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The ART (Autologous Regeneration of Tissue) Skin Harvesting System is intended for the harvesting and application of autologous, full thickness micrografts for wounds where autologous skin grafting would be appropriate.

The device is a handheld surgical skin tissue harvesting system that uses an array of coring needles to acquire full thickness skin tissue columns (hereafter referred to as "micrografts" or "microcolumns") from an appropriate healthy donor site for deposition onto an appropriate recipient treatment site (Figure 1). The procedure is minimally invasive and both the tissue acquisition (i.e., "harvest") and deposition (i.e., "scatter") processes are automatically performed by a handheld device as described below.

The device consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, single-patient use handheld protective sleeve to cover the handheld device (Figure 2). The handheld device uses embedded software to control the operation of the cartridge using user-activated tactile buttons and trigger (Figure 3). The sterile sleeve protects the handheld device from soilage and provides a physical barrier between the non-sterile handheld device and the patient.

The provided text describes the Medline ART Skin Harvesting System, a semi-automated device for autologous skin grafting. The document details the device's description, non-clinical/bench studies, animal wound healing studies, human factors/usability testing, and limited clinical information. It also outlines the risks to health and proposed mitigation measures.

However, the provided text does not contain explicit acceptance criteria tables or a structured comparative effectiveness study (MRMC) with human readers improving with AI vs. without AI assistance. The evaluation of the device's performance is primarily based on bench testing, animal studies, usability studies, and limited human clinical observations. The core of the evaluation focuses on the device's mechanical function, biocompatibility, sterility, software integrity, electrical safety, and its ability to facilitate wound healing compared to untreated wounds and, to some extent, traditional STSG.

Therefore, the following response compiles the available information in the format requested, making it clear where specific details (like acceptance criteria tables or MRMC study details) are not explicitly present in the provided document.

Acceptance Criteria and Device Performance Study for Medline ART Skin Harvesting System

The provided documentation focuses on a De Novo classification request for the Medline ART Skin Harvesting System. The evaluation of this device is primarily based on demonstrating its safety and effectiveness through various non-clinical (bench, animal) and limited clinical studies, rather than a quantifiable AI-driven performance assessment against explicit numerical acceptance criteria for diagnostic accuracy.

The document does not explicitly provide a formal table of "acceptance criteria" for the device's performance as if it were an AI diagnostic algorithm. Instead, it outlines performance characteristics that were tested and the results of those tests, demonstrating the device's functionality and safety. The "acceptance criteria" are implied by the successful completion of these tests and their favorable outcomes compared to controls (untreated wounds) or, in some cases, a standard of care (STSG).

Here's a synthesis of the implicit acceptance criteria and the reported device performance based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

2. Sample Size and Data Provenance

• Animal Study:
  • Sample Size: 18 female Yorkshire pigs. Each pig had 6 full thickness wounds created (3 wounds per side), for a total of 108 wounds.
  • Data Provenance: Prospective animal study (porcine model). Location not specified beyond "full thickness porcine wound healing study."
• Clinical Studies (Supplemental/Confirmatory):
  • Study 1 (Early version): 25 patients (23 completed).
  • Study 2 (Early version): 12 patients (11 completed).
  • Study 3 (Final finished device - NCT05076578):
    • Group A: 10 healthy volunteers (tissue acquisition only).
    • Group B: 10 subjects with chronic wounds.
  • Data Provenance: Retrospective for Study 1 & 2 (early device version, "confirmatory information"). Prospective for Study 3 (final device, limited clinical data, "confirmatory information"). Country of origin for clinical data is not specified.

3. Number of Experts and Qualifications for Ground Truth

• Animal Study: The document refers to "scores" for erythema, edema, re-epithelialization, wound contracture, fluid/exudate, slough/necrosis, and other observations. These scores were likely assigned by trained personnel (e.g., veterinarians, researchers). Histological evaluations were also performed. No specific number or qualifications of "experts" are provided for establishing ground truth in the animal study, but the methodology implies trained observation.
• Human Factors/Usability Testing: The "experts" in this context are the users being tested.
  • Study 1: 18 nurse or doctor (HCPs) users.
  • Study 2: 7 physicians and 8 surgical podiatrists.
  • Their "ground truth" is their ability to perform tasks correctly based on training and the manual.
• Clinical Studies: For human clinical studies, "complete re-epithelialization" and "percentage area reduction (PAR)" were used as metrics of wound healing. These were likely assessed by the study investigators/clinicians. No specific number or qualifications of experts establishing ground truth for clinical outcomes are provided beyond being "investigators."

4. Adjudication Method for the Test Set

• Animal Study: Not explicitly stated, but the "internal scale" for scoring suggests a standardized, single-observer or consensus method. Numerical data and statistical comparisons are reported.
• Human Factors/Usability Testing: Success rates for tasks were recorded. No explicit multi-rater adjudication method is described.
• Clinical Studies: Clinical outcomes (re-epithelialization, PAR) were measured. No specific adjudication method across multiple evaluators is mentioned.

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

• No MRMC comparative effectiveness study was done or described. The device is a surgical instrument, not an AI-based diagnostic tool that assists human readers in interpreting images. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not applicable to this submission.

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

• Not applicable in the context of an AI-driven algorithm. The device itself is a semi-automated surgical tool. Its "standalone performance" is best represented by the effectiveness of the tissue harvesting and deposition process as demonstrated in bench and animal studies (e.g., ability to extract tissue to depth, deposit tissue). The human user remains "in the loop" by controlling the device activation and placement.

7. Type of Ground Truth Used

• Animal Study: Ground truth for donor and recipient site healing was established through a combination of:
  • Macroscopic Visual Scoring: (blinded or unblinded, not specified) for erythema, edema, re-epithelialization, wound contracture, fluid/exudate, slough/necrosis based on an internal scale.
  • Measurements: Wound cross-sectional diameters, circumferences, and contracture normalized to Day -2.
  • Histology: Microscopic examination of tissue samples from donor and recipient sites.
• Human Factors/Usability Testing: The ground truth for usability was the successful completion of pre-defined critical tasks performed by users following instructions.
• Clinical Studies: Ground truth for wound healing was based on:
  • Clinical Observation/Measurement: Complete re-epithelialization (visual confirmation), Percentage Area Reduction (PAR) of wounds, and observation of adverse events.

8. Sample Size for the Training Set

• Not applicable as a traditional "training set" for an AI algorithm. This is a hardware device with embedded software. The software "training" would be its development and testing phases, which are not detailed in terms of "sample size" in the same way as an AI model.
• The "development" for the device's functionality would be encompassed in the design verification, durability, and performance testing, which utilized various samples (e.g., cadaver legs for durability, porcine model for performance).

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

• Not applicable as a traditional "training set" for an AI algorithm. The "ground truth" for the device's design and software capabilities would be derived from engineering specifications and objective performance requirements validated through a rigorous design control process, including bench testing, and animal studies used to refine the device's mechanical and software functions. The provided text outlines these extensive verification and validation efforts.

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Intended to add moisture to breathing gases for administration to pediatric through adult patients weighing ≥ 10 kg >1 month in homecare, hospital, extended care and hospice.

There are two models of the Hudson RCI Disposable Humidifier. Both models have identical intended uses and modes of operation. One model has a 4 PSI pressure relief valve (referred to as model 3230) and the other has a 6 PSI pressure relief valve (referred to as model 3260). Regardless of device model, the disposable humidifier delivers humidified gases to the patient. Both models of the non-prefilled disposable humidity in water vapor form to respiratory gases delivered to patients to make the gases more comfortable to breathe. The disposable humidifier incorporates a pressure relief valve with an audible alarm at 4 psi or 6 psi. depending on the model selected.

In both models, air is channeled through the water-containing bottle where it becomes humidified before exiting the device and being administered to the patient.

The patient can influence the use of these devices by occluding or loosening secure connections. In cases where the patient is also the user, over or under filling the device and selection of incorrect oxygen percent concentration and gas input pressures may influence the use of the device.

This is a 510(k) premarket notification for the "Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve" and "Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve". The document asserts substantial equivalence to the predicate device "Salter Labs Bubble Humidifier (K161719)".

However, the provided text does not contain a study that proves the device meets specific acceptance criteria in the format requested. Instead, it summarizes non-clinical testing performed to demonstrate safety based on industry standards and establish substantial equivalence to a predicate device.

The document lists various tests performed and standards utilized, but it does not provide:

• A table of acceptance criteria with reported device performance values against those criteria.
• Sample sizes used for test sets.
• Information about ground truth establishment, experts, or adjudication methods.
• Details about MRMC studies or effect sizes for AI assistance.
• Information on standalone algorithm performance or training set details.

The document provides a "Summary of Non-Clinical Testing" and then lists specific types of tests, such as "Humidification Output," "Flow Rate," "Alarm," and "Pull Test." While it states that the results of these tests indicate substantial equivalence, it does not detail the acceptance criteria for each test or the specific reported performance values that met those criteria.

Therefore, I cannot populate the requested table or provide the detailed information about study design, ground truth, and sample sizes that would typically be found in a study demonstrating device performance against acceptance criteria.

The information that is available regarding acceptance criteria and performance is very high-level and can be inferred from the "Comparison of Technological Characteristics" table and the "SUMMARY OF NON-CLINICAL TESTING" section:

Inferred Information from the Document:

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

The document does not provide information for the following points as they are typically associated with clinical studies or more detailed performance reports, which are not present here:

2. Sample size used for the test set and the data provenance: Not mentioned.
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 a device performance summary focusing on non-clinical engineering and biocompatibility tests, not diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is a device performance summary focusing on non-clinical engineering and biocompatibility tests. For these tests, the "ground truth" would be established by the defined test methods and measurement standards (e.g., a specific method to measure humidification output).
8. The sample size for the training set: Not applicable, as this is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning device.

Conclusion from the document:
The document concludes that "Based on the testing performed, including humidification output and additional gas pathway biocompatibility testing according to ISO 18562, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed Hudson RCI Bubble Humidifiers are assessed to be substantially equivalent to the predicate devices." This statement implies that all the non-clinical tests were successfully completed and the devices met the performance expectations for substantial equivalence.

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The Hudson RCI AQUATHERM® III Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications.

The AquaTherm devices are adjustable output temperature heaters. The AquaTherm Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When a gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless-steel puncture pin in the center of the AquaTherm Heater. The solution is heated as it flows through the pin. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the patient gas stream.

This document, K223100, is a 510(k) premarket notification for a medical device (Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than independently proving the device meets specific performance acceptance criteria through a clinical study or a similar robust evaluation of its diagnostic capabilities.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert reads, MRMC studies, ground truth establishment) is not applicable to this document.

This FDA submission is for a heating device used with nebulizers, classified as a Class II device (Nebulizer, product code CAF). The purpose of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.

Here's why the requested information is not present and what is provided:

1. No Diagnostic Acceptance Criteria or Performance Reporting: This is not a diagnostic AI device or a device that relies on interpreting data to provide a diagnosis. Its function is to heat sterile solution for aerosolization. Therefore, there are no metrics like sensitivity, specificity, AUC, or other diagnostic performance indicators to report in a table.

2. No Clinical Study on Efficacy/Accuracy: The submission demonstrates substantial equivalence through:

   • Comparison of Technological Characteristics: Showing similar design, intended use, operating principles, and materials to the predicate.
   • Non-Clinical Testing: This includes:
     • Biocompatibility: To ensure materials are safe for patient contact (even if indirect).
     • Packaging: To ensure the device remains sterile/intact until use.
     • Cleaning: To ensure proper reprocessing if applicable (though the device is non-sterile).
     • EMC Testing: To ensure electromagnetic compatibility and safety.
   • Compliance with Standards: Adherence to relevant ISO and IEC standards (e.g., for safety, quality, and electrical compatibility).

   This type of submission does not typically involve clinical trials or multi-reader studies to establish diagnostic accuracy or performance improvement for human readers.

3. No Test Set/Ground Truth Details: Since there's no diagnostic performance being evaluated, there are no test sets, data provenance, expert ground truth establishment, or adjudication methods described. "Ground truth" in this context refers more to established engineering and safety standards rather than medical diagnostic truth.

Summary of Relevant Information (from the document) despite the non-applicability of the full request:

• Type of Device: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (a nebulizer heater).
• Purpose: To provide continuous heated aerosol for respiratory applications.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Aero-Mist Nebulizer Heater/Pegasus Research Corporation (K880473).
• Demonstration of Safety and Effectiveness: Through non-clinical testing (Biocompatibility, Packaging, Cleaning, EMC Testing) and compliance to industry standards (ISO 10993 series, IEC 60601 series).
• Conclusion: The device is substantially equivalent to the predicate and does not raise new issues of safety or effectiveness.

In essence, the "acceptance criteria" for this device are its ability to meet the specified non-clinical performance and safety standards, and to be functionally and technologically similar to the legally marketed predicate device, rather than diagnostic accuracy metrics.

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The Medline UNITE® Ankle Fusion Plating System is indicated for use in arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodesis, in conjunction with stabilization of fresh fractures, revision procedures, and reconstruction of bones in the feet and ankles.

The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline UNITE® Ankle Fusion Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system can be used in both adult and pediatric (adolescent and child) patients.

Medline UNITE® Ankle Fusion Plates and Screws used for the surgical treatment of pediatric patients should not cross an active growth plate as this may impede bone growth and development in skeletally immature patients. Implanted Medline UNITE® Ankle Fusion Plates and Screws which span an active growth plate in a pediatric patient. should be considered for hardware removal after primary arthrodesis or bone healing has been achieved.

The Medline UNITE® Ankle Fusion Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6A1-4V ELI). The system includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 4.5mm and 5.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. Additionally, several plates in the system can accommodate 3.5mm and 4.0mm locking and non-locking cortical screws. Previously cleared 3.5mm (K151235) and 4.0mm locking and non-locking cortical screws, ranging from 16-40mm will be included in the tray with the Medline UNITE® Ankle Fusion Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drills, drill guides, tissue protectors, targeting guides, targeting guide sleeves, and a tray.

I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification for a medical device (Medline UNITE® Ankle Fusion Plating System) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing.

The document explicitly states:

• "This section does not apply. No animal testing was performed."
• "This section does not apply. No clinical testing was performed."
• "Summary of Clinical Testing: Not applicable."

Therefore, there is no information regarding:

• Acceptance criteria and reported device performance related to a clinical study.
• Sample size used for the test set or its data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical study.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).

The provided text describes a 510(k) premarket notification for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical efficacy study. Therefore, much of the requested information regarding clinical study design (sample size, expert ground truth, MRMC studies, training set details) is not applicable or explicitly stated in this document because the regulatory pathway chosen focuses on device characteristics and bench testing.

However, based on the document, here's what can be extracted regarding acceptance criteria and the study performed, focusing on the "Performance Testing (Bench)" and "Usability Testing" sections as these are the closest to performance evaluation.

Acceptance Criteria and Device Performance (Summary based on available information)

The primary "acceptance criteria" from a regulatory perspective for this 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is evaluated through a series of bench tests and a simulated clinical use study as recommended by FDA guidance.

Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, explicit numerical "acceptance criteria" and "reported device performance" are presented as compliance with established standards and successful outcomes of specific tests, rather than clinical efficacy metrics.

Study Details

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

   • Test Set (Simulated Clinical Use Study for Sharps Injury Prevention): 1,000 safety needles were tested (500 per "safety needle type" – though the document details multiple configurations, it doesn't specify if "safety needle type" refers to Sure-Snap Safety Needle vs. Sure-Snap Safety Syringe types or different gauge sizes).
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission, the studies would typically be conducted prospectively as part of the premarket submission process, and are likely to be conducted under a quality system by the manufacturer (Medline Industries, Inc. in Northfield, Illinois, USA).

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

   • For the simulated clinical use study (usability testing), "Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback." The specific number of professionals or their detailed qualifications (e.g., years of experience, specific role like nurse, phlebotomist) are not specified in the document.

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

   • The document implies a direct "pass/fail criteria" assessed by the participating healthcare professionals during the simulated clinical use study. It does not mention any formal adjudication method (like 2+1 or 3+1 consensus) for the results, suggesting a direct observation of the device's functional activation.

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

   • No. This is a medical device (syringe and needle) and not an AI/imaging device. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm. Bench tests evaluate the physical properties and functional aspects of the device itself (e.g., needle sharpness, sheath activation), which could be considered a form of "standalone" performance testing for a physical object.

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

   • For the simulated clinical use study, the "ground truth" for the device's safety feature activation was based on direct observation of its functional activation against pre-defined pass/fail criteria by "participating healthcare professionals." It's a performance truth based on observed mechanical function in a simulated setting, rather than a diagnostic truth like pathology or outcome data.
   • For other performance tests (e.g., biocompatibility, functional performance under ISO standards), the "ground truth" is defined by the requirements and test methods specified in the cited international consensus standards. Compliance with these standards indicates the device performs as expected for its class.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. All listed tests are for device verification/validation.

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

   • Not applicable. As there is no training set for an AI model.

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The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.

The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
The Konig Mogen Clamp consists of an arm with a locking mechanism in order facilitate compression on the foreskin. The locking mechanism consists of a lock connected to a lock bar using a pin. The clamp is fixed with a spot welding point, which allows for a maximum opening of 2.5 mm. The edges of the closing area are chamfered and rounded to avoid tissue injury.
The Konig Mogen Clamp is a reusable instrument that is provided non-sterilyzed by the user. The Konig Mogen Clamp will be validated for use in pre-vacuum steam sterilization.

The provided text describes a 510(k) premarket notification for a medical device called the Konig Mogen Clamp. This submission is for demonstrating substantial equivalence to a predicate device, not for establishing clinical efficacy or safety from scratch through the rigorous testing typically performed for novel devices or AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested about acceptance criteria, study details (sample size, data provenance, expert ground truthing, MRMC studies, standalone performance, training set details) that would be relevant for an AI/SaMD device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical bench testing for physical performance, biocompatibility, and cleaning/sterilization validation, as detailed in the "Summary of Non-Clinical Testing" section.

Here's a breakdown based on the provided document, highlighting why most of the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of non-clinical tests. The "Acceptance Criteria" for this type of device are typically met by passing standard international and ASTM (American Society for Testing and Materials) tests for surgical instruments. The "Reported Device Performance" is stated as "Test articles met the acceptance criteria" and "The Konig Mogen Clamp was non-toxic," and "No growth at the end of the incubation period." Specific numerical results or detailed acceptance ranges are not provided in this summary.

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

This document describes non-clinical bench testing for a physical surgical instrument. The "test set" would refer to the number of physical clamps subjected to the various physical, chemical, and sterilization tests. The document does not specify the exact number of units tested.

• Sample Size: Not specified for non-clinical tests. Medical device bench testing for performance and cleaning/sterilization typically involves a representative sample size of devices, often in the range of 3-30 units, depending on the test and statistical considerations.
• Data Provenance: Not applicable in the sense of patient data. The tests are performed on manufactured devices.

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

Not applicable. "Ground truth" in the context of this device's testing refers to objective measurements against engineering standards (e.g., material composition, hardness, successful sterilization, resistance to corrosion) rather than expert interpretation of patient data. These tests are performed by technicians or engineers.

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

Not applicable. This refers to establishing consensus among human readers for diagnostic tasks, which is not relevant for this type of device's non-clinical 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 type of study is relevant for AI or diagnostic imaging devices that assist human readers. The Konig Mogen Clamp is a manual surgical instrument.

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

Not applicable. This refers to the performance of an AI algorithm, not a manual surgical instrument.

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

The "ground truth" for this device's non-clinical testing is based on:

• Pre-defined engineering specifications and ASTM/ISO standard requirements (e.g., chemical composition, hardness values, corrosion resistance, maximum opening, sterilization success).
• Objective measurements obtained through laboratory testing (e.g., spectral analysis for material, physical force measurements, microbial growth assays).

8. The sample size for the training set:

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

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

Not applicable, for the same reason as #8.

In summary: The provided FDA 510(k) clearance document details the substantial equivalence of a manual surgical instrument and, therefore, focuses on non-clinical performance, safety (biocompatibility), and sterilization validation against established industry standards. It does not involve the types of clinical studies, AI performance metrics, or ground truth establishment relevant for an AI/SaMD device that the questions are implicitly structured to address.

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The Hudson RCI Triflo II Incentive Deep Breathing Exerciser is intended as an inspiratory deep breathing positive exerciser for adult and pediatric (above 5 years) patients.

Intended for single-patient, multi-use in a hospital or home care setting.

The Hudson RCI Triflo II Incentive Deep Breathing Exerciser. The device is a non-diagnostic, therapeutic spirometer (inspiratory deep-breathing exerciser) designed for a maximum flow rate of approximately 1200 cc/sec. It is supplied in clean, sanitary condition, ready for use. It is designed for single patient use and discarded when no longer needed by the patient to whom assigned. By sequentially lifting the balls that are inside every chamber it provides an exercise incentive to patients who require sustained maximal inspiration (SMI), or similar maneuvers.

The provided document is a 510(k) premarket notification for a medical device, specifically an Incentive Spirometer. It contains information about the device, its intended use, comparison with predicate devices, and performance data.

However, the document does not describe a study involving:

• An AI/algorithm-based device.
• Establishment of ground truth by experts.
• Sample sizes for test sets or training sets in the context of an AI study.
• Multi-reader multi-case (MRMC) studies.
• The effect size of human readers improving with AI assistance.
• Standalone algorithm performance.

The "Performance Data" section (Section VII) details bench testing for the physical device (biocompatibility, cleaning validation, and various physical performance tests like flow accuracy, useful life, drop testing, packaging). These are standard engineering and safety tests for a physical medical device, not a study evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving an AI device meets acceptance criteria. The document describes a traditional medical device (an incentive spirometer) and its associated regulatory clearance process.

If you can provide a document that discusses the development and validation of an AI-powered medical device, I would be happy to analyze it against your specified criteria.

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The Medline General Surgery Tray contains a single-use sterile surgical drape intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The drape is packaged and sterilized with disposable devices intended for professional use/used by licensed physicians in preparing the operating environment for, and performing procedures and surgeries. The intended products assembled in these kits will not be changed from the manufacturer's original intended use.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Medline General Surgery Tray" does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) letter is a regulatory document indicating that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory requirements, classification, and general controls, rather than detailed performance study results or acceptance criteria.

The "Indications for Use" section describes how the device is intended to be used (as a single-use sterile surgical drape to isolate a surgical site) but does not provide details of any studies or performance metrics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, adjudication methods for test sets.
3. Information on MRMC studies or human reader improvement.
4. Stand-alone algorithm performance.
5. Type of ground truth used.
6. Sample size for the training set or how ground truth was established for the training set.

This type of information is typically found in the full 510(k) submission, not in the public clearance letter.

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Medline's Universal Grounding Pads are designed for surgical applications where monopolar electrosurgery is utilized in order to provide a safe return path for the electrosurgical current. Solid Grounding Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split style Grounding Pads are for use with electrosurgical units (ESU) that have a CQMS (i.e. REM, ARM, NESSY etc.). Medline's Universal Grounding Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this universal style grounding pad. Use of this product for unintended applications could lead to an unsafe condition.

Not Found

The provided document is an FDA 510(k) clearance letter for the Medline Universal Grounding Pad. It describes the device, its indications for use, and confirms its substantial equivalence to a predicate device.

However, this document DOES NOT contain information about acceptance criteria, device performance testing, study methodologies (like sample sizes, expert ground truth, adjudication methods, MRMC studies), or detailed performance metrics like sensitivity, specificity, or AUC.

The letter is a regulatory document stating that the device is cleared for market based on its similarity to existing devices and compliance with general controls. It does not include the detailed technical study data that would typically be associated with an AI/ML device or a device requiring extensive performance validation against acceptance criteria through a study.

Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is not an AI/ML device, nor is a MRMC study mentioned).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this is not an AI/ML device).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/provided.
8. The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
9. How the ground truth for the training set was established: Not applicable.

This document is for a medical device (a grounding pad for electrosurgery) that gains 510(k) clearance through demonstrating substantial equivalence to a predicate, not through a performance study that would typically be described with the criteria you've outlined. The clearance process for such a device focuses on electrical safety, biocompatibility, and functional equivalence, rather than a clinical performance study with human readers or AI algorithms.

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Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.

Medline's Smoke Evacuation Shroud is a single use, sterile product.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Medline Smoke Evacuation Shroud" does not contain the information necessary to answer your request about acceptance criteria and a study proving device performance as it relates to AI/machine learning devices.

The document is a standard FDA 510(k) clearance letter for a Class II medical device (a smoke evacuation shroud, which is a physical accessory for electrosurgical pencils) and primarily addresses regulatory compliance and substantial equivalence to predicate devices. It does not discuss:

• Acceptance criteria for an AI/ML algorithm.
• Performance studies involving AI/ML.
• Sample sizes for test or training sets.
• Expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes for human readers.
• Stand-alone algorithm performance.
• Types of ground truth.

Therefore, I cannot populate the table or provide any of the requested details based on the given input. This document is not relevant to the kind of AI/ML device performance study you are asking about.

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