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The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2. which extend through the epidermis, dermis, 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 dearee 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 applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

Model OW100S and applicator OP155S includes a "break circuit" in the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses at low energy flux density in the device. Updates to labeling of the OW 100S includes revisions to contraindications/warnings/ cautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use. 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.

The provided text does NOT include acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the OW100S device, which is an extracorporeal shock wave device. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (also named OW100S, K231710), rather than providing performance data against novel acceptance criteria.

Here's what the document indicates regarding performance:

• No specific acceptance criteria are listed.
• No new clinical study was conducted to demonstrate performance against acceptance criteria.
• The manufacturer states: "The same verification and validation testing is applicable for the current device design as the predicate and demonstrated that the OW100S meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed." (Page 4)
• The "Performance Data" section (Page 4) lists standards to which the device conforms, such as IEC 61846 (ultrasonics - pressure pulse lithotripters - characteristics of fields), AAMI/ANSI ES60601-1 (medical electrical equipment - general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-36 (particular requirements for extracorporeally induced lithotripsy), IEC 60601-1-6 (usability), IEC 63045 (non-focusing short pressure pulse sources), and IEC 62304 (medical device software - software life cycle processes). Conformance to these standards implies certain performance characteristics, but the specific acceptance criteria derived from these standards or the results against those criteria are not detailed.
• The document largely relies on comparing the technical characteristics of the new OW100S device to its predicate (K231710), finding them to be identical across various parameters like indications for use, modes of action, intensity settings, applicator characteristics, power, penetration depth, energy flow density, and acoustic pressure metrics (pages 5-7). This comparison suggests that since the characteristics are identical to a previously cleared device, the performance is also considered identical and therefore "substantially equivalent."

Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics (beyond being "identical" to the predicate's specifications) are provided.
2. Sample size used for the test set and the data provenance: No test set from an independent study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical test set with ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical acoustic wave device, not an algorithm. Performance validation relates to physical specifications and safety standards.
7. The type of ground truth used: Not applicable as no diagnostic ground truth for a test set is described.
8. The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable.

The document clearly states under "Clinical Information": "Not applicable. Bench and performance testing support the substantial equivalence in this submission." This explicitly indicates that no clinical study with acceptance criteria and results was part of this submission for demonstrating substantial equivalence. The "performance testing" referenced is likely limited to verification and validation against the device's design specifications and conformance to listed standards, as opposed to a clinical efficacy study.

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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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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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