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The AHIP Internal Trigger Point Wand is a self-massager used to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity. It helps to relieve painful trigger points through this direct, manual therapeutic massage technique. Painful intrapelvic trigger points are associated with chronic pelvic pain syndromes.

The AHIP Internal Trigger Point Wand is a single-patient-use internal therapeutic massager as depicted in Figure 1. The wand (ULTEM®) consists of a ball pressure applicator (Santoprene™) on a rod with a distal hook-shaped curve. A strain gauge is attached to the straight portion of the wand, which is connected to a battery-operated readout device that measures the amount of pressure being exerted at the tip of the wand. The wand also has an adjustable "stop" (to be set by the therapist) to limit the depth of insertion. The wand is to be covered with a disposable covering and lubricant (e.g., FDA-cleared KY-Jelly or other waterbased lubricants without sensates) prior to use.

Acceptance Criteria and Device Performance for AHIP Internal Trigger Point Wand

This document outlines the acceptance criteria for the AHIP Internal Trigger Point Wand and summarizes the study findings that demonstrate the device meets these criteria. It also addresses various aspects of the studies conducted, including sample sizes, data provenance, ground truth establishment, and the absence of certain types of studies.

1. Acceptance Criteria and Reported Device Performance

The provided text focuses on the device's overall safety and effectiveness, as demonstrated through clinical outcomes and various safety tests. Specific numerical acceptance criteria for performance were not explicitly stated as distinct measurable thresholds in the text, but rather broad indicators of benefit and safety. Therefore, the "Reported Device Performance" column reflects the positive outcomes presented that support the stated benefits and low risk profile.

2. Sample Sizes and Data Provenance

• Prospective Clinical Trial (Test Set):
  • Initial Enrollment: 393 patients.
  • Final Sample Size for Reported Results: 219 subjects. (143 withdrawals and 31 not completed by data cutoff were part of the initial 393).
  • Data Provenance: Prospective. Country of origin not specified, but the "National Center for Pelvic Pain Research Devices. Inc." is based in California, USA, suggesting the study was likely conducted in the US.
• Retrospective Study (Subcohort vs. Historical Control):
  • Device Cohort (Subcohort of prospective study): n=75.
  • Historical Control Cohort ("Immersion patients"): n=82.
  • Data Provenance: Retrospective, comparing a subcohort from the prospective study with historical control data. Country of origin not specified, but presumably from centers with similar training and treatment programs, possibly in the US.

3. Number of Experts and Qualifications for Ground Truth

• The studies described are primarily patient-reported outcome studies (sensitivity reduction, satisfaction, effectiveness) and safety monitoring.
• No external experts were explicitly mentioned as establishing a "ground truth" for the test sets in the traditional sense of diagnostic accuracy studies. The primary outcomes were self-reported by patients.
• The study involved a "training period with a physician or physical therapist" for proper device use and locating trigger points. These healthcare professionals established the initial diagnosis of "muscle related pelvic pain, dysfunction and symptoms" and guided patients. However, they were facilitators and guidance providers rather than "ground truth" adjudicators for the effectiveness outcomes.
• The "prescriber is instructed to evaluate and confirm that the patient's pain is myofascial pelvic pain syndrome in origin and other causes have been ruled out before the use of this device." This implies expert medical diagnosis is a prerequisite for patient inclusion, but not for the outcome assessment itself.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1 or 3+1 consensus) was described for the clinical trial outcomes. The effectiveness and satisfaction data were based on self-reported patient assessments through questionnaires or scales (e.g., sensitivity scale from 1-10, satisfaction/effectiveness scale from 1-3).
• Adverse events were reported and collected, implying a clinical assessment of their occurrence and resolution, but not a blinded or multi-expert adjudication process for the events themselves.

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

• No MRMC comparative effectiveness study was done. The studies described assessed the device's performance through patient self-reported outcomes and safety data. There was no direct comparison of human readers' performance with and without AI assistance, as the device is a therapeutic massager, not a diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

• No standalone (algorithm only) performance study was done. The device is a physical therapeutic massager with a mechanical force feedback mechanism. While it contains software for the strain gauge, the "performance" is inherently tied to human use and interaction, not an autonomous algorithmic output. Bench testing evaluated the mechanical and electrical aspects (tensile strength, gauge accuracy, software functionality), but these are supportive tests for the hardware, not standalone performance of an algorithm.

7. Type of Ground Truth Used

• Clinical Efficacy/Effectiveness: Patient self-reported outcomes (e.g., reduction in sensitivity, satisfaction level, perceived effectiveness).
• Safety: Clinical observation and patient reporting of adverse events.
• Device Functionality (Bench Testing): Engineering specifications and measurements for mechanical strength, gauge accuracy, and electrical/software performance.
• Biocompatibility: Established through ISO 10993-1:2003 testing standards.

8. Sample Size for the Training Set

• The document describes a prospective clinical trial and a retrospective study, both serving as evaluation sets. It does not mention a distinct "training set" in the context of machine learning or AI algorithm development. The device is a mechanical/electrical therapeutic tool, not an AI diagnostic system that requires a separate training set for its core function.

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

• Since there was no explicit "training set" for an AI algorithm as described above, this question is not applicable based on the provided text. The patient data collected in the clinical studies served to evaluate the device's performance directly, rather than to train an underlying algorithm.

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