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The Balanced Knee System TriMax PS Plus Tibial Inset is in cemented total knee arthroplasty procedures with the following indications:

1. Loss of knee joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System (BKS) TriMax PS Plus Tibial Insert is a line extension of the TriMax PS Tibial Insert (K131337) that offers slightly more constraint than the original PS Insert. The PS post geometry is the only design difference between the previously cleared predicate device and the subject device. The change slightly modifies the post's shape to provide additional internal/external and varus/valgus constraint if the surgeon determines the need exists. The balance of the design is identical including the articulating surface, locking mechanism, as well as the PS post location and height. The PS Plus inserts are intended for use in primary and revision knee surgeries with the same indications for use as the predicate. This implant is used with existing BKS and BKS Revision (BKSR) tibial travs. TriMax femoral components and the BKSR modular femoral components. The material is identical as well as all manufacturing processes, cleaning, sterilization and packaging that were cleared under K131337.

This document describes a 510(k) premarket notification for a medical device called the "Balanced Knee® System TriMax PS Plus Tibial Insert." The submission is a "Special 510(k)" because it is a line extension of a previously cleared predicate device (K131337).

Since this is a Special 510(k) for a line extension of an existing device, and the primary change is a slight modification to the PS post geometry, the provided document does not contain information about a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device through engineering analysis and verification testing.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance (in the context of a clinical study or AI performance evaluation)
2. Sample size used for a test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method for a test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm-only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document describes the engineering and material performance evaluations conducted to demonstrate that the new device's design outputs meet the design inputs, similar to the predicate. The "performance data" section refers to:

• Sterilization: Stated adherence to ISO 11135-1 with a Sterilization Assurance Level (SAL) of 10-6.
• Shelf Life: Validation according to ASTM D4169:2016.
• Biocompatibility: Suitability for implantation verified per ISO 10993.

The comparison of technological characteristics mentions evaluations in the following areas, indicating what was assessed, but not specific acceptance criteria or performance numbers:

• Geometric Analysis
• Contact Area and Pressure
• Constraint
• Wear
• Range of Motion
• PS Post Fatigue

It concludes that "The results showed similar or identical performance indicating that the design outputs of the PS Plus Tibial Insert meet the design inputs." This is a general statement of engineering conformance, not a specific performance metric from a study as typically requested for AI/diagnostic device approvals.

In summary, this document is a 510(k) premarket notification for a mechanical orthopedic implant, not a software or AI-driven medical device. Therefore, the types of studies and acceptance criteria typically associated with AI/software performance evaluations (e.g., sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable to the content of this FDA letter.

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Focus 43C and TRIMAX 43C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Focus 43C Detector and TRIMAX 43C Detector (Hereinafter referred to as Focus 43C and TRIMAX 43C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models TRIMAX 43C and Focus 43C are totally same except for label and trademark. The sensor plate of Focus 43C and TRIMAX 43C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 43C and TRIMAX 43C detectors are to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers.

The provided text describes a 510(k) premarket notification for the "Focus 43C Detector" and "TRIMAX 43C Detector". The submission focuses on demonstrating substantial equivalence to a predicate device, the "Wireless Digital Flat Panel Detector (Mars1717XF-CSI, K183713)".

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it compares the technical characteristics of the proposed device to the predicate device to demonstrate substantial equivalence. The performance metrics are generally presented as improvements or minor changes compared to the predicate.

The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, safety, and effectiveness. The document asserts that the proposed devices meet this through direct comparison and noting improvements where applicable.

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

The document does not specify a distinct "test set" in the context of clinical images or patient data for evaluating the device's diagnostic performance. The evaluation is primarily focused on non-clinical performance testing and comparison of technical specifications to the predicate device.

• No specific sample size for a test set of images or patient data is mentioned.
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided for such a test set.

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

This information is not applicable to the provided document. The submission does not describe a study involving expert readers establishing ground truth for a diagnostic test set. The evaluation is based on technical specifications and engineering testing.

4. Adjudication Method for the Test Set

This information is not applicable as no diagnostic test set or adjudication process is described in the provided text.

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 MRMC comparative effectiveness study is mentioned. This device is a digital X-ray detector, not an AI-powered diagnostic tool, so such a study would not typically be performed or described in this type of submission.

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

This is not an AI algorithm. The device is a digital X-ray detector. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not relevant to this submission, as it focuses on the technical performance specifications of the X-ray detector rather than its diagnostic accuracy in interpreting images. The "ground truth" for the device's performance characteristics (e.g., spatial resolution, MTF, DQE) would be established through physical measurements and standardized test phantoms according to industry standards.

8. The Sample Size for the Training Set

No training set is mentioned as this device is an X-ray detector, not an AI model requiring a training set.

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

Not applicable, as no training set is mentioned or relevant for this device.

Summary of Device Performance Demonstration:

The submission demonstrates substantial equivalence primarily through:

• Comparison of Technical Specifications: A detailed table comprehensively compares various technical characteristics, showing that the proposed device is either similar to or improved upon the predicate device (e.g., higher image matrix size, smaller pixel pitch, better spatial resolution, MTF, and DQE).
• Non-Clinical Performance Testing:
  • Electrical Safety and EMC testing: Performed according to IEC/ES 60601-1 and IEC 60601-1-2, with results meeting standard requirements.
  • Biological Evaluation: Materials contacting skin evaluated per ISO 10993-1, with results assuring safety "the same as the predicate device."
  • Other Non-Clinical Considerations: These studies showed that non-clinical considerations mentioned in the "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" are substantially equivalent to the predicate. This likely includes aspects like image quality, dose performance, and environmental testing.
• Clinical Consideration: The document explicitly states that "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." It also states, "There was no significant difference between the images of the Focus 43C/TRIMAX 43C and those of the predicate device." This implies that while no formal clinical study is presented, the technical improvements are not expected to negatively impact clinical performance, and the output images are comparable.

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Focus 35C and TRIMAX 35C are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. This device is not intended for mammography or dental applications. There are no differences between the 2 models except the model name and trade mark.

Focus 35C Detector and TRIMAX 35C Detector (Hereinafter referred to as Focus 35C and TRIMAX 35C) are a kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 34.56cm×42.00cm. Two models TRIMAX 35C and Focus 35C are totally same except for label and trademark. The sensor plate of Focus 35C and TRIMAX 35C detectors are direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics. consequently to form a panel image by transmitting to PC through the user interface. The major function of the Focus 35C and TRIMAX 35C detectors are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This kind of detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software. iRay SDK(include iDetector) is intend to supply API interface for DR system manufacturers. DR system manufacturer control the detector by SDK interface. SDK is not intend to use directly by other users beside DR system manufacturers. The iRay SDK is unchanged from the predicate device.

The provided text describes the 510(k) premarket notification for the iRay Technology Taicang Ltd. Focus 35C Detector and TRIMAX 35C Detector. This submission asserts substantial equivalence to a predicate device (Mars1417XF-CSI, K182551). For devices like X-ray detectors, acceptance criteria often revolve around physical performance specifications and safety, rather than diagnostic accuracy as would be the case for an AI diagnostic device. The study described focuses on demonstrating that the proposed devices meet these technical and safety standards, and are substantially equivalent to the predicate.

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

The provided text does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might typically expect for a diagnostic AI device (e.g., Sensitivity, Specificity, AUC). Instead, it presents a comparison of technological characteristics between the proposed device (Focus 35C / TRIMAX 35C) and its predicate device (Wireless Digital Flat Panel Detector, Mars1417XF-CSI). The acceptance is implied by demonstrating that the proposed device performs at least as well as or better than the predicate for key technical specifications, and meets relevant industry standards.

Here's a table compiled from the "Technological Characteristic" section comparing the proposed device to the predicate device, which implicitly serves as the baseline for performance acceptance:

Study Proving Acceptance:

The study proving acceptance is primarily a non-clinical performance study and safety testing demonstrating that the proposed devices (Focus 35C and TRIMAX 35C) are substantially equivalent to the predicate device.

• Electrical Safety and EMC Testing: "Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements."
• Biological Evaluation: "The materials of the detector which contact operators' or patient's skin have been evaluated with the ISO 10993-1. And the evaluation results and test result assured the safety the same as the predicate device."
• Non-clinical Considerations: "The non-clinical studies have been performed and the results have shown that sections of the non-clinical consideration mentioned in the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' are substantially equivalent to the non-consideration of predicate devices on the Market (Mars1417XF-CSI, K182551)."
• Clinical Consideration: "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device." This suggests an informal comparison of image quality, likely by engineers or qualified personnel during the non-clinical evaluation.

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

This information is not provided in the document. The studies were non-clinical performance and safety tests, not clinical studies involving patient data in the typical sense for evaluating diagnostic performance. The comparisons were primarily based on technical specifications and output image quality (likely using phantoms or test targets, rather than a "test set" of patient images with ground truth diagnoses).

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

This information is not applicable and not provided. This device is an X-ray detector, not an AI diagnostic algorithm. Ground truth, in the context of diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for its technical performance would be the specifications and measurements from calibration and performance tests. The statement "There was no significant difference between the images of the Focus 35C/TRIMAX 35C and those of the predicate device" implies an informal assessment of image quality, likely by qualified personnel (engineers, physicists, or potentially radiologists if consulted for image perception) rather than a formal expert consensus for a diagnostic task.

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

Not applicable and not provided. This is not a study requiring adjudication of diagnostic findings.

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 and not provided. This is an X-ray detector, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable and not provided. This is an X-ray detector, not an AI algorithm. Its performance is measured by its physical and technical capabilities to produce an image.

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

Not applicable in the typical sense. For this device, the "ground truth" for its performance evaluation comes from:

• Engineering specifications and measurements (e.g., spatial resolution, MTF, DQE).
• Compliance with international safety and electromagnetic compatibility standards (IEC/ES 60601-1, IEC 60601-1-2).
• Biocompatibility testing against a standard (ISO 10993-1).
• Comparison of image characteristics to the predicate device, likely using phantoms or standard test patterns.

8. The sample size for the training set

Not applicable and not provided. This is not an AI device that requires a training set.

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

Not applicable and not provided. This is not an AI device that requires a training set.

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The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis.

The TriMAX™ Implant System is a staple system which gives the surgeon a means of bone fixation in the management of bone fractures and reconstructive surgery. Prior to implantation, the legs of the implant are held substantially parallel to facilitate insertion into the prepared bone. Once implanted and released from the insertion device, the implant will move towards each other in a converging fashion. This movement creates compression across the adjoining bone members.

The provided text describes the 510(k) premarket notification for the TriMAX™ Implant System, a metallic bone fixation device. However, this document does not contain information about studies proving the device meets acceptance criteria related to an AI/ML-based medical device.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Indications for Use: The TriMAX™ Implant System is indicated for hand and foot bone fragment osteotomy fixation and joint arthrodesis, which is similar to the predicate devices.
• Technological Characteristics: Similarity in basic design, materials of manufacture (implied as metallic), and mechanical properties to the predicate devices.
• Performance Testing (Mechanical): Theoretical analysis and mechanical testing were performed to confirm substantial equivalence in mechanical strength to the predicate CrossRoads MotoCLIP™/HiMAX Implant System (K181410) and the CrossRoads Screw System (K152072).
• Pyrogen Testing: Confirmed the device meets the endotoxin limit of 20 Endotoxin Units (EU)/Device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional orthopedic implant, not an AI/ML system. The questions regarding sample size, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details are relevant to AI/ML device evaluations, which are not described in this submission.

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The Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts are intended for single use cemented total knee arthroplasty procedures with the following indications:

• 1. Loss of knee joint configuration and joint function.
• 2. Osteoarthritis of the knee joint.
• 3. Rheumatoid arthritis of the knee joint.
• 4. Post-traumatic arthritis of the knee joint.
• 5. Valgus, varus, or flexion deformities of the knee joint.
• 6. Revision procedures where other treatments or devices have failed.

The Balanced Knee® System TriMax™ CR femoral component is a highly polished Co-Cr-Mo cruciate retaining femoral component that is designed to accommodate increased range of motion up to 150° of flexion. E-Vitalize® CR and UC tibial inserts are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE (same material as K131337). All components are single use only and the TriMax™ CR femoral component is intended for cemented use only.

The E-Vitalize® CR and UC tibial inserts may be used with TriMax™ CR or BKS CR femoral components. E-Vitalize® CR and UC tibial inserts may also be used with all Ortho Development's tibial tray component offerings. The TriMax™ CR femoral component may be used with all Ortho Development patella component offerings.

The provided text is a 510(k) summary for the Balanced Knee® System TriMax™ CR Femoral Component and E-Vitalize® CR and UC Tibial Inserts. It does not describe a study involving detailed acceptance criteria, sample sizes, expert adjudication, or AI performance metrics as requested in the prompt. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance rather than clinical study data from human subjects or AI-driven analysis.

Therefore, I cannot extract the requested information from the provided text. The document details the product description, intended use, technological characteristics, and predicate devices, along with a list of non-clinical evaluations performed. However, it does not provide:

1. A table of acceptance criteria and reported device performance: The document mentions "non-clinical evaluations were performed and demonstrated substantial equivalence," but does not list specific acceptance criteria or corresponding performance values for these evaluations.
2. Sample size used for the test set and data provenance: The document refers to "non-clinical evaluations" but does not specify test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts and their qualifications for ground truth: This information is irrelevant for a non-clinical evaluation submission.
4. Adjudication method for the test set: Irrelevant for non-clinical evaluations.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human reader improvement with AI: This is not an AI device, so an MRMC study related to AI assistance is not applicable.
6. Standalone (algorithm only) performance: This is not an AI device, so standalone algorithm performance is not applicable.
7. Type of ground truth used: Irrelevant for non-clinical mechanical testing.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section merely states: "The following non-clinical evaluations were performed and demonstrated substantial equivalence to the predicate devices: Range of Motion, Femorotibial Constraint, Femorotibial Contact Area, Patellofemoral Constraint, Patellofemoral Contact Area, Femoral Component Fatigue Strength, Insert Assembly/Disassembly, and Knee Wear." This indicates that mechanical and material testing was conducted to show the new device performs similarly to existing, legally marketed devices, which is the basis for 510(k) clearance.

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Convertors® Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.

SMS polyolefin, the standard, fabric and poly-reinforced gowns are comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.

The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.

The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.

The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.

The provided text describes the Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, and O.R. Surgical Gowns. This document is a 510(k) summary for these surgical gowns, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for the device itself.

Therefore, much of the requested information regarding detailed performance studies, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, as typically found for AI/ML medical devices, is not present in this document because it pertains to traditional medical device clearance based on substantial equivalence.

However, I can extract the available information, particularly regarding the acceptance criteria as defined by the "performance attributes" being the same as the predicate devices, and the general testing conducted.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of explicit numerical acceptance criteria and corresponding device performance values. Instead, the primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing predicate devices. This means that the new devices are considered safe and effective if their performance attributes are "the same" as the legally marketed predicate devices.

• Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices": Cytotoxicity, sensitization, and primary skin irritation were performed and found acceptable.
• Industry recognized test methods: Materials were tested and found acceptable for the intended use. (Specific tests/results are not detailed). |
  | Sterilization:
  Ability to withstand specified sterilization methods (Industrial Moist Heat Sterilization and Ethylene Oxide). | The single-use product is designed to be repackaged and sterilized prior to use. It may be sterilized using Industrial Moist Heat Sterilization (under ANSI/AAMI/ISO 11134) and Ethylene Oxide (under ANSI/AAMI/ISO 11135).
  However, the SMS polyolefin reinforced gown cannot undergo steam sterilization as it may damage the impervious reinforcement; Ethylene Oxide is the only method for this specific gown. |

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

• Sample Size: Not specified for the performance testing. The document states "All materials used in the fabrication of this Convertors® SMS Polyolefin Gowns... were evaluated through biological qualification safety tests" and "These materials also were tested in accordance with industry recognized test methods." The exact number of gowns or material samples tested is not provided.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily lab-based (biological and material performance tests). The country of origin of the data is not specified beyond being generated by Cardinal Health Inc.

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

This information is not applicable/not provided. The "ground truth" for this type of device clearance is generally established through adherence to recognized consensus standards for material properties and biological safety (e.g., ISO 10993) and comparison to predicate devices, rather than through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typical in diagnostic studies where multiple readers interpret images. This document describes material and biocompatibility testing.

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/not provided. MRMC studies are relevant for diagnostic devices that involve human interpretation assisted by AI. This document is for surgical gowns.

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

This information is not applicable/not provided. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Consensus Standards: Adherence to established standards such as ISO 10993 Part-1 for biological evaluation of medical devices.
• Industry Recognized Test Methods: Performance against established material and barrier property tests.
• Predicate Device Equivalence: The performance of the new gowns is considered "acceptable" because their intended use and performance attributes are "the same" as legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

The provided text is a 510(k) summary for the TriMax Surgical Gown. It outlines the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not describe acceptance criteria in quantifiable terms or a comparative study as typically performed for diagnostic or AI-driven medical devices.

The document focuses on claiming substantial equivalence to a predicate device (ComPel XTR® Surgical Gowns #K922753) based on the performance of the gown materials and the gown itself after undergoing a specified number of processing cycles. The "acceptance criteria" here are implied through successful completion of standardized material and product performance tests.

Here's an attempt to extract the requested information, acknowledging that some fields may not be directly applicable or fully detailed given the nature of a 510(k) for a surgical gown:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria (Implied by success)": For a 510(k) of this nature, the demonstration of "success" in meeting the requirements of recognized standards is the primary form of acceptance criterion. The document states "The tests that have been successfully completed include:", indicating that the device met the performance thresholds defined by each respective standard.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of gowns tested for viral resistance or durability). It broadly states that the gown "will function as surgical gowns... through 75 complete wash, dry and sterilization cycles," implying a test sample was put through this process, but the number of units is not quantified.
• Data Provenance: Not specified. However, the tests are against international (ISO) and US (ASTM, AATCC, CFR) standards, suggesting the testing was performed in compliance with these regulations. It does not mention country of origin for the data or if it was retrospective or prospective, as these are typically not relevant for material performance tests of this type.

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

• Not Applicable. This type of information (experts establishing ground truth) is typically relevant for diagnostic devices where human interpretation is involved. For a surgical gown, the "ground truth" is based on objective, standardized physical and material performance tests. The standards themselves are generally developed by expert committees, but there isn't a "ground truth" established by individual experts for this specific test set.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in diagnostic or imaging studies. For objective material performance tests, the outcome is determined by the test protocol and measurement, not by expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of a system (often AI) on human reader performance in tasks like diagnosis or detection. This is not applicable to a surgical gown, which is a physical barrier device. The document does not describe any human reader involvement.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

• Yes, in spirit, but not in the context of an algorithm. The tests described are "standalone" in the sense that they evaluate the gown's material properties and performance objectively, without human intervention in the outcome assessment (beyond conducting the test and recording results). There is no "algorithm" involved, as this is a physical medical device, not a software or AI product.

7. The Type of Ground Truth Used

• The ground truth used is primarily objective physical and chemical testing against established industry and regulatory standards. This includes:
  • Material properties: Flammability, strength, lint.
  • Barrier performance: Viral resistance, hydrostatic pressure.
  • Biocompatibility: Cytotoxicity, systemic toxicity, skin irritation.
  • Durability and integrity: Performance after repeated processing cycles.
  • The "ground truth" is defined by the passing criteria of the specific ASTM, AATCC, EDANA, ISO, and CFR standards cited.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not an AI/ML algorithm or software. Therefore, there is no "training set" in the computational sense. The product's design and manufacturing processes are refined through engineering and material science, not through machine learning.

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

• Not Applicable. As there is no training set for an algorithm, there is no ground truth established for it. The performance of the gown itself is proven through the testing detailed in Section 7.

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Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.

Imation Trimax Cassettes are intended for use during diagnostic x-ray procedures to hold radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film. The cassettes are in a family of film sizes. The Trimax C-1 series contain a window that permits writing by a radiographic film marking system. The Trimax C-2 series is windowless.

Radiologic cassettes are comprised of a light-tight chamber for preventing radiologic film exposure, a compressible backplate material to assure intimate film screen contact, a latching mechanism for removal and replacement of radiographic film, a patientoriented surface transparent to x-ray energy, lead shielding to prevent unwanted exposure to stray x-ray energy and suitable support structure for durability of the assembly.

The provided text does not contain detailed information regarding specific acceptance criteria, device performance metrics, or study designs with sample sizes, expert qualifications, or ground truth establishment for the Imation Trimax™ Cassette. The submission focuses on substantial equivalence to a predicate device and conformance to voluntary design standards.

Therefore, I cannot populate the table or answer the questions with the requested level of detail regarding performance data.

However, based on the limited information provided, here's what can be inferred:

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)
No information provided. The submission relies on conformance to voluntary standards and comparison to a predicate device, rather than a specific performance study with a test set.

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, as no specific performance study with a test set requiring expert ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was mentioned. The device is a radiographic film cassette, not an AI-powered system for image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical component, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no specific performance study with a test set requiring ground truth is described. The "ground truth" for the submission is based on the established safety and effectiveness of the predicate device and the adherence to relevant industry standards.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI model requiring a training set.

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

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Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening shortening femur reconstruction following turnor resection and grafting. fractures in osteoporotic bone: severely comminuted shaft fractures, pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.

Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.

Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.

The TriMax Nail System is intended to be removed upon fracture healing.

The TriMax Nail System includes femoral nails and screws. All components are manufactured from stainless steel.

This document, "Summary of Safety and Effectiveness TriMax Nail System," describes a medical device, the TriMax Nail System, and its substantial equivalence to other systems. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The document is a traditional 510(k) summary for a medical implant (nail system) from 1996. It focuses on:

• Substantial Equivalence: Comparing the TriMax Nail System to existing, legally marketed predicate devices, a common pathway for medical device approval.
• Device Description: What the device is made of and its components.
• Indications for Use: The medical conditions the device is intended to treat.
• Mechanical Testing: Confirmation that the physical implant can withstand "normal in vivo loading."

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC/standalone studies because this document is not about an AI/ML powered medical device and does not present data in that format.

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