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This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.

This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.5" (L) x 7.49" (W) x 4.18" (H) and weighs 3.3 lbs. It consists of a motor-driven piston compressor and a switch; it contains no consists of a noter electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a Sidestream (510(k) cleared) nebulizer. The Inspiration Elite, Model HS456 is not be used without the nebulizer.

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

The provided text describes a medical device submission (510(k)) for a nebulizer compressor but does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for such a study.

The document is a summary of the 510(k) submission for the "Inspiration Elite Nebulizer Compressor with Nebulizer, Model HS456". It focuses on demonstrating substantial equivalence to a predicate device (InvaCare Envoy Jr., K# 992643) rather than proving performance against specific acceptance criteria through a clinical study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: The document provides a "Functional Comparison Chart" (Section 8) comparing the subject device to the predicate device based on specifications like dimensions, weight, electrical requirements, average power consumption, and average flow rate. This chart does not present "acceptance criteria" in the sense of predefined thresholds for performance, but rather shows how the subject device's specifications align with those of the predicate.
• Study That Proves the Device Meets Acceptance Criteria: Section 9 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical study was performed to "prove the device meets acceptance criteria." Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence.
• Sample size for the test set and data provenance: No test set is described as no clinical study was performed.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no clinical study with a ground truth was performed.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Functional Comparison Chart" which outlines specifications for the subject device and its predicate. While not framed as "acceptance criteria," these are the performance characteristics presented for comparison:

   FUNCTION	INSPIRATION ELITE (Reported Performance)	ENVOY JR. (Predicate Performance)
   Model	HS456	1001RC
   Dimension	4.2" x 7.5" x 7.5"	4.1"x 7.0"x 7.0"
   Weight	3.3 lbs	3.5 lbs
   Electrical requirements	115VAC/60Hz	115VAC/60Hz
   Avg. Power consumption	89 -90 watts*	88 -89 watts*
   Avg. Flow Rate @ 10-15 psig	7.6 -6.8 Lpm*	7.6 -6.8 Lpm*
   Power Indication	No	No
   Intensity Control	No	No
   Intensity Indication	No	No
   Turn ON/OFF switch	Yes (switch)	Yes (switch)
   *Reference Exhibit #2 (Rietschle Thomas Compressor Comparison Data Table dated 8/10/04)

2. Study that proves the device meets the acceptance criteria:
   The submission explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." The basis for demonstrating safety and effectiveness and substantial equivalence is non-clinical testing: "electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'."

The remaining points about sample sizes, data provenance, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in the provided text because no clinical or AI performance study, as typically understood in those contexts, was conducted or reported. The device's approval hinges on its substantial equivalence to a legally marketed predicate based on non-clinical performance characteristics and adherence to relevant standards and guidance documents.

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