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The Xomed XPS Tissue Aspiration System is intended for the removal of tissue and fluids from the body during general surgical procedures.

The XPS Tissue Aspiration System remains essentially the same as originally described in K963246. There is a Power Control Unit, a footswitch, reusable handpiece and various interchangeable, disposable cannulas. Suction is provided by either standard hospital wall vacuum or a commercially available medical aspirator.

The provided text describes a 510(k) premarket notification for the Xomed XPS Tissue Aspiration System. The focus of the submission is to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a new drug or novel medical device. Therefore, much of the requested information (e.g., sample size for test sets, ground truth methodology, MRMC studies) is not present in this document.

The "study" described here is primarily a bench-top comparison against predicate devices and an assessment of technological differences.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly those required to demonstrate "substantial equivalence" to predicate devices as defined by the FDA's 510(k) process. This means showing that the device is as safe and effective as a legally marketed device and does not raise new safety or effectiveness concerns.

Note: The document does not provide specific quantitative acceptance criteria (e.g., minimum aspiration rate, maximum clogging frequency) or numerical results from the laboratory testing.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The document refers to "Laboratory testing," but doesn't detail the number of samples, types of tissue, or duration of tests.
   • Data Provenance: The testing appears to be internal "Laboratory testing" conducted by Xomed Surgical Products. There is no mention of country of origin of data or whether it was retrospective or prospective in a clinical sense. This would typically be bench-top testing.

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

   • Not applicable. The document describes engineering/bench testing rather than a study requiring expert-established ground truth in a diagnostic context. The "ground truth" for function would be direct observation and measurement of aspiration and penetration capabilities.

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

   • Not applicable. There is no mention of human adjudication for data interpretation in this context.

4. 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. This is not an AI-powered diagnostic device, and thus no MRMC study or AI-assisted improvement study was conducted or is relevant to this submission.

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

   • Not applicable, as this is not an AI algorithm. The device performance (aspiration and penetration) is evaluated as a standalone product through "laboratory testing."

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

   • The "ground truth" for the laboratory testing would likely be direct experimental measurement and observation of the device's functional performance (e.g., volume of fluid aspirated, depth of penetration into a tissue simulant, ability to morcellate tissue). It is not based on expert consensus, pathology, or clinical outcomes data in this context.

7. The sample size for the training set:

   • Not applicable. As this is not a machine learning device, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set."

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The MicroAire PAD System is indicated for the removal of tissue or fluid from the body during general surgical procedures.

The MicroAire® PAD™ System differs from the predicate devices in that it possesses a powered reciprocating cannula. The small (2-6 mm), rapid stroke of the PAD" cannula simulates the manual hand motion that the surgeon would use during aspiration with the predicate devices. Thus, use of the PAD" System does not raise safety and effectiveness issues that are significantly different from those of the predicate devices. At the same time, the powered cannula minimizes surgeon effort by reducing the amount of necessary arm motion. Furthermore, the slight reciprocating action of the PAD" System facilitates the passage of the cannula through tissue. When the reciprocating action is not activated by the surgeon, the PAD" device functions in an identical manner to the predicate devices.

This submission pertains to the MicroAire® “Power Aspiration Device” PAD™ System, which is a surgical aspiration system. The main difference from predicate devices is its powered reciprocating cannula.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Aspiration Rate Study: The text indicates "The volume of aspirated fluid was measured several times for both tools." The exact sample size (number of repetitions or devices tested) is not specified.
• Penetration Force Study: No specific sample size is provided for the "in vitro animal experiments."
• Data Provenance: The studies are described as "Laboratory tests" and "Nonclinical evaluations... using in vitro animal experiments." This suggests the data is prospective and generated within a laboratory setting, likely in the US where MicroAire is based. Specific country of origin for the "animal experiments" is not mentioned.

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

Not applicable. This device is a surgical instrument, and its performance evaluation focused on physical properties (aspiration rate, penetration force) and compliance with safety standards, not on diagnostic accuracy requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements of physical properties, not subjective interpretations requiring adjudication.

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

No, an MRMC study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is assessed. This submission is for a surgical instrument.

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

Yes, the studies conducted (aspiration rate, penetration force, safety compliance) are standalone evaluations of the device's physical and functional properties without human interpretation of results being a primary endpoint. The device's function is evaluated intrinsically.

7. The Type of Ground Truth Used

• Aspiration Rate: The ground truth for comparative aspiration rate was the direct measurement of fluid volume aspirated under controlled conditions.
• Penetration Force: The ground truth for comparative penetration force was the direct measurement of force required for tissue entry.
• Sterility, Electrical Safety, Biocompatibility: The ground truth was established by adherence to recognized industry standards (AAMI, ANSI/AAMI/ISO 11137-1994, UL-544, IEC-601-1) and historical safety data for materials.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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