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The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The modification to the OrthoGold 100 (OW100) is identified as model OW100S and applicator OP155S includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at high energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device.

The provided text is a 510(k) summary for the OW100S device, which is an extracorporeal shock wave device. It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about:

• Acceptance criteria for an AI/device performance study (as it's not an AI device in the context of the prompt's implied AI/imaging study)
• Reported device performance against such criteria
• Sample size used for a test set or data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication method
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• Sample size for a training set
• How ground truth for a training set was established

The document explicitly states "Clinical Information: Not applicable. Bench and performance testing support the substantial equivalence in this submission." This indicates that no clinical studies (like those typically associated with AI/ML device performance or human-in-the-loop studies) were conducted or are being presented here for the purpose of demonstrating substantial equivalence. Instead, the equivalence is based on technical specifications and performance characteristics compared to a previously cleared predicate device.

The "Performance Data" section solely refers to:

• Verification and validation testing.
• Software validation (Moderate level of concern).
• Hazard analysis/risk management.
• Conformance to various IEC and AAMI standards (e.g., IEC 61846 for ultrasonics, AAMI/ANSI ES60601-1 for medical electrical equipment, IEC 62304 for medical device software).

The table provided compares the OW100S (subject device) to its predicate device (OrthoGold 100/OW100) and a reference device (OW100S, K213120). This comparison focuses on physical and technical characteristics, not clinical performance metrics or AI/ML model performance.

Therefore, based on the provided document, I cannot answer the questions related to acceptance criteria and an AI/ML performance study because the submission is for a physical medical device (extracorporeal shock wave device) and relies on technical equivalence, not AI/ML-based clinical performance data.

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