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The RMI Hemoconcentrator Preference Pack is a medical device convenience pack that is intended to allow RMI customers to specify their preference for one or more of the following devices that will be provided in their hemoconcentrator pack :

• Rinse-Required Hemoconcentrator with tubing set and prime lines, LCH-500-A
• Pre-Rinsed BioFilterTM 140 Hemoconcentrator, HEM-001
• 24 inch Hemoconcentrator Tubing Set, TS-024
• 36 inch Hemoconcentrator Tubing Set, TS-036
• Hemoconcentrator Adapter Set, HEM-001 Adapters --
• Hemoconcentrator Waste Bag, WB-001
• BioFilterTM 140 with Adapter Set, HEM-001-A -
• BioFilterTM 140 with 24 inch Tubing Set, HEM-024 (
• BioFilter™ 140 with 36 inch Tubing Set, HEM-036 I
• BioFilterTM 140 with 24 inch Tubing Set and Maste Bag, HEM-O24-B
• Biofilter TM 140 with 36 inch Tubing Set and Waste Bag, HEM-024-B
• Hemoconcentrator Pole Mount, WEW OV
• Hemoconcentrator Pole Mount, HEM-OIH

The hemoconcentrator is intended for relief or mitigation of overhadration in patients undergoing cardiopulmonary bypass procedures and to decrease the concentration of plasma water in blood.

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This document is a 510(k) premarket notification for the RMI Hemoconcentrator Preference Pack. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain information on acceptance criteria or a study that proves the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as might be seen for devices undergoing PMA (Premarket Approval) or for AI/ML-based software as a medical device (SaMD).

The provided text only includes:

• Predicate Device Identification: A list of previously cleared or pre-amendment devices to which the RMI Hemoconcentrator Preference Pack claims substantial equivalence.
• FDA Clearance Letter: Official communication from the FDA confirming the device's substantial equivalence and allowing it to be marketed.
• Intended Use Statement: Describes the purpose of the hemoconcentrator (relief of overhydration during cardiopulmonary bypass and decrease plasma water concentration in blood) and the various components that can be included in the preference pack.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details based on the provided text.

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The RMI Dual Fluid Irrigating Syringe consists of two Becton Dickinson 10cc syringes pre-assembled in a PVC holster. The dual lumen applicator tip of the Dual Fluid Irrigating Syringe consists of two separate lines of tecoflex tubing that form a "Y" connection, then remain parallel to deliver two separate solutions or fluids simultaneously onto the surgical site. A three-way stopcock is connected to each syringe to accommodate attachable 36" fluid transfer sets used to draw prescribed solutions or fluids into each syringe. The plunger ends of the 10cc syringes are coupled together with an LDPE yoke. The RMI Dual Fluid Irrigating Syringe is ethylene oxide (EtO) sterilized and is sold as a disposable, single use, non-pyrogenic device.

The provided text describes a medical device, the RMI Dual Fluid Irrigating Syringe, and its testing for safety and effectiveness. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in the context of an AI/ML algorithm or a comparative effectiveness study involving human readers.

The document focuses on the device itself and its manufacturing, biocompatibility, and basic functional performance, comparing it to predicate devices. It does not involve any AI components, image analysis, or diagnostic capabilities that would typically be evaluated with metrics like those commonly used for AI in healthcare (e.g., sensitivity, specificity, AUC).

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Specifically, the following information is missing or not applicable based on the provided text:

• A table of acceptance criteria and the reported device performance: While there is a "Table of Tests and Results" for functional parameters (leak, flow, pull), these are for the physical device, not for an AI algorithm's performance against clinical acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set for an AI algorithm is mentioned. The sample sizes for functional tests (e.g., 13 units for leak/flow tests) refer to physical devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no AI algorithm requiring ground truth from experts.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For the functional tests, the "ground truth" is simply the physical measurement or observation (e.g., "Passed" leak test).
• The sample size for the training set: Not applicable as there's no AI algorithm.
• How the ground truth for the training set was established: Not applicable.

The document primarily covers:

• Product Description: RMI Dual Fluid Irrigating Syringe.
• Component Materials: List of materials in contact with fluids.
• Predicate Device Identification: Micromedics, Inc. Surgical Sealant Dispenser (SSD) and Duoflo™ Dispenser.
• Summary of Biocompatibility: Various tests (skin irritation, sensitization, cytotoxicity, systemic toxicity, hemocompatibility, pyrogenicity, muscle implantation, Ames test) and their results, all indicating acceptable biocompatibility for medical device use.
• Functional/Performance Information:
  • Functional Testing: Leak tests, flow tests, and pull tests on stopcocks/tubing with reported results (e.g., "Passed," "all pulled to 17 lbs. or more").
  • Performance Testing: States the device is substantially equivalent in performance to two separate 10cc syringes or two taped-together syringes in delivering fluids simultaneously and in an equal 1:1 ratio.
• Comparison to Predicate Device (Micromedics SA-4310): Tabular comparison of characteristics like model, syringe volume, assembly, applicator tip configuration, and sterilization method.

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The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container.

The RMI Hemoconcentrator Tubing Set is a set of tubing, fittings and connectors that is used to interconnect an RMI hemoconcentrator to: 1) a location in an extracorporeal circuit that will sustain blood flows up to 500 ml/min, 2) either a cardiotomy or venous reservoir, and 3) a graduated ultrafiltrate collection container. The RMI Hemoconcentrator Tubing Set is provided sterile and non-pyrogenic.

Here's an analysis of the provided text regarding the RMI Hemoconcentrator Tubing Set, structured to address your specific questions.

Note: The provided text primarily focuses on biocompatibility and basic functional performance testing. It does not contain information related to AI/ML device performance, ground truth establishment, expert consensus, or multi-reader multi-case studies. Therefore, many of your requested points will be marked as "Not Applicable" or "Not Provided in Text."

Acceptance Criteria and Device Performance for RMI Hemoconcentrator Tubing Set

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The RMI Internal Mammary Artery Cannula is composed of a chrome-plated brass female luer hub and 304 stainless steel tubing with smooth bulb tip.

The provided text describes a medical device, the RMI Internal Mammary Artery Cannula, and its comparison to a predicate device, the DLP I.M.A. Cannula, for the purpose of a 510(k) premarket notification. However, the information provided does not pertain to the performance of a software algorithm or AI-based device, but rather a physical medical instrument. Therefore, most of the requested categories related to AI/algorithm performance and study design are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The text explicitly states "Since the flowrate through a cannula indicated for flushing the internal mammary artery with a vasodilator is only an issue if the pressure needed to create the desired flow is too high, it may be concluded that in terms of flow rates, the RMI Internal Mammary Artery Cannula, IMA-001, is substantially equivalent to the DLP I.M.A. Cannula, I.M.A. 31001." This implies that a higher flow rate, as long as it doesn't lead to excessive pressure, is acceptable and contributes to substantial equivalence.

Study Details (as much as can be extracted or inferred for a physical device)

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

   • Sample Size: The text mentions "A comparative performance test... was completed" but does not specify the number of cannulae tested (i.e., the sample size) for either the RMI or DLP devices.
   • Data Provenance: Not specified. It's an internal comparative performance test, likely conducted by the manufacturer or a contracted lab. Neither country of origin nor retrospective/prospective status is mentioned, but given it's a physical device performance test, these classifications are less standard than for clinical data.

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

   • Not Applicable. This is a performance test for a physical device (flow rate measurement), not an interpretative task requiring expert ground truth in the way medical imaging or diagnostic algorithms do. The "ground truth" would be the measured flow rates themselves, established by the testing methodology.

3. Adjudication method for the test set:

   • Not Applicable. No expert adjudication is described or needed for a physical performance test like a flow rate comparison.

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/software device, and no MRMC study was conducted.

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

   • Not Applicable. This is not an algorithm.

6. The type of ground truth used:

   • For the flow rate comparison, the "ground truth" is the measured flow rate of each cannula, determined empirically through the specified performance test.

7. The sample size for the training set:

   • Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

   • Not Applicable. No training set for an algorithm.

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