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The Lubrina 2 is for lubricating and cleaning the inside of dental instruments.

The Lubrina 2 device is used to maintain optimum performance and prolong the working life of dental handpieces. The Lubrina 2 delivers oil and air automatically to handpieces, and is used after dental treatment and before autoclaving. The Lubrina 2 is not installed in a dental operative unit, but rather is to be used on a table or shelf.

There is only one model. The type varies depending on the country/area the device is to be shipped to and the power cord for that region is included in the package. For the USA, only model HIM-2 Type US, is to be marketed, together with the power cord for the USA.

Operating Mechanism:
The Lubrina 2 supplies lubrication oil to the inside of handpieces by automatically discharging pressurized air from spray can lubricant. Excess oil is removed from the handpiece by pressurized air.

The Lubrina 2 has four operation modes:

• Chuck Lubrication
• Handpiece Body Lubrication
• Flushing (Extended lubrication)
• Air blow mode

The provided text is a 510(k) premarket notification for the Lubrina 2, a dental handpiece accessory maintenance device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance benchmarks. Therefore, it does not contain the typical "acceptance criteria" and "device performance" in the way one might expect for a diagnostic or therapeutic medical device measured by clinical metrics.

Instead, the acceptance criteria are implicitly met by demonstrating that the Lubrina 2 is substantially equivalent to its predicate device, the Lubrina (Model HIM-1, K#070074), and by conforming to relevant international standards. The "study" that proves the device meets these criteria is a combination of non-clinical bench testing and a comparison of technological characteristics.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set: Not specified in terms of number of devices or number of tests conducted. The document states "Testing was conducted to confirm that the device is capable of lubrication and cleaning handpieces" and "Performance bench testing was conducted to demonstrate the compatibility of the device with various lubricating cans." Specific quantities of tests or handpieces are not provided.
• Data Provenance: The tests are non-clinical bench tests, likely performed in a controlled laboratory environment by the manufacturer (J. Morita MFG. CORP). The country of origin for the testing is not explicitly stated, but the manufacturer is J. Morita MFG. CORP. (Japan), though J. Morita USA, Inc. is the submitter. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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

This information is not applicable and not provided in the document. For a 510(k) submission of a device like Lubrina 2, which is an accessory maintenance device, ground truth in the sense of expert medical diagnosis or pathology is not relevant. The "ground truth" here is adherence to engineering standards and demonstrated functionality through bench testing.

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 where expert consensus is needed to establish a medical ground truth, for example, in imaging diagnostics. For a device like Lubrina 2, which is assessed through engineering and performance bench tests, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are typical for AI-powered diagnostic devices where human reader performance is a key metric. This device is a mechanical accessory maintenance unit.

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

This question is not applicable as the Lubrina 2 is a mechanical device for cleaning and lubricating dental handpieces, not an algorithm, and does not involve human-in-the-loop performance in the context of an AI-driven system. Its performance is standalone in the sense that its function (lubricating and cleaning) does not directly involve human intervention during the process itself, but it's not an "algorithm only" performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through engineering standards, functional bench testing, and comparison to the predicate device's established performance. It's not based on expert consensus, pathology, or outcomes data in a clinical sense. The device's ability to lubricate and clean handpieces, its electrical safety, electromagnetic compatibility, usability properties, and adherence to risk management principles constitute the "ground truth" that it performs as intended and is as safe/effective as the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Lubrina 2 is a mechanical accessory maintenance device and does not utilize a "training set" in the context of machine learning or artificial intelligence.

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

This information is not applicable. As the device does not employ a "training set," there is no ground truth to be established for it.

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