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The VMAP PRO is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

The VMAT PRO is a pressure pulse device that creates pneumatically generated pressure pulses caused by compressed air delivering ballistic projectile through a handpiece coming into contact with the skin. VMAT PRO is equipped with one handpieces that includes four transmitters [VAT120 (diameter of 20mm), VAT220 (diameter of 20mm), VAT215 (diameter of 15mm), and VAT 135 (diameter 35mm)] that allow radial treatments, ergonomically designed to allow the user to work in various areas of the body. To facilitate the movement of the transmitter on the skin, and guarantee a correct contact, an ultrasound gel FDA cleared should be used (i.e. Aquasonic 100 Ultrasound Transmission Gel K802146).

The provided text is a 510(k) Summary for the VMAT PRO device, seeking substantial equivalence to a predicate device (D-Actor 200 Vibration Massage System). It focuses on demonstrating that the new device is as safe and effective as the legally marketed predicate. However, this document does not describe a study involving human readers, AI assistance, or the establishment of ground truth by multiple experts for a test set.

The closest information provided is about performance testing to establish that the VMAT PRO control unit performs as intended, and a comparison of its technological characteristics with the predicate device.

Therefore, I cannot fully address all the points in your request as the information is not present in the provided document. I will fill in what can be inferred and explicitly state where information is missing.

Here's an analysis based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the format of a threshold that must be met. Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing various technical specifications. The acceptance criterion is implicit: the device's performance characteristics must be sufficiently similar to the predicate device, or any differences must not impact safety or efficacy.

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 technical and performance testing of the device itself (e.g., electrical safety, EMC, acoustic characteristics), not a clinical study or a study involving a "test set" of patient data for AI evaluation. Therefore, this information is not applicable to this 510(k) summary. The testing refers to the device unit's performance, not a dataset.

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. This document does not concern an AI/clinical diagnostic device requiring expert adjudicated ground truth. The "ground truth" for the device's technical specifications is established through engineering and physical measurements according to international standards (IEC).

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

Not Applicable. As no diagnostic test set is used, no adjudication method is relevant.

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

No. The document explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission." Therefore, no MRMC study was performed.

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

No. This is not an AI algorithm but a physical therapeutic device. The "performance testing" described refers to the device's physical and electrical characteristics as per IEC standards, not an algorithm's output.

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

For the technical characteristics comparison, the "ground truth" is derived from:

• Engineering measurements and specifications of the VMAT PRO device itself, conducted in a laboratory setting (e.g., "measured in a laboratory, using ultrasound" for applicator displacement).
• Published specifications of the predicate device (D-Actor 200) from its own 510(k) submission or technical documentation.
• Adherence to international standards such as IEC 60601-1, IEC 60601-1-2, and IEC 63045:2020 for safety, EMC, and ultrasonic characteristics.
• Biocompatibility testing according to ISO 10993-1:2018.

For the purpose of this 510(k) submission, the "ground truth" is primarily device-centric technical specifications and compliance with recognized standards, not clinical diagnostic outcomes or human expert interpretations of patient data.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable. As there is no training set.

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The ShockPhysio Mobile (model SW3200 Basic) is indicated for:

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

Not Found

This document is a 510(k) clearance letter from the FDA for a therapeutic massager, the "ShockPhysio Mobile (model SW3200 Basic)".

It does not contain any information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or specific study details like those expected for AI/software-based medical devices.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This indicates a substantial equivalence (SE) determination, which often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested table and study information based on the provided text. The document is for a Class I Therapeutic Massager (a device with lower regulatory controls), and the FDA clearance process for such devices often focuses more on substantial equivalence to existing devices and adherence to general controls, rather than complex performance studies.

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BTL-094 is indicated to be used for:

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

The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.

The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.

The main unit is equipped with a color touch screen, which considerably simplifies its operation. The onscreen information guides the user step through the entire therapy process. A secondary screen is placed on the applicator for the presentation of the actual state of main therapy parameters. The therapeutic parameters are adjustable via touch-screen, buttons and knob. The user is able to set following therapy parameters: intensity, frequency and number of shocks.

The provided text describes a 510(k) premarket notification for the BTL-094 therapeutic massager, which is a Class I device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, a direct 'acceptance criteria' and 'reported device performance' based on a clinical study for the BTL-094 device itself are not applicable as per the document.

The document explicitly states: "Clinical Testing: Not applicable" on page 5. This indicates that no clinical study was performed or required for this 510(k) submission to assess the device's performance against specific acceptance criteria.

Instead of a clinical study, the submission relies on demonstrating that the BTL-094 device has "technological characteristics" (on pages 6-11) that are substantially equivalent to those of two predicate devices: D-Actor 200 (K173692) and DolorClast® Radial (K220538). The "acceptance criteria" in this context are implicitly that the technological characteristics of the BTL-094 are comparable enough to the predicates that they do not raise new questions of safety or effectiveness.

Here's an analysis based on the information provided, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was conducted for the BTL-094 to establish new acceptance criteria and measure its performance against them, a direct table for this is not available in the document. The acceptance for this submission is based on the comparison of the BTL-094's technological characteristics to those of the predicate devices. The table below summarizes key comparative information presented in the document, which serves as the basis for the declaration of substantial equivalence.

Comparison of BTL-094 to Predicate Devices (Basis for Substantial Equivalence)

• Temporary increase in local blood circulation.
• Activation of connective tissue. | - Relief of minor muscle aches and pains.
• Temporary increase in local blood circulation.
• Activation of connective tissue. | Same - "None" (meaning no difference identified, thus accepted as equivalent). |
  | Modes of Action | Extracorporeally induced pressure waves. | Radial pressure waves, or extracorporeal pulse activation respectively. | Not Significantly different - "The technology used in BTL-094 device differs from the predicate device. Nevertheless, the technology creates the same type of acoustic pressure delivered to the tissue." (page 9) |
  | Mechanisms of Action | Vibrations generated by electroacoustic technology. | Pneumatically generated vibrations. | Not Significantly different - "Differences are caused by alternative technology of the pressure wave generation." (page 6), but "creates the same type of acoustic pressure delivered to the tissue." (page 9) |
  | Max & Min Intensity Settings | 5-30% alternative output power setting scale. | D-Actor 200: 1-5bar; DolorClast® Radial: 1-4bar. | Not Significantly different - "Differences are caused by alternative technology of the pressure wave generation." (page 6). BTL-094 is limited to 30% max power for comparability. (page 9) |
  | Number & Size of Applicator Heads | 2; L Pad - 12.2 cm², U Pad - 7.3 cm². | D-Actor 200: 4 (6mmOD, 15mmOD, 20mmOD, 35mmOD); DolorClast® Radial: 7 (5mm OD, 10 mm OD, 15 mm OD, 25 mm OD, 40 mm OD). | Not Significantly different - "The application area of the pads in contact with the patient is within the set range of the predicate devices." (page 6). |
  | Max & Min Vibration Frequency | 1-25 Hz. | D-Actor 200: 1-21Hz; DolorClast® Radial: 1-25 Hz. | Not Significantly different - Differs from one predicate (D-Actor 200) by up to 4Hz higher max frequency, but same range as the other (DolorClast® Radial). (page 6, 9) |
  | Maximum Penetration Depth | 35 mm. | D-Actor 200: 32.3mm; DolorClast® Radial: 40 mm. | Not Significantly different - "comparable within setting range of predicate devices." (page 7, 10) |
  | Energy Flow Density | In the range of 0.01 - 0.11 mJ/mm². | D-Actor 200: 5bar/0.284mJ/mm², 3bar/0.176mJ/mm²; DolorClast® Radial: 0.29 mJ/mm² at 4 bar, 0.14 mJ/mm² at 2.4 bar. | Not Significantly different - EFD of BTL-094 "differs from the predicates but it is lower or within setting range of predicat devices." (page 7, 9). |
  | Positive Peak Pressure Amplitude | In the range of 3 - 10 MPa. | D-Actor 200: 5bar/18.5MPa, 3bar/13.4MPa; DolorClast® Radial: 17 MPa at 4 bar, 11.24 MPa at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
  | Negative Peak Pressure Amplitude | In the range of 3 - 10 MPa. | D-Actor 200: 5bar/6.8MPa, 3bar/5.0MPa; DolorClast® Radial: 10 MPa at 4 bar, 7.2 MPa at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
  | Derived Focal Acoustic Pulse Energy | In the range of 0.1 – 1.4 mJ. | D-Actor 200: 5bar/6.5mJ, 3bar/2.4mJ; DolorClast® Radial: 5.9 mJ at 4 bar, 2.2 mJ at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
  | Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-36, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10. | Not explicitly listed for predicates in this document, but predicate devices are assumed to be compliant with applicable standards. | Compliant - "The BTL-094 device has been thoroughly evaluated for electrical safety." (page 5). |

2. Sample size used for the test set and the data provenance

Not Applicable. As stated, "Clinical Testing: Not applicable." No test set of patient data was used for a clinical study to prove the device meets acceptance criteria. The submission relies on non-clinical testing (safety and performance standards, biocompatibility) and a comparison of technological characteristics to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set requiring expert ground truth establishment was used.

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. The device is a therapeutic massager, not an AI-assisted diagnostic tool.

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

Not Applicable. The device is a physical therapeutic massager, not an algorithm.

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

Not Applicable. No clinical performance study was conducted that would require a ground truth based on patient data. The "ground truth" for this 510(k) submission, in a broad sense, is the demonstration of adherence to recognized safety standards and the established safety and effectiveness profiles of the legally marketed predicate devices through a comparison of technological attributes.

8. The sample size for the training set

Not Applicable. No training set of data was used, as no artificial intelligence or machine learning component is described for this device.

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

Not Applicable. There was no training set mentioned in the provided document.

In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on non-clinical testing (compliance with recognized safety and performance standards like IEC 60601 series and ISO 14971/10993 for electrical safety, EMC, usability, and biocompatibility) and a detailed comparison of the device's technological characteristics to those of two legally marketed predicate devices. The absence of clinical testing is explicitly stated, indicating that the FDA determined it was not necessary for this type of device and submission pathway.

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The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Omnispec™ ED1000 is a portable, self-contained Shock Wave Therapy unit. It employs an electro-hydraulic method of creating shock waves. With this technique, an electrode, located within a water-containing stainless-steel reflector chamber called Shock Wave Applicator (SWA), ignites an electrical discharge, evaporating a small portion of the water and creating a shock wave reflecting outward off the reflector through a flexible membrane. The result is a shock (pressure) wave that passes through a conducting medium (patient). The shock wave is transmitted through the skin surface of the patient to the treatment site. The device provides focused pressure pulses where the second focus (F2) occurs within the membrane of the applicator.

The provided document is a 510(k) summary for the Medispec Omnispec ED1000, a therapeutic massager. It details the device's characteristics, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML model's performance. The performance testing section specifically refers to hardware and software validation, biocompatibility, safety standards, and physical parameters of the shockwave output. It emphasizes that this device is a physical therapeutic massager, not an AI/ML powered device.

Therefore, I cannot provide the requested information regarding AI/ML model acceptance criteria, study design, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as these elements are not present in the provided document for this specific device.

The "Performance Testing" section states:
"Verification and validation testing were performed and demonstrated that Omnispec™ ED1000 met the design specifications and it was safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed successfully."

And the "Clinical Testing" section states:
"Not applicable"

This indicates that the device's performance was evaluated through non-clinical, engineering, and bench testing, rather than studies involving AI/ML performance metrics.

In summary, none of the specific requests related to AI/ML model acceptance criteria and validation studies can be fulfilled from the provided text because the device described is not an AI/ML device.

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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 DolorClast® Radial is indicated for:

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

The DolorClast® Radial is a portable radial pressure pulse device with an integrated air compressor. The DolorClast® Radial system is composed of the DolorClast® Radial console, handpiece, interchangeable applicator heads, and optional cart. Swiss DolorClast® Gel, previously approved under P050004, is also provided for coupling the treatment applicator to the patient's skin.
The DolorClast® Radial console generates and controls the pressure pulse frequency and intensity. Air pressure from the console drives a projectile within the handpiece against the applicator head to generate the pressure pulses at the set frequency and intensity. Device activation is done by the practitioner via a trigger button on the handpiece. The applicator at the distal end of the handpiece transmits the radial pressure pulses to the targeted tissues via the coupling gel applied to the treated skin.

This document is an FDA 510(k) summary for a medical device (DolorClast® Radial), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance. Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment for AI, MRMC studies, expert qualifications) are not applicable or not present in this type of regulatory submission.

However, based on the provided text, I can extract information related to the device's functional performance testing against internal protocols.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several functional performance tests and generally states that "All tests were passed," indicating the device met internal EMS protocols. Specific numerical acceptance criteria are generally not provided in this summary, but the reported performance is that the device met those criteria.

Note: The document states "Averaged across all applicator sizes" for derived focal acoustic pulse energy.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated for any of the performance tests. The testing described appears to be engineering verification and validation, likely involving a limited number of test units or prototypes.
• Data Provenance: The origin of the data is stated as "internal EMS protocols" and "internal EMS testing." It is prospective testing conducted specifically for this regulatory submission on the device itself. No mention of geographical data origin (e.g., country) is made as it's not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts. The "ground truth" for these tests refers to engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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 device is a therapeutic massager, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical therapeutic device, not an algorithm. Its performance is inherent in its physical operation.

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

The "ground truth" effectively used for this regulatory submission is adherence to engineering specifications, internal EMS protocols, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISTA 2A/3A). For biocompatibility, the "ground truth" was established by prior approval (P050004) of identical materials.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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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 intended for the 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.

This document is a 510(k) summary for the OrthoGold 100™ therapeutic massager. It does not provide information specific to an AI/ML device, therefore, many of the typical acceptance criteria and study details for such devices are not applicable.

Here's the breakdown of the requested information based on the provided text:

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

The document does not specify quantitative acceptance criteria in the typical sense of a human-in-the-loop or standalone AI performance study (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through various performance tests.

2. Sample size used for the test set and the data provenance

Not applicable. This device is a therapeutic massager, not an AI/ML diagnostic tool that would typically use a "test set" of patient data for performance evaluation. The testing involved in-vitro performance measurements, electrical safety, and electromagnetic compatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is not an AI/ML diagnostic device, there was no need for experts to establish ground truth on a test set of medical images or patient data.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication of ground truth 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/ML assisted device for human readers.

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

Not applicable. This is a physical medical device (therapeutic massager), not a standalone algorithm.

7. The type of ground truth used

For the in-vitro performance testing, the "ground truth" was established by objective measurements against known physical standards and comparison data from the predicate device. For example, measurements of applicator displacement, force, and penetration depth would have physical accuracy.

8. The sample size for the training set

Not applicable. This product is a physical device, not an AI/ML model that requires a training set. The "training" for such a device would refer to its engineering, design, and manufacturing processes.

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

Not applicable. As above, this is not an AI/ML device.

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The D-ACTOR® 200 Vibration Massage System is intended for:

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

The D-ACTOR® handpiece uses pressurized air pulses to accelerate a projectile within a guiding tube. The accelerated projectile hits a skin-contacting steel activator which is dampened by elastic O-rings that affix it to the distal end of the handpiece and a vibration absorber at proximal end of the handpiece. When the projectile impacts the activator, slow-rising, low-amplitude pressure pulses are generated. Standard coupling gel is typically used to reduce the loss of pulse amplitude to surrounding air. The D-ACTOR 200 System consists of a Control Unit, Handpiece, Mains Cable, Commercially available coupling gel, Foot switch (optional), and Tablet PC (optional). The password protected GUI interface software allows the operator to create, save and edit treatment programs for application to various muscle groups, and permits the operator to create, edit and save individual patient treatment program routines and progress notes. Various software features permit the operator to: (1) adjust energy level, number of pulses, frequency and total pulses delivered, (2) display and adjust skin contact intensity of the applicator, (3) save treatment images/videos to track progress, and (4) utilize Visible Body® interactive 3D musculature to allow the operator to "mark" and save treatment regions to patient records.

The Storz Medical AG D-ACTOR® 200 Vibration Massage System, as described in K173692, is a Class I medical device intended for the relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue. The provided documents detail its substantial equivalence to predicate devices based on technological characteristics and performance testing rather than acceptance criteria for clinical efficacy.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI device, nor does it define specific clinical performance endpoints with associated thresholds for a therapeutic device. Instead, the "performance testing" section and the "Substantial Equivalence Comparison" table demonstrate that the D-ACTOR® 200 meets design specifications and is functionally equivalent to its predicate devices.

The acceptance criteria here appear to be primarily focused on meeting design specifications, safety standards, and demonstrating technological equivalence to legally marketed predicate devices.

The "Substantial Equivalence Comparison" table (page 6) directly compares the D-ACTOR® 200 to the predicate AW Modules, showing largely equivalent or comparable characteristics across 20 parameters, including:

• Indications for Use: Same
• Modes/Mechanisms of Action: Same
• Max/Min Intensity Settings: 1-5bar (compared to 1-5bar and 1-3bar for predicates)
• Number/Size of Applicator Heads: 4 (6mmOD, 15mmOD, 20mmOD, 35mmOD) (compared to 3/2 for predicates with slightly different sizes)
• Max/Min Displacements: 0.6 – 2.0mm (compared to 0.6 – 2.0mm and 2.0mm for predicates)
• Max/Min Vibration Frequency: 1-21Hz (compared to 0.5-21Hz and 0.5-3Hz for predicates)
• Maximum Penetration Depth: 32.3mm (compared to 17mm and 32.3mm for predicates)
• Energy Flow Density: 5bar/0.284mJ/mm², 3bar/0.176mJ/mm² (compared to 3bar/0.176mJ/mm² for predicates). Note: At 5bar, the D-ACTOR® 200 has a higher energy flow density than the predicate, but this is reported as part of the substantially equivalent comparison.
• Operating Mode, Projectile Mass, Type of Acoustic Wave Generation: Same |
  | Software Validation: The device software must be validated to an appropriate level of concern. | "The D-ACTOR® 200 software was validated and demonstrated to be of a Moderate level of concern..." It also complies with IEC 62304:2006: Medical Device Software Software Life Cycle Process. |
  | Hazard Analysis/Risk Management: All identified risks must be mitigated to an acceptable level. | "...hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level." It complies with ISO 14971:2000/A1:2003: Medical devices: Application of risk management to medical devices. |
  | Biocompatibility: Skin-contacting components must be biocompatible. | "The skin contacting component was tested for biocompatibility and found to conform to elements of ISO 10993-1:2003." |
  | Electrical Safety and Electromagnetic Compatibility (EMC): The device must conform to relevant international safety and EMC standards. | "The D-ACTOR® 200 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012 (Ed. 3.1); as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2007 (3rd Ed.)." It also complies with IEC 61000-3-2:2000 and IEC 61000-3-3:2000 for EMC. |
  | In-vitro Performance: In-vitro measurements of applicator displacement, force, and penetration depth should be equivalent to the predicate devices. Ultrasonic energy parameters should also be evaluated and comparable. | "In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module (i.e., D-ACTOR provided as OEM) of the predicate devices. Ultrasonic energy comprises approximately 5% of D-ACTOR® 200 total output and this parameter was evaluated by employing modified protocols from IEC 61846. Those tests demonstrated energy flow densities (ED) of 0.176mJ/mm2 at 3 bar pressure (same ED as the predicates) and 0.284mJ/mm2 at 5 bar pressure." |

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

The provided document describes performance testing related to device characteristics (e.g., electrical safety, EMC, biocompatibility, in-vitro physical parameters) and comparisons to predicate devices, but not a clinical study with a "test set" of patients or data. Therefore, typical sample size and data provenance (country of origin, retrospective/prospective) for a study evaluating diagnostic or treatment efficacy in a patient population are not applicable here.

The "testing" mentioned is for engineering verification and validation, involving laboratory measurements and comparisons to established standards and predicate device specifications.

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

This information is not applicable as there is no clinical "test set" requiring expert ground truth establishment for patient outcomes or conditions. The "ground truth" in this context would be the measured physical properties of the device and compliance with engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable as there is no clinical "test set" requiring adjudication.

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 information is not applicable. The D-ACTOR® 200 Vibration Massage System is a therapeutic device, not an AI-powered diagnostic tool used by human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an algorithm, and its performance inherently involves human operation and interaction with a patient.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

• Engineering Specifications and Design Requirements: The device's internal design parameters and intended operational characteristics.
• International Consensus Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, and IEC 62304.
• Predicate Device Characteristics: Direct comparison of physical and operational parameters (e.g., intensity, frequency, penetration depth) with the legally marketed predicate devices (AW module of Dermablate Effect and TattooStar Effect Y).
• In-vitro Measurements: Laboratory measurements of physical properties such as applicator displacement, force, and penetration depth.

8. The Sample Size for the Training Set

This information is not applicable. The D-ACTOR® 200 is a physical therapeutic device, not an AI/machine learning algorithm, and thus does not have a "training set" in the context of data-driven model development. Its development and testing follow traditional engineering verification and validation processes.

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

This information is not applicable for the same reasons as point 8.

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Reduction of Secondary Lymphedema of the Arm (SLA) Post Mastectomy Improvement of Secondary Lymphedema Improvement of lymphatic circulation in the treated area

The Cellu M6 Keymodule i electrical therapeutic massager is comprised of a program console housing a vacuum pump and a regulation system. The main treatment head 150 consists of two parallel motorized rollers housed in a chamber which produces both negative pressure above the rollers and positive pressure below the rollers. This technology creates a skin fold between the two rollers in a suction chamber. thus mimicking the "rolled palpation" of manual massage techniques. In addition to Head i50 which is meant primarily for the upper arm and for legs, auxiliary heads T615, T615-A, T630, T630-A, T644 and T644-A are also used, as they better suit smaller morphology (parts) of the body. Details are provided along the labeling provided. This device has the capability to produce both constant and sequential aspiration. Constant aspiration provides a deeper massage, which also mobilizes the muscle fascia. With sequential aspiration, the suction power is cyclically interrupted to provide pulsation to the skin fold between the two rollers and a softer, gentler stroking action of the tissues. The suction power ranges from 45 mm Hg to 180 mmHg, which is represented by a power level scale ranging from 1 to 4.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for the "Cellu M6 Keymodule i" therapeutic massager, which focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the device, its intended use (reduction and improvement of secondary lymphedema of the arm post-mastectomy, and improvement of lymphatic circulation), and a comparison of its technological characteristics with predicate devices.

The document states: "This device is safe and effective as the predicate devices cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)". However, the "tabulated comparison" (Paragraph 14) only compares technological characteristics such as indications for use, target population, design, materials, etc., and asserts "Identical" or "Similar" for many categories. It does not provide performance metrics, acceptance criteria, or a study demonstrating that the Cellu M6 Keymodule i meets specific performance targets for lymphedema reduction or lymphatic circulation improvement.

Therefore, I cannot generate the requested table or details about a study from the provided text.

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