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MIST Systems produce a low energy ultrasound generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates, and bacteria.

MIST Systems (e.g., UltraMIST System) are low frequency ultrasound devices, which utilize a fluid (e.g., saline) mist to deliver the ultrasound to the treatment site. The atomized fluid allows the treatment to be performed without direct contact to the patient. MIST Systems are made up of a main generator component, treatment wand, and disposable applicator.

MIST Systems deliver low-frequency ultrasound to the treatment site using an atomized fluid mist. The mist is generated from a small, portable system consisting of a generator, a treatment wand (encasing an ultrasound transducer), and a disposable applicator that has been designed to connect to a user-provided fluid source (e.g., IV saline bag). The system provides a flow of fluid (irrigant) to the tissue surface by the use of low frequency, low intensity ultrasound. Only the mist touches the tissue, not the ultrasound radiation surface (horn tip), thus the term "non-contact" ultrasound. The flow of fluid as an irrigant is controlled by a peristaltic pump on the generator unit. The fluid is dispensed onto the ultrasound radiation surface where the mist is generated. The mist is projected by fundamental atomization or nebulization and acoustic streaming or acoustic radiation force respectively.

The acceptance criteria and device performance evaluation details for the Alliqua Biomedical, Inc. Stimucel System (K162721) are summarized below, based on the provided 510(k) summary.

It's important to note that this submission is a 510(k) for a device with minor modifications (enclosure material change) to an already cleared predicate device (K140782, UltraMIST® System). Therefore, the study presented focuses on demonstrating that these specific modifications do not adversely affect the safety and performance, rather than establishing original effectiveness for the first time. The information provided aligns with a non-clinical testing approach to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The submission does not detail a "test set" in the traditional sense of patient data. Instead, the testing described is related to the physical and electrical performance of the device components and biocompatibility of materials.

• General Safety Testing (IEC 60601-1 3rd Ed.): Performed on the subject device to verify changes in enclosure material. This would involve specific units of the manufactured device. The exact number of units tested is not specified in the summary but is typically dictated by testing standards.
• Biocompatibility Testing (Cytotoxicity): Performed on the new enclosure materials. This involves samples of the material itself. The exact number of samples is not specified.

Data Provenance: The non-clinical testing was performed by Intertek (for general safety) and WuXi AppTec (for biocompatibility), which are accredited testing laboratories. The data is thus derived from laboratory testing of the device and its materials. This is a form of prospective testing for the specific modifications. Country of origin of the data is not explicitly stated but generally follows the location of these testing facilities.

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

This type of information is not applicable for the non-clinical testing performed for this 510(k) submission. The "ground truth" for these tests are objective measurements against established engineering and safety standards (e.g., IEC 60601-1, ISO biocompatibility standards). The results are interpreted by qualified engineers and scientific personnel at the testing laboratories (Intertek, WuXi AppTec) who specialize in these types of evaluations.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against defined technical and safety specifications, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence for minor material changes to an existing device through non-clinical performance and safety testing. MRMC studies are typically used to evaluate the diagnostic performance of imaging devices where human interpretation is involved.

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

Not applicable. The device, UltraMIST, is a physical medical device (low energy ultrasound wound cleaner) and not a software algorithm evaluating data independently.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is based on:

• Established international standard performance requirements (e.g., IEC 60601-1 for electrical safety and performance).
• Biocompatibility standards for medical device materials (e.g., ISO standards for cytotoxicity).
• Comparison to the performance of the legally marketed predicate device (K140782), specifically demonstrating that the modified device's performance is equivalent.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for machine learning models, which is not what this device is.

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

Not applicable, as no training set was used.

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MIST Systems produce a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates and bacteria.

Not Found

The provided text is a 510(k) summary for the UltraMIST System, a low energy ultrasound-generated mist device used for wound cleansing and maintenance debridement. This document is a regulatory approval letter from the FDA and does not contain the information requested regarding acceptance criteria, study details, or performance data of the device.

Therefore, I cannot provide a response to your request as the necessary information is not present in the given document.

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The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via:

• Selective and non-selective dissection and fragmentation of soft and or hard tissue;
• Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and eschar, fibrin, tissue exudates, bacteria and other matter.
• Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue);
• Contact and or non-contact maintenance debridement for the removal ofdebris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter.
• Preparing the wound bed for graft or other subsequent procedures using contact and or non-contact techniques to achieve wound debridement.

The AR1000 Ultrasonic Wound Therapy System and its variants use ultrasonic energy from a generator delivered by a conductive cable to a hand held converter through the converter's distal end probe and liquid coupling medium: to perform wound therapy; to perform ultrasonic surgical, excisional, and or sharp-edge selective dissection procedures; with the intended end result to promote healing. The AR1000 Ultrasonic Wound Therapy System generator utilizes commonly available wall outlet power (85 -260VAC, 50/60Hz) to produce the ultrasonic signal. A conductive cable connects the generator to the hand held converter. The hand held converter converts the signal into ultrasonic mechanical displacement in the distal end probe or Qurette. The ultrasonic mechanical displacement energy is applied to the treatment site by the distal end probe or Qurette through direct contact or noncontact techniques. The ultrasonic mechanical displacement energy is also transmitted as ultrasonic energy to the treatment site via the liquid coupling medium. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve intended wound therapy modalities to promote wound healing. This is achieved through the use of the low-frequency, controlled-intensity, ultrasonic energy to perform ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue), and surgical, excisional or sharp-edge incisions. The AR1000 Ultrasonic Wound Therapy System distal end probe or Qurette is used with contact or non-contact modes to achieve wound therapy and promotes wound healing through the ultrasonic dissection and fragmentation of tissues, debridement of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) through the use of the low-frequency, controlled-intensity, non-thermal ultrasonic energy. The AR1000 Ultrasonic Wound Therapy System ultrasonic energy, via the liquid coupling medium to the treatment site, promotes wound healing through the lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation of the site for the removal of debris, exudates, fragments, bacteria, and other matter. The AR1000 Ultrasonic Wound Therapy System uses continuous ultrasonic energy to propel the liquid medium (e.g. sterile saline, or other appropriate US FDA cleared medium) into a solution stream and couples the delivery of ultrasonic energy to the treatment site. This is accomplished by the ultrasonic energy application to the treatment site where the ultrasonic energy is transmitted via the converter probe (Qurette) and also coupled via the liquid medium to the treatment site. The converter has a transducer horn that is made from titanium alloy (TI-6AL-4V). The converter probe Qurette tips are made from titanium alloy (TI-6AL-4V). No latex is used in this device, including any potential patient-contact areas, and testing has revealed no negative reactions to the materials used in this device.

This 510(k) summary is for a device, the AR1000 Ultrasonic Wound Therapy System, which is substantially equivalent to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating substantial equivalence rather than presenting an independent study with defined acceptance criteria and device performance metrics in the typical sense of a novel device.

The "acceptance criteria" here are established by compliance with recognized standards and demonstration of substantial equivalence to predicate devices, particularly regarding safety and effectiveness. The "study" proving this is primarily a compilation of comparative analyses against these predicates and adherence to safety standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence with an expanded indication for use, the "acceptance criteria" are implicitly met by demonstrating that the device is as safe and effective as the predicate devices, and that the expanded indications do not raise new safety or effectiveness concerns. The performance is therefore characterized by its equivalence to these predicates and compliance with relevant standards.

• Selective and non-selective dissection and fragmentation of soft and/or hard tissue.
• Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, burns) for removal of nonviable tissue.
• Site cleansing irrigation and lavage of wound tissue.
• Contact and/or non-contact maintenance debridement for removal of debris, exudates, fragments, bacteria, slough, fibrin, excised/fragmented tissue.
• Preparing the wound bed for graft or other subsequent procedures.
  These expanded indications are supported by expanded patient results and laboratory findings, and comparably meet the performance characteristics of the predicate devices for analogous indications (Arobella AR1000 K062544, Misonix SonicOne K112782, Celleration Mist K122246, Soring Sonoca K072904). |
  | Controlled Ultrasonic Delivery and Lavage (comparable to predicates) | Delivers controlled ultrasonic energy with 0.9% sterile saline solution (or other approved medium) to lavage wound tissue (acute and chronic wounds, burns, diseased/necrotic tissue), similar to Arobella AR1000 (K062544) and Celleration (K122246). |
  | Maintenance Debridement (comparable to predicates) | Performs maintenance debridement for removing loose fragments, debris, exudate, bacteria, and other matter, similar to Arobella AR1000 (K062544), Misonix SonicOne (K112782), Celleration (K122246), and Soring Sonoca (K072904). |
  | Ultrasonic Selective Dissection and Debridement (comparable to predicates) | Enables ultrasonic selective dissection and debridement of tissue using the probe (Qurette), including shallow separation of tissue layers, similar to predicate Arobella AR1000 (K062544) and Misonix SonicOne (K112782). |
  | Electrical Safety & Electromagnetic Compatibility (compliance with standards) | Complies with IEC 60601-1, UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, and FCC Part 18. |
  | Ultrasonic Safety (compliance with standards) | Complies with 21 CFR 1050.10 and IEC 61847. |
  | Biocompatibility (compliance with standards) | Tested for and complies with ISO 10993-1:2003 and relevant annexes (based on nature and duration of patient contact). All testing conducted under 21 CFR Part 58 Good Laboratory Practice. |
  | Reprocessing (validated methodology for sterilization) | Reprocessing instructions for the AR1000 system and converter hand piece (K062544) have been previously validated and cleared. The variant converter hand piece allows for steam sterilization (autoclave) in addition to previously cleared methods. |
  | Technical Specifications (Generator Power Source, Converter Power Output, Amplitude, Frequency, Weight, Dimensions, Storage/Operating Temperature) (comparable to K062544 and predicate devices where applicable for safety/effectiveness) | Generator Power Source: 85-260V~ (VAC), 2.5A, 50/60Hz (Similar to K062544)
  Converter Power Output:

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The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers. bedsores and vaginal ulcers. soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

The SonicOne Plus Ultrasonic Wound Care System and Accessories is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include Probe tips, Wrenches, Sterile and non sterile Tube sets and sterile Surgical Procedure bags and sterile Handpiece Sheaths.

This document describes the Misonix SonicOne Plus Ultrasonic Wound Care System and Accessories, which is an ultrasonic surgical system used for wound debridement. The submission aims to demonstrate substantial equivalence to predicate devices, namely the SonicOne Ultrasonic Wound Care System (K112782) and the AUSS-7 Ultrasonic Surgical System (K070313).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with a set of voluntary standards and successful completion of non-clinical tests. The "reported device performance" is essentially the statement that the device has "passed" these standards and tests. There are no specific quantitative performance metrics like sensitivity, specificity, or accuracy provided, as this is a medical device for physical intervention, not diagnostic imaging or AI.

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

The document explicitly states: "As such, no additional clinical data was obtained in anticipation of this submission." This indicates that there was no dedicated test set involving human subjects or clinical data for this specific 510(k) submission. The safety and performance assessment relies on non-clinical tests, engineering validations, and substantial equivalence to previously cleared predicate devices.

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

Not applicable. There was no clinical test set requiring ground truth establishment by experts for this submission. The device's safety and effectiveness are established through engineering and biological testing against established standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. There was 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

Not applicable. This device is an ultrasonic surgical system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI" is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by engineering standards and biological safety standards (e.g., ISO, IEC, UL, FCC for electrical safety, biocompatibility, sterilization, and electromagnetic compatibility). For the software component, the ground truth is its compliance with FDA guidelines and ISO 60601-1-4, as validated by previous clearance (K070313).

8. The Sample Size for the Training Set

Not applicable. The device is not an AI algorithm that requires a training set in the typical sense. Its design and operational parameters are based on established engineering principles and its predicate devices.

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

Not applicable. No training set for an AI algorithm was used.

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The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgement would require the use of an ultrasonic aspirator with sharp debridement.

The SonicOne Ultrasonic Wound Care System is comprised of a generator, which feeds a 22.5 kHz electrical signal to a piezoelectric crystals mounted in a hand-held handpiece; the crystals then vibrate at the same frequency. The titanium tip attached to the handpiece amplifies the vibration. An irrigation unit is provided to introduce irrigation solution to the operative site. Accessories include probe tips, wrenches, sterile and non sterile tube sets and sterile Surgical Procedure bags and handpiece sheaths.

The provided text describes the Misonix SonicOne Ultrasonic Wound Care System and Accessories, focusing on its substantial equivalence to predicate devices rather than independent clinical studies with specific acceptance criteria and performance metrics. Therefore, many of the requested sections regarding acceptance criteria, study data, and ground truth establishment cannot be fully populated from the given information.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

• IEC 60601-1 (Medical Electrical Equipment, Part 1: General Requirements for Safety)
• IEC 60601-1-2:2001 (Medical Electrical Equipment General Requirements for EMC)
• FCC Part 18 (EMC Requirements)
• ISO 10993-1:2009 (Biological evaluation of medical devices —Part 1: Evaluation and testing)
• ISO 10993-7:2008 (Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals)
• ISO 15223-1:2007/A1:2008 (Medical devices —Symbols to be used with medical device labels, labeling, and information to be supplied —Part 1: General requirements) |
  | Performance (Functional) | Not explicitly stated. | The SonicOne is stated to be "identical to the AUSS-6 Ultrasonic Surgical Aspirator cleared under 510K #K050776." It is also considered substantially equivalent in "Mode of Operation, Hardware Design and Output Parameters" to the predicate devices. This implies it meets the performance characteristics of those cleared devices. |
  | Clinical Efficacy | Not explicitly stated. | "The FDA has cleared all indications for use in the predicates. As such, no additional clinic data was obtained in anticipation of this submission." This refers to a determination of substantial equivalence based on predicate devices' clearance, not a new clinical study. |

Study Details (Based on Substantial Equivalence Claim)

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

   • No direct test set for performance on patients was used for this 510(k) submission. The submission relies on the substantial equivalence to predicate devices (Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System K062544 and Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776).
   • Therefore, there is no specific data provenance (country of origin, retrospective/prospective) for a new clinical test set.

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

   • Not applicable. No new clinical test set with ground truth established by experts was used for this submission. The basis for clearance is substantial equivalence to already cleared devices and their established indications for use.

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

   • Not applicable. No new clinical test set requiring adjudication was performed as part of this 510(k).

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:

   • Not applicable. This device is a physical medical device (ultrasonic wound care system), not an AI/software-based diagnostic or assistive tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission.

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

   • Not applicable. This device does not contain software and is not an algorithm.

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

   • For the purpose of this 510(k), the "ground truth" for efficacy is implicitly the established safety and effectiveness of the predicate devices for their cleared indications. The submission argues that the SonicOne is substantially equivalent in design and function, therefore sharing the same safety and efficacy profile.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no training set in the context of AI.

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

   • Not applicable. See above.

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Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter.

The AS1000 Ultrasonic Wound Therapy System promotes wound healing through the ultrasonic lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and cleansing irrigation & maintenance debridement of the removal of debris, exudates, fragments, bacteria, and other matter through the use of low-frequency, low-intensity, nonthermal non-contact ultrasonic energy and oxygenated fluid irrigation. This is accomplished by the non-contact, non-thermal application of a fine oxygenated fluid stream spray to the wound bed whereby ultrasound energy is transmitted via the stream from the applicator tip to the wound tissue. Non-contact ultrasound provides cellular stimulation, increased blood flow, and reduced bioburden with much less pain or thermal-effect than competing direct contact ultrasound devices. The AS1000 uses continuous ultrasonic energy to oxygenate the fluid (typically sterile saline) into a solution stream and couple the delivery of ultrasonic energy via the stream to the treatment site.

The provided 510(k) summary for the AS1000 Ultrasonic Wound Therapy System does not contain specific acceptance criteria or a dedicated study proving the device meets particular numerical performance targets. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, safety standards compliance, and intended use.

Therefore, many of the requested sections (e.g., specific performance values, sample sizes for test sets, number of experts for ground truth, MRMC study, training set details) cannot be extracted directly from this document. The document describes the basis for equivalence rather than presenting a performance study with detailed acceptance criteria and results against those criteria.

However, I can extract information related to safety and the general approach to demonstrating effectiveness through equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit numerical acceptance criteria for performance are not stated in this 510(k) summary. The "acceptance criteria" are implied to be substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety.

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

• The document does not describe a test set or clinical study with a specified sample size.
• The "data provenance" for performance is based on the substantial equivalence argument to existing, legally marketed predicate devices, and a general reference to clinical literature supporting the use of therapeutic ultrasound for wound healing. It does not refer to new clinical data generated specifically for the AS1000.

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

• Not applicable, as no specific test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

• Not applicable, as no specific test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The submission focuses on device equivalence, not a comparison of human reader effectiveness with or without AI assistance, as this is not an AI-based diagnostic device.

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

• Not applicable, as this is a physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• The "ground truth" implicitly used is the established safety and efficacy profile of the predicate devices and the general scientific understanding of ultrasound therapy for wound healing, as supported by referenced (though not detailed) clinical literature. There is no specific, newly generated ground truth data for the AS1000 in this submission.

8. The Sample Size for the Training Set

• Not applicable, as this is a physical medical device, not an AI/Machine Learning algorithm requiring a training set.

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

• Not applicable, as this is a physical medical device.

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The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.

MIST Therapy System is a non-contact, low-energy ultrasound device, which utilizes continuous ultrasonic energy to atomize saline and deliver a continuous mist to the treatment site to promote wound healing.

The provided text describes a Premarket Notification (510(k)) Summary for the MIST Therapy™ System 5.1, seeking clearance from the FDA. This summary focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study with quantified metrics.

Therefore, many of the requested details about acceptance criteria, specific study results, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in the provided document, as the 510(k) approval process for this type of device often relies on demonstrating equivalence through design, materials, and function, supported by a summary of clinical evidence rather than a de novo performance study with pre-defined acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not available:

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

No explicit acceptance criteria with numerical targets are provided in the document. The "Testing Summary" broadly states that "All study results supported the conclusion that the MIST Therapy System promotes wound healing." This is a qualitative statement of performance rather than a specific quantitative metric against an acceptance criterion.

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

• Sample Size for Test Set: Not specified. The document mentions "numerous preclinical, animal, and human clinical studies" but does not provide details on sample sizes for these studies.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 and not specified. The studies mentioned relate to wound healing, which would likely involve clinical assessments by healthcare professionals, but the document does not detail how "ground truth" was established, nor the number or qualifications of experts.

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

Not applicable and not specified.

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 an ultrasonic wound cleaning device, not an AI-assisted diagnostic or imaging tool. Therefore, MRMC studies and "human readers with/without AI assistance" are not relevant to this product.

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

Not applicable. This is a physical device used for treatment, not an algorithm.

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

The "Testing Summary" refers to "preclinical, animal, and human clinical studies." For human clinical studies, "wound healing" would likely be assessed through observable clinical outcomes (e.g., wound size reduction, removal of slough/fibrin/exudates, reduction of bacteria). The specific methods for establishing this "ground truth" (e.g., specific clinical assessments, photographic evidence, microbial cultures) are not detailed.

8. The sample size for the training set

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

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

Not applicable.

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The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.

The SonoPrep® Ultrasonic Skin Permeation System is a portable battery operated reusable device that disrupts the stratum corneum layer of the skin by means of cavitation of a fluid with ultrasonic energy. The result of the treatment allows the rapid onset of topical OTC lidocaine 4%.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative or tabular format. However, based on the study described, the implied performance criterion is the ability to produce a "rapid dermal anesthetic effect" using topical OTC lidocaine 4%, with no significant adverse events or skin irritation.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 320 subjects.
• Data Provenance: The study was a "randomized, controlled study." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted there or in a location compliant with US regulatory standards. It was a prospective study, as subjects were treated and then their pain and adverse events were assessed.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. Instead, pain was assessed by the subjects themselves using an "accepted pain evaluation scale." The clinical observations for adverse events were likely made by clinical staff involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Pain scores were self-reported by subjects, and clinical observations for adverse events were analyzed. There's no indication of multiple reviewers or an adjudication process for these outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the effectiveness of the device in facilitating anesthesia, not on human readers' performance with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical system (SonoPrep® Ultrasonic Skin Permeation System) that is used in conjunction with a topical anesthetic, not a diagnostic algorithm. Therefore, there's no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Subjective Patient Outcomes: Pain scores reported by the subjects using an accepted pain evaluation scale.
• Clinical Observations: Assessment of adverse events and skin irritation by clinical personnel.

8. The Sample Size for the Training Set

The document does not describe a "training set" as this is a medical device for facilitating drug delivery, not a machine learning algorithm requiring training data. The "evaluations" mentioned (Laboratory and bench top) refer to engineering and design verification, not algorithm training.

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

This question is not applicable for the reasons stated in point 8.

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