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The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
• Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

• This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

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

• No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

• Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

• Not applicable, as there is no training set.

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The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion out blocking excessive pronation and the resulting sequela.

The Subtalar MBA System is indicated for use in the treatment of the hyperpronated foot displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela

Severely pronated foot Walking intemperance Calcaneal stance position greater than 5° Manually correctable deformity Mid-tarsal breech (arch pain) Forefoot varus greater than 10°

The KMI Subtalar MBA System™ will be offered in Ti-6AI-4V ELI. It will be available in a range of diameters and will be cannulated for precise location of the implant. Initially, a range of four diameters will be made available in 15mm lengths. All four diameters (6,8,10, and 12mm) are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.

This submission K960692 for the KMI Subtalar MBA System™ is a 510(k) Premarket Notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than submitting extensive clinical study data to prove safety and effectiveness.

Therefore, the document does not describe traditional acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial would. Instead, it focuses on demonstrating that the device is as safe and effective as a previously cleared device.

Here's an analysis based on the provided text, addressing the points you requested where applicable, and explaining why some points are not relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for a diagnostic AI device. The "acceptance criteria" for a 510(k) are met by demonstrating substantial equivalence to a predicate device in terms of:

• Intended Use: Similar indications for use.
• Technological Characteristics: Similar design, materials, and function.
• Performance: Meets recognized voluntary standards where applicable.

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

• Not applicable / Not specified for traditional clinical testing. This is a 510(k) premarket notification for a mechanical implant, not a diagnostic or AI device requiring a "test set" for performance evaluation in the typical sense. Substantial equivalence is demonstrated through comparison of design, materials, and intended use with a predicate device. The document mentions "over 20 years of clinical evaluation" for the basic design concept of subtalar joint stabilization in general, but this refers to the established clinical understanding of these types of devices, not a specific clinical study for the KMI device itself.

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

• Not applicable. As above, no "test set" with ground truth in the context of an AI or diagnostic device evaluation is described. Material standards and design principles are followed.

4. Adjudication method for the test set

• Not applicable. No test set or corresponding adjudication method is 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

• Not applicable. This device is a subtalar arthroereisis implant, not an AI or imaging diagnostic device that would involve human "readers" or AI assistance.

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

• Not applicable. This device is a physical implant, not an algorithm or AI system.

7. The type of ground truth used

• Not applicable in the typical sense. The "ground truth" for this type of submission is:
  • Predicate Device Equivalence: The existence and established safety/effectiveness of the predicate devices (e.g., Wright Medical K792670).
  • Voluntary Standards: Meeting established ASTM standards for materials and design.
  • Clinical General Knowledge: The well-known and documented clinical performance of subtalar joint implant systems in general over many years.

8. The sample size for the training set

• Not applicable. This device is not an AI system that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of the K960692 Submission Context:

This 510(k) submission for the KMI Subtalar MBA System™ is primarily concerned with demonstrating substantial equivalence to already approved devices. The "study" proving it meets "acceptance criteria" is essentially the comparison of its design, materials, and intended use to identified predicate devices and its adherence to relevant voluntary material and manufacturing standards (e.g., ASTM standards). The FDA's acceptance is based on the determination that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a de novo clinical trial with specific performance metrics.

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