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The indications for use for the Accutorr Plus include the monitoring of the following human physiological vital signs:

• Blood Oxygenation (SpO2) measurement
• Temperature measurement
• Non Invasive Blood Pressure (NIBP) measurement
• Heart Rate derived from selected source (SpO2, NIBP)

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Accutorr Plus and Accutorr Plus with SpO2". It is a premarket notification, which means the device is being cleared for market based on its substantial equivalence to a predicate device, rather than a full premarket approval. Therefore, the document does not contain the detailed study information typically found in a Premarket Approval (PMA) application or other regulatory submission that would describe the acceptance criteria and the studies proving the device meets them.

The information requested regarding acceptance criteria and detailed study data is usually part of the submission package that led to this clearance, but it is not explicitly present in the provided FDA clearance letter and its attached "Indications for Use Statement". This letter is the result of the FDA's review of that submission, stating that the device is cleared because it was found substantially equivalent.

However, I can extract the stated indications for use, which implicitly define what the device is intended to measure. The performance metrics to prove these measurements are accurate would have been part of the 510(k) submission.

Regarding the specific questions, based only on the provided text, most of the information is not available.

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

• Acceptance Criteria: Not explicitly stated in the provided text. The device is cleared for monitoring specific vital signs. Acceptance criteria would typically involve accuracy, precision, and resolution targets for these measurements (e.g., "SpO2 accuracy within +/- 2% over a range of 70-100%"). This information would have been in the original 510(k) submission.
• Reported Device Performance: Not explicitly stated in the provided text. The text only indicates the device's intended functions.

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

• Not available in the provided text.

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 available in the provided text.

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

• Not available in the provided text.

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/Not available. This device is a vital signs monitor, not typically an AI-assisted diagnostic imaging device that would involve human readers interpreting cases. Therefore, an MRMC study in this context is unlikely, and no information is provided.

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

• This device is a standalone monitor. Its primary function is to measure and display physiological vital signs directly. The "standalone" performance is its expected performance. However, the exact methodology and results of such performance testing are not detailed in the provided clearance letter.

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

• For vital signs monitors, ground truth typically involves comparison to a reference standard device (e.g., laboratory oximeter for SpO2, invasive arterial line for NIBP, EKG for heart rate) or direct physiological measurements. The specific methods are not detailed in this document.

8. The sample size for the training set

• Not applicable/Not available. As a vital signs monitor from 1997, it's highly unlikely it employed machine learning or AI models requiring "training sets" in the modern sense. Its operation would be based on established physiological algorithms and signal processing, not data-driven learning.

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

• Not applicable/Not available for the reasons stated above.

Summary of what can be inferred from the provided document:

• Device Name: Accutorr Plus and Accutorr Plus with SpO2
• Regulatory Class: II
• Product Code: 74 DQA
• Indications for Use (Implicit Acceptance Criteria - what the device is intended to do):
  • Monitor Blood Oxygenation (SpO2) measurement
  • Temperature measurement
  • Non Invasive Blood Pressure (NIBP) measurement
  • Heart Rate derived from selected source (SpO2, NIBP)
• Target Populations: Adult and pediatric populations.
• Intended Use Setting: Health care facility.
• Study Proving Acceptance Criteria: The device was deemed "substantially equivalent" to a predicate device marketed before May 28, 1976. This means the manufacturer submitted data (likely including performance testing against standards) to demonstrate that the Accutorr Plus performs as safely and effectively as a legally marketed predicate device for its intended use. The details of these studies are not in this letter.
• Type of Ground Truth: For vital signs monitors, this would typically involve comparison to established reference measurement methods.
• Data Provenance (Implied): The company, Datascope Corp., is located in Paramus, New Jersey, suggesting the development and testing would likely have occurred in the US or under US regulatory guidance. The letter does not specify if the data was retrospective or prospective, or from specific countries.

In conclusion, this FDA clearance letter confirms the device is allowed to be marketed but does not provide the detailed technical study data requested. Such data would be found in the original 510(k) submission package, which is generally not publicly released in its entirety.

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