(50 days)
To provide a means for a person to administer artificial ventilation using the mouth-to-mouth technique while reducing the risk of the operator's mouth coming in contact with body fluids from the non-breathing victim.
The CPR ISO-SHIELD is a device designed as an adjunct for mouth-to-mouth ventilation on a non-breathing adult or child mouth-co-mouth vehiclate the operator's mouth from the victim's body fluids. The CPR ISO-SHIELD has a shield barrier, a plastic bite block/air tube with walve which is placed between the victim's teeth. The operator blows into the tube and uses victim's ceeth. The victim's exhalation is acceptable of their breath escaping around the valve and between the shield and their face. The large surface area of the barrier, 40 Square inides reduces the risk of vomitus coming in contact with the operator's face side of the shield. Two plastic grips are added to the ISO-SHIELD, attached to the valve housing below the barrier on the victim's side. This allows the operator to handle the device under the protective the operator of ize the transfer of contamination to the top surface. These grips also have memory which should help lift " surface. "Incoc getim's face after the operator releases his mouth. ISO-SHIELD has a polyethylene material. ISO-SHIELD uses a silicone rubber flapper design for the valve. This results in less valve. This is claires by the operator blowing into the valve as compared to Microshield. The ISO-SHIELD has two plastic grips attached to the valve housing.
The provided text is a 510(k) summary for the "Rondex CPR Iso-Shield" and does not contain a detailed study with acceptance criteria and reported device performance in the way a clinical trial or a performance study for complex medical devices would.
However, based on the information provided, I can extract the relevant details that align with the questions you've asked, focusing on the equivalence demonstration:
1. Table of Acceptance Criteria and Reported Device Performance
The submission argues for substantial equivalence by comparing its design and safety/effectiveness features to predicate devices. While not presented as a formal table with quantitative acceptance criteria, the document implicitly uses the performance of predicate devices as the benchmark for acceptance.
| Feature/Criterion (Implicit) | Predicate Device Performance (Microshield, Res-Cue Key) | Rondex CPR Iso-Shield Performance | Meets Criterion? |
|---|---|---|---|
| Operator protection from body fluids (mouth-to-mouth technique) | Yes | "reducing the risk of the operator's mouth coming in contact with body fluids" | Yes |
| Ability for victim to breathe spontaneously | Yes (Microshield) | Yes, when the shield is released from the victim's face | Yes |
| Efficacy of ventilation (sealing and ventilation effectiveness) | Equivalent to predicate (Microshield) | Equivalent to Microshield on adult Laerdal and child manikin | Yes |
| Material of shield barrier | Vinyl (PVC?) for Microshield, Polyethylene for Res-Cue Key | Polyethylene (4 mil) | Yes (Different but equivalent or superior) |
| Valve design | Flapper valve (Res-Cue Key), unspecified (Microshield) | Silicone rubber flapper design (similar to Res-Cue Key) | Yes |
| Easy handling/reduced contamination risk | No specific mention for grips | Two plastic grips to position/remove without touching top surface; helps lift from face | Yes (Improved feature) |
| Facilitates exhalation | No specific mention (Microshield, Res-Cue Key) | Aids lifting from face, especially if nose is pinched closed | Yes (Improved feature) |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the simulated testing performed on manikins.
- Sample Size: "an adult Laerdal manikin" and "an Anne and Armstrong child manikin Timmy - Southly". This implies a very small sample size of two manikins.
- Data Provenance: The testing was likely conducted by Rondex Products, Inc. (the manufacturer) in the USA. The data is prospective in the sense that the company conducted these specific tests for the 510(k) submission, even though it wasn't a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications for establishing a "ground truth" for the manikin tests. It's likely that the assessment of "effective resuscitation" and "equivalent" ventilation was made by company personnel or a consultant based on standard CPR manikin testing protocols.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears to be a direct comparison or assessment of performance against the predicate.
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 device is a manual CPR shield, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. As mentioned above, this is a manual medical device, not an algorithm. Standalone performance of an algorithm is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" used for the manikin testing appears to be based on simulated performance metrics (effective resuscitation, sealing, ventilation effectiveness) as established by generally accepted protocols for evaluating CPR devices on manikins. It's not pathology, expert consensus in a clinical setting, or outcomes data. It's an engineering and functional performance assessment.
8. The Sample Size for the Training Set
- This concept is not applicable here as the device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable as the device is not an AI algorithm.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).