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The Antegrade/Retrograde Perfusion Adapter is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus. The Antegrade/Retrograde Perfusion Adapter with Pressure Line is indicated for use to deliver cardioplegia solution to either the aortic root or coronary sinus while continually monitoring the pressure of the coronary sinus.

The Antegrade/Retrogarde Perfusion Adapters are designed to deliver cardioplegia solution to either the coronary sinus or aortic root by the turn of a stopcock and are available with or without a pressure monitoring line. The model with a pressure monitoring line allows for simultaneous monitoring of the coronary sinus pressure while administering cardioplegia solution to either the coronary sinus or aortic root.

In general, a red color-coded tubing with a standard male luer connects to the aortic root cannula's infusion port while a blue color-coded tubing with a standard male luer connects to the coronary sinus cannula's infusion port for delivery of cardioplegia solution. The model provided with a pressure monitoring line is connected to the pressure monitoring outlet of the coronary sinus cannula at one end and the other end is connected to a transducer via a female luerlock connector. An optional male luer-lock swivel adapter is also supplied for this connection. The cardioplegia inlet tubing, which is white color-coded in the pressure monitoring line model, connects to the cardioplegia administration line. The adapter also has a base plate, which allows for either suturing or clamping of the stopcock to the surgical drape.

The provided text is a 510(k) summary for a medical device (Antegrade/Retrograde Perfusion Adapters) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, device performance studies to meet those criteria, sample sizes, expert involvement, or grand truth establishment.

Therefore, most of the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text.

Here's what can be inferred or explicitly stated based on the given information, with the understanding that many sections will be marked as "Not provided in the text":

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

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

• Sample Size for Test Set: Not provided in the text.
• Data Provenance: Not provided in the text.

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 provided in the text. This type of detail is typically associated with clinical performance studies, which are not described here beyond the declaration of substantial equivalence.

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

• Not provided in the text.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. This device is not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was not described or referenced in the provided text. This device is a mechanical adapter, not an algorithm.

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

• Not applicable as no performance studies requiring ground truth were described. The basis for approval is "substantial equivalence" to a predicate device based on intended use and technological characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, and therefore, does not have a "training set" in that context.

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

• Not applicable. This is not an AI/machine learning device.

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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 Malleable Vent Catheter is intended for use during cardiopulmonary bypass Surgery to vent/drain the left ventricle.

The Malleable Vent Catheter is designed to vent/drain the left ventricular during coronary artery bypass surgery.

It consists of soft polyviny] chloride (PVC) tubing with a radius tip and vent holes 3.5 cm along the distal tip. The soft PVC tubing consists of two lumens; one large lumen for venting/drainage and one smaller lumen which encapsulates the stainless steel wire. The encapuslated stainless steel wire enables preshaping of the catheter prior to insertion and support during catheter placement. The proximal end of the catheter contains a rigid PVC connector and depth markings along the farge lumen.

The provided document is a 510(k) premarket notification for a medical device, the California Medical Laboratories Inc. Malleable Vent Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a de novo submission.

Therefore, the document does not contain the acceptance criteria or reported device performance data from a study that proves the device meets those criteria in the way you've outlined. The information you are requesting is typically found in clinical trial reports or performance testing documentation, which are not usually included in full in a 510(k) summary that focuses on substantial equivalence.

Here's an explanation of why the requested information isn't available in this document and what is typically presented in a 510(k) for devices like this:

• Acceptance Criteria and Reported Performance: For a 510(k), particularly for a Class II device like a catheter, the "acceptance criteria" are primarily related to demonstrating that the new device has the same technological characteristics and same intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" proving this often involves non-clinical testing (e.g., biocompatibility, sterility, material strength, dimensional accuracy) compared to established standards or the predicate device's specifications, rather than clinical efficacy studies with specific outcome metrics. The document explicitly states: "The California Medical Laboratories, Inc devices have technologic characteristics which are substantially equivalent to the predicate device."

• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set, etc.: These concepts (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are highly relevant to complex diagnostic algorithms, AI/ML-based devices, or clinical efficacy trials for novel devices. They are not typically applicable to a mechanical device like a vent catheter seeking 510(k) clearance based on substantial equivalence to existing devices. For such devices, performance is usually assessed through engineering bench testing, material testing, and sometimes simulated-use testing.

In summary, the provided K981601 document does not contain the specific information requested in your bullet points because:

• It is a 510(k) submission focused on proving substantial equivalence to a predicate device, not on presenting novel clinical performance data against predefined acceptance criteria from a comprehensive clinical study.
• The device (a malleable vent catheter) is a mechanical device, and its safety and effectiveness are typically demonstrated through material testing, functional testing, and comparison of characteristics to a predicate, rather than through extensive clinical trials with the types of performance metrics and study designs relevant to AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, training/test sets).

If this were a more complex diagnostic device or an AI-driven device, the 510(k) summary (or the full submission, if available) would contain much more detail on validation studies, potentially including some of the elements you've listed.

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The vessel cannula will be supplied with a wing or without a wing, with or without a check valve to deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery and to perfuse a vein graft or access the patency of the vessel to be used as a graft during cardiopulmonary bypass surgery.

The aortic root cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery and aspirate air from the aorta at the end of the cardiopulmonary bypass surgery. The aortic root cannula with vent line is designed to deliver cardioplegia solution and vent the heart during cardiopulmonary bypass surgery.

The cardioplegia "Y" perfusion adapter is designed for use with the aortic root cannula and vessel cannula to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia "Y" recirculation adapter is designed for recirculating of cardioplegia solution during cardiopulmonary bypass surgery. The cardioplegia straight adapter is designed for use during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration or vent line. The cardioplegia "Y" venting adapter is designed for use during cardiopulmonary bypass surgery to deliver cardioplegia solution and vent the left heart.

The Vessel Cannula is indicated for use in the delivery of cardiopleqia solution during cardiopulmonary bypass surgery or to perfuse a vein graft or access the patency in a harvested vein which will be used for a graft. The Vessel Cannula is a flexible, tapered, polyvinyl chloride tube with a soft distal tip. The distal tip is composed of two sizes of anchor hubs (3mm distal-3.6mm proximal) designed to accommodate vessels of various diameters. The proximal female luer-lock is designed to securely connect with a standard cardioplegia delivery line. The cannula is available with or without wings and with or without a check valve.

The Aortic Root Cannula is designed to deliver cardioplegia solution during cardiopulmonary bypass surgery. The cannula consists of flexible polyvinyl chloride tubing with a movable sew ring attached to a soft distal tip. The distal tip has a flange with four suture holes. An introducer needle assembly is provided to facilitate entry into the aorta.

The Cardioplegia Straight Adapter is indicated during cardiopulmonary bypass surgery for connecting a cannula or catheter to an administration and or a vent line. The straight adapter consists of flexible polyvinyl tubing, and connecting adapters in a straight configuration.

The Cardioplegia "Y" Venting Adapter is designed to be used in conjunction with cardiopulmonary bypass surgery to deliver cardioplegia solution, and venting the left heart. It may also be used as an extension line by itself. The adapter consists of flexible polyvinyl chloride tubing, "Y" connector, tubing clamps, and connecting adapters in a "Y" configuration.

The Cardioplegia "Y" Recirculation Adapter is indicated for recirculation of cardioplegia solution during cardiopulmonary bypass surgery, to keep the cardioplegia solution at constant temperature. The "Y" recirculation adapter consists of a flexible polyvinyl chloride tubing, "Y" connector, tubing clamps and connecting adapters in a "Y" configuration.

The Cardioplegia "Y" Perfusion Adapter is indicated for use in delivery of cardioplegia solution during cardiopulmonary bypass surgery. "The perfusion adapter consists of polyvinyl chloride tubing, tubing clamps, "Y" connector, and connecting adapters in a "Y" configuration.

This 510(k) submission (K972503) for California Medical Laboratories Inc. devices (Vessel Cannulas, Aortic Root Cannulas, and Cardioplegia Adapters) does not contain a study that establishes acceptance criteria and proves the device meets them in the way modern regulatory submissions typically do.

Instead, this is a Substantial Equivalence (SE) determination based on comparison to legally marketed predicate devices. The "study" here is essentially a comparison of technological characteristics and intended use to existing devices.

Therefore, many of the requested fields about quantitative performance, sample sizes, expert ground truth, adjudication, and MRMC studies are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Deliver cardioplegia solution to the heart during cardiopulmonary bypass surgery.
• Perfuse a vein graft or access patency in a harvested vein.
• Aspirate air from the aorta (Aortic Root Cannula).
• Vent the left heart (Aortic Root Cannula with Vent Line, "Y" Venting Adapter).
• Connect cannulas/catheters to administration/vent lines (Straight Adapter).
• Recirculate cardioplegia solution (Recirculation Adapter). | The devices have substantially equivalent intended uses as the predicate devices. This implies they perform these functions comparably. |
  | Technological Characteristics:
• Material (Polyvinyl Chloride).
• Design elements (tapered tube, soft distal tip, anchor hubs, luer-lock, movable sew ring, flange with suture holes, introducer needle, "Y" connectors, tubing clamps, connecting adapters).
• Availability with/without wings, check valve, vent line. | The devices have technologic characteristics which are substantially equivalent to the predicate device. This implies their design and material properties are comparable, leading to comparable performance. |
  | Safety: (Implicit in SE determination) | The FDA's finding of substantial equivalence suggests the device is as safe as the predicate. |
  | Effectiveness: (Implicit in SE determination) | The FDA's finding of substantial equivalence suggests the device is as effective as the predicate for its intended use. |

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

• Not applicable. This submission is based on a comparison to existing predicate devices, not on a new clinical or laboratory test with a defined sample size in the traditional sense. The "test set" would implicitly be the body of evidence and performance of the predicate devices.
• Data Provenance: Not specified. The reference is to "legally marketed devices" in interstate commerce prior to May 28, 1976, or reclassified devices. This implies historical data and established clinical use of the predicate devices.

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

• Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices as determined by their long-standing market presence and regulatory clearance. There isn't a specific panel of experts establishing ground truth for a novel "test set" in this context. The FDA's review staff (e.g., Division of Cardiovascular, Respiratory, and Neurological Devices) makes the determination of substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. There was no independent test set requiring adjudication in the context of this 510(k) submission. The FDA's review process is its own form of "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

• Not applicable. This device is a physical medical device (cannulas and adapters), not an AI-powered diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

• Not applicable. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Predicate Device Performance and Regulatory Status: The ground truth is the established safety, effectiveness, and regulatory clearance of the predicate devices (Research Medical, Inc. Vasoplegia Cannula, DLP, Inc. Aortic Root Cannula, DLP, Inc. "Y" Adapter-Coronary Perfusion, DLP, Inc. Straight Adapter, DLP, Inc. "Y" Adapters). The applicant is demonstrating that their new devices are sufficiently similar to these predicates that they can rely on the predicates' existing "ground truth" of performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Device development involves design, manufacturing, and testing, but not machine learning training sets.

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

• Not applicable. See point 8.

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