(81 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Aspiration and Penetration Functionality (for tissue and fluids) | "Laboratory testing demonstrates that the proposed XPS System will aspirate and penetrate tissue the same as the predicate suction cannulas." |
| General Surgical Procedures Indication (removal of tissue and fluids) | The XPS System's intended use ("for the removal of tissue and fluids from the body during general surgical procedures") is stated to be "equivalent to the current intended use of the XPS System, is the same as the predicate devices." The predicates were also cleared for general surgical procedures. |
| Technological Differences Not Raising New Safety/Effectiveness Concerns (e.g., morcellation mechanism vs. reciprocation) | "The only difference is that the cannula has an internal rotating cannula to morcelize the tissue into smaller pieces... making aspiration easier and to help prevent clogging." |
| "Although their dynamics are different [XPS rotary vs. PAD reciprocating], they are both intended to assist in the tissue removal process." | |
| "...the minor technological differences compared to the predicate devices raise no new issues of safety or effectiveness." |
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
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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.
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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.
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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.
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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.
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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."
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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.
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The sample size for the training set:
- Not applicable. As this is not a machine learning device, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set."
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.