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The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors indicated for use exclusively with Spectrum Medical Systems is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods up to 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adolescent (i.e., patients greater than 12 through 21 years of age).

The Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.

This document describes the 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors. This is a medical device, not an AI/ML powered device, so several aspects of your request (e.g., number of experts, adjudication method, MRMC study, ground truth for AI/ML models) are not applicable.

Here's an analysis of the provided text in relation to your request, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format as one might find for an AI/ML device where metrics like sensitivity, specificity, or AUC are reported against specific thresholds.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device (K220842) through non-clinical performance testing. The reported performance is an affirmation that the device met these implicit criteria by performing comparably to the predicate.

The non-clinical performance tests conducted to demonstrate this are listed:

• Operating Parameters
• Dynamic Blood Damage
• Heat Generation
• Air Entrapment
• Mechanical Integrity
• Durability/Reliability

The conclusion is that "Performance data confirmed that the subject device is equivalent to the predicate device and any differences in the device do not raise new questions of safety or effectiveness." This statement is the reported device performance in the context of a 510(k) for this type of device – it met the standards for substantial equivalence. No specific numerical thresholds or results are provided in this summary, as is common for non-AI/ML 510(k) submissions unless a specific performance standard requires it to be explicitly stated in the summary.

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

The document states "In vitro performance tests have been performed to support claimed substantial equivalence."

• Sample Size: The document does not specify the exact sample sizes (e.g., number of pumps tested) for each of the non-clinical performance tests. This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.
• Data Provenance: The tests are described as "In vitro performance tests," implying laboratory-based testing. "Performance testing in accordance with the special controls of 21 CFR 870.4360 was performed with the subject device (CP20V-NG)." This is prospective testing performed on manufactured devices. The country of origin of the data is not specified, but the applicant company is located in Italy (Spectrum Medical S.r.l., Mirandola, Italy).

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

This question is not applicable. This is a physical medical device, not an AI/ML device that requires human expert annotation for ground truth. The "ground truth" for a device like this comes from standardized engineering and biocompatibility testing methods, not expert consensus on medical images or patient outcomes.

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

This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Performance is measured against physical properties and engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable. This is not an AI-powered diagnostic or assistive device. No MRMC study was conducted.

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

This question is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is established through:

• Engineering Specifications and Standards: The device's performance is measured against established engineering parameters and standards (e.g., relating to flow, pressure, heat, mechanical durability, blood damage).
• Biocompatibility Standards (ISO 10993-1:2018): Ensuring the materials are safe for biological contact.
• Sterilization Standards (ISO 11135:2014): Verifying the sterility of the device.
• Packaging Standards (ISO 11607-1:2019): Ensuring the integrity of the packaging.
• Regulatory Special Controls (21 CFR 870.4360): Specific performance requirements for nonroller-type blood pumps.

The "ground truth" is not based on expert consensus, pathology, or outcomes data in the traditional sense of an AI/ML diagnostic.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/ML device that uses a "training set." The device is designed, manufactured, and tested, not "trained."

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

This question is not applicable. There is no "training set" or corresponding "ground truth" establishment in the context of this device.

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The Integral Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The Integral Dental Unit (Model: YD-A4) is a dental operative unit specially designed and provided for a qualified dentist to be used in a professional clinic or hospital facility to carry out dental procedures.

Integral Dental Unit is intended to be used in a professional environment for dental diagnosis, treatment, or operation.

It includes a treatment chair, dentist element, assistant element and a dental light as offering several additional options and electronically-controlled chair movements with software and water/air unit functions.

The dental unit consists of an electronically operated dental chair and integrated control unit control for electricity, water and air supply to handpieces or some other dental instrument. The device is equipped with an instrument tray, pipes for water supply and tube air supply, a mouth lamp, a saliva aspirator, a spittoon, a three-way syringe, a film viewer, a foot switch and chair with driving motors and armrest.

The dental chair is intended to be used with dental hand pieces, cure light, ultrasonic scaler, camera system or other doctor stool, which is not provided by the manufacturer. The user will select the dental instruments and accessories with FDA clearance by themself. So, the device in the submission does not include these parts and accessories. The connector standard type complies with ISO 9168.

Basic parameters/use conditions/power supply specifications is as follows:

◆Noise ＜70 dBA

◆Base box Power supply: 115/230 Vac, 50/60Hz, single-phase 3core, protective grounding.
Power input: 380 VA
Water filter hole diameter: 15 kPa;

• water pumping rate＞80 mL/min

Strong saliva:

• vacuum degree >25 kPa;
• water pumping rate＞1000 mL/min

◆Instrument tray Rotating angle: >270º
Up-down moving range: >440mm
Max. Load: 85 Ra

◆Foot switch Tripping force: >10N and 25 000 repeats

◆Dental chair Power supply: 24 V dc Inside power supply
Loading capacity: 1323N (about 135 Kg)
Loading capacity of headrest: 300N (about 30Kg)
Moving range of headrest: 120mm
Range of backrest when going backwards: 90º~170º
Seat cushion's maximum height away from ground: 730mm
Seat cushion's minimum height away from ground: 450mm

Attachment
----- Amalgam separation device
It has a medical device product registration card
Attachment parameters are reflected in its operating instructions

◆Work space L: ≥3 000 mm; W: ≥2 000 mm; H: ≥2 500 mm

◆Environment for operation
Temperature: +5°C to +40°C
Relative humidity: 30% - 80%
Atmospheric pressure: 86kPa ~ 106kPa

The provided FDA 510(k) clearance letter pertains to the Integral Dental Unit, a Class I medical device. This device is an "Operative Dental Unit and Accessories" and is intended to supply power to and serve as a base for other dental devices and accessories, including a dental chair, for use by trained dental professionals in a dental clinic environment.

The document states that clinical performance testing was not performed for this device. As such, information regarding acceptance criteria derived from a clinical study, sample size for test sets (including data provenance, ground truth establishment, expert qualifications, and adjudication methods), MRMC studies, or standalone algorithm performance, and training set details are not provided in this submission.

Instead, the device's acceptance criteria are based on conformance to established international standards for electrical safety, electromagnetic compatibility, biocompatibility, software verification and validation, software life cycle processes, and general performance for stationary dental units and dental patient chairs.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. Clinical performance testing was not performed. The testing conducted was primarily engineering and bench testing against recognized standards.

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

Not applicable. Ground truth as typically understood for clinical studies (e.g., expert interpretation of medical images) was not established. Performance was assessed against engineering specifications and international standards by relevant testing laboratories.

4. Adjudication method for the test set

Not applicable. No expert review or adjudication method was described as clinical performance testing was not performed.

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. No MRMC study was conducted as this device is an Integral Dental Unit, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is based on conformance to international engineering and safety standards (e.g., IEC, ISO) and the device's adherence to its own design specifications and functional parameters. There is no clinical "ground truth" derived from patient outcomes or expert consensus in this submission.

8. The sample size for the training set

Not applicable. This is not an AI/Machine Learning device that requires a training set.

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

Not applicable. This is not an AI/Machine Learning device.

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The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors indicated for use exclusively with the Quantum Centrifugal Drive is intended to pump the blood through an extracorporeal circuit and to monitor pressure for periods lasting less than 6 hours for the purpose of providing either:

(i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or

(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Device is intended for adult patients.

The Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a standalone, single-use device intended for use in medical procedures requiring extracorporeal circulation. The device is designed to pump blood via centrifugal force through an extracorporeal circuit for periods lasting up to six (6) hours.

The device is non-toxic, non-pyrogenic, EtO-sterilized, and packaged in a single blister. Blood contact surfaces are coated with a stable, biocompatible compound to reduce platelet activation and adhesion while preserving platelet function.

The furnished document is a 510(k) clearance letter for a medical device which is a physical blood pump, not an AI/software as a medical device (SaMD). Therefore, the questions related to AI/SaMD testing methodologies (such as sample size for training/test sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.

However, I can extract the relevant information regarding the performance data and the conclusion of the substantial equivalence for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that performance testing was conducted according to the special controls of 21 CFR 870.4360 and confirmed the subject device is equivalent to the predicate. While specific numerical acceptance criteria and precise performance data are not explicitly detailed in this summary, the categories of tests performed indicate the areas where the device's performance was evaluated against established benchmarks (likely derived from the predicate device's performance or regulatory standards).

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

This information is not provided in a quantifiable manner (e.g., number of units tested).

• Sample Size: Not specified. The document states "Performance testing...was performed with the subject device (CP22V-NG)." This implies a sufficient number of devices were tested to draw conclusions, but the exact count is not given.
• Data Provenance: The tests were likely conducted by the manufacturer, Spectrum Medical S.r.l., as part of their 510(k) submission. The document lists the company's address in Mirandola, MO, Italy. It's a retrospective study from the perspective of the submission, as the tests were completed before the submission.

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

This is not applicable as the device is a physical blood pump, not an AI/SaMD requiring human expert annotation for ground truth. The "ground truth" for this type of device would be established through engineering specifications, validated test methods, and performance against established physiological or mechanical standards as outlined in the special controls (21 CFR 870.4360).

4. Adjudication Method for the Test Set

Not applicable for a physical device. Performance is measured objectively through lab tests and engineering evaluation, not through subjective reviewer adjudication.

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

Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool designed to be used by human readers.

6. Standalone Performance

Yes, standalone performance testing was conducted. The non-clinical performance tests listed (Operating Parameters, Dynamic Blood Damage, Heat Generation, Air Entrapment, Mechanical Integrity, and Durability/Reliability) directly evaluate the device's inherent performance characteristics independently. The device's performance was then compared to that of the predicate device to establish substantial equivalence.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

• Engineering Specifications: The device is designed to meet specific technical parameters (e.g., flow rate, pressure monitoring accuracy, heat generation limits).
• Regulatory Standards: Performance was measured against the special controls outlined in 21 CFR 870.4360, which define acceptable parameters for non-roller type blood pumps.
• Predicate Device Performance: The primary method for proving substantial equivalence was demonstrating that the subject device's performance was equivalent to that of its predicate device, which has a proven safety and effectiveness record.

8. Sample Size for the Training Set

Not applicable. This is a physical device, 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 reason stated above.

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The Insighters(TM) Single-use Bronchoscope System provides images for the observation, diagnosis and treatment of trachea, bronchus and lung area.

It is indicated for diseases of the trachea and bronchi other than contraindications.

The Insighters(TM) Single-use Bronchoscope System is generally in-hospital use.

The Insighters(TM) Single-use Bronchoscope System is for use by trained clinicians/physicians only.

The Single-use Flexible Video Bronchoscope (Insighters™ Single-use Bronchoscope System) consists of an Single-use Bronchoscope (iS-B12A/ iS-B22A/iS-B26A) and an Insight Workstation(iS-PF1) which is a compatible displaying unit.

The Single-use Bronchoscope consists of an insertion part (including the head end part, a bending part, and Main Hose part) and an operation part (including an electrical interface, a suction interface, a suction button, and clamp channel interface). It comes in 3 models: iS-B12A, iS-B22A, iS-B26A. The differences among the different models are only in size. This product is sterilized by ethylene oxide, single use, disposable, body orifices invasive and short-term use device.

The Insighters™ Insight Workstation (iS-PF1) consists of a display host and accessories: Power adaptor (model PH50-12), Connection Cable. The Insight workstation supports connection with Single-use bronchoscope by Connection Cable. It can supply power and processes the images for medical electronic endoscope. It is a reusable monitor and no contact with the patient.

The Insighters™ Single-use Bronchoscope System is to provide images for the observation, diagnosis and treatment of trachea, bronchus and lung area.
This product is a portable electronic endoscope. It has the characteristics of clear image, small size, light weight, easy to carry, flexible operation, easy to learn and use, etc.
This product contains a working channel, which is convenient for use after insertion of endoscopic accessories.
The applied part of this product is the insertion part of the Single-use Bronchoscope.
Single use application of this product minimises the risk of cross-contamination of the patient.

There appears to be a misunderstanding of the provided FDA 510(k) clearance letter. The document details the clearance of a Single-use Flexible Video Bronchoscope and an accompanying Insight Workstation.

Crucially, this document does NOT describe an AI/ML-driven medical device, nor does it present any studies proving the device meets acceptance criteria related to AI/ML performance. The "Insight Workstation" mentioned is a display unit, not an AI component.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving an AI device meets those criteria, as the provided document pertains to a traditional medical device (a bronchoscope) and makes no mention of AI or machine learning.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 4 Broncho Family) based on:

• Identical indications for use, patient population, and environment of use.
• Similar technological characteristics (flexible scope, working length, illumination, color performance, image/video capture, single-use, EO sterilization, shelf life, packaging).
• Non-clinical performance testing (electrical safety, EMC, optical performance, bending angle, aging, sterile packaging integrity, thermal safety, reliability, usability, chemical properties, photobiological safety, mechanical performance, color performance).
• Biocompatibility testing.

The document explicitly states: "Based on the similarities of the device specifications, intended use, indications for use between the Single-use Flexible Video Bronchoscope and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This means there are no clinical studies or AI performance studies to discuss within the scope of this FDA clearance letter.

To provide the requested information, a document describing the clearance of an AI/ML-based medical device would be required.

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The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.

The Integral dental unit is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professionals in the field of general dentistry. The Integral dental unit consists of a dental chair, side box, dental light, instrument tray, 3-way syringe, strong suction, weak suction, cuspidor, x-ray film viewer, and the wired foot pedal. Optional accessories include ultrasonic scalers, curing lights, dental handpieces and dental electrical motor, which are to be purchased by the user. The dental operative unit is equipped with a dental light and water heater. The dental operative unit mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Integral dental unit which are attached by means of industry standard ISO connections. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are manufactured by the Mipont Medical Equipment Co., Ltd. None of the Integral dental unit parts or accessories are provided sterile.

This document is a 510(k) clearance letter for "Integral Dental Units" (K242611). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and safety data, rather than clinical accuracy or AI performance.

Therefore, many of the requested sections related to acceptance criteria, MRMC studies, standalone AI performance, and AI-specific ground truth establishment cannot be fulfilled from this document as it does not describe AI-powered functionality or clinical accuracy testing for a diagnostic or AI-assisted system.

The "device" in this context is a dental operative unit, which is a piece of physical medical equipment, not an AI or software algorithm requiring clinical accuracy validation as typically seen in AI/ML medical devices.

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

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" for this device are primarily met by demonstrating compliance with various national and international performance, safety, and quality standards, as well as showing substantial equivalence to existing predicate devices. The performance data presented are primarily in the context of electrical safety, EMC, usability, physical operation parameters, and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical dental unit and not an AI-powered diagnostic device, the "acceptance criteria" are compliance with established standards and comparable specifications to predicate devices. There aren't specific accuracy metrics like sensitivity or specificity for a diagnostic algorithm.

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

• Sample Size: Not applicable in the context of device performance testing. The "sample" here refers to the physical device units tested for compliance with standards. The document does not specify the number of units tested.
• Data Provenance: The tests are non-clinical, meaning they were likely performed in a laboratory or manufacturing setting. The manufacturer is Mipont Medical Equipment Co., Ltd. from China. The data provenance is from non-clinical bench and laboratory testing of the physical dental unit, not clinical data from patients.

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

• Not Applicable: This document describes non-clinical performance and safety testing of a physical medical device (dental unit), not an AI algorithm requiring expert-established ground truth for clinical accuracy.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this pertains to clinical study design for AI algorithms, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No: The document states, "There was no clinical testing performed." This type of study is specifically for evaluating the impact of AI on human performance, which is not relevant to this device's clearance.

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

• No: This device is a physical dental unit, not a standalone algorithm. The document explicitly states "There was no clinical testing performed."

7. The Type of Ground Truth Used

• For the non-clinical tests, the "ground truth" is defined by the specifications and requirements outlined in the referenced international standards (e.g., IEC, ISO, ASTM). The device is tested against these predefined, objective engineering and safety criteria. There is no "expert consensus" or "pathology/outcomes data" in the clinical sense for these types of non-clinical hardware tests.

8. The Sample Size for the Training Set

• Not Applicable: This device is not an AI/ML algorithm that requires a training set.

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

• Not Applicable: This device is not an AI/ML algorithm that requires a training set or associated ground truth.

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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Here's an analysis of the provided FDA 510(k) clearance letter, focusing on the acceptance criteria and the study proving the device meets them:

The VERIFY STEAM Integrating Indicator (K243876) is a chemical indicator designed to monitor steam sterilization cycles. It is intended to be placed within containment devices (packs, pouches, etc.) during sterilization to independently verify that critical parameters have been met. The device is considered to "pass" if a dark bar on the indicator enters the "ACCEPT (OK)" window.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical testing performed to evaluate the performance of the VERIFY STEAM Integrating Indicator and demonstrate its substantial equivalence to a predicate device (K213412).

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

• The document does not specify the exact sample sizes (number of indicators) used for each individual test (Stated Value, Simulated Use, Stability, Comparison with Biological Indicator).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission for a medical device, it is highly likely that these were prospective, laboratory-based studies conducted by the manufacturer (STERIS Corporation, Franklin Park, IL, USA) to evaluate the device's performance under controlled conditions.

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

• This device is a chemical indicator that produces a visual change (dark bar entering an "ACCEPT (OK)" window) based on exposure to sterilization parameters. The "ground truth" for these tests is established by the controlled sterilization cycle conditions (temperature, time, presence of steam) and the objective physical change of the indicator, rather than subjective expert interpretation.
• Therefore, no human experts were used to establish the ground truth for the test set in the way radiologists or pathologists would interpret an image. The performance is assessed against defined physical and chemical criteria.

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

• As the "ground truth" is determined by objective physical and chemical changes under controlled conditions, and the outcome (pass/fail) is a direct observation of the indicator's state, no adjudication method involving human experts was necessary for the test set.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VERIFY STEAM Integrating Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its primary function is to react chemically, not to be "read" in a complex interpretive sense by multiple human readers.

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

• This question is not applicable in the context of a chemical indicator. The device is entirely standalone in its function – it reacts chemically without any human intervention or an algorithm. Its "performance" is its physical color change, which is then observed by a human. There is no separate "algorithm" to evaluate.

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

• The ground truth for these tests is based on objective physical and chemical properties and predefined standards. Specifically:
  • Controlled Sterilization Parameters: The cycles are run at precisely defined temperatures and times, and the presence of steam is controlled. The "truth" is whether these parameters were met or not.
  • ANSI/AAMI/ISO 11140-1:2014: This international standard defines the performance requirements for chemical indicators, providing the objective benchmarks against which the device is evaluated.
  • Biological Indicator Inactivation: For comparison testing, the inactivation of a biological indicator (a highly resistant microorganism) serves as an objective "gold standard" for sterilization efficacy.

7. The sample size for the training set:

• The document does not mention a "training set" in the context of device development. This concept is typically associated with machine learning or AI models. For a chemical indicator, the "development" involves chemical formulation, material science, and engineering to achieve the desired reaction kinetics and visual endpoint. There isn't a "training set" in the computational sense.

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

• As there is no "training set" in the conventional sense for this type of device, this question is not applicable. The development of such an indicator would involve extensive research and development in chemistry and material science, where performance is iteratively optimized against the physical/chemical principles of sterilization and the requirements of relevant standards.

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The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.

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The Affera Integrated Mapping System is intended to be used cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

The Affera Integrated Mapping System (integrated mapping system) is a computerized storage and display system with embedded software designed to present the user with information regarding the state and location of compatible catheters within the body. The integrated mapping system provides real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The integrated mapping system uses magnetic localization technology similar to localization systems used in other EP mapping systems, with a magnetic field generator placed under the table and one or more passive magnetic-based tracking and navigation, the integrated mapping system provides optional capability for hybrid electromagnetic-impedance tracking and navigation, including the ability to visualize Medtronic and third-party therapeutic and diagnostic devices that do not contain electromagnetic location sensors. The integrated mapping system collects and displays surface electrocardiogram (ECG) signals using commercially available body surface electrodes. Electrogram signals from electrodes on connected catheters can also be collected. Data derived from these signals can be overlayed on the reconstructed anatomy to display cardiac maps in multiple formats. The integrated mapping system can connect to electrophysiology (EP) catheter lab equipment such as external stimulators to deliver pacing stimuli through third-party intracardiac (IC) catheters. Internally generated pacing stimuli can also be routed directly from the integrated mapping system CIU. The integrated mapping system can be used with compatible cardiac ablation systems for tracking and navigation of catheters during ablation procedures. When connected via a communication link to a compatible ablation system, the integrated mapping system displays ablation data such as temperature and power on the user interface.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative manner. The document is a 510(k) summary for the Affera Integrated Mapping System, indicating it has undergone performance testing, but the results and acceptance thresholds are not explicitly stated.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of acceptance criteria and reported device performance:

The document states: "Performance testing applicable to the subject devices was completed to ensure it performs as intended per the product specifications and requirements... all acceptance criteria were met in accordance with appropriate standards". However, it does not provide a table of

• specific acceptance criteria (e.g., accuracy thresholds, precision values, sensitivity/specificity targets)
• the reported device performance measurements against those criteria.

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

• Test set sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified, as the type of ground truth and method of establishment are not detailed in the provided text.

4. Adjudication method for the test set:

• Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• Not explicitly mentioned. The document focuses on the device's performance against its own specifications rather than a comparative study with human readers with or without AI assistance.

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

• The device is a "computerized storage and display system with embedded software" for "electrophysiological mapping". The testing mentioned ("Design verification testing", "Design validation", "Pre-clinical animal testing", "Software validation") generally refers to the standalone performance of the system, but this is not explicitly stated as "algorithm only without human-in-the-loop performance". The system is intended to provide "real-time visualization" and "display" of information to a user, implying a human-in-the-loop context for clinical use.

7. The type of ground truth used:

• Not explicitly stated. The testing includes "Design verification testing", "Design validation", and "Pre-clinical animal testing", which would imply some form of established "truth" or reference standard relevant to cardiac mapping, but the specific nature of this ground truth (e.g., direct measurement, expert consensus on a gold standard, pathology) is not detailed.

8. The sample size for the training set:

• Not specified. The document does not mention details about the development or training of any AI/algorithm components, only general software validation.

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

• Not specified, as information about a training set is not provided.

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The True Indicating Type 5 Integrating Indicator for Steam CSPN-15 is designed to chemically react over time with the critical parameters of steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Gravity Displacement: 121° C for 30 minutes, 132° C for 15 minutes, 132° C for 25 minutes, 132° C for 3 minutes. 135° C for 10 minutes;

Dynamic Air Removal (Vacuum Assist): 132° C for 4 minutes, 135° C for 3 minutes.

Minimum Stated Values as determined in a resistometer:

SV121°C/16.5 min., SV132°C/2.0min. SV134°C/1.4 min. SV135°C/1.2 min.

The True Indicating Chemical Indicator for Steam CSPN-15 consists of a white polyester substrate with acrylic adhesive married to a paper substrate. The paper substrate (with acrylic adhesive) has True Indicating water-based steam indicating ink, ISPN-01 (pink to dark brown/black), and general artwork printed. After printing, the top layer of the Type 5 Integrating Indicator strip is covered with a clear colorless polyester laminate with acrylic adhesive. The Integrating Indicators have been designed for Steam sterilization processes, ensuring the effectiveness of sterilization by monitoring all critical process variables (time, temperature and steam). The pink indicating ink was developed to turn to dark and conceal the word "NOT" when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of a 105 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer).

The provided document describes the acceptance criteria and study results for the True Indicating Type 5 Integrating Indicator for Steam (CSPN-15). This device is a chemical indicator designed to monitor steam sterilization cycles.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Testing was performed for steam sterilization processes using multiple lots of True Indicating Chemical Indicator for Steam CSPN-15 over the range of the shelf-life". Specific numerical sample sizes for each test are not explicitly provided in this summary. The data provenance is derived from nonclinical tests conducted by or for True Indicating, LLC, following FDA and ISO guidelines. The context suggests prospective testing specific to the device's development and validation.

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

This device is not an AI/imaging device requiring expert interpretation for ground truth. The ground truth for chemical indicators is established by objective physical and chemical measurements (e.g., specific temperatures, times, and presence/absence of steam for sterilization cycles, and color change observation). There is no mention of human experts being used to establish ground truth for this type of device.

4. Adjudication method for the test set

Not applicable. This device is a chemical indicator, and its performance is assessed by objective chemical/physical reactions and visual color changes, rather than subjective interpretation requiring adjudication.

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

Not applicable. This is not an AI/imaging device.

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

Yes, in a sense. The testing performed on the chemical indicator (Type 5 Integrating Indicator for Steam CSPN-15) is a standalone evaluation of its performance without human-in-the-loop interaction for interpretation, except for visual confirmation of the color change. The indicator itself is designed to provide a direct visual output.

7. The type of ground truth used

The ground truth used for this chemical indicator is based on:

• Physical and Chemical Parameters: Precisely controlled steam sterilization conditions (temperature, time, and steam presence) established in resistometers and hospital sterilizers.
• Biological Indicator Inactivation: For the "Side-by-Side Testing with a Biological Indicator," the ground truth for successful sterilization is the inactivation of biological indicators (BIs), which contain a known population of resistant bacterial spores. The chemical indicator's performance is compared against this biological standard.
• Color Change: The specific, objectively defined color change from pink to dark brown/black that indicates successful exposure to sterilization parameters.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not an AI model that requires a training set.

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

Not applicable. As noted above, this device does not utilize a training set in the way an AI model would.

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Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles
132 °C, 4 minutes
135 °C, 3 minutes

Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles
132 °C. 4 minutes
135 °C. 3 minutes

Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores.

Bionova® Photon Process Challenge Devices consist of a disposable pre-assembled package as outlined in ANSI/AAMI ST79:2017 which contain a Bionova® Photon Biological Indicator (BT225), a Record Card and a chemical integrator that gives instant visible indication that sterilizing conditions have been reached. Each Bionova® Photon PCD consists of a stack of porous cards holding a Self-Contained Biological Indicator (SCBI) that contains a population of Geobacillus stearothermophilus ATCC®7953 spores on a carrier as well as growth indicator medium contained in a glass ampoule. Each SCBI has a process indicator on the label that changes from pink to brown when exposed to steam. These PCDs present a challenge to the sterilization process equivalent to the 16-towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes (number of devices or test runs) used for each performance study. It only mentions "Performance study" in the test descriptions.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The studies are related to the performance of sterilization indicators and likely involve laboratory testing rather than human expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies involve objective physical and biological tests, not human interpretation that would require adjudication.

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 sterilization indicator, not a diagnostic imaging device that would typically involve human readers.

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

Yes, the studies described are standalone performance tests of the device (Process Challenge Device and its components) in various sterilization cycle conditions. The device's performance (e.g., color change of chemical integrator, fluorescence of biological indicator) is directly observed and compared to established standards or other devices.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established standards: Specifically, ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) for comparison against the 16-towel test pack.
• Known sterilization conditions: Labs would define "passing" and "failing" sterilization cycles for testing accuracy.
• Performance of predicate device: The predicate device (K191021) served as a benchmark for equivalent performance.
• Intrinsic BI and CI performance: The standalone biological and chemical indicators' known performance characteristics establish a baseline for comparison with the PCD.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical diagnostic tool (sterilization indicator), not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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