FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document describes a 510(k) premarket notification for a medical device called the "Megadyne Foot Switch." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might see for an AI/ML device.

Therefore, many of the typical acceptance criteria and study elements you've asked for (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific submission. This is a hardware device (a foot switch), not an AI/ML diagnostic or therapeutic device.

Here's how to interpret the provided document in the context of your questions:

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

For a hardware device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating compliance with relevant industry standards and showing that the new device is as safe and effective as a predicate device. Performance is shown through non-clinical testing.

Acceptance Criteria (Demonstrated Equivalence and Safety/Performance)	Reported Device Performance (Summary of Non-Clinical Testing)
Substantial Equivalence to Predicate Device: Functionally similar (on/off inputs for compatible smoke evacuation systems).	The Megadyne Foot Switch controls the same on/off inputs as the predicate. The key difference is wired vs. wireless connection.
Electrical Safety: Compliance with relevant medical device safety standards.	Tested and compliant with IEC 60601-1 (electrical safety).
Electromagnetic Compatibility (EMC): Compliance with relevant medical device EMC standards.	Tested and compliant with IEC 60601-1-2 (electromagnetic compatibility).
Durability/Ingress Protection: Ability to withstand environmental factors and maintain labeling integrity.	Meets IPX8 rating per IEC 60529 Ed. 2.2. Legibility of Label and Durability of marking per IEC 60601-1 Ed. 3.1.
Mechanical Safety/Durability: Withstanding shipping, storage, and operational demands.	Meets IEC 60601-1 Ed. 3.1 standard for Shipping, Storage and ME Test.
Biocompatibility: Safe for patient contact (or non-contact, as applicable).	Non-patient contact (same as predicate).
Radiation Safety: Non-radioactive.	Non-radioactive (same as predicate).

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

Sample Size: Not applicable in the context of a "test set" for a clinical study. The device itself (Megadyne Foot Switch) was tested. The "sample size" would refer to the number of units tested during the engineering validation and verification processes (e.g., how many foot switches were subjected to durability testing), but this detail isn't provided in the summary.
Data Provenance: Not applicable. This involves non-clinical engineering and laboratory testing, not human patient data.

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

Not applicable. There's no "ground truth" established by experts in the sense of clinical annotations (e.g., for images or patient outcomes). Ground truth for a foot switch relates to its functional performance (e.g., does it turn on/off when pressed, does it resist water intrusion as specified). This is verified through engineering tests against predefined specifications.

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

Not applicable. This is a method used for reconciling discrepant expert opinions in clinical studies; it is not relevant for hardware performance testing.

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. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI) on human reader performance. This is a simple hardware accessory (a foot switch for a smoke evacuation system).

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

Not applicable. This is a hardware device; there is no algorithm or AI component to evaluate in a standalone manner. Its "standalone performance" would be its ability to pass the electrical, mechanical, and durability tests, which was summarized as "compliant with" relevant standards.

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

The "ground truth" for this device's performance is objective engineering and electrical/mechanical standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). The device's performance is measured directly against these quantifiable standards (e.g., Does it meet the IPX8 rating? Does it pass defined electrical safety tests?).

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

Not applicable. No training set for an AI/ML model was used.

Summary

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.