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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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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.

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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