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The KeYi Total Knee System indications for use are:

· Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.

• · Correction of functional deformities.
• · Post-traumatic loss of knee joint configuration and function.
• · Moderate valgus, varus, or flexion deformity.
• · Knee fractures untreatable by other methods.

The KeYi Total Knee System is indicated for cemented use only.

The KeYi Total Knee System is a fixed-bearing, posterior stabilized (PS) arthroplasty device. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, ultra-highmolecular-weight polyethylene (UHMWPE) tibial insert, titanium (Ti) alloy tibial baseplate and UHMWPE patellar component. The device has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.

The provided text describes the 510(k) summary for the KeYi Total Knee System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data from mechanical and material testing, rather than clinical study data from an AI/imaging device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance for an AI/imaging device (which would involve concepts like sensitivity, specificity, expert readers, ground truth, etc.) is not applicable to this document.

The document discusses mechanical and material performance data for the knee implant, which are proven through engineering tests against established ASTM and ISO standards for orthopedic implants.

Here's a breakdown of what is present in the document related to "acceptance criteria" and "proof of meeting criteria," reinterpreted for a physical medical device:

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

The document doesn't present a table in the exact format requested for AI, but it lists the types of mechanical tests performed, implying that the device met the corresponding acceptance criteria defined by the relevant ASTM and ISO standards.

The following points (2-9) are not applicable in the context of this device submission (a knee implant) and its associated performance testing (mechanical). They are relevant for AI/imaging device studies.

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical tests, the "sample size" refers to the number of physical samples of the implant components tested. The provenance is internal lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for mechanical properties is established by engineering specifications and physical measurements, not human expert consensus.

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth is derived from engineering design specifications and established material/mechanical properties standards.

8. The sample size for the training set: Not applicable. This concept mainly applies to machine learning models.

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

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The KeYi Total Hip System is designed for total hip arthroplasty. The indications for use are:
a. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
b. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
c. Proximal femoral fractures.
d. Avascular necrosis of the femoral head.
e. Non-union of proximal femoral neck fractures.
f. Other indications such as congenital dysplasia, arthrodesis conversion, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The Ke Yi femoral stems are indicated for cementless use. The KeYi acetabular shells are indicated for cemented or cementless use.

The KeYi Total Hip System is a porous-coated, semi-constrained, hip prosthesis designed for either primary or revision hip arthroplasty. The system is comprised of femoral stems and mating metal femoral heads; acetabular shells and mating acetabular liners; optional acetabular cancellous bone screws; and optional acetabular dome hole plug.
The KeYi Femoral Stems are forged titanium alloy, feature a proximal CP Titanium plasma porous coating, and are offered in a range of sizes. The KeYi Femoral Heads are polished cobalt chromium alloy and designed to mate with 12/14 taper of the femoral stem through taperlocking arrangement and to articulate with the acetabular liner. The heads are available in different sizes with various offsets.
The KeYi Acetabular Shells are manufactured from titanium alloy and feature a porous CP Titanium plasma porous coating. The shells feature a dome hole, are available with a two or three-hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The KeYi Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard/non-crosslinked UHMWPE).
Optional components include threaded acetabular dome hole plugs and acetabular cancellous bone screws, all manufactured from titanium alloy.

The provided text is a 510(k) summary for the KeYi Total Hip System, a medical device. It describes the device's components, intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, study methodologies, or performance data related to AI/algorithm-driven components, human reader performance, or comparative effectiveness studies involving AI assistance.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The questions asked, such as those about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are relevant to the evaluation of AI/ML-driven medical devices, which is not what this document addresses.

This document focuses on the mechanical and material performance of a physical orthopedic implant (hip replacement system) and its substantial equivalence to established predicate devices, a typical pathway for traditional medical devices.

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The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The KeYi Spinal Fixation System implant consists of a variety of shapes and sizes of rods, screws and cross-connectors which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The proposed device is made of Titanium Alloy (Ti6Al4V) which meets ASTM F136-13 and CoCrMo which meets ASTM F1537-11. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text is a 510(k) summary for the "KeYi Spinal Fixation System," a medical device. This document details the process and data used to demonstrate the device's substantial equivalence to predicate devices, focusing on non-clinical testing.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. The performance is assessed against established ASTM standards for spinal implants.

Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample size (number of constructs or tests performed) for the non-clinical tests (ASTM F1717). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
• Data Provenance: The data comes from non-clinical testing, specifically mechanical bench testing performed to established ASTM standards. The location of the testing is not explicitly stated, but the company is based in Beijing, China. This data is part of a premarket notification (510(k)) submission to the U.S. FDA, indicating it's intended for regulatory review in the US. The timeframe is from April 2019. It is not retrospective or prospective clinical data.

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

• Not Applicable. For this type of mechanical device, "ground truth" is established through engineering specifications and standardized test methods (like ASTM F1717). There are no human experts in the traditional sense involved in establishing "ground truth" for the performance of the non-clinical tests themselves, beyond the engineers and technicians conducting and analyzing the tests according to the standard protocols.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is non-clinical mechanical testing against a standard, there is no "adjudication method" in the sense of reconciling divergent human expert opinions. The determination of whether a test result meets the standard is objective based on the protocol.

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

• No. The document explicitly states: "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not performed as part of this particular submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study:

• Not Applicable. This is a physical spinal fixation system, not a software algorithm or AI-based device. Performance is assessed through mechanical testing and comparison to predicate physical devices.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical testing is based on established engineering standards and material specifications (e.g., ASTM F1717-15 for mechanical performance, ASTM F136-13 for Titanium Alloy, ASTM F1537-11 for CoCrMo, and ISO 17665-1:2006 for sterilization). The performance of the device is assessed against these quantifiable, objective criteria.

8. The Sample Size for the Training Set:

• Not Applicable. This is a traditional medical device (spinal implant), not an AI/ML-based device that requires a training set. The performance is based on the inherent properties of the manufactured components and their assembly.

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

• Not Applicable. See point 8.

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Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

The provided text describes a 510(k) submission for a Locking Plate System. This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical testing. No acceptance criteria for device performance in the context of diagnostic accuracy, image quality, or clinical effectiveness (as would be applicable to AI/ML software or imaging devices) are provided.

Instead, the "acceptance criteria" here refer to the device's ability to meet established ASTM standards for metallic bone plates and screws, as well as material specifications. The "study that proves the device meets the acceptance criteria" refers to non-clinical bench testing performed according to these ASTM standards.

Here's the information extracted from the document, framed in the context of device performance in a non-clinical setting:

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

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

• The document does not explicitly state the sample sizes (e.g., number of plates or screws tested) for the non-clinical bench tests.
• The data provenance is from non-clinical (bench) testing performed by the manufacturer, Beijing Keyi Medical Device Technology Co., Ltd., based in China.

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

• This is not applicable to this type of submission. Performance is judged against engineering standards, not expert interpretation of clinical data.

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

• This is not applicable as there is no human interpretation or adjudication involved for the non-clinical bench tests against specified 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 MRMC or studies involving human readers or AI assistance were performed. This device is a passive metallic implant, not an AI/ML diagnostic or imaging device.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for the non-clinical tests is defined by the specifications and methodologies outlined in the referenced ASTM international standards. These standards set physical and mechanical requirements (e.g., strength, torque, pull-out force) that the device must meet.

8. The sample size for the training set

• Not applicable. 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 as there is no training set.

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