalone algorithm performance.

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

• The ground truth used for these non-clinical tests is based on objective scientific and engineering standards and measurements:
  • Sterilization Efficacy: Absence of microbial growth and a 6-log reduction of the indicator organism, as per ISO 17665-1.
  • Packaging: Meeting predefined "packaging endpoints" which are likely quantitative metrics for package integrity after simulated shipping (e.g., no damage, seals intact), as per ASTM D4169-16.
  • Cleaning: Meeting predefined "cleaning endpoints" which are likely quantitative metrics for residual soil (e.g., protein, hemoglobin levels below specified limits), as per FDA guidance.
  • Biocompatibility: Absence of cytotoxicity (i.e., no adverse cellular response to device extracts), as per ISO 10993-5:2009.

8. The sample size for the training set:

• This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI that would be relevant to these non-clinical validation tests. The testing performed is to validate the manufactured product against performance criteria.

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

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

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The TSolution One® Surgical System Model 210 is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/ reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

The TSolution One® Surgical System Model 210 is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Surgical System Model 210 is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Surgical System Model 210 facilitates accurate positioning of THA implants, relative to these alignment axes.

The TSolution One® Surgical System Model 210 is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN® Preoperative Planning Workstation and TCAT®, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN® and TCAT® when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.

The provided document is about a 510(k) premarket notification for the TSolution One® Surgical System Model 210, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device (TSolution One® Cup1 Surgical System, K162195) rather than providing detailed acceptance criteria and a study dedicated to proving the device meets those criteria with specific performance metrics as typically expected for complex AI/ML devices.

However, based on the information provided, I can infer the acceptance criteria within the context of this 510(k) submission as the successful completion of verification and validation activities demonstrating the device functions as intended and does not raise new safety or efficacy issues compared to its predicate.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

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 document does not specify a sample size for any test set or the data provenance. The verification and validation activities are described broadly as "Software Testing" and "Support Surgical Instrument Testing," implying internal testing rather than a clinical study with real patient data.

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)

The document does not mention the use of experts to establish ground truth for a test set. This type of information is typically not included in a 510(k) summary focused on substantial equivalence for a surgical robotic system unless a specific clinical study with expert reviews was conducted to prove a clinical endpoint.

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

The document does not mention any adjudication method.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a robotic system for performing surgery based on a presurgical plan, not an AI-assisted diagnostic tool that helps human readers.

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

The document implies that the "Software Testing" and "Support Surgical Instrument Testing" evaluate the system's performance in a standalone capacity (as an algorithm and robotic system functioning as intended) without explicit human-in-the-loop performance described in the context of effectiveness evaluation. However, the device itself is "under the direction of the surgeon," indicating a human-in-the-loop for actual surgical procedures. The testing described focuses on the proper functioning of the software and instruments.

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

The document does not explicitly state the type of ground truth used for its internal verification and validation activities. Given the nature of a surgical robotic system, it's likely based on engineering specifications, kinematic accuracy, planned surgical outcomes (e.g., bone preparation dimensions) against actual robotic execution, and functional tests.

8. The sample size for the training set

The document does not describe any "training set." This device is a robotic system with software for planning and execution, not an AI/ML system that undergoes a training phase with a dataset in the way a diagnostic algorithm would.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

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The TSolution One® Cupl Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surqeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

The TSolution One® Cup1 Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Cup1 Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Cupl Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.

The TSolution On® Cup1 Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.

The provided text does not contain information about acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) premarket notification for the TSolution One® Cup1 Surgical System, outlining its intended use, a comparison to a predicate device, and general performance data from verification/validation activities.

Specifically, the document does not include:

• A table of specific acceptance criteria (e.g., accuracy, precision metrics with numerical thresholds).
• Detailed results of a study designed to demonstrate adherence to such criteria.
• Information on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
• Details about a multi-reader, multi-case (MRMC) comparative effectiveness study or the effect size of AI assistance on human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how ground truth was established for the training set.

Instead, it presents:

• Performance Data: "The TSolution One® Cup1 Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements: TPLAN Bug Fixes, TCAT Bug Fixes, TCAT Instrument Changes, System User Manuals Changes."
• Verification/Validation Activities: A table (Table 2) lists "Software Testing" and "Support Surgical Instrument Testing" with the purpose to "Verify TPLAN presurgical planning and TCAT surgical system software function as intended to successfully complete THA procedure including Acetabular Cup Guidance" and "Verify TCAT surgical support instruments function as intended to successfully complete THA procedure including Acetabular Cup Guidance and meet user needs." Both activities report "PASS" as results.

The document concludes that "The results of performance testing indicated the device performed within the intended use and the differences between the predicate and the TSolution One® Cup1 Surgical System do not raise any new safety or efficacy issues." This implies that the device met internal verification and validation criteria, but those specific criteria and detailed study results are not provided in this regulatory summary.

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The TSolution One™ w/ACG+ Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/ reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

The TSolution One w/ACG+ Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made. The TSolution One™ w/ACG+ Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One™ w/ACG+ Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.

The TSolution One™ w/ACG+ Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.

The provided document is a 510(k) summary for the TSolution One™ w/ACG+ Surgical System, which is a robotic surgical system for Total Hip Arthroplasty (THA). This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not detail specific acceptance criteria or a dedicated study proving device performance against those criteria in the way typically expected for an AI/algorithm-driven device's clinical performance.

Instead, the performance data section outlines verification and validation activities conducted to assess modifications and improvements to the system. These activities include Software Testing, Usability Testing, Benchtop Accuracy Testing, and Cadaver Testing. The results for all these activities are simply reported as "PASS."

Therefore, based on the provided document, I cannot fulfill all parts of your request as it pertains to a detailed description of acceptance criteria met by a specific study with clearly defined metrics, sample sizes, and ground truth methodologies for an AI/algorithm.

However, I can extract the information that is present:

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

The document does not provide a table of explicit, quantitative acceptance criteria for clinical performance (e.g., accuracy, precision of cuts against target) or reported numerical performance metrics. Instead, it lists verification/validation activities and reports them as "PASS."

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

• Test Set Sample Size: Not specified for any of the testing activities beyond "cadaver testing."
• Data Provenance: Not specified. The document is a 510(k) summary submitted to the FDA in the USA, but it does not detail where the studies were conducted or the origin of any data used.

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 specified. The document does not mention any expert involvement in establishing "ground truth" for quantitative performance metrics. For cadaver testing, it mentions validating workflow and meeting "customer requirements," which might imply expert input, but details are not provided.

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:

• No. The document describes a robotic surgical system, not an AI diagnostic or assistance tool that would typically involve human readers.

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

• The TSolution One™ system is described as a "robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan." This indicates it's a human-in-the-loop system where the surgeon directs the robot based on the presurgical plan. While software testing verifies the algorithm's function, it's not discussed as a standalone diagnostic or interpretative algorithm.

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

• For "Benchtop Accuracy Testing," the ground truth implicitly refers to "specified requirements," which would likely be engineering or design specifications for accuracy.
• For "Cadaver Testing," the ground truth relates to the system's ability to "successfully complete a THA procedure" and meet "customer requirements," which would involve surgical outcomes in a simulated environment.
• No specific mention of expert consensus, pathology, or long-term outcomes data as ground truth.

8. The sample size for the training set:

• Not specified. The document doesn't discuss a "training set" in the context of machine learning model development. The system involves validated control software and hardware, but details regarding its development, training data, or methodology are not provided.

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

• Not applicable, as a "training set" for a machine learning model is not discussed in this document.

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The TSolution One™ w/ACG Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.

The TSolution One™ w/ACG Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.

The TSolution One™ w/ACG Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One™ w/ACG Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.

The TSolution One™ w/ACG Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLANTM and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.

The provided text describes a 510(k) premarket notification for the TSolution One™ w/ACG Surgical System, a robotic surgical system for total hip arthroplasty (THA). The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and performance testing.

However, the document does not contain the level of detail required to fulfill all aspects of your request, particularly regarding specific acceptance criteria values, sample sizes for test sets where performance metrics are quantified, the number and qualifications of experts, adjudication methods, details of MRMC studies, or the provenance of detailed data. The "Performance Data" section lists "Benchtop Accuracy Testing" as verifying overall system accuracy against specified requirements, but it does not provide the specific numerical acceptance criteria or the reported device performance against those criteria. It only states "PASS".

Based on the provided text, here's what can be extracted and what cannot:

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

Important Note: The document states "Benchtop Accuracy Testing" verifies accuracy in "meeting specified requirements" but does not explicitly state what those numerical requirements are (e.g., a specific tolerance in mm or degrees) or the measured accuracy. It only indicates "PASS."

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

• Sample Size for Test Set: Not explicitly stated for any of the listed tests (Software, Usability, Benchtop Accuracy, Cadaver).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The cadaver testing is a simulated use environment, which is a type of prospective lab-based testing.

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.

4. Adjudication method for the test set

• Adjudication Method: Not specified. Given the nature of these tests (software functionality, usability, benchtop accuracy, cadaver workflow), it's likely that a predefined protocol and objective measurements were used for "PASS/FAIL" rather than expert adjudication in the sense of consensus reading of medical images.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This type of study is typical for AI-assisted diagnostic devices to measure improvement in human reader performance. This device is a robotic surgical system, not a diagnostic AI.

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

• Standalone Performance: The "Benchtop Accuracy Testing" would be the closest to a standalone performance evaluation, as it aims to verify the "overall system (TPLAN presurgical planning, and TCAT surgical system) accuracy." However, the exact metrics and whether this is "algorithm only" are not detailed. The system, by its description, always involves a human surgeon "under the direction of the surgeon" and implementing a "presurgical software plan." Thus, a purely standalone algorithm evaluation in the sense of a diagnostic AI is not applicable.

7. The type of ground truth used

• Ground Truth Type:
  • For "Software Testing" and "Usability Testing": Implied ground truth is the predefined functional specifications and user requirements for the system.
  • For "Benchtop Accuracy Testing": Implied ground truth would be precise measurements from a known reference standard (e.g., phantom, jig) against which the system's output is compared. The "specified requirements" define this ground truth.
  • For "Cadaver Testing": Implied ground truth would be successful completion of the THA procedure workflow as per established surgical protocols and meeting "customer requirements" in a simulated environment.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document describes a robotic surgical system, not a machine learning model that requires a distinct training set. The "software" mentioned refers to the system's control software and planning software, which are developed through traditional software engineering processes, not trained on a data set in the AI sense.

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

• Training Set Ground Truth: Not applicable, as it's not a machine learning model that undergoes training on a data set with established ground truth.

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