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The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE or WHITESTAR SIGNATURE PRO Systems ("WHITESTAR SIGNATURE System(s)"). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

The Dual Pump Pack, Model OPO73 is a single-use phacoemulsification pack that is an optional accessory for use with the WHITESTAR SIGNATURE Phacoemulsification Systems (K151636, K111697 and K060366), which are used to facilitate the emulsification and removal of a cataractous lens. Similar to the predicate device, the Dual Pump Pack, Model OPO73 supports peristaltic and venturi aspiration by means of a tubing interface in combination with an over-molded rear cover consisting of a diaphragm (also called the gasket with fluid channels) and a rear cover designed to generate fluid outflow from a patient's eye through aspiration tubing lines.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Dual Pump Pack, Model OPO73":

Based on the provided document, the device described (Dual Pump Pack, Model OPO73) is a single-use phacoemulsification pack, an accessory for WHITESTAR SIGNATURE Phacoemulsification Systems, intended for irrigation and aspiration during anterior segment cataract surgery. The submission is an Abbreviated 510(k), claiming substantial equivalence to a predicate device, the FUSION Dual Pump Pack, Model OPO71 (K060366).

Acceptance Criteria and Device Performance:

The document states: "During performance testing, all anterior segment ophthalmic surgery modes that require the OPO73 functionality, including irrigation/aspiration, were conducted; all tests passed and all acceptance criteria were met."

However, specific quantitative acceptance criteria and corresponding reported device performance values are not provided in the text. The document broadly states that the device "performs as safely and as effectively as the predicate device" and that "all tests passed and all acceptance criteria were met."

1. Table of Acceptance Criteria and Reported Device Performance:

As specific quantitative criteria and performance metrics are not detailed in the provided text, a table like the one requested cannot be constructed. The document only states that:

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

The document mentions "design verification and validation testing, which include parametric measurements testing and irrigation and aspiration testing." However, it does not specify the sample size used for these test sets (e.g., number of devices tested, number of in-vitro runs).

The data provenance is not explicitly stated in terms of country of origin, but it is implied to be from Abbott Medical Optics Inc., located in Santa Ana, California, USA, which submitted the 510(k). The studies conducted are non-clinical (laboratory/bench testing), not patient studies. Therefore, it is considered retrospective in the sense that it's an evaluation of the device itself rather than collecting data from live cases.

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

This information is not applicable and not provided in the document. The studies performed are non-clinical verification and validation tests, not studies requiring expert interpretation of medical images or outcomes to establish ground truth. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving human interpretation or outcomes to resolve discrepancies. The studies described are bench tests with objective pass/fail criteria based on engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were deemed necessary to determine the safety and effectiveness of the Dual Pump Pack - OPO73." The assessment is based on substantial equivalence to a predicate device through non-clinical testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This concept is not applicable here. The device is a physical medical device (tubing and manifold for a phacoemulsification system), not an AI algorithm. Its performance is inherent in its mechanical and fluidic characteristics, not an "algorithm."

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was based on engineering specifications and performance standards. The document states that "all tests passed and all acceptance criteria were met," implying these criteria were predefined technical parameters the device had to meet to be considered safe and effective and substantially equivalent to the predicate. Compliance with various ISO and AAMI standards (e.g., ISO 14971, ISO 10993 series, ISO 11135, ANSI/AAMI ST72) also defines aspects of this "ground truth."

8. Sample Size for the Training Set:

This information is not applicable and not provided. The "Dual Pump Pack" is a hardware medical device and does not involve AI or machine learning algorithms that would require a training set.

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

This information is not applicable as there is no training set for this type of device.

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