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These devices are intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves or stem extensions.

The BKS Revision is indicated for cemented application only. The porous-coated metaphyseal sleeves are intended for cemented and uncemented biological fixation application.

The BKS® Revision Sleeves System expands the capabilities of the Balanced Knee® System (BKS®) Revision through the introduction of femoral and tibial sleeves, a tapered junction box, locking bolt, and a sleeve specific tibial tray. All new implants are a single-use modular system used in revision knee surgery to accommodate metaphyseal bone defects and provide rotational stability. The system is designed for cemented or uncemented fixation with the bone. The porous-coated femoral sleeve is affixed to the modular femoral component via a tapered junction box. The porous-coated tibial sleeve is affixed to a sleeve tibial tray.

This document describes a 510(k) premarket notification for the "BKS Revision Sleeves System." This is a medical device submission, and the focus is on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving a specific clinical performance metric against acceptance criteria in the way a diagnostic AI device would.

Therefore, the requested information about acceptance criteria, study design, ground truth, and human reader performance is not applicable in the context of this device submission. The primary "study" conducted here is non-clinical mechanical testing to ensure the device meets engineering standards and performs similarly to existing devices.

Here's a breakdown of what the document provides, and why the requested information is not present:

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

• Acceptance Criteria (Non-Clinical): The document states that the following non-clinical tests were conducted and "successfully met the predetermined acceptance criteria":
  • Static Disassembly per ASTM F-1814 and ASTM F-2083
  • Cyclic fatigue per ASTM F1800, ASTM F1814, and ASTM F2083
  • Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72:2011
• Reported Device Performance (Non-Clinical): The document simply states that the tests were "successfully met," indicating compliance with the standards. It does not provide specific numerical results or performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic device.

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

• Not applicable. This device is an orthopedic implant, not a diagnostic or AI-driven system that uses data in this manner. The "test set" consists of physical devices subjected to mechanical and biological safety tests. The document doesn't specify the number of individual sleeve components tested for each mechanical test, but it would be a small number of physical samples, not a dataset of patient information.

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 in this context refers to the engineering standards themselves (e.g., ASTM standards) and the established methods for bacterial endotoxin testing. These are defined by scientific and engineering bodies, not established by individual experts reviewing a test set for clinical accuracy.

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

• Not applicable. No adjudication method is described or required for this type of non-clinical testing. The tests are designed to objectively measure physical properties or biological safety against defined 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, not applicable. This device is an implant, not an AI-assisted diagnostic tool. No MRMC studies were performed.

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

• No, not applicable. This device is an implant, not an algorithm.

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

• Ground Truth (Non-Clinical): The "ground truth" for this submission is adherence to established engineering standards (ASTM) for mechanical properties and biological testing standards (ANSI/AAMI ST72:2011) for pyrogenicity. The device's performance is compared against these predetermined, objective standards rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. See point 8.

In summary: The BKS Revision Sleeves System is an orthopedic implant. Its "acceptance criteria" and "study" are focused on demonstrating mechanical integrity, biocompatibility, and substantial equivalence to existing devices through non-clinical testing against established engineering and biological safety standards. Clinical studies or AI-specific performance metrics (like those for diagnostic devices) were not part of this 510(k) submission, and the document explicitly states: "No clinical studies were performed."

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