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The KISS Dynamic Solid Drop Seat and Back Support devices are wheelchair components intended for medical purposes that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part.

The KISS Dynamic Solid Drop Seat and Back Support are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seating platform or back support with dynamic motion.

The KISS devices are wheelchair components intended for medical purposes generally sold as an integral part of a wheelchair but may also be sold separately as a replacement seat and back support. The KISS devices are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seat and back support with dynamic motion.

The KISS Seat consists of (1) a solid seating platform, (2) an adjustable seat frame, (3) pivot blocks, and (4) springs. The KISS seat replaces the standard cloth seat on a wheelchair frame. It attaches to the wheelchair with (5) four drop hooks and is locked in place with (6) securing hardware.

The KISS Back Support consists of (1) a lumbar support with (2) mounting brackets and (3) an upper back support with a solid ventilated (4) backrest. The lumbar support and the upper back support are hinged together with (5) springs therebetween. (6) Mounting hardware connects the KISS back support to the wheelchair frame in place of the standard cloth backrest. (7) A removable upholstered cover encases the back support assembly.

The provided document describes a 510(k) Premarket Notification for a medical device, the KISS Dynamic Solid Drop Seat and Back Support. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials for a novel technology.

Therefore, the document does not present a typical study proving a device meets specific acceptance criteria in the manner of a clinical trial for a new drug or a novel, high-risk device. Instead, it focuses on demonstrating that the performance characteristics of the KISS devices are similar to or better than predicate devices, and that they comply with relevant international standards for wheelchair components.

Here's an analysis of the available information in the context of your questions, noting where the information is absent due to the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" for clinical performance in the way you might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, it focuses on engineering specifications, safety standards, and comparative performance to predicates.

Here's a summary of the performance claims based on the described tests, which serve as the implicit "acceptance criteria" for substantial equivalence:

Important Note: The "acceptance criteria" here are largely implicit from the standards the device was tested against and its mechanical properties relative to predicates, rather than strict clinical outcome thresholds (like symptom reduction or disease progression). The failure on one part of the ISO 16840-10 test is noted, but the overall conclusion still asserts substantial equivalence.

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

For mechanical and engineering tests (ISO, RESNA, bench tests), "sample size" typically refers to the number of devices or components tested. The document doesn't provide specific numbers (e.g., "3 units were tested for ISO 16840-3"). It simply states "The KISS devices passed..." For the "Influences of the KISS dynamic seat on a Wheelchair Cushion's Force-Deflection relationship" and "Wheelchair Compatibility," it implies single or small numbers of tests rather than a large "dataset."

For the clinical testing for interface pressure, the document mentions "Clinical testing indicates..." but provides no details on:

• Sample Size: Not stated.
• Data Provenance: Not stated (e.g., country of origin, retrospective/prospective). Given the nature of a 510(k) for this type of device, it's highly likely it was a small, focused study, possibly done domestically. It is not presented as a large, multi-center trial.

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

This concept (experts establishing ground truth for a test set) is typically relevant for AI/ML devices that interpret images or signals, where human experts label the data. For a mechanical device like a wheelchair component, "ground truth" is established by:

• Objective physical measurements: Performed by engineers and technicians according to standard protocols (e.g., measuring dimensions, force, deflection).
• Standardized test methods: As defined by ISO or RESNA.
• Predicate device specifications: Used for comparison.

Therefore, this section is not applicable in the traditional sense for this device.

4. Adjudication Method for the Test Set

Again, this is largely applicable to AI/ML or clinical imaging studies involving human readers. For mechanical testing, test results are typically objective, and adjudication (e.g., 2+1 reader consensus) is not performed.

Therefore, this section is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. An MRMC study is relevant for evaluating the impact of AI assistance on human readers' diagnostic performance (e.g., radiologists interpreting images with or without AI). This type of study was not conducted for the KISS devices as they are mechanical components, not diagnostic aids.

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

This question is primarily for AI/ML algorithms. The KISS devices are mechanical. While they were tested as "standalone" components in some bench tests (e.g., ISO and RESNA tests are performed on the device itself or installed on a wheelchair frame, without a human user actively operating them as part of the test setup), it's not "algorithm only performance."

Therefore, this concept is not applicable in the context of AI.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily based on:

• Engineering specifications and measurements: Directly measured physical properties of the devices.
• Adherence to International Standards (ISO, RESNA): The device's performance is compared against predefined, objective pass/fail criteria from these standards.
• Comparison to Predicate Devices: Demonstrating similar physical and performance characteristics to existing, legally marketed devices.
• Limited Clinical Observation (Interface Pressure): The "clinical testing" mentioned likely involved measuring interface pressure under controlled conditions, with the "truth" being the pressure readings themselves, compared against previous data or industry understanding of acceptable pressure levels to prevent issues like pressure injuries. This would not typically involve "pathology" or "outcomes data" in the sense of long-term patient health outcomes for a 510(k) of a wheelchair component.

8. The Sample Size for the Training Set

This question applies to AI/ML models. The KISS devices are mechanical components and do not involve a "training set" in the machine learning sense.

Therefore, this section is not applicable.

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

As there is no "training set" for an AI/ML model for this mechanical device, this question is not applicable.

In summary of the provided text:

The document serves as a 510(k) submission for a Class I wheelchair component. It demonstrates substantial equivalence primarily through:

• Compliance with relevant mechanical and material standards (ISO, RESNA).
• Bench testing to show physical characteristics and performance (e.g., deflection, compatibility).
• Limited clinical observation (interface pressure) to ensure the device does not negatively impact user safety/comfort in this specific aspect.
• Direct comparison of technical specifications and intended use with predicate and reference devices.

The "study" here is a combination of engineering and bench tests, with a small clinical observation for specific parameters, rather than a large-scale clinical trial to prove efficacy or diagnostic accuracy.

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