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The AutoPulse™ Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

This device description is for the AutoPulse Resuscitation System Model 100, an automated chest compression device.

Based on the provided text, there is no specific acceptance criteria or detailed study results that prove the device meets acceptance criteria mentioned.

The document states:

• "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Section 1)

However, it does not provide any data, metrics, or specific acceptance criteria that were used in this testing. It only concludes that the device is "substantially equivalent" to predicate products based on indications for use, basic overall function, and materials.

Therefore, I cannot populate the requested table or provide details for most of the other questions.

Here's an assessment based on the available information:

1. Table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not specified in the provided text.
   • Reported Device Performance: Not specified in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.
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, as no test set details or ground truth establishment are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an automated mechanical device, not an AI-based diagnostic or assistive system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device itself as an "automated, portable, battery powered device that compresses the chest." While its performance would inherently be standalone in its function, no specific "standalone performance study" details (like accuracy or efficacy metrics) are provided. It operates as an adjunct to manual CPR, implying it's often used with human oversight, but its core function is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not a machine learning model with a training set.
9. How the ground truth for the training set was established: Not applicable.

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The AutoPulse™ Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

The provided text describes a 510(k) submission for the AutoPulse™ Resuscitation System Model 100, which is an automated chest compression device. However, it does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as requested.

The document states:

• "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (Page 1, "Testing" section)
• "The AutoPulse Resuscitation System Model 100 is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent." (Page 1, "Summary of Substantial Equivalence" section)

This indicates that some testing was performed to demonstrate substantial equivalence to predicate devices (Thumper™ Model 1005, K011046, and K022345), but the specifics of what those tests were, what the acceptance criteria were, and what the reported performance was are not included in this document.

Therefore, I cannot populate the table or answer most of the follow-up questions from the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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

• MRMC study: Not specified. This device is an automated chest compressor, not an AI-assisted diagnostic tool, so an MRMC study in the context of "human readers" is unlikely to be relevant here.

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

• This device is inherently "standalone" in its operation as an automated chest compressor, but no specific study reporting its standalone performance metrics are provided in this document. The term "algorithm only" might not directly apply in the same way it would to a diagnostic AI, but the device's mechanical performance would be its standalone metric.

7. The type of ground truth used

• Type of ground truth: Not specified. For a resuscitation system, ground truth would typically relate to physiological parameters (e.g., blood flow, chest compression depth/rate) or clinical outcomes, but this is not detailed.

8. The sample size for the training set

• Sample size: Not specified.

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

• Ground truth establishment: Not specified.

Ask a specific question about this device

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

The provided document describes a Special 510(k) for a device modification, focusing on substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study proving its performance. The document explicitly states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, it does not disclose the specific acceptance criteria or the full details of the studies conducted.

Therefore, many of the requested details cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission focuses on substantial equivalence based on overall function and materials, rather than specific performance metrics against defined acceptance criteria.

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Appropriate product testing was conducted."

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

This information is not provided. The nature of this device (a resuscitation system) means "ground truth" would likely relate to physiological outcomes or device performance in simulated/clinical settings, not expert interpretation of data like images.

4. Adjudication method for the test set:

Not applicable and not provided. As no expert-based ground truth interpretation is mentioned, an adjudication method for such a ground truth would not be relevant.

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:

This device is an automated resuscitation system, not an AI-assisted diagnostic or interpretative device that augments human readers. Therefore, an MRMC study with human readers assisting AI or vice-versa is not applicable and not mentioned.

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

The device is an "automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR." This implies its primary function is standalone mechanical operation, though as an "adjunct to manual CPR," it inherently involves human interaction. The document doesn't detail standalone performance tests, focusing broadly on "conformance to product specification and substantial equivalence."

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

The document does not explicitly state the type of ground truth. For a resuscitation device, ground truth would typically involve:
* Physiological measurements during CPR (e.g., compression depth, rate, effectiveness in maintaining blood flow).
* Biomechanical performance (e.g., force applied, consistency).
* Safety parameters.
The document broadly states "conformance to product specification," which would imply testing against internal specifications for these types of parameters.

8. The sample size for the training set:

Not applicable and not provided. This device is a mechanical resuscitation system, not a machine learning or AI-driven system that would require a "training set" in the conventional sense of machine learning.

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

Not applicable and not provided, as there is no mention of a training set for an AI/ML model for this device.

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Ask a specific question about this device