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Blood Pressure Monitor DSK-1031 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.

The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guideline, display of cuff condition, display of body movement detection and two memory accounts to save measurement results.

Blood Pressure Monitor DSK-1031 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at upper arm non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the nylon cuff that is applicable to arm circumference between 8.7 and 16.5 inches (between 220 and 420 mm) and is powered by four AA alkaline batteries or AC adaptor. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines appropriateness of cuff application. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO (World Health Organization) guideline also on the display. User can choose to activate clock function of the device to review measured readings with measurement date and time.

The provided 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620) focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. It explicitly states that no clinical tests were submitted because "differences between the subject device and the predicate devices do not affect clinical performance" (Section 6, (2) Clinical tests).

Therefore, the document does not contain the acceptance criteria or a study proving the device meets performance criteria through clinical data. The information below is extracted from the provided text, primarily relating to its equivalence claims which are based on established standards rather than a de novo clinical performance study.

Here's an attempt to answer your request based on the available information:

Acceptance Criteria and Device Performance Study for Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor DSK-1031 (K112620)

Based on the provided 510(k) summary, the device's "acceptance criteria" for performance are not explicitly stated in terms of specific clinical accuracy thresholds (e.g., mean difference and standard deviation against a reference standard in a clinical study). Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical tests and adherence to recognized standards.

The document states that the device was evaluated "in accordance with IEC and SP-10" to demonstrate substantial equivalence and establish better safety. ANSI/AAMI SP-10 is a key standard for blood pressure monitors. While the specific numerical acceptance criteria (e.g., AAMI accuracy standards for mean difference and standard deviation) are not explicitly listed in the summary, adherence to ANSI/AAMI SP-10 implies meeting those criteria for accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria derived from clinical studies are not presented in this 510(k) summary, and no clinical performance data is reported, this table cannot be fully completed as requested.

However, based on the implicit criteria of substantial equivalence and adherence to ANSI/AAMI SP-10, the "reported performance" is that the device is expected to meet the accuracy requirements of this standard through its design and non-clinical testing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable for a clinical test set, as no clinical tests were submitted.
• Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and performance testing against standards.

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

• Not applicable as no clinical test set with expert-established ground truth was submitted.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set was submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No MRMC comparative effectiveness study was done or reported. The device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool involving human readers.

6. If a Standalone Performance Study (algorithm only without human-in-the-loop performance) was done

• Yes, a form of standalone performance assessment was implicitly done through the non-clinical tests demonstrating compliance with recognized standards such as ANSI/AAMI SP-10. This standard sets forth requirements for the accuracy of automated sphygmomanometers, which constitutes a standalone performance assessment for the device's core function. However, the details of the specific tests and resulting numerical accuracy are not provided in this summary.

7. The Type of Ground Truth Used

• For the non-clinical performance (accuracy) relative to standards like ANSI/AAMI SP-10, the "ground truth" would typically be established by a reference method (e.g., auscultation by trained observers with a mercury sphygmomanometer) as specified in these standards. The specific ground truth used in the underlying tests is not detailed in the summary.

8. The Sample Size for the Training Set

• Not applicable as this is a traditional medical device submission, not an AI/ML-based device that typically involves training sets. The device uses an oscillometric method, which is a well-established algorithm.

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

• Not applicable as this is not an AI/ML-based device using a "training set." The oscillometric algorithm's principles are based on established physiological measurements and engineering.

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Wrist Blood Pressure Monitor WSK-1011 is intended for noninvasive measurement of systolic and diastolic blood pressure, determination of pulse rate and calculation of pulse pressure in adults in a homecare environment.

The device features include display of irregular pulse rhythm detection, classification display of measured blood pressure values against WHO (World Health Organization) guidelines, display of body movement detection and two memory account to save measurement results.

Blood Pressure Monitor WSK-1011 is an automatic sphygmomanometer to be used in a homecare environment. Blood pressure, systolic and diastolic, and pulse rate are taken at wrist non-invasively using oscillometric method, which is one of the most common methods with recent automatic sphygmomanometer that determines blood pressure and pulse rate with oscillations against cuff applied to measurement site. The device consists of the main unit and the cuff that is applicable to wrist circumference between 4.9 and 8.9 inches (between 125 and 225 mm), singly mounted. The device is powered by two AAA alkaline batteries. The device not only determines blood pressure and pulse rate from oscillations but also analyses pulse wave and determines whether measurement was made with or without body movement and regularity of pulse rhythm. Besides these auxiliaries, user can get pulse pressure value and blood pressure level according to WHO guideline also on the display. User can chose to activate clock function of the device to review measured readings with measurement date and time.

The provided text is a 510(k) summary for the Nihon Seimitsu Sokki Co., Ltd. Blood Pressure Monitor WSK-1011. It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, a standalone study for the device's performance against those criteria, or an MRMC comparative effectiveness study.

The summary states:

• "No clinical test report is submitted because differences between the subject device and the predicate devices do not affect clinical performance."
• "The subject device was evaluated in accordance with IEC and SP-10 not only to demonstrate the substantial equivalence but also to establish the better safety."

Therefore, based solely on the provided text, I cannot directly answer most of your detailed questions regarding acceptance criteria, study specifics, ground truth, and sample sizes for a clinical performance study. The document explicitly states no clinical test report was submitted due to assumed equivalence in clinical performance.

However, I can extract information related to the non-clinical tests that were performed.

Here's what can be inferred or directly stated from the provided text, with limitations:

1. Table of acceptance criteria and the reported device performance:

Since no clinical study report is provided, specific numerical acceptance criteria (e.g., mean difference, standard deviation) for blood pressure accuracy cannot be extracted from this document, nor can the device's performance against such criteria. The document states the device was evaluated according to IEC and SP-10 standards. These standards (such as ISO 81060-2 for non-invasive sphygmomanometers) would define the acceptance criteria for accuracy.

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

• Test Set Sample Size: Not applicable/Not provided. No clinical test set details are given.
• Data Provenance: Not applicable/Not provided for clinical data. The non-clinical tests follow IEC and SP-10 standards.

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

• Not applicable/Not provided. No clinical test set details are given.

4. Adjudication method for the test set:

• Not applicable/Not provided. No clinical test set details are given.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a blood pressure monitor, not an AI-powered diagnostic imaging device involving human readers.

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

• The document implies that the device's performance was evaluated through non-clinical bench testing against established standards (IEC and SP-10) for substantial equivalence in safety and effectiveness. A standalone clinical performance study was explicitly stated as not submitted.

7. The type of ground truth used:

• For non-clinical tests, the "ground truth" would be measurements obtained using reference standards and calibrated equipment as specified by IEC and SP-10 standards for blood pressure monitor testing.
• For clinical performance, if a study were done, the ground truth for blood pressure measurement would typically be established by validated invasive or non-invasive reference methods (e.g., auscultatory method by trained observers using a mercury sphygmomanometer). However, as stated, no clinical tests were submitted.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a hardware blood pressure monitor, not an AI/machine learning model that typically requires a training set.

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

• Not applicable/Not provided, for the same reason as above.

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