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The ERKA. Perfect-Aneroid sphygmomanometer is intended for the non-invasive blood pressure measurement of adult and paediatric, but not neonatal patients. The device is not designed, sold or intended for use except as indicated.

The ERKA. Perfect-Aneroid Sphygmomanometer is an established manual noninvasive blood pressure measurement device that facilitates the auscultatory measuring method of Riva Rocci / Korotkoff. The ERKA. Perfect-Aneroid Sphyqmomanometer is designed to non-invasively measure the systolic and diastolic blood pressure of adult and paediatric, but not neonatal patients together with a common stethoscope. The ERKA. Perfect-Aneroid Sphygmomanometer contains the following components:

• the manometer consisting of the main body, gauge, valve, bulb and spoon and
• the cuff consisting of cover, bladder and tubing.
  The ERKA. Perfect-Aneroid comes in two model types: As Model ERKA. Perfect-Aneroid 48, with a 48mm scale diameter scale and as ERKA. Perfect-Aneroid 56, with a 56mm scale diameter. Both types differ solely in the size of the scale. The larger scale allows an easier reading, e.g. for users with reduced eyesight. The smaller 48mm device realizes a weight advantage while ensuring equal precision and functionalitv.
  The ERKA. Perfect-Aneroid gauge works with a traditional gear driven pointer movement that is triggered by pressure induction on a sealed membrane. The manometer features a brass chrome plated housing and a membrane protecting 2tube technology. The mechanics function in exactly the same way in both diameter sizes. The device comes with a polyurethane coated wipeable cuff. The duo-tubing is made of latex-free silicone and the inflatable bladder in the cuff is made of polyurethane material. The cuffs meet the required biocompatibility standards and are substantially equivalent to the cuffs marketed under 510(k) clearance K071885 and K001333. The cuffs may be obtained in the following sizes:
• Pediatric: Limb circumference 14 cm 21.5 cm
• Small adult: Limb circumference 20.5 cm 28 cm
• Adult: Limb circumference 27 cm 35 cm
• Large Adult: Limb circumference 34 cm 43 cm
• Thigh: Limb circumference 42 cm 54 cm 54 cm '

Here's an analysis of the provided text to extract the requested information, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a manual, non-invasive blood pressure measurement device (sphygmomanometer). These types of devices operate based on well-established physical principles and human interaction, unlike AI/ML-driven devices. Therefore, many of the questions related to AI/ML studies, ground truth establishment for algorithms, training sets, and expert consensus/adjudication methods will not be applicable or explicitly stated in this type of submission. The focus here is on demonstrating substantial equivalence to a predicate device, primarily through technical specifications and adherence to recognized standards for accuracy.

Acceptance Criteria and Device Performance Study for ERKA. Perfect-Aneroid Sphygmomanometer

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Study" and Basis for Performance Claims:

The primary "study" or basis for demonstrating that the ERKA. Perfect-Aneroid meets its acceptance criteria is a substantial equivalence comparison to a legally marketed predicate device (RUDOLF RIESTER PRECISA N Blood Pressure Sphygmomanometer, K972379), rather than a prospective clinical trial in the modern sense of AI/ML device evaluations.

For traditional medical devices like manual sphygmomanometers, performance is often established by:

• Demonstrating that the device adheres to recognized national or international standards for sphygmomanometers (e.g., ANSI/AAMI SP10, ISO 81060-1). While these aren't explicitly referenced as the "study" itself in this summary, the accuracy and range specifications (+/- 3 mmHg, 0-300 mmHg) are standard requirements from such norms.
• Showing that the fundamental scientific concept, technical characteristics, and materials are the same or result in equivalent performance to a predicate device that has previously met these standards.

The submission highlights identical or equivalent technical specifications (measurement range, accuracy, scale graduation, principle of operation, etc.) to the predicate device. These performance metrics are inherent to the design and manufacturing of the device and are expected to be verified through quality control and testing according to relevant standards, though the specific testing methodology is not detailed as a separate "study" report in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the provided 510(k) summary. For a manual sphygmomanometer demonstrating substantial equivalence, performance is often verified through bench testing and, potentially, a small number of human subject validations conforming to standards like AAMI SP10. The summary does not provide details on such a "test set" in the context of subject recruitment or data collection.
• Data Provenance: Not explicitly stated. Given it's a German manufacturer, initial developmental testing would likely occur in Germany. However, for 510(k) submission, adherence to recognized international standards is key.

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

• Not Applicable in the AI/ML sense. For a manual sphygmomanometer, "ground truth" for blood pressure measurements would typically be established by highly trained clinicians or reference devices (e.g., mercury sphygmomanometer, invasive arterial line) during validation studies. The 510(k) summary does not detail the number or qualifications of such experts, as it is focused on technical equivalence rather than a specific clinical validation study report for this submission.

4. Adjudication Method for the Test Set

• Not Applicable in the AI/ML sense. Adjudication methods (like 2+1, 3+1) are common in AI/ML studies where multiple human readers interpret medical images or data and discrepancies are resolved. For a manual blood pressure device, performance is evaluated against established reference measurements, typically through statistical analysis of differences (e.g., Bland-Altman analysis if it were a clinical validation study). This summary does not describe such an adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, not performed as described for AI/ML. MRMC studies are specific to evaluating how AI impacts human reader performance (e.g., radiologists interpreting images). This device is a standalone manual measurement tool and does not employ AI or involve human-in-the-loop performance augmentation for interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, in the sense that its performance is inherent to its design and manufacturing. While not an "algorithm" in the AI sense, the device’s ability to accurately measure blood pressure to +/- 3 mmHg is its standalone performance, independent of human interpretation beyond simply reading the gauge. The 510(k) summary relies on the device's technical specifications being identical or equivalent to the predicate, which itself would have demonstrated this standalone accuracy.

7. Type of Ground Truth Used

• Reference Measurements/Standards. For manual blood pressure devices, the "ground truth" during device validation is typically established against highly accurate reference methods, such as a calibrated mercury sphygmomanometer or an invasive arterial line. The specified accuracy requirement of +/- 3 mmHg is derived from widely accepted international standards for sphygmomanometers. This summary doesn't detail the method of ground truth collection for its specific internal verification, but it would align with these established standards.

8. Sample Size for the Training Set

• Not Applicable. This device is not an AI/ML system that requires a "training set" for model development.

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

• Not Applicable. No training set is used for this type of device.

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