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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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For E-XPE Insert (CR, PS and UC type) and Patella:
The 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 a single use implant and intended for cemented use only.

For E-XPE Insert (PSA type)
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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended for cemented use only.

The subjected device includes E-XPE Tibial insert (CR, PS, UC and PSA type) and E-XPE Patella. It is an extension to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System.

The provided document is a 510(k) summary for the U2 Total Knee System E-XPE Products. It focuses on demonstrating substantial equivalence to pre-existing predicate devices for a medical device, specifically a knee implant. As such, it details pre-clinical performance data (mechanical tests) and explicitly states "None provided" for clinical performance data.

Therefore, it does not contain the information required to answer the prompt, which is about acceptance criteria and study results for an AI/algorithm-based medical device. The prompt is looking for details about an AI's performance, such as:

• Accuracy/performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test and training sets related to image or data analysis
• Ground truth establishment by expert readers or pathologists
• Human-in-the-loop studies (MRMC studies)
• Adjudication methods for AI performance validation

None of this type of information is present in the provided text, as it describes a physical implant and its material/mechanical testing.

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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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance.

"UNITED" U2 Total Knee System – PSA Type, Offset Stem Adapter is a modification of cleared Offset Stem Adapter (K082424). This device is manufactured from Ti-6AI-4V alloy (ASTM F136) and identical to the previously cleared offset stem adapter. The Offset Stem Adapter is intended for use in patients with inadequate bone stock. It allows the stem extension to be positioned away from the center of femoral or tibial component, and to center the stem extension within the bone medullar canal. There are three available offset sizes for the subjected device including 2, 4 and 6mm. It is able to be assembled with the femoral component, tibial baseplate and stem component utilizing Morse taper locking mechanism, and the Morse taper design is identical to our cleared Offset Stem Adapter (K082424). The modification 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) premarket notification for a medical device, specifically the "U2 Total Knee System - PSA Type, Offset Stem Adapter." The documentation focuses on demonstrating substantial equivalence to predicate devices and includes a section on performance data.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the fatigue strength test. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for this test.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated through engineering tests (fatigue strength), not clinical studies requiring expert ground truth for interpretation of medical data.

4. Adjudication method for the test set

Not applicable, as the evaluation is based on a fatigue strength test rather than subjective interpretation requiring adjudication among 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

Not applicable. This document pertains to a mechanical knee implant, not an AI-powered diagnostic device.

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

Not applicable. This document pertains to a mechanical knee implant, not an algorithm.

7. The type of ground truth used

For the fatigue strength test, the "ground truth" would be the engineering standards and specifications against which the device's performance is measured. The document implies that the device met these standards, leading to the conclusion that it is "safe and effective."

8. The sample size for the training set

Not applicable. This document pertains to a mechanical knee implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is a mechanical device, not an AI system with a training set.

Summary of the Study:

The primary study mentioned to prove the device meets acceptance criteria is a fatigue strength test. This test was conducted to evaluate the structural integrity and durability of the Offset Stem Adapter. The report concludes that "the test result demonstrated that this device is safe and effective."

The basis for substantial equivalence is primarily focused on the device's similarity in intended use, raw material, design rationale, and sterilization method to previously cleared predicate devices (K082424, K093293, and K102437). This suggests that the fatigue strength test was likely performed to confirm that the modifications (specifically, the different offset sizes) did not negatively impact the mechanical performance compared to the predicate 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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Stem - PSA Type is included in U2 Total Knee System-PSA type. U2 Total Knee System-PSA type is indicated for use in skeletally mature patients with severe knee pain and disability undergoing surgery for knee arthroplasty 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. U2 Total Knee System-PSA type is designed for cemented use only.

"UNITED Stem-PSA Type is an additional size extension of stem to the existing, previously cleared "UNITED" U2 Total Knee system product line (K082424). The materials, design, safety and effectiveness of this subject are identical to the previously cleared U2 Total Knee system. The only difference from the existing products is the length of stem. This subject stem made of Ti-6A1-4V alloy and will be offered in two types which include straight stem and curved stem. The length of extended straight stem distribute to 150, 200 and 240mm, while the curved stem has 240mm only. Each size of stem has fifteen options in diameter which ranging from 10mm to 24mm. Canal filling stems with spline and flute design provide immediate rigid fixation and resistance to torsional movements. Distal taper is designed to address the problems associated with proximal stress shielding, resulting from distal fixation.

The provided text describes a 510(k) premarket notification for a medical device called "Stem, PSA Type" (K100981). This document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and testing methodology as one might find for a novel diagnostic or AI-driven device.

Therefore, many of the requested elements (sample size of test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details, etc.) are not applicable or not provided in this type of submission.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Indications for use
• Materials
• Design
• Manufacturing process
• Sterilization
• Comparable locking strength of Morse Taper | The subject device ("Stem, PSA Type") is stated to be identical to the previously cleared "UNITED" U2 Total Knee system in terms of materials, design, safety, and effectiveness, except for the length of the stem.
  The subject device's larger stem lengths (straight stem: 150, 200, 240 mm; curved stem: 240 mm) are substantially equivalent to:
• "UNITED" U2 Total Knee system - PSA Type (straight stem: 30, 75, 100 mm; curved stem: 150, 200 mm)
• "DEPUY" Anatomic Modular Knee (AMK) System (K864671) for the straight stem.
• "SMITH & NEPHEW" LEGION Revision Knee System (K043440) for the curved stem.
  Locking strength test of Morse Taper demonstrated the device is safe and effective and substantially equivalent to the predicate device. |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable/not provided. This submission is for a new size extension of an existing mechanical implant, relying on substantial equivalence to predicates, not a clinical trial or performance study requiring a test set of patient data.
• Data Provenance: Not applicable/not provided. There are no patient data used for "testing" in the traditional sense. The data relates to mechanical property testing.

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

• Not applicable/not provided. Ground truth, in the context of patient data, is not established for this type of submission. The evaluation is based on engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging reader.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a mechanical implant, not an algorithm.

7. Type of Ground Truth Used

• Not applicable in the conventional sense. The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearances and the engineering standards applied to their design, materials, and manufacturing. For the specific performance data mentioned (locking strength), the ground truth would be established mechanical engineering standards for such components.

8. Sample Size for the Training Set

• 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

• Not applicable/not provided.

Summary of the Study (Performance Data):

The "study" referenced in the 510(k) is a locking strength test of the Morse Taper. This mechanical test was performed as part of the design assurance process. The purpose was to demonstrate that the expanded stem sizes maintain similar safety and effectiveness characteristics to the predicate devices. The document states that this test demonstrated the device is safe and effective and is substantially equivalent to the predicate device in this regard. No specific acceptance values or detailed test results are provided in this summary, but the conclusion of substantial equivalence is drawn based on these tests.

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