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The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia.

The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.

The United Orthopedic Knee Patient Specific Instrumentation is comprised of: United Orthopedics (UO) surgical guides (hardware), anatomical models (physical replica), Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine (software), and Intelligent Surgery Knee Implant Recognition Engine (software). Enhatch is responsible for design and development of all three components of the system.

The subject device is intended to facilitate the implantation of the U2 Knee protheses under the U2 Knee System developed and distributed by United Orthopedics Corporation: U2 Total Knee System.

[THE SOFTWARE]

The Intelligent Surgery Knee Segmentation Engine consists of two imaging modalities, CT (Knee CT Segmentation) and X-ray (Knee X-ray Segmentation). The Intelligent Surgery Knee CT Segmentation Engine and X-ray Segmentation Engine are web applications that use deep learning algorithms to detect and extract region of interest (ROI) information (femur and tibia) from medical imaging data (DICOM). The segmentation engines generate 3D models which can be used for treatment planning of Total Knee Arthroplasty (TKA), design of surgical guides, or generation of 3D printed anatomical models.

The Intelligent Surgery Knee Implant Recognition Engine is a web application that uses an optimization algorithm as a treatment planning tool for total knee arthroplasty. It assists in selecting implant size and position, from a range of implants of a total knee implant system, using a range of run parameters based upon the TKA surgical technique of that system. The software identifies anatomical landmarks of the patient's bony anatomy and articular surface topographies to reference the position and alignment of the femoral and tibial implant components. This positioning and alignment in turn allows for design of surgical guides and of the United Orthopedic Knee Patient Specific Instrumentation .

Note, these algorithms are static and non-adaptive; they do not alter their behavior over time based on user input.

[THE HARDWARE]

The UO surgical guides and anatomical models are patient-specific instruments designed to facilitate the implantation of the United Orthopedics Knee protheses. The UO surgical guides are designed based on preoperative plan generated by the software Intelligent Surgery Knee Implant Recognition Engine.

The provided text describes a 510(k) submission for the "United Orthopedic Knee Patient Specific Instrumentation" and highlights different performance tests conducted. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and general software verification and validation, rather than a detailed acceptance criteria table with reported device performance specifically for an AI algorithm's diagnostic or predictive capabilities.

The AI components mentioned are:

• Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine: Uses deep learning algorithms to detect and extract region of interest (ROI) information (femur and tibia) and generate 3D models.
• Intelligent Surgery Knee Implant Recognition Engine: Uses an optimization algorithm as a treatment planning tool for total knee arthroplasty, assisting in implant selection and position.

The information provided about the study mainly focuses on general software testing and system verification, not a specific study proving the AI's diagnostic/predictive accuracy against a gold standard in a clinical context, which is typically what is asked for in such acceptance criteria discussions for AI/ML medical devices.

Therefore, I cannot fully complete all sections of your request based on the provided text, especially regarding specific performance metrics for the AI components and clinical study details (e.g., MRMC study, human reader improvement).

Here's what can be extracted and inferred, along with what's missing:

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

The document lists general testing categories and states that the device "passed the acceptance criteria and demonstrated satisfactory performance per the intended use" for each. It does not provide specific quantitative acceptance criteria or reported numerical performance metrics for the AI algorithms (e.g., sensitivity, specificity, Dice score for segmentation, or accuracy of landmark detection against a ground truth). It describes the type of testing but not the results in detail.

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

• Sample Size: Not specified for any of the tests. The document generically mentions "specimens" and "cadaver specimens."
• Data Provenance: Not specified (e.g., country of origin).
• Retrospective or Prospective: Not specified. "Cadaver specimens" suggest an ex-vivo or lab-based study rather than a direct clinical study.

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 states "Full use simulations tests using cadaver specimens were performed by multiple surgeons to verify and validate the overall system performance."
• Number of experts: "Multiple surgeons," but no specific number is given.
• Qualifications: "Surgeons," but no specific experience or specialty (e.g., orthopedic surgeon, years of experience) is provided.
• It's unclear if these surgeons established the ground truth or simply evaluated the system's performance in a simulated setting. For segmentation or landmark detection, ground truth typically involves more rigorous, independently verified annotations.

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 MRMC study described. The focus appears to be on the system's accuracy in generating models and plans, rather than its impact on human reader performance in a diagnostic context. The "multiple surgeons" evaluating the system in the System V&V test is a system performance evaluation, not an MRMC study comparing human performance with and without AI assistance for a specific task.

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

• The "Segmentation System Testing" and "Software System Testing" sections likely represent standalone algorithm testing, where the algorithm's output (segmentation masks, 3D models, landmark detection accuracy) was compared against a reference.
• However, no specific performance metrics (e.g., accuracy, precision, recall, Dice score) are provided to quantify this standalone performance.

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

• The document implies that the ground truth for "Segmentation System Testing," "Model Verification Testing," and "Software System Testing" was based on established benchmarks, comparisons to expected outputs, or potentially expert-derived ground truth for the "accuracy" claims. However, the specific method (e.g., expert consensus, manual measurements, etc.) for establishing this ground truth is not explicitly stated.
• For the "System Verification and Validation Test" using cadaver specimens and surgeons, the "satisfactory performance" seems to imply that the surgeons found the system's output acceptable and accurate for surgical planning, but the method of establishing the "true" anatomical values or optimal plans as ground truth is not detailed.

8. The sample size for the training set

• Not specified. The document mentions the use of "deep learning algorithms" but provides no details on the training data.

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

• Not specified. The document mentions deep learning but no details about the ground truth creation for training.

In summary, the provided FDA 510(k) summary focuses on general validation of a device that includes AI components, but it does not provide the highly specific, quantifiable details often required for AI/ML device submissions regarding their specific performance metrics, test set characteristics, or the rigorous establishment of ground truth that one would expect for a diagnostic AI algorithm. This submission appears to be more focused on the overall system's functionality and its role in surgical planning rather than a detailed clinical validation study of the AI's diagnostic capabilities.

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The device is indicated for use in hip arthroplasty in patients with the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid arthritis or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery.
   This device is a single use implant and intended for cemented stem which is designed for cemented use only.
   In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.

The Subject device is a size extension to the previously cleared U2 Femoral Head (K162957). The design, manufacturer, materials, manufacturing progress, sterilization of this subject are identical or similar to its primary and additional predicates.
Ceramic femoral head, delta, 22mm (Subject device) is manufactured from zirconia-toughened alumina ceramic is available in +1, +3 and +5 mm of neck length. This device is intended to articulate with U2 Bipolar Implant, 22mm I.D (K152439) and can be used in conjunction with United titanium Hip Stem. Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti porous coated Stem (K003237, K151316), Ti Press-fit Stem (K111546), Revision Hip Stem (K062978), UTS Stem (K172251), UTF Stem (K110245, K163193, K123550, K132207) and Conformity stem (K183312). The size extension does not affect the intended use or alter the fundamental scientific technology of the device.
Surgical procedures with the use of the subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided text is a 510(k) summary for a medical device (United U2 femoral head, 22mm delta ceramic head) seeking substantial equivalence to predicate devices. It does not describe an AI medical device or a study involving human readers or a training/test set for an algorithm.

Therefore, most of the requested information regarding AI device performance, expert consensus, MRMC studies, and training/test set details cannot be extracted directly from this document.

However, I can extract the acceptance criteria and performance analysis conducted for this specific medical implant device.

Analysis of the Provided Document (Non-AI Medical Device)

The document describes the performance analysis for a ceramic femoral head (a medical implant) to demonstrate its substantial equivalence to previously cleared devices. The "acceptance criteria" here refer to the predefined standards for the engineering tests conducted on the physical device.

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: Not explicitly stated. The document refers to "engineering analysis" and testing of "subject components," which typically involves a specific number of physical samples for mechanical tests.
• Data Provenance: Not applicable in the context of an AI device. For this physical implant, the "data" would be the results of the mechanical tests performed in a lab setting. No information about country of origin or retrospective/prospective nature is relevant here.

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

• This is not applicable as the document describes mechanical testing of a physical implant, not an AI device requiring expert-established ground truth. The "ground truth" here is the physical performance measured against established ISO/ASTM standards.

4. Adjudication method for the test set

• This is not applicable as the document describes mechanical testing of a physical implant, not an AI device for diagnostic or prognostic purposes. The performance is adjudicated against the predefined limits in the engineering standards.

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, an MRMC study was not done. This document is for a medical implant, not an AI device.

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

• Not applicable. This document is for a medical implant, not an AI device.

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

• For this physical medical implant, the "ground truth" implicitly refers to the established mechanical and material performance standards (ISO and ASTM). The device's performance is compared against the limits defined in these engineering standards.

8. The sample size for the training set

• Not applicable. This document is for a medical implant, not an AI device which requires a training set.

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

• Not applicable. This document is for a medical implant, not an AI device which requires a training set.

Summary for the AI context:

The provided document describes the regulatory clearance for a physical medical implant (femoral head), not an AI medical device. Therefore, the specific information requested about AI acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not present in this text. The "acceptance criteria" discussed are engineering specifications for the mechanical performance of the physical implant, and the "study" is the mechanical engineering analysis and testing.

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The United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. These face masks are single-use, disposable devices, provided non-sterile.

The United Sewing High Fluid Resistant Disposable Face Mask is a single use, disposable, nonsterile face mask intended to cover the nose and mouth of the wearer. The subject device consists of 3 layers with the outer and inner layer made with polypropylene spunbound material and middle layer made with polypropylene melt blown material, The device has a bendable nosepiece made with Polyethylene coated single wire, and ear loops made from nylon and spandex material. This device will be provided over the counter under the trade names United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Face Mask and United Sewing High Fluid Resistant Procedure Face Mask for marketing purpose. This device is not made with natural rubber latex.

The FDA 510(k) summary for K202697 provides detailed acceptance criteria and the results of non-clinical studies for the United Sewing High Fluid Resistant Disposable Face Mask, Surgical Mask, and Procedure Mask.

1. Table of Acceptance Criteria and Reported Device Performance

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United Urologics Intermittent Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

The United Urologics Intermittent Catheter is a sterile, single use, disposable, urinary incontinence device designed to drain urine from the bladder. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter may be provided with a funnel bonded to the end of the catheter tube opposite the tipped end. During use, the funnel or flared end of the catheter may be attached to a universal adapter to facilitate drainage of the urine into a standard urinary collection bag (the collection bag and universal adapter are not part of this device).

The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facilitate drainage of urine from the bladder.

This document is a 510(k) summary for the United Urologics Intermittent Catheter, establishing its substantial equivalence to a predicate device. It does not contain information about a specific study testing the device against acceptance criteria in the context of AI/machine learning performance. The information provided relates to the regulatory submission for a medical device.

Therefore, many of the requested categories are not applicable to the content provided.

However, I can extract information related to the device's performance characteristics and testing as described for its regulatory approval.

Here's the breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI/ML context:

1. Table of acceptance criteria and reported device performance:

The document describes the device's technical characteristics and how it was tested according to relevant international standards. It doesn't present a table of specific acceptance criteria in the format of "metric X value must be > Y" with a corresponding "device achieved Z." Instead, it states that the device was designed and tested in accordance with specified standards.

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

• Sample Size: Not specified in the document. The text refers to "testing" that was "completed" but does not provide details on sample sizes for biocompatibility, sterilization, or functional tests.
• Data Provenance: Not specified. This document is a regulatory submission, not a research paper detailing study methodology origins.

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

• N/A. This is a medical device approval document, not an AI/ML study involving expert ground truth establishment for a test set. The "ground truth" for this device's performance relies on its physical and functional characteristics meeting engineering and safety standards.

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

• N/A. Not relevant for this type of device and regulatory submission.

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

• N/A. This document pertains to a physical medical device (intermittent catheter) and does not involve AI or human readers.

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

• N/A. This document pertains to a physical medical device and does not involve an algorithm.

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

• The "ground truth" for this device is based on compliance with established international engineering and safety standards for medical devices (e.g., BS EN 1616, BS EN 1618, ISO 10993, ANSI/AAMI/ISO 11135). For biocompatibility, this would involve laboratory test results (e.g., cytotoxicity assays, irritation tests). For sterilization, it would involve sterility assurance level (SAL) validation.

8. The sample size for the training set:

• N/A. This document does not concern an AI/ML device that requires a training set.

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

• N/A. This document does not concern an AI/ML device.

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United Urologics Closed System Intermittent Catheterization kit is intended to be used to drain urine from the patient's bladder into a collection bag.

The United Urologics Closed System Catheter is a pre-lubricated sterile, single use, disposable, urinary incontinence device designed to drain urine from the patient's bladder into a urine collection bag. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter is provided with a funnel bonded to the end of the catheter tube opposite the tipped end. The catheter is prelubricated with a water soluble lubricant and sealed in a urine collection bag. It is designed with a molded silicone tip at the top of the bag which acts as an introducer sheath for the tip of the catheter. This introducer and holding mechanism on the inside of the bag, provide a mechanism for inserting and advancing the catheter to the bladder without direct hand contact to the catheter.

The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facility to facilitate drainage of urine from the bladder.

The provided text is a 510(k) summary for a medical device (United Urologics Closed System Catheter). It describes the device, its intended use, and comparative information with a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device.

The document primarily focuses on:

• Regulatory information: Device classification, product code, regulations.
• Predicate device comparison: Highlighting similar technological characteristics and materials.
• Performance characteristics (non-AI/ML): Functionality, biocompatibility, and sterilization, all conforming to established international standards for physical medical devices, not AI/ML performance.

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and study details for an AI/ML device.

The questions you asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set sample size) are highly relevant for the evaluation of AI/ML-driven medical devices. However, this document is about a traditional physical medical device (a catheter) and does not involve AI/ML.

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This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

This device is intended for cemented use only.

This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640). The materials; design, safety and effectiveness of this subject is identical to the previously cleared femoral components - PS type of "UNITED" U2 Total Knee System (available in sizes #1~#6 ranging from 52mm/ 56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.

The provided text describes a 510(k) summary for a medical device, the U2 Femoral Component, PS, #7, which is an additional size extension to an existing knee prosthesis.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are qualitative statements indicating that tests were completed and demonstrated safety and effectiveness.

The study that "proves the device meets the acceptance criteria" is described as the completion of these performance tests as "part of the design assurance process." The conclusion derived is that the device is "substantially equivalent to the predicate device."

Additional Requested Information:

Since this document is a 510(k) summary for a medical device (a knee prosthesis component), the requested information typically relates to AI/software performance studies. This document does not describe an AI or software-based device, but rather a physical implant. Therefore, many of the questions regarding AI-specific study details (such as sample size for test/training sets, experts for ground truth, MRMC studies) are not applicable in this context.

However, I will address what can be inferred from the provided text in relation to these points:

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

• Not applicable for AI/software. For the physical device, mechanical and material tests were performed. The "test set" would refer to the number of components tested for each performance metric (e.g., how many components underwent fatigue testing). This detail is not provided in the summary.
• Data provenance: The testing was part of the "design assurance process" presumably conducted by the manufacturer, United Orthopedic Corporation, based in Hsinchu, Taiwan.

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

• Not applicable for AI/software. For a physical implant, ground truth is established through engineering and biomechanical principles and standardized testing methods (e.g., ASTM F75 for Co-Cr-Mo alloy). Expert consensus in the traditional sense of clinical imaging interpretation is not relevant here.

4. Adjudication method for the test set:

• Not applicable for AI/software. For mechanical testing, adjudication would involve interpreting test results against engineering specifications or established standards, rather than clinical consensus.

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

• Not applicable. This device is a physical knee implant, not an AI or software diagnostic tool. No human reader study with or without AI assistance would be relevant for demonstrating its performance.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used:

• For mechanical and material properties, the ground truth is based on engineering standards, biomechanical principles, and performance characteristics established for predicate devices. For example, the Co-Cr-Mo alloy conforms to ASTM F75.

8. The sample size for the training set:

• Not applicable. This device is a physical knee implant, not an AI/ML algorithm requiring a training set.

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

• Not applicable. (See point 8)

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This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.

"UNITED" 36 mm Ceramic Femoral Head – Delta is an additional size extension to the previously cleared "UNITED" Ceramic Femoral Head (K103497). The materials, design, safety and effectiveness of this subject are identical to the previously cleared Ceramic Femoral Head - Delta Components (available in sizes 28 mm and 32 mm), except for its larger diameter (available in sizes 36 mm). 36 mm Ceramic Femoral Head - Delta manufactured from zirconia-toughened alumina ceramic is available in -3, +1, +5 and +9 mm of neck length. This device is intended to articulate against XPE cup liners (K111546) and can be used in conjunction with U2 Acetabular Cups and U2 Hip Stem made of titanium. U2 Acetabular Cups include U2 HA/Ti Plasma Spray Cup (K050262). U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Cup (K111546), while U2 Hip Stem include HA/Ti Plasma Spray Stem (K003237), Ti Porous Coated Stem (K003237), Ti Plasma Spray Revision Stem (K062978), Ti Press-fit Stem (K111546) and UTF Stem (K110245). The size extension does not affect the intended use of the device or alter the fundamental scientific technology of the device.

This document describes the acceptance criteria and the study conducted for the "36 mm Ceramic Femoral Head, Delta" device (K112463).

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly detail specific quantitative acceptance criteria or a performance table for the "36 mm Ceramic Femoral Head, Delta" device in terms of clinical outcomes or specific thresholds for mechanical tests. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

The performance data section states: "This 510(k) was prepared in accordance with 'Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems'. Burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test. completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

This implies that the acceptance criteria for each of these tests were met by comparing the results to those of the predicate devices or to established industry standards outlined in the referenced guidance document. Without the specific guidance document or detailed test reports, the precise numerical acceptance criteria and the exact reported performance cannot be extracted from the provided text.

However, based on the text, the following can be inferred:

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

The text does not specify the exact sample sizes used for each of the "burst test, fatigue test, burst test for post-fatigue, rotational resistance test and pull-off test." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "completed as part of the design assurance process." Given the nature of these tests for an orthopedic implant, they would typically be laboratory-based mechanical tests performed on newly manufactured devices.

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

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study described is a mechanical performance study, not one requiring adjudication by human experts.

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 and not provided in the document. The device is a physical orthopedic implant, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This information is not applicable and not provided in the document. The device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests (burst, fatigue, rotational resistance, pull-off) would be the objective, quantitative measurements derived from the tests themselves, as compared against established engineering standards and performance of legally marketed predicate devices. It is based on objective physical properties and not on expert consensus, pathology, or outcomes data in the context of this specific 510(k) submission for mechanical properties.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The described study is a mechanical performance evaluation of an orthopedic implant, not a machine learning model that requires a training set.

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

This information is not applicable and not provided in the document, as there is no training set mentioned.

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This device is indicated for use in total hip arthroplasty or bipolar arthroplasty undergoing primary and revision surgery for the following conditions:

• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia
• Inflammatory degenerative joint disease such as rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
• Revision procedures where other treatments or devices have failed

UTF Stem is designed for cementless use.

UTF Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A1-4V alloy conforming to ASTM F 620 and the proximal part of each femoral stem is coated with CP Ti plasma spray. The net-shape of stem was forged by the titanium bar (ASTM F136). Circumferential titanium plasma coating sprayed with CP Ti powder (ASTM F1580) provides biological fixation. This device is collarless to allow for self-seating of the implant between the lateral and medial cortices of the femoral canal. UTF Stem is available with standard offset and high offset options to restore hip biomechanics. Each type of offset is available in 10 sizes ranging.

For total hip replacement, UTF Stem can be used in conjunction with UNITED Femoral Head (K994078, K022520 and K111546), U2 Acetabular Cup Liner (K050262), XPE Cup Liner (K111546), U2 HA/Ti Plasma Spray Cup (K050262), U2 Ti Plasma Spray Cup (K050262) and U2 Ti Porous Coated Cup (K111546). As using with the U2 Acetabular Cup Liner (K050262), UTF Stem can be used with 26 mm and 28 mm Femoral Head (K994078 and K022520) and 28 mm ceramic Femoral Head (K103479). As using with XPE Cup Liner (K111546), UTF Stem can be used with 28 mm, 32 mm and 36 mm metal Femoral Head (K022520, K111546), and 28 mm and 32 mm Ceramic Femoral Head (K103479). Only U2 Ti Porous Coated Cup (K111546) and XPE Cup Liner (K111546) can be used in conjunction with the 32 mm and 36 mm Femoral Head (K111546, K103479). For bipolar hip replacement, UTF Stem also can be used in conjunction with 26 mm. 28 mm. 32mm and 36mm Femoral Head (K994078, K022520, K111546) and Bipolar implants (K050269, K101670). UNITED Femoral Head and Binolar Cap are made of Co-Cr-Mo alloy, while Ceramic Femoral Head is manufactured from alumina. Acetabular Cup Liner and Bipolar Cap Liner are made of UHMWPE, while U2 Acetabular Cup shells are manufactured from forged Titanium alloy.

The provided text describes a 510(k) summary for the "UTF Stem" total hip prosthesis. The acceptance criteria and supporting studies are limited to bench testing to demonstrate substantial equivalence to predicate devices. It does not contain information about clinical studies with human participants, expert review processes, or multi-reader multi-case studies.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the 510(k) was prepared in accordance with several guidance documents, including "Class II Special Controls Guidance Document-Hip Joint Metal Polymer Constrained Cemented or Uncemented Prosthesis" and "Guidance for Non-clinical Information for Femoral Stem Prostheses." This implies that the tests performed adhered to the acceptance criteria outlined in these guidance documents, even if the specific numerical thresholds are not explicitly listed in this summary. The successful clearance by the FDA (K110245) indicates that the device was deemed to meet these criteria.

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

• Sample Size: Not specified. The document only mentions that the listed tests "have been performed." For bench testing, the sample size would typically refer to the number of physical samples of the device components tested for each specific test.
• Data Provenance: Not applicable in the context of clinical data. For bench testing, the data would originate from laboratory experiments conducted by the manufacturer or a contracted lab. The manufacturer is United Orthopedic Corporation, located in Hsinchu, Taiwan.

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

• Not applicable. This summary only describes non-clinical, bench testing. There is no indication of a "ground truth" established by human experts for these mechanical or material property tests. The "ground truth" for bench tests is typically defined by engineering specifications, material standards (e.g., ASTM), and regulatory guidance documents.

4. Adjudication Method for the Test Set

• Not applicable. This summary pertains to non-clinical bench testing, where adjudication by multiple experts is not typically a component of determining test outcomes.

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

• No. This document focuses solely on the substantial equivalence through bench testing (mechanical and material properties) of a hip prosthesis. It does not involve human readers or image interpretation, thus no MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not a software algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the bench tests would be the established performance criteria and thresholds defined in relevant ASTM standards (e.g., ASTM F 620, ASTM F136, ASTM F1580), FDA guidance documents (e.g., "Guidance for Non-clinical Information for Femoral Stem Prostheses"), and the manufacturer's internal design specifications for a hip prosthesis.

8. The Sample Size for the Training Set

• Not applicable. This report describes the performance of a physical device, not an AI or machine learning model that would require a training set.

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

• Not applicable. As above, there is no training set for a physical medical device.

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This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device system is designed for cemented use only.

U2 XPE Total Knee System includes U2 XPE tibial inserts and U2 XPE patellar components of a Total Knee System.

U2 XPE tibial inserts are intended to be used with the cemented U2 femoral components (K051640) and the cemented U2 tibial tray (K051640) in total knee arthroplasty. U2 XPE tibial inserts will be made in Cruciate Retaining (CR) and Posteriorly Stabilized (PS) designs.

If replacement of the articular surface of the patella is required, U2 XPE patellar components are intended to be used with any one of the "UNITED" femoral components (K021657, K051640, K082424) in total knee arthroplasty. U2 XPE patellar components are available in Onset with three pegs and Inset with one peg designs. The all polyethylene patellar components are intended for implantation with bone cement only.

The geometric design and size distribution of U2 XPE tibial inserts are identical to the previously cleared tibial inserts of U2 Total Knee System (K051640). The geometric design and size distribution of U2 XPE Onset patellar components and Inset patellar components are identical to the previously cleared U2 patellar components (K051640) and UKNEE patellar components (K021657) respectively. U2 XPE tibial inserts and patellar components are manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834. The manufacturing processes are identical to the predicate devices tibial inserts and patellar components (K051640, K021657), except for the addition of irradiating the polyethylene and melt annealing steps to reduce free radicals of material. The irradiated UHMWPE material has been assessed according to the tests recommended in ASTM F2759.

The provided text describes the U2 XPE Total Knee System, a medical device. However, it does not contain specific acceptance criteria (numerical thresholds for performance) or detailed study results that demonstrate the device meets such criteria. Instead, it states that "Testing and analysis includes locking strength, range of motion and constraint, fatigue strength, wear simulation test, and materials properties of the U2 XPE Total Knee System, have been completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device." This indicates that tests were performed, but the acceptance criteria met and the detailed results are not provided in this summary.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set," "Number of experts used to establish ground truth," and "Adjudication method," the information is not available in the provided document.

Here's what can be extracted based on the provided text:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It describes laboratory testing ("wear simulation test," "fatigue strength," etc.), rather than clinical trials with human subjects.

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

• Number of Experts: Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.
• Qualifications of Experts: Not applicable.

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

• Not applicable, as this refers to laboratory-based performance testing, not human-adjudicated clinical data.

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, an MRMC comparative effectiveness study was not done. This device is a total knee system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This device is a total knee system, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance testing of this device would be defined by engineering and biomechanical standards (e.g., ASTM F2565, ASTM F648, ISO 5834, ASTM F2759), which are used to evaluate characteristics like material properties, wear, and mechanical strength. The results are compared against these predetermined specifications to ensure safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This device is a total knee system and its performance evaluation involves physical and mechanical testing, not a machine learning model that requires a training set.

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

• Not applicable. (See #8)

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This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement in skeletally mature patients with the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

"UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface between femoral head and U2 Bipolar Implant, is a hemiarthroplasty design. U2 Bipolar Implant consists of an outer shell into which a bearing insert has been permanently assembled. The bearing insert has a factory assembled stopper ring and metal wire. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surfaces of the bipolar hip prosthesis are highly polished for articulation with the patient's acetabulum. Components are available in a range of sizes to fit varying anatomical requirements. U2 Bipolar Implant are offered in 41-73 mm outer diameters and is designed to be used with either 26mm, 28mm, or 36 mm femoral heads, depending on the inner diameter liner. The minimum thickness of the polyethylene at its thinnest point at a load bearing area of the liner is at lest 5.mm in U2 Bipolar Implant.

The provided 510(k) summary for the U2 Bipolar Implant (K101670) does not contain the detailed information requested regarding specific acceptance criteria, study designs, sample sizes for test sets, expert qualifications, or ground truth establishment.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (U1 Hip System - Bipolar (K050269) and "Wright" GLADIATOR Bipolar System (K062693)) through device description, intended use, and a limited set of performance bench tests.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

Note: The document only lists the types of performance tests performed, not specific quantitative acceptance criteria or the numerical results of those tests. The basis for acceptance appears to be substantial equivalence to predicate devices, meaning the U2 Bipolar Implant performs similarly to the U1 Hip System - Bipolar and the "Wright" GLADIATOR Bipolar System for these tests.

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

The document only mentions "Performance Test - Bench" and lists two tests. It does not specify any sample sizes for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These were likely conducted in vitro (bench tests) rather than using patient data.

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

This information is not provided as the tests described are bench tests and do not involve human expert assessment for ground truth.

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

This information is not applicable and not provided as the tests described are bench tests and do not involve human adjudication.

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 and not provided. This submission is for a physical orthopedic implant, not an AI-assisted diagnostic device or software that would involve human readers.

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

This information is not applicable and not provided. This submission is for a physical orthopedic implant, not an algorithm or software.

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

For the bench tests mentioned, the "ground truth" would be the engineering specifications and design requirements for the locking mechanism and range of motion for hip implants, which are typically established through industry standards, regulatory guidance, and comparisons to predicate devices. The document does not explicitly state the type of ground truth used but implies adherence to established engineering principles for orthopedic devices.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical hip implant, not an AI model that requires a training set.

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

This information is not applicable and not provided. The device is a physical hip implant, not an AI model.

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