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The DOLORCLAST Focused Shock Waves System is intended to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DOLORCLAST Focused Shock Waves system is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DOLORCLAST Focused Shock Waves system is composed of the DolorClast console, a handpiece, interchangeable gel pads (3 different sizes) and optional cart. EMS DolorClast Gel, previously approved under P050004 and K220538, is also provided for transmitting shock waves between the piezoceramic elements to the gel pad and coupling the treatment gel pad to the patient's skin.

The DOLORCLAST Focused Shock Waves system generates acoustic pressure waves generated using piezoelectric technology. A high-voltage impulse, controlled by the console, is used to stimulate the piezoceramic elements arranged across a concave surface in the emission source (the handpiece), causing the elements to expand simultaneously and briefly by a few micrometers, thus generating a focused shock wave. The shock waves are delivered to the patient's body via the handpiece, through a gel pad in a focused manner, and the treatment depth varies in line with the gel pad used.

The provided 510(k) clearance letter and summary for the DOLORCLAST Focused Shock Waves device do not describe a study involving acceptance criteria for an AI/ML-based medical device performance benchmark (e.g., accuracy, sensitivity, specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through physical and electrical performance testing, and biocompatibility, as well as characterization of its acoustic properties and software validation.

The acceptance criteria mentioned in the document are related to:

• Acoustic Pulse Characterization: Comparing the pressure field output to publicly available information on the predicate device.
• System Functional Performance Testing: Confirming correct operation of the console and handpiece at all treatment settings.
• Lifetime Testing: Confirming the console and handpiece function and meet performance specifications for their claimed useful lifetimes.
• Software Validation: Compliance with IEC 62304.
• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility Testing: Compliance with various ISO 10993 standards.

Since the request asks for information relevant to AI/ML device performance (like acceptance criteria related to accuracy, sample size for test sets, expert ground truth, MRMC studies, etc.), and the provided text does not contain this information for the DOLORCLAST Focused Shock Waves device, I cannot fulfill the request as written.

The DOLORCLAST Focused Shock Waves device is a physical therapeutic device, not an AI/ML diagnostic or assistive device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, and expert adjudication of ground truth) are not applicable or described in this 510(k) submission.

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The CS-Pro MED is intended to provide acoustic shock waves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule but without bone exposure. The CS-Pro MED is indicated for adults (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The CS-Pro MED is a handheld, battery-operated device that produces high-pressure focused acoustic shock waves. It is designed to provide healthcare professionals with an effective and easy-to-use device for administering focused Extracorporeal Shock Wave Therapy (ESWT) treatment. The CS-Pro MED is battery-powered and utilizes an array of piezocomposite transducers to create acoustic shock waves. The device delivers a drive signal to the piezocomposite transducers to create pressure pulses that propagate through the elastomeric standoffs and into the patient's tissue. Each pressure pulse is calibrated to arrive simultaneously at the focal point. The device includes a touch-sensitive display that indicates useful information and allows the operator to adjust the energy level, set the number of shock wave pulses, and adjust the pulse repetition frequency. The CS-Pro MED includes five standoffs of varying sizes to control the depth at which the therapy is focused, allowing the physician to target a specific tissue depth based on the treatment protocol.

The provided FDA 510(k) clearance letter for the CS-Pro MED does not include any information about the acceptance criteria or a study that proves the device meets specific performance acceptance criteria related to its clinical effectiveness.

The document discusses performance in terms of:

• Electrical Safety, Electromagnetic Compatibility, and Biocompatibility: These are engineering and safety standards, not clinical performance metrics. The document states "meets applicable biocompatibility requirements" and "Electrical Safety testing in accordance with IEC 60601-1," etc. which indicates compliance with these technical standards.
• Bench Testing: This includes "Characterization of acoustic" per IEC 61846 and "Nonclinical verification and validation testing... demonstrated that the CS-Pro MED meets the design specifications and is safe and effective for its intended use." This refers to physical and technical performance (e.g., how the shock waves are generated and characterized), not clinical efficacy.
• Substantial Equivalence: The primary focus of the 510(k) summary is to demonstrate substantial equivalence to a predicate device (DuoLith SD1 with C-ACTOR, K202112) based on similarities in indications for use, technological characteristics, and mechanism of action. Differences are argued to "not raise any new questions of safety or effectiveness."

Crucially, the "Clinical Information" section explicitly states "Not applicable. Bench and performance testing support the conclusion of substantial equivalence in this submission." This means no clinical study data (such as a multi-reader, multi-case study, or a standalone algorithm performance study) was submitted or evaluated for the substantial equivalence determination for clinical efficacy.

Therefore, I cannot fulfill your request for the specific acceptance criteria for clinical performance and the details of a study proving the device meets those criteria, as this information is not present in the provided 510(k) clearance letter. The clearance is based on substantial equivalence to a predicate device and engineering/safety performance, not a demonstration of clinical efficacy through specific performance metrics outlined in a clinical study.

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The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, fullthickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2. which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second dearee burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

Model OW100S and applicator OP155S includes a "break circuit" in the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses at low energy flux density in the device. Updates to labeling of the OW 100S includes revisions to contraindications/warnings/ cautions which do not raise different questions of safety and effectiveness, as they are in line with currently marketed acoustic wave devices for the same indications for use. There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change.

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

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

Here's what the document indicates regarding performance:

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

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

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

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

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The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).

The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The modification to the OrthoGold 100 (OW100) is identified as model OW100S and applicator OP155S includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at high energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device.

The provided text is a 510(k) summary for the OW100S device, which is an extracorporeal shock wave device. It describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about:

• Acceptance criteria for an AI/device performance study (as it's not an AI device in the context of the prompt's implied AI/imaging study)
• Reported device performance against such criteria
• Sample size used for a test set or data provenance
• Number of experts or their qualifications for establishing ground truth
• Adjudication method
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• Sample size for a training set
• How ground truth for a training set was established

The document explicitly states "Clinical Information: Not applicable. Bench and performance testing support the substantial equivalence in this submission." This indicates that no clinical studies (like those typically associated with AI/ML device performance or human-in-the-loop studies) were conducted or are being presented here for the purpose of demonstrating substantial equivalence. Instead, the equivalence is based on technical specifications and performance characteristics compared to a previously cleared predicate device.

The "Performance Data" section solely refers to:

• Verification and validation testing.
• Software validation (Moderate level of concern).
• Hazard analysis/risk management.
• Conformance to various IEC and AAMI standards (e.g., IEC 61846 for ultrasonics, AAMI/ANSI ES60601-1 for medical electrical equipment, IEC 62304 for medical device software).

The table provided compares the OW100S (subject device) to its predicate device (OrthoGold 100/OW100) and a reference device (OW100S, K213120). This comparison focuses on physical and technical characteristics, not clinical performance metrics or AI/ML model performance.

Therefore, based on the provided document, I cannot answer the questions related to acceptance criteria and an AI/ML performance study because the submission is for a physical medical device (extracorporeal shock wave device) and relies on technical equivalence, not AI/ML-based clinical performance data.

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The DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DUOLITH SD1 with C-ACTOR is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DUOLITH SD1 with the C-ACTOR Sepia Handpiece uses an electromagnetically generated shock wave produced within the hand-held applicator. The shock wave is generated by discharging a high voltage capacitor located in the Control Unit into a cylindrically shaped coil system in the C-ACTOR Handpiece which is surrounded by a cylindrical metallic membrane. The transient magnetic field produced by the coil induces eddy currents in the metal membrane, causing it to repel from the coil, producing a pressure wave. The membrane is immersed in water and the pressure wave produced by the membrane propagates through the water to a concentric parabolic reflector, where it is reflected to a focal point outside of the Handpiece in front of the reflector. The DUOLITH SD1 with C-ACTOR incorporates micro-processor control of the operating parameters.

Here's an analysis of the provided text regarding the DUOLITH SD1 T-Top & Tower System with C-ACTOR Sepia Handpiece, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly list "acceptance criteria" in a quantitative, measurable format for performance, as might be found in a clinical trial protocol. Instead, it describes compliance with design specifications, safety standards, and then reviews clinical literature to demonstrate effectiveness.

Here's an interpretation of the performance claims based on the clinical literature review:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document refers to a "review of published literature" that included "89 chronic soft tissue wounds having a range of etiologies including diabetes mellitus." This suggests that the clinical evidence is based on data from 89 patients (cases), at least, with a focus on chronic diabetic foot ulcers within that group. It's unclear if all 89 specifically had diabetic foot ulcers, but the indications for use focus on this specific condition.
• Data Provenance: The document states "The reports from five independent studies." This implies the data were collected from multiple sources, likely different medical institutions or research groups. The country of origin is not specified, nor is whether the studies were retrospective or prospective, though typical clinical studies used for such purposes are prospective.

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

This information is not provided in the document. As this relies on a literature review of previously published studies, the methodology for establishing ground truth within those original studies is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. As this relies on a literature review, the adjudication methods of the individual studies are not described.

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

No, an MRMC comparative effectiveness study was not done, or at least not described in this 510(k) summary. The document focuses on the device's standalone performance based on existing clinical literature, not on how human readers would improve with AI assistance. The DUOLITH SD1 is a therapeutic device, not a diagnostic AI tool, so an MRMC study comparing human reader performance with and without AI assistance would not be applicable here.

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

Yes, in essence. The entire clinical performance section describes the standalone effectiveness of the DUOLITH SD1 device in treating diabetic foot ulcers. The device itself is a therapeutic modality, and its "performance" is its ability to heal wounds or reduce wound area, independent of any human interpretive intervention like with an AI diagnostic algorithm. The results presented (wound healing rates, wound area reduction) represent the direct outcomes of using the device.

7. The Type of Ground Truth Used

The "ground truth" used in the clinical studies reviewed would be clinical outcomes data. Specifically:

• Complete wound healing (defined clinically, likely by visual inspection and measurement).
• Reduction of wound area (measured clinically).

8. The Sample Size for the Training Set

This information is not applicable/not provided because the DUOLITH SD1 is a medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves iterative design, engineering, and nonclinical testing to meet specifications, not data-driven machine learning.

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

This information is not applicable. As explained above, the device does not employ a machine learning model that would need a "training set" with established ground truth. Its development relies on engineering principles and nonclinical testing to ensure it meets performance specifications and safety standards.

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

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The provided document describes the FDA 510(k) clearance for the OrthoGold 100 device, an extracorporeal shock wave device. The information details the device's indications for use, a comparison to a predicate device, and performance data including non-clinical, animal, and clinical studies.

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

Acceptance Criteria and Reported Device Performance

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

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The OrthoGold 100™ is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OrthoGold 100 is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The OrthoGold 100™ is a pulsed acoustic wave device. It includes an electrically powered generator to generate transient compressed air that rapidly expands to create the acoustic waves, which in turn are propagated through a water-filled coupling membrane attached to the hand-held applicator. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel.

The provided document is a 510(k) Premarket Notification from the FDA regarding the OrthoGold 100 device. While it attests to the device's substantial equivalence based on non-clinical performance and a literature review, it does not contain the kind of detailed information typically found in a clinical study report for an AI/device performance evaluation that would include acceptance criteria, specific performance metrics for the device, and detailed information about test sets, ground truth establishment, or multi-reader studies.

Therefore, I cannot extract the specific information requested in your prompt regarding:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size of human reader improvement with AI).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses "Performance Data – Non-Clinical" (electrical safety, EMC, pressure field measurements) and "Performance Data – Clinical" which refers to a literature review demonstrating successful clinical use and efficacy. It states:

• Clinical Performance: "A literature review represents the published literature with the subject device through systematic, comprehensive literature searches and those articles known to the manufacturer. These studies demonstrate the successful clinical use with the OrthoGold technology in 224 diabetic foot ulcers. The studies show significant results in complete wound healing and reduction of wound area. The data from these studies establish the efficacy of the subject device to treat chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure and the safety of the device as shown with the lack of adverse events."

This describes the basis for efficacy and safety claims, but not a specific study with defined acceptance criteria and performance metrics for a device (especially an AI-driven one, which this is not) against a held-out test set as per your prompt's requirements. The OrthoGold 100 is an extracorporeal shock wave device, not an AI/software as a medical device (SaMD) that would typically have the metrics and study designs you are asking for.

The core of this document is a 510(k) submission seeking substantial equivalence to a predicate device, not necessarily a de novo clinical trial proving novel performance against specific statistical targets like an AI model would need.

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The SANUWAVE dermaPACE System is indicated to provide acoustic pressure shockwaves in the treatment of chronic. full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm', which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The dermaPACE System is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The dermaPACE System consists of a bench-top Control Console and the PACE Applicator (Figure 1). The PACE Applicator is connected to the Control Console via a six-feet-long cable. The Control Console and PACE Applicator are intended to be reusable. Single use, disposable, sterile sleeves are used to cover the applicator during use. Sterile ultrasound coupling gel ensures proper transfer of the acoustical waves to the treatment area. Both the sterile sleeves and the coupling gel are provided with the device. The PACE Applicator generates shock waves by the electrohydraulic method. A high voltage current (18,000-23,000 Volts) (b) (4) the applicator at its tip which contacts the patient (Figure 2a and b). The acoustic pressure shock waves generated by the device consist of a dominant compressive pressure pulse, low negative pressures, and the tensile wave (Figure 3). The device has multiple output settings, but the software will default to a standard setting of 500 pulses and a frequency of 4 pulses per second.

The information provided describes the de novo classification request for the dermaPACE System, an extracorporeal shock wave device for the treatment of chronic diabetic foot ulcers. The device's acceptance criteria are primarily related to its safety and effectiveness, demonstrated through two prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center studies (Study 1 and Study 2).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• All AEs: 80.4% dermaPACE vs. 78.8% control (p=0.725).
• SAEs: 31.8% dermaPACE vs. 37.4% control (p=0.384).
• TESAEs: 11.2% dermaPACE vs. 20.2% control (p=0.069).
• DR-AEs: 6.5% dermaPACE vs. 2.0% control (p=0.117).
• Osteomyelitis: 0% dermaPACE vs. 3% control.
• No significant change in pain from baseline or between groups. |
  | | | Study 2 (up to 8 treatments):
• All AEs: 61.5% dermaPACE vs. 52.3% control.
• SAEs: 32.3% dermaPACE vs. 21.5% control.
• TESAEs: 32.3% dermaPACE vs. 21.5% control.
• DR-AEs: 3.1% dermaPACE vs. 3.1% control.
• Osteomyelitis: 13.8% dermaPACE vs. 7.7% control. Increased rates of SAE, TESAE, and osteomyelitis observed in Study 2 dermaPACE group, especially with >7 treatments. |
  | Biocompatibility | Patient-contacting components must be biocompatible (per ISO 10993-1). | PACE Applicator coupling membrane: Passed Cytotoxicity (Neutral Red Uptake & MTT), USP Intracutaneous, Sensitization (Kligman Maximization), USP Muscle Implant, and USP Systemic Toxicity tests. |
  | Reprocessing | Reusable components can be reprocessed for subsequent use. | Cleaning and low-level disinfection validated (3 log reduction in bacteria). Reusability study confirmed PACE applicator can deliver pre-programmed pulses after multiple reprocessing rounds. |
  | Electrical Safety & EMC | Complies with relevant standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). | Complies with ANSI/AAMI ES60601-1:2005/(R2012) + A1:2012 and IEC 60601-1-2: 2007. |
  | Software | Software performs as intended, and all software-related risks are adequately mitigated (based on FDA guidance for MAJOR level of concern). | Adequate documentation (SRS, architecture design, traceability, configuration, fault insertion/white box testing, validation, revision history, unresolved anomalies, usability validation) provided and deemed adequate. V&V testing conducted with satisfactory results. |
  | Performance (Bench) | System produces anticipated and reproducible acoustic pressure shock waves; consistent and repeatable. Technical parameters measured (volume of pressure field, focal volume, peak pressures, energy flux density, energy per pulse, audible noise). | Complies with IEC 61846:1998 (Pressure field characterization) and IEC 60601-2-36:2014 (Focal volume, peak pressures, energy flux density, energy measurements). Measured at no, typical, and maximum compression. |
  | Use Life | Continued system functionality over the labeled use life. | PACE applicator shown to deliver (b)(4) repeatable shock wave pulses during bench testing. Software deactivated and replaced after (b)(4) pulses (set at 19% of total successful pulses as safety factor). |

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

• Test Set (Clinical Studies):
  • Study 1: 206 subjects randomized (293 screened). 107 dermaPACE, 99 sham-control.
  • Study 2: 130 subjects randomized (261 screened). 65 dermaPACE, 65 sham-control.
  • Total Subjects: 336
• Data Provenance: Prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center studies.
  • Study 1: 22 centers in the US, 1 in England, and 1 in Germany.
  • Study 2: 18 centers in the United States and 1 site in Canada.

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

• The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set (clinical data).
• However, wound closure was defined as "skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)." This implies that the assessment was made by clinical evaluators who were blinded to the treatment assignment. Their specific qualifications (e.g., dermatologists, wound care specialists, years of experience) are not detailed.

4. Adjudication Method for the Test Set

• The document states that "Complete wound closure was defined as skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)."
• This suggests that agreement between "blinded evaluators" (plural) was part of the confirmation process, potentially indicating an adjudication method like multiple independent reviews or a consensus approach. However, the specific method (e.g., 2+1, 3+1) is not explicitly detailed.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluated the effectiveness of a medical device (extracorporeal shock wave therapy), not an AI algorithm assisting human readers. The clinical studies compared the device (dermaPACE) plus standard of care to sham treatment plus standard of care.

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

• No, this device is not an AI algorithm. It is an extracorporeal shock wave device. Therefore, a standalone algorithm performance study is not applicable to this device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth for the primary effectiveness endpoint (complete wound closure) was based on clinical observation and assessment by blinded evaluators. Specifically, "skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks (as determined by blinded evaluator)."
• For safety endpoints, the ground truth was based on reported adverse events (AEs), serious adverse events (SAEs), and device-related AEs as observed and assessed by investigators.

8. The Sample Size for the Training Set

• This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning. The clinical studies served as the pivotal evidence for safety and effectiveness.

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

• Not applicable, as there is no AI training set for this device.

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