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The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
The Standard and Small Rigid Tip Suction Wands are indicated for use to remove excess fluid from the surgical field.

The Standard and Small Rigid Tip Suction Wands are designed to remove excess fluid from the surgical field.
The Standard Rigid Tip Suction Wand consists of an angled Stainless Steel suction wand bonded to a rigid, fluted style suction tip at the distal end and a ¼" barbed connector at the proximal end both of which are made of ABS. The stainless steel wand has a lightweight plastic handle made of medical grade ABS material.
The Small Rigid Tip Suction Wand is manufactured in a similar manner and consisting of the same materials as the Standard Rigid Tip Suction Wand.

This is a 510(k) premarket notification for a medical device (suction wands), not an AI/ML device. Therefore, the typical acceptance criteria and study information requested for AI models (like performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable or present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device, which is the primary criterion for 510(k) clearance.

Here's a breakdown based on the provided text, addressing the points where possible and noting why others are not applicable:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria (Implicit for 510(k)): Substantial equivalence in intended use and technological characteristics to a legally marketed predicate device. Safety and effectiveness.
   • Reported Device Performance: The document states: "The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the predicate device." No specific performance metrics (like suction rate, material strength, etc.) are reported in this summary, as the focus is on equivalence rather than novel performance claims.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not Applicable. This is a medical device clearance, not an AI/ML study. There isn't a "test set" in the context of data for an algorithm. Device testing would likely involve bench testing or possibly limited clinical testing to support safety and performance, but the details are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable. See point 2.

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

   • Not Applicable. See point 2.

5. 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 device.

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

   • Not Applicable. This is not an AI device.

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

   • Not Applicable in the AI/ML sense. For a physical medical device like this, "ground truth" relates to engineering specifications, material properties, and functional performance benchmarks, often established through standards, predicate device characteristics, and internal testing. No specific "ground truth" data is detailed for analysis in this document.

8. The sample size for the training set

   • Not Applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

   • Not Applicable. This is not an AI/ML device.

Additional Information from the Document:

• Intended Use: To remove excess fluid from the surgical field.
• Predicate Device: Research Medical, Inc. Rigid Intracardiac Suction Wand.
• Basis of Equivalence: "The California Medical Laboratories, Inc. devices have technologic characteristics, which are substantially equivalent to the Research Medical predicate device."
• Device Description:
  • Consists of an angled Stainless Steel suction wand, a fluted style suction tip (ABS) at the distal end, and a ¼" barbed connector (ABS) at the proximal end.
  • Has a lightweight plastic handle made of medical grade ABS material.
  • Two sizes: Standard and Small.
• Regulatory Class: II
• Product Code: DTS

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