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The AgaChamber Spacer is intended to be used by patients, who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or healthcare professional. The device has been developed for use, with or without mask, in accordance with necessity and medical orientation. The intended environments for use include home, hospitals and clinics.

AgaChamber Spacer is composed of a conical chamber with openings on both of its sides, where in one of these opening there is an attached base with an orifice into which the medication dose is inserted and the Metered Dose Inhaler dispenses the medication. On the other side, there is a nozzle which holds the mask. which the patient will fit over his/her nose and mouth so that the medication can be inhaled. The device has been developed for use, with or without mask. The percentage of the drug dose delivered into the chamber is totally dependent on the Metered Dose Inhaler's pressure and guantity of metered doses the healthcare provider prescribes. Another point that should be clear is that, AgaChamber is a passive device and its main function is to provide a space extension between the Metered Dose Inhaler and the patient's nose and mouth in order to facilitate the inhalation of the medication. AgaChamber is composed of wrought plastic parts and assembled I together by a process of thermoplastic injection. IMPORTANT NOTE: AGACHAMBER SPACER IS LATEX FREE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AgaChamber Spacer:

Based on the provided K101348 510(k) summary, the device is a medical spacer, and the acceptance criteria and study are focused on demonstrating substantial equivalence to a predicate device rather than novel performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of devices, number of MDI actuations) used for the biocompatibility or aerosol performance testing. It only states that "Verification, validation and testing activities were conducted."
• Data Provenance: The testing was conducted by a "Third party." The country of origin for the data is implied to be where these third-party tests were performed, but this is not explicitly stated. The submission is from Agaplastic Industria e Comercie Ltda in Brazil, and the official correspondence is handled by MDI Consultants, Incorporated in New York, USA. The data itself is likely from a lab, but its geographical location isn't provided. The study is retrospective in the sense that the testing was performed on the completed device for submission.

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

• This type of information is not applicable (N/A) for this submission. The tests performed (biocompatibility, aerosol performance) are objective physical/chemical tests, not requiring expert human interpretation to establish a ground truth like in image analysis or clinical diagnosis. The "ground truth" for these tests is defined by the standards (ISO) and guidance documents (FDA) themselves.

4. Adjudication Method for the Test Set

• N/A. As mentioned above, the tests are objective. There's no human interpretation or consensus required to adjudicate results like a "2+1" or "3+1" method. The results are compared against pre-determined Pass/Fail criteria directly.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or image interpretation devices where human performance with and without AI assistance is being evaluated. The AgaChamber Spacer is a passive medical device for drug delivery, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. The AgaChamber Spacer is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. Type of Ground Truth Used

• Laboratory and Technical Standards:
  • For biocompatibility, the ground truth is defined by the objective pass/fail criteria of ISO 10993-10:2002/AM:2006 (sensitization) and ISO 10993-5:2009 (cytotoxicity).
  • For aerosol performance, the ground truth is defined by the objective pass/fail criteria outlined in the FDA Guidance document "Reviewer Guidance for Nebulizers, MDI's, Spacers and Actuators."
  • For functional and technological characteristics, the ground truth is the performance and characteristics of the legally marketed predicate device (Aerochamber Plus Anti-Static Valved Hold), against which the AgaChamber Spacer was found to be "similar" and "substantially equivalent."

8. Sample Size for the Training Set

• N/A. The AgaChamber Spacer is a manufactured physical device, not an AI or machine learning model that requires a "training set" of data. The design and manufacturing process would involve engineering specifications and quality control, but not a data training set in the AI sense.

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

• N/A. As there is no "training set" in the context of this device, this question is not applicable.

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