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Elcam Antimicrobial Stopcock [or Manifold] is indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Antimicrobial Stopcock [or Manifold] has a feature of an antimicrobial agent using a compound containing silver.

The inclusion of an antimicrobial agent into the material formulation is intended to prevent/reduce the growth of contaminants on the device.

The device is NOT intended to be used as a treatment for patient infections.

Elcam Antimicrobial Stopcock [or Manifold] is identical to Elcam conventional legally marketed Stopcocks. A model of typical Stopcock is illustrated in Figure 1, section 11, page 33 of this submission.

Stopcocks and Manifolds have port(s) that provide access for medications injection, IV administration and blood sampling. The Stopcock usually has three ports and a handle that directs the fluid flow. It has one female side port that is used for medication injection or blood sampling. Both opposite ports (female/male) are connected to the IV line. The Manifold is assembled from two to five stopcocks bonded to each other to create a "stopcocks line" so the Manifold can have between two to five side ports for injection or sampling. Naturally, when the port is open, it can be a potential portal of entry for microorganisms into the device fluid path.

Elcam's Antimicrobial Stopcock [or Manifolds] provides an effective solution in preventing/reducing bacterial colonization in the device.

The antimicrobial agent is based on silver like in Medex's antimicrobial stopcock legally marketed device, cleared by 510(k) number K954970.

All body/fluid contact materials that composed the Antimicrobial Stopcock were tested widely for chemical and biocompatibility in accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.

The Elcam Antimicrobial Stopcock [or Manifold] received 510(k) clearance (K053405) based on its substantial equivalence to predicate devices and performance in non-clinical testing.

Here's an analysis of its acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact numerical sample sizes for the antimicrobial effectiveness tests or mechanical tests. It states "Extensive tests were performed with a variety of organisms" for antimicrobial effectiveness and "Mechanical tests were performed according to Elcam conventional stopcock specification."
• Data Provenance: The studies were conducted by Elcam Medical (Israel). The data is retrospective in the sense that it was collected and submitted for the 510(k) application, but the tests themselves would have been prospective experiments designed to evaluate the device.

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

The provided document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic imaging studies. The assessment of the device's performance was based on laboratory testing against established specifications and standards (e.g., "at least 2 log reduction" for antimicrobial effectiveness, "according to Elcam conventional stopcock specification" for mechanical, and ISO 10993-1:2003 for biocompatibility). The "ground truth" for these types of devices is typically defined by the objective results of these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "truth" for these non-clinical performance studies is derived from objective laboratory testing against pre-defined criteria, not from expert consensus or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging AI devices where human readers interpret medical images, and the AI assists or performs the interpretation. The Elcam Antimicrobial Stopcock is a physical medical device, and its effectiveness is determined through laboratory performance tests, not through human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, in essence, the "non-clinical performance data" described (mechanically and microbiologically) constitutes a standalone performance study of the device. The antimicrobial stopcock's effectiveness in preventing/reducing bacterial colonization and its mechanical functionality were tested independently of human intervention during its operation in a simulated environment. The device's antimicrobial feature is an inherent property of its material composition, not an algorithm.

7. Type of Ground Truth Used

The ground truth used was based on objective laboratory test results against predefined performance specifications and industry standards. Specifically:

• For antimicrobial effectiveness, the ground truth was a "significant reduction of bacteria levels (at least 2 log)."
• For mechanical functionality, the ground truth was "Elcam conventional stopcock specification."
• For biocompatibility and chemical properties, the ground truth was compliance with "FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data. Its performance is due to its physical design, materials, and the incorporation of an antimicrobial agent. Development and optimization of a physical device would involve design iterations and testing, but not in the sense of an algorithm training on a dataset.

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

Not applicable, as there is no "training set" for this physical device.

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For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.

For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).

Single patient use. Duration of use up to 24 hours.

The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Munktell Bacstop Filter and Filter/HME:

Acceptance Criteria and Device Performance

Study Information

Based on the provided Non-Confidential Summary of Safety and Effectiveness (510(k) K014282), the "study" is primarily a bench-testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

Here's the breakdown of the requested information based on the document:

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

   • Sample size: Not explicitly stated for specific tests. The document refers to "Nelson Lab." for bacterial and viral filtration, implying laboratory testing. For other parameters like resistance and humidification, it would involve testing multiple units to ensure consistency, but specific numbers are not provided.
   • Data provenance: "Nelson Lab." is mentioned for BFE and VFE, which is a known independent testing laboratory. The overall data likely originates from testing performed by or for Munktell Filter AB (Sweden). The studies appear to be prospective bench tests designed to evaluate specific performance attributes.

2. 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)

   • This question is not applicable to this type of device submission. Medical device filters do not typically use expert ground truth for performance metrics in the same way an imaging AI algorithm would. Performance is measured against physical standards and laboratory methods (e.g., measuring pressure drop, bacterial retention, water vapor content). The "ground truth" is defined by the physical or microbiological measurement standards themselves.

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

   • None. Adjudication methods are typically used in clinical studies or expert review of image interpretation, which is not relevant for the bench testing of a breathing circuit filter.

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

   • No. An MRMC study is relevant for an AI-powered diagnostic imaging device involving human readers. This submission is for a medical filter, which does not involve human readers or AI assistance in its function.

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

   • Yes, in spirit. The performance metrics (BFE, VFE, resistance, humidification) are "standalone" in that they measure the device's intrinsic physical and biological filtering capabilities without human intervention during its operation. There is no "algorithm" in the sense of software interpreting data, but the filter itself performs its function independently.

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

   • The "ground truth" for the performance claims in this submission is the measured output from standardized laboratory testing. For example:
     • Bacterial Filtration (BFE) and Viral Filtration (VFE): Ground truth is established by standardized microbiological testing methods (e.g., aerosol challenge tests) that measure the percentage of bacteria/viruses retained by the filter.
     • Resistance to flow: Ground truth is established by physical measurement of pressure drop across the filter at specified flow rates using calibrated equipment.
     • Humidification Output: Ground truth is established by standardized tests (e.g., ISO 9360) that measure the absolute humidity delivered by the HME.

7. The sample size for the training set

   • Not applicable. This device is hardware (a filter), not an AI algorithm that requires a "training set."

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

   • Not applicable. As above, there is no "training set" for this type of device.

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BACSTOP is intended for use in dental unit waterlines as a means of preventing the retraction of orally contaminated finids into the coolant and irrigant water hoses. The unit is intended to be used for one day only, and is then to be discarded, and replaced daily.

BACSTOP is a disposable, normally closed Anti-retraction check valve, consisting of a flat silastic rubber disc valve membrane in a housing made up of top and bottom parts, united by a sonically sealed joint. The two parts of the valve housing are made of clear Lexan 124R Polycarbonate, with the top (entry) port being in the form of a female Luer fitting, and the bottom (exit) port being in the form of a male Luer fitting, with locking collar. Total length of the device is 0.93 inches, width 0.5 inches. Nominal Cracking (Opening) pressure for the valve is 1.5 PSI.

The provided text is a 510(k) summary for the BACSTOP Valve and describes non-clinical performance testing. It does not contain information about clinical studies with human participants. Therefore, I will respond to your request based on the non-clinical performance testing described.

Here's an analysis of the provided text in relation to your questions regarding acceptance criteria and the study proving the device meets them:

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

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical laboratory test focused on the ability of the BACSTOP valve to prevent backflow of a bacterial suspension, simulating its intended use in dental waterlines.

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: The text does not specify the exact number of BACSTOP valves or Aseptico valves tested in each experiment. It refers to "Both devices" and "BACSTOP valves" in plural, implying more than one, but a specific number is not provided for the backflow tests or the cycling tests.
• Data Provenance: The study is reported as "Non-clinical Performance Testing" and "Non-clinical Laboratory Tests." This implies prospective testing specifically designed to evaluate the device's performance. The country of origin of the data is not explicitly stated, but the submission is from "SciTech Dental, Inc., Seattle, WA 98104," suggesting it's likely US-based.

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. This was a non-clinical laboratory study involving bacterial growth and flow dynamics, not human interpretation or assessment. Therefore, no "experts" in the sense of medical professionals were used to establish ground truth. The "ground truth" was determined by the presence or absence of bacterial growth in the broth.

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

• Not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. This was a laboratory test with objective endpoints (bacterial growth).

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. This was a non-clinical laboratory study of a valve, not a study involving human readers or AI.

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

• Yes, in essence. The device (BACSTOP valve) was tested in a standalone manner, meaning its performance was evaluated independently without human intervention during the "backflow prevention" process itself. Humans set up the experiment and observed the results, but the valve's function was autonomous.

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

• The ground truth for the backflow prevention tests was determined by laboratory culture for bacterial growth. The absence of bacterial growth in the broth after exposure to the challenge suspension indicated effective backflow prevention.

8. The sample size for the training set

• Not applicable. This device (a physical valve) does not involve a "training set" in the context of machine learning or AI algorithms. The "training" for its design and manufacturing would be engineering and material science principles, not data-driven learning.

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

• Not applicable. As above, there is no "training set" for a physical device in this context.

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