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LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is a single use device for the delivery of fluids from a container to a patient's vascular system.

The intended use and indications for use are the same as other commercially available IV administration sets designated for use with the Omni-Flow® Medication Management Systems™. This set is not intended for gravity use.

The device is used with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.

The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is designed to be used exclusively with Omni-Flow® Medication Management Systems™. The set is equipped with two pressure-activated anti-siphon valves. The two valves limit gravity flow (free flow) to 1ml per hour when the set is primed and attached to a solution bag hanging vertically at full set extension (72 inches).

The provided text is a 510(k) summary for a medical device (LifeShield® Latex-Free Primary IV Pump Set), focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert involvement, or comparative effectiveness studies for AI/algorithm-based devices).

The document is a regulatory submission for a physical medical device, not a software or AI-driven device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "standalone (i.e. algorithm only) performance," are not applicable to this type of submission.

The "study" referenced in this type of submission is typically a comparison of the new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial with acceptance criteria for performance metrics as might be found for a novel AI diagnostic tool.

However, based on the information provided, here's an attempt to answer the relevant sections:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance values for the new device against those criteria. Instead, it demonstrates substantial equivalence by comparing characteristics to a predicate device.

The closest equivalent to a performance claim and its fulfillment is regarding gravity flow protection:

2. Sample size 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 510(k) for a physical IV administration set, not a data-driven device that would involve a test set of data. The submission relies on comparative analysis of specifications and design to a predicate device.

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. There is no mention of experts or ground truth establishment for a test set in this context.

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

Not applicable. There is no test set or adjudication process described.

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 or imaging device.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable. There is no concept of "ground truth" as relevant to data-driven performance in this submission. The "truth" is established through engineering specifications, material compatibility, and demonstrated functional equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable. There is no training set for this device.

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The BACSTOP™ dental waterline Anti-retraction valve is normally closed disposable valve, which is replaced every week, or 5 working days. It is intended to be used in-line on dental unit water lines as a means of preventing the retraction of orally contaminated fluids into the coolant and irrigant water hoses. It is to be used for all patients.

BACSTOP™ is to be installed within the last several inches of tubing, before the dental handpiece, air/water syringe or ultra sonic scaler. It opens only under sufficient pressure (equivalent to 1.5 psi) and snaps closed and seals against backflow when the pressure drops below this point. The device is inserted by connection to luer mounts placed permanently in-line.

BacStop™ valve is a weekly disposable, normally closed antiretraction 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. The nominal cracking (opening) pressure for the check-valve is 1.5 psi.

Here's an analysis of the provided text regarding the BACSTOP™ VALVE, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The test set used 6 valves. The data provenance is not explicitly stated in terms of country of origin but is from a non-clinical performance test, implying a laboratory setting rather than a human study. The study appears to be prospective as it involves the testing of the devices' capacity to prevent backflow over a specified period of use.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be based on direct measurement of fluid retraction and bacterial contamination in a controlled laboratory environment.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as human experts were not involved in establishing the ground truth. The evaluation was based on direct measurement of physical parameters.

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 MRMC study was performed. This device is a mechanical valve, not an AI or imaging device involving human readers.

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

Yes, a standalone performance test was done, as the device's function was evaluated directly under controlled laboratory conditions without human interaction in its primary function of preventing backflow.

7. The Type of Ground Truth Used

The ground truth used was based on direct quantitative measurement of fluid retraction and bacterial contamination in a controlled laboratory setting. Specifically, it involved measuring the volume of fluid withdrawn into the waterline and implicitly, the presence or absence of bacterial markers in that withdrawn fluid (indicated by the "99.975% reduction in contamination").

8. The Sample Size for the Training Set

There is no mention of a training set. This is a physical device, and its performance is evaluated through direct testing rather than through machine learning or AI models that typically require training data.

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

Since there is no training set mentioned, there is no information on how its ground truth would have been established.

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The Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

• 2- 65 ml syringes (K935668)
• 96" Low Pressure Connector Tube/T-connector assembly (K943189) .
• . Fluid Delivery Device (Spike) - (K810624)
• Normally closed check-valve B. Braun/Burron (K790062) ●
• Female/Female Luer Adapter B.Braun/Burron (K942391) .
  The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.
  The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.
  The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.
  All other components of the kit are identical to those in K943189.
  The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.

Here's an analysis of the provided text regarding the Medrad Disposable MRI Kit with Check Valve, focusing on acceptance criteria and the supporting study information:

It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, the level of detail regarding comprehensive studies and acceptance criteria is different from what might be found in a full efficacy study report for a new drug or high-risk medical device. The focus here is on demonstrating that the new device does not raise new issues of safety or effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly present acceptance criteria in a quantitative, pass/fail table format, nor does it detail a standalone study proving the device meets specific performance metrics with numerical results for each criterion regarding its primary function (fluid delivery). Instead, it demonstrates substantial equivalence by comparing features and performing validation tests related to manufacturing and safety attributes.

However, we can infer some "acceptance criteria" based on the validation tests performed and the comparison to the predicate devices. The "reported device performance" is primarily stated as compliance with established standards and equivalence to the predicate.

• Predicate Device Characteristics: The existing Medrad Qwik-Fit MRI Disposables Kit (K943189) and its components serve as a ground truth for substantial equivalence, specifically for features that are identical or closely matched.
• Functional Specifications: The intended behavior of the check-valve (restricting flow, preventing trickle) and the luer adapter (fluid transfer) define the functional "ground truth" against which device performance is validated internally.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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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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