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The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.

The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.

The provided text describes a medical device, the ESTECH Clearview™ MV Atrial Depressor, and its regulatory submission. It does not contain information about acceptance criteria for device performance, nor details of a study (clinical or otherwise) proving it meets such criteria. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to predicate devices, biocompatibility, and preclinical performance data.

Therefore, I cannot provide the requested information. The text explicitly states "Preclinical performance data was supplied to demonstrate that the Estech Clearview™M MV Atrial Depressor can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate device," but it does not provide the details of this data or the specific acceptance criteria.

The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) are typical for studies assessing the diagnostic accuracy or effectiveness of AI/imaging devices. The device described here is a surgical instrument for fluid collection and tissue retraction, and its performance evaluation would likely focus on different metrics (e.g., fluid collection rate, suction integrity, material strength, biocompatibility, ease of use in a surgical setting) rather than accuracy against a ground truth in an AI context.

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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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The IBC Cardiac Suction Wand is intended for use by a Cardiac Surgeon during open heart surgery for the collection of blood and other fluids from the sterile surgical field for filtering and return to the patient via the Cardiotomy line. It is also intended for use by surgeons for the removal of waste fluids from the surgical field.

The IBC Cardiac Suction Wand is a single use, sterile, disposable surgical instrument intended for the collection of blood and other fluids from the surgical field for return the cardiotomy system during open heart surgery.

The provided 510(k) summary for the IBC Cardiac Suction Wand does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the way typically expected for performance-based medical device studies. Instead, this submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a "Table of Comparison" which outlines characteristics of the new device (IBC Cardiac Suction Wand) and the predicate device (Research Medical Intracardiac Sucker). This table serves as the primary means to demonstrate that the new device meets the implicit acceptance criteria of being "substantially equivalent" to an already legally marketed device.

Discussion of Similarities and Differences: The submission explicitly states: "The IBC Cardiac Suction Wand is in most ways identical to the Research Medical Intracardiac Sucker." It acknowledges minor differences in the stainless steel tube (larger flow diameter, electropolished) and the tubing adapter construction ("overmolded" vs. "molded and bonded"), but asserts these differences are "primarily cosmetic" and do not affect the intended use or safety/effectiveness. This assertion implicitly serves as the "proof" that the device meets acceptance criteria, specifically non-inferiority to the predicate device.

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

• Sample Size: The document does not describe a specific test set or clinical study with a defined sample size in the traditional sense (e.g., number of patients, number of devices tested in a clinical setting). The "testing" appears to be based on design specifications, material comparisons, and adherence to recognized standards for biocompatibility and sterilization.
• Data Provenance: Not applicable, as there's no clinical trial data presented. The "data" consists of design specifications and characteristics of the device itself and its predicate.

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

• Number of Experts: Not applicable. There is no mention of external experts consolidating ground truth for a test set. The ground truth for this type of submission is the documented performance and characteristics of the legally marketed predicate device, and the manufacturer's own assessment that their new device aligns with these.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there is no test set in the clinical evaluation sense that would require adjudication.

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

• MRMC Study: No. This device is a surgical instrument (suction wand), not an AI-powered diagnostic or imaging tool. An MRMC study is completely irrelevant to this device.

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

• Standalone Performance: No, not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used is the documented characteristics, safety, and effectiveness of the legally marketed predicate device, the Research Medical Intracardiac Sucker. The IBC Cardiac Suction Wand demonstrates substantial equivalence by showing its own characteristics align with this established predicate. Additional "ground truth" comes from adherence to established standards for materials (e.g., passivated stainless steel, non-hemolytic materials), sterilization (Ethylene Oxide), and toxicity testing (Tripartite Guidelines).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable. There is no training set for this type of device.

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