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The OW100S (model OW100S-US) is intended for:

• Relief of minor muscle aches and pains

• Temporary increase in local blood circulation

• Activation of connective tissue

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. 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) , 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 higher 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. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling.

There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.

The provided documents describe the medical device OW100S (model OW100S-US), a therapeutic massager, and its substantial equivalence to a predicate device, the TRT, OrthoGold 100 (OW100). The submission does not contain information about a study with acceptance criteria and device performance results as typically described for software or AI-enabled medical devices.

Instead, this submission is a 510(k) premarket notification that demonstrates substantial equivalence to a legally marketed predicate device. The core of the submission relies on:

• Identical Indications for Use.
• Similar technological characteristics, with minor modifications to improve durability (e.g., increased electrode lifetime).
• Performance and bench testing to ensure the modified device meets design specifications and relevant safety standards.

Therefore, many of the requested details, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies, are not applicable or not provided within this type of submission for a non-software/AI device.

However, I can extract the information that is available about performance and the basis for equivalence.

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly state "acceptance criteria" in the format of specific quantitative benchmarks (e.g., sensitivity > X%, specificity > Y%). Instead, the acceptance is based on demonstrating that the subject device (OW100S) is substantially equivalent to the predicate device (OrthoGold 100) and meets applicable safety and performance standards. The "reported device performance" is essentially a comparison of the OW100S's physical and operational characteristics to those of the predicate device, showing that any differences do not impact safety or effectiveness.

Here's a table based on the comparison provided in the submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This submission does not discuss a clinical "test set" in the context of patient data. The performance evaluation was based on bench testing and verification and validation (V&V) testing of the device's engineering specifications. Therefore, data provenance from a patient population (country, retrospective/prospective) is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The submission focuses on hardware modifications and engineering performance, not on diagnostic accuracy requiring expert interpretation of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This is not an AI-enabled device, and no MRMC study was performed or required.

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

Not applicable. This is not an algorithm-only device. Performance was demonstrated through V&V and bench testing of the physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission is implicitly the engineering specifications and demonstrated performance of the predicate device, alongside international consensus standards (e.g., IEC 61846, AAMI / ANSI ES60601-1, IEC 60601-1-2) for safety and performance testing. The "truth" is that the device, after modifications, still operates safely and effectively within expected parameters compared to the predicate and standard requirements.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not have a training set.

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

Not applicable. No training set was used.

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The OrthoGold 100 is intended for:

• Relief of minor muscle aches and pains
• · Temporary increase in local blood circulation
• · Activation of connective tissue

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air 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 provided FDA 510(k) summary for the OrthoGold 100 device does not describe a study involving an artificial intelligence (AI) component or its acceptance criteria.

Instead, this document is a premarket notification for a Class I therapeutic massager, which is a physical device (a pulsed acoustic wave device). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance testing of the physical device to ensure it meets design specifications, safety standards, and is substantially equivalent to a predicate device.

Therefore, many of the specific questions you asked about AI-related acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to the information provided in this document.

Here's an analysis based on the document, focusing on the engineering and performance testing described for a Class I medical device, and explaining why the AI-related questions are not relevant here:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with corresponding performance results in the way one might see for an AI model's clinical endpoints. Instead, it describes various performance tests and compliance with standards as evidence of meeting design specifications and safety requirements.

Here's a summary of the performance claims:

• Max penetration depth: 25.4 mm at energy level 16
• Energy flow density: 0.00017 - 0.04403 mJ/mm2 at energy level 1-16
• Peak compressional acoustic pressure: 0.43 - 9.27 MPa at energy level 1-16. |
  | Probe Cover Testing & Transport Verification/Validation | "In addition, probe cover testing and transport verification and validation was also conducted." (Page 5) – No specific results detailed, but implied successful. |
  | Substantial Equivalence | "The performance testing demonstrated that the OrthoGold 100 is substantially equivalent to the predicate device." (Page 5) "The bench testing demonstrates that the performance characteristics of the OrthoGold 100 are equivalent to those of other legally marketed therapeutic massagers, and therefore supports a determination of Substantial Equivalence for the proposed indications for use." (Page 9) |
  | Clinical Data | "Clinical performance data is not relied upon to establish the substantial equivalence of the subject and predicate device." (Page 6) |

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes engineering and laboratory performance testing, not a clinical trial or AI model validation using patient data. Therefore, the concept of "sample size for the test set" (referring to patient data) and "data provenance" (country, retrospective/prospective) is not applicable. The "test set" would be the device itself and its components undergoing various mechanical, electrical, and physical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document describes physical device testing for safety and performance, not diagnostic AI. "Ground truth" here relates to physical measurements and engineering specifications, established by standard test methods and calibrated equipment, not by medical experts interpreting data for diagnostic purposes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI model validation when multiple human readers assess data and their consensus forms the ground truth for comparison. This document describes physical device testing.

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

This is not applicable. An MRMC study is relevant for assessing the impact of a diagnostic AI tool on human clinician performance. The OrthoGold 100 is a therapeutic massager, not a diagnostic AI device, and the document explicitly states clinical data was not relied upon for substantial equivalence (Page 6).

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

This is not applicable. This question refers to the performance of a diagnostic algorithm without human interaction. The OrthoGold 100 is a physical therapeutic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is based on engineering specifications, verified physical measurements (e.g., force, penetration depth, acoustic pressure), and compliance with recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2). These are objective measurements and adherence to established safety and performance benchmarks for therapeutic medical devices, not clinical outcomes or expert consensus for diagnostic interpretation.

8. The sample size for the training set

This is not applicable. The OrthoGold 100 is a physical device, not an AI model that requires a training set.

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

This is not applicable as there is no AI training set.

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The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years and older). The OrthoGold 100 is indicated for use in conjunction with standard of care burn treatment(s).

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air 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 provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly demonstrated through the clinical study's primary endpoint, which showed a statistically significant improvement in the time to epithelialization. The safety was also assessed by monitoring adverse events.

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