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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) primarily focus on demonstrating substantial equivalence to predicate devices through non-clinical testing. This type of clearance generally does not require extensive clinical performance studies with detailed acceptance criteria and human reader studies as would be seen for a new or complex AI/ML-driven diagnostic device.

Based on the provided information, the device is a light-based therapy device for over-the-counter use, intended for aesthetic purposes (facial wrinkles and mild to moderate inflammatory acne). The "study" proving the device meets acceptance criteria is a non-clinical performance testing approach demonstrating compliance with relevant electrical safety, electromagnetic compatibility, photobiological safety, battery safety, and biocompatibility standards. Software verification and validation, and usability validation were also performed.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance

Since this is a non-clinical submission, the "acceptance criteria" are compliance with established safety and performance standards. There isn't a table of statistical performance metrics, but rather successful adherence to defined technical and safety requirements.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Compliance)

Study Details (as applicable for a non-clinical submission):

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Device Testing): The "test set" here refers to the device prototypes/units that underwent the non-clinical tests. The document does not specify the number of units tested for electrical safety, EMC, etc., which is typical for such submissions.
   • Data Provenance: The testing was conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) in China, as indicated by the submitter's information. It's inherently "prospective" in the sense that the tests were performed on the device designed for submission.

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

   • This is a non-clinical submission for a device used for aesthetic purposes. The concept of "ground truth" established by medical experts (like radiologists for image analysis) is not applicable here. The "ground truth" for these tests is defined by the passing criteria of the international standards themselves (e.g., specific thresholds for electrical leakage, EMC emissions, irradiance, etc.). Compliance is assessed by qualified test engineers and labs.

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

   • Not applicable. Adjudication methods are typically used in clinical studies, especially those involving subjective assessments or disagreements among human readers. Non-clinical testing against objective standards does not involve expert adjudication in this manner.

4. 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. An MRMC study is not relevant for this type of aesthetic, light-based therapy device where the claim is not for assisting human readers in diagnosis. The clearance is based on safety and functional equivalence.

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

   • Not applicable. This device is not an algorithm for diagnosis or image analysis. It is a physical device providing light therapy. Its "standalone" performance refers to its ability to meet the specified technical parameters and safety standards.

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

   • The "ground truth" for demonstrating substantial equivalence and safety in this context is compliance with recognized international consensus standards (e.g., IEC, ISO). The performance is measured against these technical specifications, not against clinical outcomes or expert consensus on medical conditions.

7. The sample size for the training set:

   • Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the traditional sense of AI/ML software. The software component, as described, is for controlling device functions ("Basic Documentation Level software"), not for learning from data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML algorithm.

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The KALA Therapy Wand (Model: KALA-03) is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne.

The KALA Therapy Wand (Model: KALA-03) is indicated for over-the-counter aesthetic use. The red light is intended for the treatment of wrinkles, and the blue light is intended for the treatment of mild to moderate inflammatory acne. The device is vibrating in red light model. The device is powered by a Lithium-Ion rechargeable battery, and it has a charging cable, USB charging stand, protective goggles, storage case and instruction manual.

The wand can be rotated 135 degrees in either direction.

There are two switches of the device: one function is red light to wrinkle removal and vibration for relax, the other function is blue light to treat mild to inflammatory acne.

The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes per area. After every three minutes of treatment, the device will vibrate to indicate the time. If you need to continue treatment, simply turn on the device again.

The provided FDA 510(k) clearance letter and summary for the KALA Therapy Wand (Model: KALA-03) indicate that no clinical performance study was conducted to prove the device meets acceptance criteria. The summary explicitly states:

"7.2 Summary of Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, the following information cannot be extracted from the provided document as it pertains to clinical performance which was not performed or deemed necessary for this 510(k) clearance.

1. A table of acceptance criteria and the reported device performance (for clinical performance)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
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 typically for AI/imaging devices, not a light therapy wand)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done (Not applicable for this device type)
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

However, based on the non-clinical tests performed, we can infer the acceptance criteria for those tests and their reported performance:

Non-Clinical Acceptance Criteria and Reported Device Performance

Additional Information Not Applicable/Provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed. For non-clinical tests, these metrics are not typically reported in this format.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
• Adjudication method: Not applicable as no clinical study was performed.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is typically for AI/imaging devices.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is typically for AI/software devices.
• The type of ground truth used: Not applicable as no clinical study was performed.
• The sample size for the training set: Not applicable as no clinical study was performed.
• How the ground truth for the training set was established: Not applicable as no clinical study was performed.

In summary, the KALA Therapy Wand (Model: KALA-03) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and compliance with relevant safety and performance standards, without the need for a separate clinical effectiveness study.

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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 Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient. The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head. The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.

This document is a 510(k) summary for the Indiba S.A.U. Reverso Pro System (K243139). It details the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is an electrosurgical cutting and coagulation device. The information provided outlines the non-clinical (bench) performance data for the device, and a qualitative assessment of its similarities to predicate devices to establish substantial equivalence. However, there is no detailed clinical study or acceptance criteria table in the format requested, nor is there information about AI/ML algorithm performance.

The document states:

• "Clinical Performance Data: Not Applicable" (Page 8)
• The "Non-Clinical (Bench) Performance Data" section primarily discusses the device's RF performance specifications and thermal effects. It does not describe a study involving human or expert evaluation for determining accuracy or clinical efficacy in the context of an AI/ML device.
• The entire submission focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety standards, rather than proving the device meets specific performance criteria through a rigorous clinical trial or AI/ML validation study.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets them, specifically for an AI/ML algorithm with human-in-the-loop performance, ground truth establishment, or sample sizes for test/training sets, because this submission is for a medical device that does not appear to involve an AI/ML component or a clinical performance study in the way typically required for AI/ML-driven devices.

The information provided relates to the physical device's electrical and mechanical safety, electromagnetic compatibility, and thermal performance.

Based on the provided text, the device is a radiofrequency aesthetic device, not an AI/ML-driven diagnostic or therapeutic device. As such, the types of studies and acceptance criteria you've asked about (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information presented in this 510(k) summary. The "study" mentioned for performance is a skin temperature test on 3 human volunteers for the Quadro RF Applicator, which is a very different type of study than an AI/ML validation.

Therefore, providing a specific table and detailed answers to your questions on AI/ML performance would be misleading as the document does not contain this information.

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Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.

This document is a 510(k) Premarket Notification from the FDA for a medical device called the "Breo Laser Hair Growth Comb (Scalp 3L)". It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics for a novel AI/medical device.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them (especially those related to AI algorithm performance or direct clinical efficacy studies with specific metrics) are not present in the provided text. The document states "Clinical study: Not applicable" (Section 9), indicating that a clinical trial to prove efficacy or safety in the traditional sense was not required for this 510(k) clearance due to the device's similarity to an already cleared predicate.

Here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device (Laser Therapy Hair Growth Comb, Lasercomb-001, K230134). This means the device performs similarly in terms of its technical specifications and intended use.

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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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The GENEO X ELITE system with the TriPollar RF Applicator is intended for use in the non-invasive treatment of mild to moderate facial wrinkles for adult users who have Fitzpatrick Skin Types I-IV.

The GENEO X ELITE system with the OxyGeneo Applicator is intended to provide massage by a mechanical vibration of an electrically powered applicator. The OxyGeneo treatment is suitable for all skin types.

The GENEO X ELITE device is a non-invasive, tabletop console with a graphical user interface (GUI), which supports two applicator types: the TriPollar Radiofrequency (RF) Applicator utilizing bipolar radiofrequency technology for facial wrinkles treatments and the OxyGeneo Applicator utilizing mechanical vibration for facial massage sensation.

The GENEO X ELITE device is manufactured by Pollogen Ltd. Similar to the predicate device, the STOP U Model UXV device, the GENEO X ELITE device constitutes the same underlying TriPollar technology to employ bipolar RF energy in a non-invasive manner utilizing the TriPollar RF Applicator.

In addition to the TriPollar RF applicator the GENEO X ELITE device comprises the OxyGeneo Applicator. The OxyGeneo Applicator is an electrically powered massager utilizing mechanical vibration generated by an electrically powered motor housed in the applicator.

The provided document is a 510(k) summary for the Pollogen Ltd. GENEO X ELITE device and does not contain detailed information about specific acceptance criteria or a dedicated study setup to prove device performance against those criteria in the way typically found for AI/ML devices.

However, based on the non-clinical and clinical performance data sections, and the general context of a 510(k) submission for an electrosurgical device, we can infer some "acceptance criteria" based on compliance with recognized standards and successful completion of various tests related to safety and functionality. The study described is primarily a Human Factors (Usability) study and various bench performance tests, rather than a clinical efficacy study with quantitative performance metrics.

Here's an attempt to structure the information based on your request, with the understanding that direct quantitative acceptance criteria and corresponding performance from a single study are not explicitly detailed for clinical efficacy in this document.

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary focused on substantial equivalence rather than a detailed clinical trial report, specific quantitative acceptance criteria for clinical effectiveness (e.g., specific reduction in wrinkle severity) and their statistically proven performance are not explicitly stated. Instead, "acceptance criteria" are inferred from compliance with recognized safety and performance standards and successful completion of bench and human factors testing.

2. Sample Sizes Used for Test Set and Data Provenance

• Human Factors Validation Testing (Phase II):
  • Sample Size: The document does not explicitly state the number of participants (users or cases) in the Human Factors Validation Testing (Phase II). It only mentions that the study involved "use of the device by the device target users (estheticians / cosmeticians) and performing device operation and knowledge tasks."
  • Data Provenance: The document states that the GENEO X Human Factors (Usability) validation test further validated the device "in a real-world environment." Phase I (formative assessment) was performed "on the GENEO X TriPollar RF device (precursor to the GENEO X) in the EU (Belgium and Switzerland) and Canada." The Phase II validation study's specific location is not detailed beyond "real-world environment." This study is prospective, as it involves testing with target users.

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

• For the Human Factors Validation Testing, "ground truth" would relate to the assessment of usability and the effectiveness of training materials. The document implies that "target users (estheticians / cosmeticians)" performed the tasks and their performance/feedback constituted the data for assessing usability. No explicit mention of independent "experts" establishing a separate "ground truth" for usability, outside of the direct user experience and observation during the study, is made.

4. Adjudication Method for the Test Set

• The document does not describe a clinical performance study with an adjudication method (like 2+1, 3+1). The Human Factors study's assessment method is not detailed in terms of adjudication.

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

• No MRMC comparative effectiveness study is described for clinical efficacy. The Human Factors study is not an MRMC study for clinical outcomes, but rather for usability. The document focuses on substantial equivalence to a predicate device based on similar technology, safety, and performance, not on demonstrating improved effectiveness over human readers or other devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• This device is an electrosurgical device for aesthetic use, involving a human operator (esthetician/cosmetician). It is not an AI/ML diagnostic or predictive algorithm, so the concept of "standalone performance" for an algorithm without human-in-the-loop does not apply in the typical sense. The device's operation inherently involves a human user.

7. Type of Ground Truth Used

• For Bench Performance Data: The "ground truth" for technical specifications (e.g., RF output power, frequency, electrical safety) is established by measurements against recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• For Human Factors Validation Testing: The "ground truth" is derived from user performance, observations, and feedback from the device's target users (estheticians/cosmeticians) as they interact with the device and training materials in a simulated real-world environment.

8. Sample Size for the Training Set

• This document does not describe an AI/ML device in the context of a "training set" for an algorithm that learns from data. Therefore, the concept of a training set sample size is not applicable. The device design and safety features are based on engineering principles and compliance with standards, not machine learning training.

9. How Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of an AI/ML algorithm learning.

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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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