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Ultra-Fast Vitri is indicated for use in the preparation, vitrification and storage of oocytes (MII).
Ultra-Fast Warm is indicated for use in the preparation and warming of vitrified oocytes(MII).

The Ultra-Fast Vitri and Ultra-Fast Warm is composed of a set of three media to vitrify and warm oocytes for assisted reproductive technology (ART) procedures.

The Ultra-Fast Vitri includes two components, Equilibration Solution (ES) and Vitrification Solution (VS), containing the cryoprotectants ethylene glycol and dimethyl sulfoxide. There are two vitrification procedures to choose from. During the vitrification process, oocytes are first exposed to ES then in VS within several minutes. Using this methodology, permeating cryoprotectants can replace water in the oocytes prior to vitrification and storage in liquid nitrogen. The Ultra-Fast Vitri comes prepackaged with 1.5 mL vial or 4 mL vial of ES, three 1.5 mL vials or three 4 mL vials of VS.

Ultra-Fast Warm is composed of one media used for warming and removing cryoprotectants from vitrified oocytes. It is composed of Thawing Solution (TS). The Ultra-Fast Warm comes pre-packaged with four 4.0 ml vials of TS.

All the media in the Ultra-Fast Vitri and Ultra-Fast Warm contain Gentamicin. The media undergoes aseptic filtration, while the vials are sterilized by radiation.

Based on the provided FDA 510(k) Clearance Letter, here's a description of the acceptance criteria and the study that proves the device meets them:

Device: Ultra-Fast Vitri; Ultra-Fast Warm
Description: A set of three media used for the vitrification (cryopreservation) and warming of oocytes (MII) for Assisted Reproductive Technology (ART) procedures.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device, as demonstrated through non-clinical and clinical performance data, revolve around its biological compatibility and effectiveness in preserving and recovering oocytes without compromising their viability or subsequent reproductive outcomes.

Study Proving Device Meets Acceptance Criteria

The provided document describes both non-clinical (bench) and clinical performance studies to demonstrate the safety and effectiveness of the Ultra-Fast Vitri and Ultra-Fast Warm device and its substantial equivalence to the predicate device.

1. Non-Clinical Performance Data (Bench Testing):

• Description: A series of laboratory tests conducted directly on the media to confirm its physical, chemical, and biological properties.
• Specific Tests: Color/Appearance, pH Testing, Endotoxin testing, Osmolality Testing, Sterility Testing, Gentamicin Test, Initial Media Dispensing Validation, Mouse Embryo Assay (MEA), and Biocompatibility.
• Proof of Concept: The device passed all these tests, including achieving >80% one-cell development in the Mouse Embryo Assay, which is a critical biological performance indicator for reproductive media as per FDA guidance.

2. Clinical Performance Data:

• Study Design: A comparative study referenced from literature that evaluated the effectiveness of the ultra-fast vitrification and warming protocols using the subject device against conventional protocols (presumably using the predicate or similar conventional vitrification/warming solutions).
• Study Objective: To demonstrate comparable outcomes (oocyte survival, clinical pregnancy, live birth rates) between the ultra-fast protocol and conventional protocols.

Here's a breakdown of the specific requested information about the clinical study:

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

  • Sample Size: 1,077 mature oocytes in total.
    • 519 oocytes for the conventional vitrification and warming protocols group.
    • 558 oocytes for the ultra-fast protocols (subject device) group.
  • Data Provenance: The document states "The referenced literature used Kitazato's vitrification and warming solutions (K171748 and K160864)".
    • It does not explicitly state the country of origin of the data.
    • It does not explicitly state if the study was retrospective or prospective. However, given it's a "study" comparing protocols, it's typically prospective, but this cannot be confirmed from the text.

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

  • This information is not provided in the document. The study focuses on clinical outcomes (survival, pregnancy, live birth rates) rather than human interpretation of images or other subjective assessments that would require expert consensus for ground truth.

• 4. Adjudication Method for the Test Set:

  • This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation where reviewer disagreement needs to be resolved (e.g., radiology studies). This study measures biological/clinical outcomes.

• 5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

  • No, an MRMC study was not done. MRMC studies are used to assess the impact of a device (often AI) on human reader performance, typically in diagnostic imaging. This study evaluated the direct clinical effectiveness of the media itself.
  • Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

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

  • Yes, in a sense, the clinical study assessed the "standalone" performance of the media with its associated protocols. It compared the outcomes from using the media (with its specific ultra-fast protocol) to conventional media/protocols. There isn't an "algorithm" in the traditional sense for this device; it's a chemical formulation and protocol. The "performance" is the biological outcome achieved by the oocytes.

• 7. The Type of Ground Truth Used:

  • The ground truth was based on clinical outcomes data:
    • Oocyte survival rate after vitrification and thawing.
    • Clinical pregnancy rate (following embryo transfer resulting from these oocytes).
    • Live birth rate (following clinical pregnancy).
  • These are considered objective biological and clinical endpoints.

• 8. The Sample Size for the Training Set:

  • This information is not applicable/not provided. This device is a media (consumable), not an AI algorithm that requires a separate "training set" of data. The "development" of the media and protocols would be based on laboratory research and refinement rather than a data training paradigm.

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

  • This information is not applicable/not provided for the same reasons as #8.

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The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.

The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."

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

Acceptance Criteria and Reported Device Performance

The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.

Study Details for Liver Elastography Optimization (SWE Performance Testing)

The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.

1. Sample Size Used for the Test Set and the Data Provenance:

   • Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
   • Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.

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

   • Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
   • Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.

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

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.

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

   • Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.

6. The Type of Ground Truth Used:

   • Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.

8. How the Ground Truth for the Training Set Was Established:

   • Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.

Summary regarding AI components:

While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.

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Unimed Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 30 kg and pediatric patients weighing 10-50 kg. These devices are for prescription use only.

The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with GE B40i, and are supplied non-sterile.

Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.

The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

Here's a breakdown of the acceptance criteria and the study details for the Unimed Reusable SpO2 Sensors, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

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

   • Sample Size: Twelve human adult volunteers were enrolled for the clinical study. The study contains more than the minimum 200 data points.
   • Data Provenance: The study was conducted on human adult volunteers and includes sufficient darkly pigmented subjects (three dark subjects with Fitzpatrick Type 5-6). It is a prospective clinical study. The country of origin is not explicitly stated but implies testing in a controlled clinical environment, likely linked to the manufacturer's location or a designated clinical trial site.

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

   • The document implies that arterial oxygen saturation (SaO2) as determined by co-oximetry was used as the ground truth. This is a direct measurement from blood samples. Therefore, typical "experts" in the sense of human readers adjudicating images are not applicable here. The accuracy of co-oximetry itself is the standard.

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

   • Not applicable. The ground truth (SaO2 by co-oximetry) is a direct, objective measurement, not subject to human interpretation or adjudication in the same way as an imaging study.

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

   • Not applicable. This device is a sensor (hardware) for SpO2 and pulse rate measurement, not an AI-assisted diagnostic tool or an imaging system that would involve human reader interpretation. No MRMC study was conducted.

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

   • Not applicable. The device is a sensor that measures physiological parameters. Its performance is inherent to its design and function, not an algorithm's performance. The "clinical test data" section describes the validation of the sensor's accuracy in vivo.

6. The type of ground truth used:

   • Arterial oxygen saturation (SaO2) as determined by co-oximetry. This is an objective "gold standard" for blood oxygen measurement.

7. The sample size for the training set:

   • Not applicable. This device is a hardware sensor, not a machine learning model that requires a training set. The clinical study described is for validation/testing, not training.

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

   • Not applicable, as there is no training set for this type of device.

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This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney.

The device is suitable for professional healthcare facility environments such as hospitals and clinics.

This product shall not be used for other purposes.

The Single-Use Video Flexible Cysto-Nephroscope mainly consist of insertion portion, handle and connector section which include a detachable video cable which connect the endoscope to the Endoscopic Video Image Processor.

The provided FDA 510(k) clearance letter and summary describe a physical medical device (Single-Use Video Flexible Cysto-Nephroscope), not an AI/ML-driven software device. Therefore, the information requested about acceptance criteria and studies (especially those related to AI performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a predicate device based on non-clinical performance testing of the physical properties and functionality of the endoscope itself. There is no mention of any AI component or software that processes images or provides diagnostic assistance.

Here's a breakdown of what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The proposed device has met the testing acceptance criteria in accordance with internal requirements and applicable standards to support substantial equivalence of the proposed device." However, it does not provide a specific table listing detailed acceptance criteria and the corresponding reported performance values for each physical test. It only lists the types of tests performed.

• Sterilization Validation:
  • Acceptance Criteria: Determined by ISO 11135:2014 half-cycle method to establish routine control and monitoring parameters.
  • Reported Performance: Method validated. (Specific parameters not provided).
• Shelf Life and Simulated Transportation Distribution followed by Sterile Packaging Integrity Test:
  • Acceptance Criteria: Validated according to ASTM F1980-21, ISO11607-1:2019, ISO11607-2:2019, ASTM F1929-23, ASTM F88/F88M-23, ASTM F1886/F1886M-16, ASTM D4169-23.
  • Reported Performance: Validated. (Specific results not provided).
• Performance Testing (using methods and acceptance criteria from K241500):
  • Surface and Edges:
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.
  • Deflection system and Fatigue test of Rocker and Bending Section: (Note: Downward deflection angle changed from 135° to 225° for all models).
    • Acceptance Criteria: Not specified but refers to previous submission K241500.
    • Reported Performance: Met testing acceptance criteria.

Information Not Applicable to this Device/Document (for AI/ML products):

The following points are typically relevant for AI/ML device submissions but are not found in this document because it pertains to a physical, non-AI medical instrument.

• Sample sized used for the test set and the data provenance: Not applicable. Evaluation was based on physical device testing, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI algorithm.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The study described is a non-clinical performance testing study for a physical medical device (endoscope), designed to demonstrate substantial equivalence to a previously cleared predicate device. It involves component and system-level testing of physical characteristics, sterilization, packaging integrity, and functionality based on established industry standards and previous submission's methodologies. There is no AI or software performance evaluation in this clearance.

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The DeepSight NeedleVue LC1 Ultrasound System is intended for use in Abdominal, Pediatric, Small Organ, Peripheral Vascular, Fetal, Urological, and Musculoskeletal Conventional and Superficial Imaging. This device is indicated for Prescription Use Only and by qualified healthcare professionals (HCPs). The DeepSight NeedleVue LC1 ultrasound system is intended to be used by qualified and trained physicians or sonographers with at least basic ultrasound knowledge. The operator must have read and understood the user manual. The DeepSight NeedleVue LC1 ultrasound system is intended to be used in medical practices and clinical environments including healthcare facilities, hospitals and clinics.

The DeepSight NeedleVue LC1 Ultrasound System is a general-purpose diagnostic ultrasound system that is mounted on a movable cart and has a mobile console that provides digital acquisition, processing, and display capabilities. The subject device has three major functional blocks that are consistent across ultrasound systems including the predicate:

• A front end, which includes a single curved (a.k.a. convex) array transducer and analog signal processing functions. This transducer transmits acoustic energy into the body and receives the resulting reflections, and performs the signal processing functions on them required to produce an ultrasound image (e.g., analog to digital conversion, noise filtering);
• A back end, which includes a user interface, memory, and export via USB. The user interfaces include a computer keyboard, standard ultrasound parameter controls, an LCD touch screen, acoustic output display and an LCD image display. The touch screen is divided into a display area and a user interaction area, and allows for patient data entry, transmit voltage adjustment, transducer/preset selection, depth and focus adjustment, annotation, freeze, image and clip capture, and measurements.
• Power systems which generate, regulate and supply the required voltages to the system parts.

The provided FDA 510(k) Clearance Letter for the DeepSight NeedleVue LC1 Ultrasound System does not contain acceptance criteria for device performance nor does it describe a study to prove the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Healthcare Logiq E9 Ultrasound System) based on:

• Intended Use and Indications for Use: Showing similarities in target patient populations and anatomical regions.
• Technological Characteristics: Comparing functional blocks, power sources, beamforming, controls, and display.
• Performance Testing (Non-clinical): Verifying compliance with relevant FDA guidance documents and recognized international standards for software, electromagnetic compatibility, thermal/mechanical/electrical safety, acoustic output, acoustic power, and reprocessing.

Therefore, it is not possible to provide the requested information based on the input document.

Here's why and what information is missing:

1. Acceptance Criteria and Reported Device Performance: The document lists various standards and guidance documents that the device's non-clinical performance testing complied with. However, it does not explicitly state specific acceptance criteria (e.g., image resolution in millimeters, signal-to-noise ratio in dB, penetration depth) for the DeepSight NeedleVue LC1 Ultrasound System and does not report quantitative data on how the device performed against any such criteria. It only states that the device was "found to have a safety and effectiveness profile that is similar to the predicate device."

2. Sample Size, Data Provenance, and Ground Truth for a Test Set (Clinical Study): The document explicitly states: "Clinical data was not required for this submission." This means there was no clinical study conducted to evaluate the device's performance in a real-world setting with patient data. Consequently, there is no information regarding:

   • Sample size used for a test set.
   • Data provenance (country, retrospective/prospective).
   • Number of experts or their qualifications.
   • Adjudication method.
   • Type of ground truth used.

3. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Since no clinical study was performed, an MRMC study comparing human readers with and without AI assistance was not conducted. The DeepSight NeedleVue LC1 is described as a general-purpose diagnostic ultrasound system, with no mention of AI features that would necessitate such a study.

4. Standalone Performance Study (Algorithm Only): The document describes the DeepSight NeedleVue LC1 as a general-purpose ultrasound system. While it mentions software testing, it does not describe an "algorithm only (standalone)" performance study in the context of diagnostic accuracy, as it's not an AI/CADe (Computer-Aided Detection) device in the sense that it provides an interpretation or analysis beyond standard imaging. The software testing mentioned relates to compliance with software life cycle processes, cybersecurity, and off-the-shelf software use.

5. Training Set Information: As no clinical study was reported and the device is a general-purpose ultrasound system (not an AI/ML-based diagnostic algorithm requiring a training set for diagnostic outcome prediction), there is no information about a training set, its sample size, or how its ground truth was established.

In summary, the provided document details a 510(k) clearance process based on substantial equivalence and compliance with non-clinical performance standards and guidance. It does not include information on clinical acceptance criteria or a study that specifically measures the device's performance against such criteria using patient data, as such a study was not required for this submission.

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U2 Total Knee System - PF+ 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 joint surface erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. Femoral Component, PF+, Tibial Baseplate, PF+, Tibial Extension Stem, Patella, Onset, E-XPE, PF+, and Patella, Asymmetric Onset, E-XPE, PF+ are indicated for both cemented and cementless use.

USTAR II Total Knee System

1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.
2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.
3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.
4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.
5. Joint instability resulting from excessive bone resection.

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and intended for cementless use only.

The subject PF+ Patella is a line extension of the U2 Total Knee System, and is compatible to the USTAR II System. The subject device, U2 Total Knee System–PF+ Patella; USTAR II System - PF+ Patella, is a Metal-Backed Patella, indicated for both cemented or cementless application. There are two variations available: (1) Patella, Onset, E-XPE, PF+, and (2) Patella, Asymmetric Onset, E-XPE, PF+. Patella, Onset, E-XPE, PF+ is a symmetric, dome-type metal-backed patella, and Patella, Asymmetric Onset, E-XPE, PF+ is an asymmetric, anatomic-type patella. Each type is available in five sizes. The body of PF+ patella is manufactured from Vitamin E blended highly cross-linked UHMWPE (ASTM F2695, ASTM F648/ISO5834-1), while the part of the metal back and the three pegs are produced by additive manufacturing according to the FDA guidance "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff", "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement", and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Post market Surveillance Requirements." The metal back is made of Ti-6Al-4V alloy (ASTM 2924) and has a porous Ti structure on the bone side, peg side, and poly side. All types of PF+ Patella are compatibility with "United" U2 Total Knee System-Femoral components (K051640, K120507, K140073, K140075, K150829, and K150832), Femoral component, PSA (K082424), Femoral components, PF+ (K221705), and USTAR II System-Femoral components (K190100).

The provided text is a 510(k) Clearance Letter from the FDA for a total knee system. It details the device's name, regulation, a summary of its description, intended use, and a comparison to predicate devices, along with a list of non-clinical tests conducted.

However, the document specifically states "No clinical data is necessary." This means that the clearance was not based on a clinical study demonstrating the device's performance against detailed acceptance criteria in human patients with the format typically requested in your prompt (e.g., sensitivity, specificity, human-in-the-loop performance, ground truth establishment by experts, etc.).

Instead, the clearance is based on the substantial equivalence of the new device to existing legally marketed predicate devices, primarily through non-clinical testing and technological comparison.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from a clinical study, as no such study was presented or required for this 510(k) clearance.

The "acceptance criteria" for this device, as implied by the FDA clearance, revolve around demonstrating that its technological characteristics and non-clinical performance are substantially equivalent to already cleared devices.

Here's what I can extract from the document regarding the non-clinical tests that functionally served as part of the "proof" that the device meets some form of performance criteria:

Summary of Non-Clinical Tests (Implicit Acceptance Criteria & Performance):

Since no clinical study was conducted or referenced in this 510(k) clearance documentation, the following points of your request cannot be addressed from the provided text:

• Sample size used for the test set and data provenance: Not applicable, as no clinical test set was used. The non-clinical tests were performed on device prototypes or samples.
• Number of experts used to establish the ground truth... / qualifications of those experts: Not applicable. Ground truth for clinical performance was not established.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards and methodologies (e.g., ASTM standards for material properties, mechanical testing protocols).
• The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

In essence, this 510(k) clearance is a regulatory determination of substantial equivalence based on non-clinical performance data and technological comparisons to predicate devices, not on a clinical trial demonstrating performance against specific diagnostic or treatment outcome acceptance criteria in humans.

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