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Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.

The intended for use of this over-the-counter device is for adult patients with arm circumference between 24cm-44cm (approx. 9.4" to 17.5").

Not Found

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain the detailed information required to fulfill the request regarding acceptance criteria and study descriptions.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
5. Information about a standalone (algorithm only) performance study.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
7. The sample size for the training set.
8. How the ground truth for the training set was established.

The document primarily focuses on the regulatory clearance for the device, stating its indications for use and confirming its substantial equivalence to a predicate device. It briefly mentions that the device "Measures automatically human beings Systolic, Diastolic blood pressure and heart rate using the oscillometric method," but it does not provide performance metrics, study details, or acceptance criteria.

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Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.

The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-44cm (approx. 9.4" to 17.5").

Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.

This looks like a 510(k) clearance letter for a non-invasive blood pressure monitor. Such letters generally do not contain detailed information about acceptance criteria or specific study results as they primarily confirm substantial equivalence to a predicate device.

Therefore, the requested information cannot be extracted from the provided text.

Here is a summary of why the information is unavailable:

• Acceptance Criteria and Device Performance: The document is a clearance letter, which determines substantial equivalence. It does not contain performance data, clinical trial results, or specific acceptance criteria. These would typically be found in the 510(k) submission itself, not the clearance letter.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set, etc.: All these categories relate to a detailed study design and results, which are not part of the FDA's clearance decision letter. The letter confirms the device is substantially equivalent to a predicate, based on information provided in the original 510(k) submission, but does not reiterate or summarize the study specifics.

To obtain this information, one would need to access the full 510(k) submission for K043186, which is usually a much more extensive document.

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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel .

The intended for use of this over-the-counter device is for age 16 and above.

Not Found

This is a 510(k) clearance letter for a non-invasive blood pressure measurement system (HL168H, HL168J, HL168Q). The provided text indicates that the device is substantially equivalent to a legally marketed predicate device. However, it does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The letter only states that the device measures systolic, diastolic blood pressure, and heart rate using the oscillometric method for individuals aged 16 and above. It also mentions that the device is for over-the-counter use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.

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The H & W Hospital Ethylene Oxide Sterilizer Control System is an accessory in the form of an electronic control system for the retrofit of existing sterilizers to provide operator and information monitoring capabilities of a personal computer (PC) together with the functional reliability, safety, and dependability of control obtained through the use of a programmable logic controller (PLC). The H & W Hospital Ethylene Oxide Sterilizer Control System is intended to retrofit existing Steris (Amsco) Eagle Model 2000 & 3000 series and Getinge (Castle) Model M/C 3500, 3600 or 4200 series Hospital EO Sterilizers only. The automated cycle performs in such a manner as to assure the repeatability of the process. The predetermined cycles duplicate the cycles provided by the original equipment manufacturer and are demonstrated to deliver the biological performance as stipulated in the consensus standard ANSI/AAMI ST-24.

This device is an accessory to an electronic ethylene oxide sterilizer control system. This control system is a modern, programmable logic controller (PLC)-based system with Personal Computer (PC) user interface. This accessory control system uses a PLC and a Visual Basic/Windows user interface. These two features, a PLC for control and a Windows -based user interface provide multiple advantages. First being the inherent safety and reliability of the PLC and second the operator's ease of use of the Windows "based user interface. This accessory control system kit is intended for the retrofit of existing sterilizers or for use on sterilizers remanufactured by original equipment manufacturers, third party remanufacturers or their licensees.

The provided text describes an ethylene oxide sterilizer control system, an accessory for existing sterilizers, and its compliance with standards and safety. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance with numerical metrics, nor does it detail a clinical study with elements like sample sizes, expert ground truth establishment, or multi-reader multi-case studies as typically expected for medical imaging or diagnostic AI devices.

The submission is for a control system for a sterilizer, not a diagnostic or imaging device, which explains the absence of the typical "study" information. The "study" here refers to validation against engineering and performance standards for sterilizers.

Here's an attempt to answer based on the provided text, highlighting the limitations due to the nature of the device and the available information:

Acceptance Criteria and Device Performance Study for H & W Hospital Ethylene Oxide Sterilizer Control System

The H & W Hospital Ethylene Oxide Sterilizer Control System is an electronic control system accessory designed to retrofit existing hospital ethylene oxide (EO) sterilizers. The primary objective is to maintain or improve the reliability, safety, and performance of the sterilizer, particularly its biological performance, according to established consensus standards.

Given that this is a control system for sterilizers and not a diagnostic or imaging device, the "acceptance criteria" and "study" details differ significantly from what would be expected for AI-powered diagnostic tools. The "performance" largely revolves around adherence to industry standards, safety regulations, and functional equivalence to predicate devices, rather than statistical metrics like sensitivity, specificity, or AUC from a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of data for an algorithm. Instead, the validation appears to be centered on the system itself when installed on existing sterilizers.

• The "test set" is implied to be actual sterilizers where the system is retrofitted and its performance validated on-site.
• Sample Size: Not explicitly stated as a number of devices. The validation process refers to "a sterilizer" (singular) but implies this process is to be followed for each retrofitted unit: "Performance is assured... by validating the performance of the system, on-site in a sterilizer with known and already defined characteristics."
• Data Provenance: This is an industrial control system, not a data-driven AI. "Data provenance" as typically understood (e.g., country of origin of patient data) is not applicable. The performance is validated against the physical characteristics and operational output of the sterilizer itself. The context is practical engineering validation rather than clinical data analysis.

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

This information is not explicitly provided. The "ground truth" for the biological performance is the successful sterilization outcomes as stipulated by consensus standard ANSI/AAMI ST-24. This standard itself is developed by experts in the field. The operational validation (on-site testing) would likely involve qualified technicians or engineers, but their number and specific qualifications are not detailed in this submission.

4. Adjudication method for the test set

Not applicable. There is no mention of "adjudication" in the context of panel reviews or conflict resolution for expert opinions, since the "test set" is the biological and mechanical performance of the sterilizer, measured against established standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is typically performed for diagnostic devices (e.g., medical imaging AI) to compare human reader performance with and without AI assistance. This device is an industrial control system accessory, not a diagnostic tool, so an MRMC study is not relevant or described.

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

The device is a control system, which functions "standalone" once programmed, but always within the context of physically controlling a sterilizer. The "algorithm" here refers to the PLC-based control logic, which operates independently to execute sterilization cycles. The validation focuses on whether these automated cycles achieve the required biological performance and safety standards, which is essentially its standalone or automated performance. Human interaction is primarily for monitoring and initiation through the PC interface.

7. The type of ground truth used

The primary ground truth is compliance with consensus standards and demonstrated biological performance as stipulated by ANSI/AAMI ST-24. This includes the successful inactivation of biological indicators, which is an objective measure of sterilization efficacy. Other ground truths include adherence to engineering and electrical safety standards (ASME, IEC).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model in the sense of requiring a "training set" of data to learn from. Its logic is programmed based on engineering principles and industry standards, not data-driven model training.

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

Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the design and programming of the control system is based on the requirements defined by the Product Development Life Cycle (PDLC) procedure, industry best practices, and the consensus standard ANSI/AAMI ST-24. These requirements are established by experts and regulatory bodies in the field of sterilization.

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