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SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.

Not Found

This document is a 510(k) premarket notification decision letter for a Peak Flow Meter, not an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, such as details on a test set, expert ground truth, MRMC studies, or training data. The document focuses on regulatory compliance and substantial equivalence to predicate devices for a physical medical device.

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Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

• · Dentin and Enamel
• · Porcelain, Zirconia
• Metal
• · Composite

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

This is a 510(k) premarket notification for a resin tooth bonding agent, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not found in this document.

The document discusses the substantial equivalence of the "Peak Universal Bond" device to a predicate device, focusing on its physical properties, technological characteristics, and indications for use in dentistry. It references non-clinical testing performed to establish this equivalence, specifically to ISO standards for bonding agents.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device, Peak Universal Bond, is a traditional medical device (a resin tooth bonding agent). It does not involve artificial intelligence or machine learning for diagnosis, prognosis, or treatment.
• Non-Clinical Testing: The "study" mentioned is "verification and validation testing" to show substantial equivalence. This involves testing physical properties according to ISO standards (e.g., ISO 29022 for shear bond strength, SEM imaging for dentinal tubule blockage) and simulated use by dental professionals. This is not a clinical study in the typical sense for AI/ML performance, nor does it generate the metrics you've requested.

Therefore, the specific points of inquiry about acceptance criteria, device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable and not present in this regulatory submission for a conventional dental bonding agent.

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This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.

The Peak flow meter is composed of Main Unit and Mouthpiece.
Mouthpiece: Mouth blowing.
Main Unit: Containing a segment LCD, a pressure sensor and a Microcontroller Unit.
The pressure sensor records the gas flow rate in real time and delivers to MCU for processing, to get the flow volume of gas and volume, after the measurement, LCD displays the measurement results.

The provided document describes the Shanghai Sonmol Medical Equipment Co., Ltd. Peak Flow Meter (models SMPF-2S, SMPF-3A) and its substantial equivalence to a predicate device. Below is a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to performance tests conducted according to the American Thoracic Society Standard of Spirometry (2005 Revision). The acceptance criteria are implicit in the accuracy specifications, which are compared to the predicate device.

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

The document does not explicitly state the sample size for the performance test set. It mentions "Performance test has also been conducted to verify the measurement accuracy, intra instrument repeatability, PEF inter instrument repeatability and performance of the device according to American Thoracic Society Standard of Spirometry (2005 Revision)."

The data provenance is not explicitly mentioned as country of origin, retrospective or prospective. However, based on the context of a 510(k) submission, these would typically be controlled laboratory or simulated environment tests, not involving human patient data collection in a clinical setting in the same way a clinical trial would.

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

This information is not provided in the document. The performance tests appear to be based on engineering and standardized testing rather than expert-established ground truth from clinical cases.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1, none) are not applicable or mentioned as the testing performed is based on direct measurement validation against established standards for spirometry devices, not interpretation by human readers.

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

No, an MRMC comparative effectiveness study was not done. The device is a measurement instrument, not an AI diagnostic tool that assists human readers in interpreting images or data.

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

While not an "algorithm" in the AI sense, the performance tests (accuracy, repeatability, range) are essentially standalone studies of the device's measurement capabilities. The device is intended for direct measurement by the patient/user, not for interpretation by a human-in-the-loop in a collaborative diagnostic setting.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be based on:

• Established physical standards: The American Thoracic Society Standard of Spirometry (2005 Revision) provides the specifications for expected performance.
• Reference measurements: The accuracy and range are compared against predicate and reference devices, implying a standard of truth is upheld by these devices or by the testing methodologies described in the ATS standard.
• Engineering specifications: The device is tested against its own design specifications and regulatory standards (e.g., IEC 60601 series).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a hardware measurement tool; it does not involve a "training set" in the context of machine learning algorithms.

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

This information is not applicable and not provided, as there is no machine learning training set for this device.

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Peak.me is intended for monitoring FEVI (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.

Peak.me is a hand-held Peak Flow Meter device that is intended for monitoring FEV1 (forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for pediatric to adult users. Peak.me is not recommended for children under 5 years of age.

Peak.me consists of a mechanical unit, which physically attaches to the user's smartphone, and a software application which analyzes the measurements and serves as a disease management platform. The device uses the smartphone's internal upper microphone as a sensor and does not include any electrical parts.

As the user exhales through the mechanical unit, it produces acoustic waves with a frequency proportional to the exhalation airflow rate, which then propagates to the smartphone's internal upper microphone.

Peak.me software application analyzes the sound and displays the results. Furthermore, the application includes a review of past measurements. It enables manual input of symptoms and medication usage and provides guidance for correct usage and more.

The provided text describes the 510(k) summary for the "Peak.me" device, a peak-flow meter for spirometry. The document focuses on demonstrating substantial equivalence to a predicate device ("Wing Smart FEV1 and Peak Flow Meter," K152276) rather than a comprehensive de novo validation study. Therefore, some of the requested information regarding detailed study methodology (e.g., sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies) is not explicitly present.

However, based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Peak.me device are primarily based on the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update for accuracy and precision.

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

• Test Set Sample Size: The document does not explicitly state a specific "test set" sample size for either the accuracy/precision validation or the other performance tests. The performance data section broadly indicates that "Lab performance tests, design validation and software verification and validation tests were conducted."
• Data Provenance: The studies were laboratory-based performance tests, not clinical studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable. The device validation included testing with specific smartphone models: Samsung Galaxy S6, Samsung Galaxy S6 edge, Samsung Galaxy S7, and Samsung Galaxy S7 edge.

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

This information is not provided in the document. The performance data describes lab tests against a known standard (ATS 1994 Update), which would typically be measured using calibrated equipment rather than expert consensus on medical images or patient data.

4. Adjudication Method for the Test Set

This information is not provided as the device's validation was based on objective performance measurements against a standard, not expert review or adjudication of data points.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "No clinical study was conducted. Peak.me has the same intended use, clinical indication and technology and no clinical studies were necessary to show substantial equivalency with its predicate device."

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

The performance data primarily focuses on the standalone mechanical unit's ability to accurately measure PEF and FEV1 when connected to a smartphone and using the application. The measurements themselves are generated by the device's mechanism and software analysis of the acoustic signal. While the user interacts with the device, the core performance validation (accuracy of measurements) is essentially standalone performance against a gold standard.

7. The Type of Ground Truth Used

The ground truth used for the performance evaluation was based on objective measurements against the accuracy and precision requirements defined by the American Thoracic Society (ATS) Standardization of Spirometry, 1994 Update. This implies the use of calibrated spirometry equipment as a gold standard for comparison during lab testing.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Peak.me device is a mechanical unit that uses a smartphone's microphone to derive measurements through physical principles (acoustic waves proportional to airflow). It is not an AI/machine learning device that requires a "training set" in the conventional sense for model development. The software "analyzes the sound and displays the results" based on established algorithms for converting acoustic signals to flow rates and volumes, not via a learned model from a dataset.

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

This information is not applicable as there is no mention of a training set for an AI/machine learning model. The device's operation is based on physical principles and signal processing, not a trained statistical model.

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this device is to be used as a heavy body material for:

• · Two step putty/wash technique
• · Sigle step putty/wash technique
• · Functional peripheries
• Crown/bridge work

Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.

The provided text is a 510(k) summary for a dental impression material (PEAK NS033CF, PEAK NS017CF). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic medical device.

Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document because the premarket notification for this type of device does not typically require such detailed clinical study information.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with international standards for dental impression materials and biocompatibility. The "reported device performance" section primarily states that the new device meets these standards, rather than providing specific numerical performance metrics.

2. Sample Size for the Test Set and Data Provenance

Not provided in the document. The document states that performance and biocompatibility tests were carried out, but it does not specify the sample sizes or the provenance of the data (e.g., country of origin, retrospective/prospective nature). These tests would typically be laboratory-based rather than involving human subjects for effectiveness testing in the way a diagnostic AI would.

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

Not applicable/Not provided in the document. For a dental impression material, "ground truth" would relate to its physical and chemical properties and biocompatibility as measured in laboratory settings against established standards, not interpretation by human experts in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable/Not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical diagnostic studies where multiple readers interpret cases and their consensus defines ground truth. This is not relevant for the type of testing described for an impression material.

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

Not applicable/Not done. An MRMC study is relevant for diagnostic devices that assist human readers (e.g., AI for radiology). This device is a dental impression material, not a diagnostic AI.

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

Not applicable/Not done. This concept applies to AI algorithms. The device in question is a physical material.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by international standards (ISO 4823:2015 for physical properties and ISO 10993-5, ISO 10993-10 for biocompatibility). This involves objective measurements and tests according to the methodologies defined by these standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

Not applicable/Not provided in the document. The concept of a "training set" applies to machine learning algorithms. This device is a physical product, not an AI.

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

Not applicable/Not provided in the document. As stated above, this device does not involve a training set for an AI algorithm.

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The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.

The Peak Left Ventricular Vent Cannula is a single lumen, PVC cannula intended for use in venting the left ventricle during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. The 36cm Cannula has an open end at the distal tip and a series of side holes at the distal end of the cannula to allow for venting when inserted into the left ventricle. The device is designed with an open-ended smooth, tapered tip to minimize trauma to the tissues. The cannula body slip connector allows for connection to ¼" tubing for venting by the physician. The device is supplied with a malleable PVC Introducer which has a length of stainless steel wire enclosed within the Introducer sheath. The Introducer has a smooth rounded tip at the distal end. When the Introducer is inserted into the cannula body, the luer hub fits into the internal diameter of the slip connector. When the luer hub is seated in the cannula slip connector, the smooth rounded end of the introducer extends beyond the open tip of the Cannula. The device is provided sterile and is intended for single-use.

I am sorry, but based on the provided text, there is no information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) premarket notification for a Peak Left Ventricular Vent Cannula, which is a physical medical device used during cardiopulmonary bypass procedures. The performance data section describes biocompatibility testing and performance testing (e.g., flow testing, pressure testing, kink resistance) for this physical device. These tests are to demonstrate the physical and biological characteristics of the cannula, not an AI/ML algorithm's performance or diagnostic accuracy.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and the reported device performance for an AI/ML device.
2. Sample size used for the test set and data provenance in the context of an AI/ML model.
3. Number of experts and qualifications to establish ground truth for an AI/ML model.
4. Adjudication method for an AI/ML model test set.
5. MRMC comparative effectiveness study for an AI/ML device.
6. Standalone performance for an AI/ML algorithm.
7. Type of ground truth used for an AI/ML model.
8. Sample size for the training set for an AI/ML model.
9. How the ground truth for the training set was established for an AI/ML model.

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NS033C is to be used as a light body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• · Silicon dental impressions
• Crown/bridge work
• Inlays, Onlays

NS017C/NS017T is to be used as a heavy body material for:

• Two step putty/wash technique
• Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• Inlays, Onlays

MSP is to be used as a putty body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• Crown/bridge work
• Inlays. Onlays

MSBC is to be used as a bite type for:

• Making accurate occlusal registrations
• · Standards bite registrations in the end bite position.
• · Key material for needle point registration.
• Production of small model segments

MSRC is to be used as a regular body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• Functional peripheries
• Reline impressions
• Crown/bridge work
• Inlays, Onlays

MSCC is to be used as a regular body material for:

• Two step putty/wash technique
• · Single step putty/wash technique
• · Functional peripheries
• · Reline impressions
• Crown/bridge work
• Inlays. Onlays

PEAK is a two component (base paste and catalyst, mixing ratio 1:1) vinyl polysiloxane impression material to be used for impressions, where typically alginates are used. The PEAK offers four different viscosities (light, heavy, putty and regular) in delivery systems of cartridges and jars. The device includes accessories such as a spoon.

PEAK offers one light body type: NS033C.

PEAK offers two regular body types: MSRC and MSCC with different material compositions and color. The MSCC has clear appearance.

PEAK offers two heavy body types: NS017C/NS017T and MSBC with different material compositions and color. MSBC is a bite type particularly.

This document describes the Neosil Co., Ltd. PEAK dental impression material and its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore, the requested information regarding acceptance criteria and study details for such a device is not present.

However, based on the provided text for the PEAK dental impression material, I can extract the acceptance criteria and performance data for this traditional medical device.

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

The document compares the PEAK device to a predicate device (BONASIL A+ by DMP, Limited) based on physical properties, which serve as the acceptance criteria.

Note: For the MSRC and MSCC types, direct predicate comparisons for their specific physical properties are not listed in the table, but the conclusion states "All the test results support substantial equivalence to the predicate devices." indicating their performance met relevant criteria.

The study that proves the device meets the acceptance criteria is a series of non-clinical bench tests.

The requested information regarding AI/ML device studies is not applicable to this document. The document describes a traditional dental impression material, not an AI/ML powered device. Therefore, the following points cannot be answered:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, 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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

Details available from the document regarding the study:

• Type of Study: Non-Clinical Performance Testing and Biocompatibility Testing.
• Tests Performed:
  • ISO 4823 (Consistency Test, Mixing Time Test, Working Time Test, Detail Reproduction Test, Test for Compatibility with Gypsum, Linear Dimensional Change Test, Elastic Recovery Test, and Strain-in-Compression Test)
  • ISO 10993-5 (Cytotoxicity Test)
  • ISO 10993-10 (Skin Sensitization Test, Oral Mucous Irritation Test)
  • ISO 10993-11 (Acute Systemic Toxicity Test)
  • Other bench testing (Shelf life, Visual Inspection, Weight and Component Color Check)
• Conclusion: The manufacturer concluded that the PEAK device is substantially equivalent to the predicate devices based on these testing results.

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Peak® Z is intended for use as a surface treatment for restorations made of the following materials: Zirconia, Aluminum oxide, Metal/Alloy, Titanium.

Peak® Z is a single component surface treatment that enhances bond values when applied to zirconia, alumina, and metal/alloys. It contains 12methacryloyIdoeceylphosphate (MDP), which produces a chemical bond that significantly increases adhesion between a resin-based material and the bonding surface of the restoration. Peak® Zr Primer can be applied through a syringe delivery or brush and bottle. Peak® Z is supplied in a pre-mixed syringe for easy delivery and no waste, and also in bottles with brushes that can be directly applied to surfaces.

I am sorry, but I cannot provide a detailed analysis of acceptance criteria, study design, and results based on the provided text. The document is a 510(k) summary for a dental bonding agent (Peak® Z) and focuses on establishing substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a full study report from the R&D and clinical phases.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

Key Missing Information for a Comprehensive Answer:

• Explicit Acceptance Criteria: The document mentions "acceptance criteria" generally but does not list specific quantitative or qualitative acceptance criteria that the device must meet in the same format as the table requested.
• Detailed Study Results (Quantitative): While it mentions "bench tests" and "literature review," it does not provide the actual raw data, statistical analysis, or performance metrics (e.g., specific bond strength values with standard deviations, p-values, or confidence intervals). It only states that Peak® Z "performs as well or better than the predicate device."
• Test Set/Training Set Details: There is no mention of distinct test sets or training sets, as the studies described are bench tests comparing the new device to a predicate and a literature review.
• Expert Details, Adjudication, MRMC, Standalone Performance: These concepts are typically relevant for AI/ML-based diagnostic devices, which is not the nature of this dental bonding agent. Therefore, this information is not present.
• Ground Truth Definition and Establishment: For bench tests, the "ground truth" is the measured physical property (e.g., shear bond strength). For the literature review, it's about established safety and efficacy from existing products, not a directly established "ground truth" on a new dataset.

What can be extracted or reasonably inferred from the text regarding the provided questions:

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

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

• Sample Size for Bench Tests: Not explicitly stated. The document only mentions "various surfaces" for shear bond tests.
• Data Provenance: "In-vitro test," "in-house testing," and comparison to a "predicate device currently on the market." This suggests laboratory-based testing, likely conducted by the applicant (Ultradent Products, Inc.) or contracted labs. The literature review provides "safety and effectiveness of this product," which would be based on existing published studies. This would be prospective for the bench tests (new measurements) and retrospective for the literature review (using existing data).
• Country of Origin: Implied to be the US, as the applicant is a US company (South Jordan, UT) and the submission is to the FDA.

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

• Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of results for ground truth. For the bench tests, "ground truth" is established by direct physical measurement (e.g., bond strength).

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

• Not applicable for this type of device and testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI-assisted diagnostic or interpretive device.

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

• Not applicable. This is a physical product (dental bonding agent), not an algorithm.

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

• For Shear Bond Strength tests: The ground truth is the measured bond strength (quantitative physical characteristic).
• For Biocompatibility tests: The ground truth is determined by the results of standardized ISO 10993 tests (e.g., cell viability for cytotoxicity, skin reaction for sensitization).
• For Stability tests: The ground truth is the measured performance/functionality over time under different conditions.
• For overall safety and effectiveness: This was supported by a literature review, relying on previously established scientific and clinical evidence for similar products.

8. The sample size for the training set

• Not applicable. The document describes bench testing and a literature review for substantial equivalence, not the training of an algorithm or model.

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

• Not applicable (as above).

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The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.

The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.

The provided text describes the 510(k) submission for the PEAK Suction Coagulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, the information required to populate most of the acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not available in the provided document.

Instead, the submission relies on:

• Comparison to a predicate device (Valleylab Suction Coagulator): The primary claim is that the PEAK Suction Coagulator is "substantially equivalent" due to similar output energy, delivery system, blade specifications, and the use of monopolar electrosurgery for tissue coagulation.
• Compliance with recognized standards: The device met various IEC and ISO standards related to electrical safety, electromagnetic compatibility, surgical equipment safety, sterilization, and biocompatibility.
• Histological studies: These were conducted to compare the thermal effects of the PEAK Suction Coagulator to the predicate device, aiming to show similar safety and effectiveness. The specific acceptance criteria for these histological studies are not detailed, nor are the number of samples, ground truth establishment, or expert involvement.

Here's a breakdown of what can be gathered from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified for the histological studies or laboratory/performance tests.
• Data Provenance: Implied to be laboratory tests and histological studies, conducted for this regulatory submission. No information on country of origin or whether it's retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth & Qualifications

• Number of Experts: Not specified.
• Qualifications: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of histological comparisons, it would typically involve expert pathologist review, but the method isn't described.

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

• MRMC Study: No, this type of study is not mentioned. The device is a surgical instrument, not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between the device and a predicate device/standards.

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

• Standalone Performance: Not applicable in the context of an electrosurgical device. The device itself is a tool used by a human surgeon. Its performance is evaluated through its physical and electrical characteristics, and its effects on tissue.

7. The Type of Ground Truth Used

• For the "Safety (Thermal Effects)" criterion, the ground truth was likely derived from histological examination by qualified personnel (e.g., pathologists) comparing tissue effects between the PEAK Suction Coagulator and the predicate device.
• For other criteria, the "ground truth" would be established by compliance with published international standards (IEC, ISO) and internal design specifications.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document describes a medical device requiring regulatory clearance based on substantial equivalence, not an AI/ML algorithm that undergoes "training."

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

• Ground Truth Establishment: Not applicable, as there is no "training set" in this context.

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The PEAK PlasmaBlade® PLUS Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.

The provided text is a 510(k) Summary for the PEAK PlasmaBlade® PLUS, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance from a study in the format typically used for AI/ML device submissions.

Based on the content provided, here's an attempt to answer your questions, highlighting where information is absent or not applicable:

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

The document does not explicitly present a table of acceptance criteria and device performance in numerical terms for the PEAK PlasmaBlade® PLUS. Instead, it states that the device "functioned as intended and met design specifications" and "complies with" various electrical safety, sterilization, and biocompatibility standards. It also mentions "Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria."

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

The document mentions "Laboratory and performance tests were executed" and "Histological studies," but does not specify sample sizes for these tests or studies. It also does not provide information on the country of origin of the data or whether the studies were 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)

The document mentions "Histological studies," which implies microscopic examination, likely performed by pathologists. However, it does not specify the number of experts used, their specific qualifications, or how ground truth was established regarding the "thermal effects" in these histological studies.

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

The document does not describe any adjudication method for the tests or studies conducted.

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 MRMC comparative effectiveness study was conducted or reported. This device is an electrosurgical tool, not an AI/ML diagnostic aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The PEAK PlasmaBlade® PLUS is a physical surgical device, not a standalone algorithm.

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

For the "histological studies," the ground truth was presumably based on pathology (microscopic examination of tissue samples to assess thermal effects). The exact nature of the assessment (e.g., specific measurements of thermal damage zones) is not detailed.

8. The sample size for the training set

This question is not applicable. As this is not an AI/ML device, there is no concept of a "training set" in the context of machine learning model development.

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

This question is not applicable for the same reason as above.

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