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The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

SIGMA Spectrum is a large volume pump within the SIGMA Spectrum infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.

The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy through administration sets at clinician's selectable rates and volumes.

The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.

The Master Drug Library (MDL) is a stand-alone (not embedded in the pump) software application installed on a hospital-provided computing platform and used to create a drug library file. MDL facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.

This submission includes software design and labeling changes to address the issues leading to recalls Z-0530-2022 and Z-2103-2023.

This FDA 510(k) clearance letter pertains to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories in your prompt (such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," and "Training set sample size/ground truth establishment") are not applicable to this type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technical characteristics and verification of performance against established requirements.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the overall device in a quantifiable manner that would typically be found in an AI/ML context (e.g., specific sensitivity, specificity, or AUC targets). Instead, it demonstrates compliance with a range of technical specifications, which inherently act as acceptance criteria for the design and performance. The "Reported Device Performance" is implied by the statement that "Non-clinical testing met all acceptance criteria."

Below is a table summarizing key technical characteristics that function as performance criteria for the infusion pump. Since the subject device is deemed "substantially equivalent" to the predicate, and no new performance claims are made that deviate from the predicate, their performance characteristics are identical as presented.

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

The document indicates that "Non-clinical testing has been executed against requirements for performance and safety." However, it does not specify the sample sizes for this testing.

The "data provenance" is implied to be from internal lab testing ("Non-clinical testing") conducted by Baxter Healthcare Corporation for verification of the device's functional and safety requirements. Details regarding country of origin or whether it's retrospective/prospective are not provided, but typically such testing for physical devices like infusion pumps would be prospective, controlled lab experiments.

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

This information is not applicable and therefore not provided in the document. For an infusion pump, "ground truth" is typically defined by physical and engineering measurements against established standards and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication is a concept typically relevant to human review of (often ambiguous) data in clinical studies or AI performance evaluations, which is not the primary mechanism for verifying an infusion pump's compliance with engineering specifications.

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

This information is not applicable and therefore not provided. The device is an infusion pump, not an AI-assisted diagnostic or therapeutic device used by human readers for interpretation.

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

This information is not applicable and therefore not provided. While the infusion pump contains software (algorithms), the "standalone performance" concept as typically applied to AI refers to the algorithm's performance in interpreting data directly without human intervention. The pump's performance is intrinsically linked to its electromechanical components and its interaction with fluids, administration sets, and clinical settings.

7. The Type of Ground Truth Used

For this infusion pump, the "ground truth" is established through design specifications, engineering standards, and direct physical/electrical measurements. For example, flow rate accuracy is measured against known volumes over time, alarm thresholds are tested against specific pressure or bubble sizes, and battery life is measured under defined operating conditions. This is not "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. Infusion pumps are not typically "trained" using data sets in the way AI/ML models are. Their functionality is programmed based on engineering principles and validated through testing.

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

This information is not applicable and therefore not provided for the reasons outlined in point 8. The "ground truth" for developing an infusion pump's functionality is its detailed engineering design and the physical laws and medical requirements it must adhere to.

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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

• · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
• · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
• · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
• · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
• · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
  · EO sterilization cycle is 4 hours at 55°C (131°F) with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.
  Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouches and rolls are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.
The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.
The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

The provided document is a 510(k) premarket notification for the SIGMA Sterilization Pouch and Roll. It does not describe an AI/ML medical device, but rather a sterilization packaging product. Therefore, the questions related to AI/ML device performance metrics such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K180661) through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study as presented for this non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are extensively detailed across multiple tables, primarily Table 2 ("Summary of the Proposed and Predicate Devices Technological Characteristics") and Table 3 ("Summary of Non-Clinical Testing"). I will extract the key information from these tables.

Regarding the sections that are not applicable to non-AI/ML devices (points 2-9):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a physical medical device. The testing involves laboratory evaluations of material properties and sterilization efficacy, not interpretation of data. The document does not specify general "sample sizes" in terms of number of patients/cases, but rather the number of units tested for specific physical and chemical properties. The provenance is likely from the manufacturer's testing facilities in Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of AI/ML refers to expert-labeled data. For this device, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI) and their specified pass/fail criteria for physical and chemical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling of AI/ML data. The "acceptance criteria" here are objective measurements against defined standards.

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 a standalone physical product, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm. The device's performance is inherently standalone in its function as a sterilization pouch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI device. For this physical device, the "ground truth" for its performance is determined by adherence to established international and national standards for sterilization packaging, material science, and chemical indicators (e.g., microbial barrier, tensile strength, peel strength, chemical indicator color change).

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML model for which a training set would be required.

9. How the ground truth for the training set was established: Not applicable. Same reason as point 8.

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INDICATIONS
The SIGMA High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

The DePuy SIGMA® High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint.

The unicompartmental femoral components are Co-Cr-Mo metal implants, available with or without a porous coating. The metal backed tibial components are Co-Cr-Mo and polyethylene and are available without a porous coating. The all-polyethylene unicompartmental tibial component manufactured from polyethylene.

The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

The provided text describes a 510(k) premarket notification for a medical device, the SIGMA High Performance (HP) Partial Knee System. While the document outlines information about the device itself and its equivalence to predicate devices, it does not contain the acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI/ML-driven device's performance.

The document states:

• "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE": This lists a number of engineering and material tests (Biocompatibility, UHMWPE Material Property Characterization, Range of Motion/Constraint, Contact Area/Stress, Wear Testing, Pull-Off, Bacterial Endotoxin testing).
• "SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION - Clinical testing was not necessary to demonstrate substantial equivalence."

This indicates that the submission is focused on demonstrating substantial equivalence based on material properties, design, and manufacturing processes, rather than the performance of an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not present in the provided text, as these are typically associated with the evaluation of AI/ML software performance.

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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.

The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the steam/or EO Sterilization cycles.

The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.

The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

This document is a 510(k) Premarket Notification from Sigma Medical Supplies Corp. to the FDA regarding their SIGMA Sterilization Pouch and Roll. It seeks to prove substantial equivalence to a previously cleared device (K102158).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the comparison of the proposed device to the predicate device and the requirement to meet various ISO and ASTM standards. The study's "performance" is reported as "Passed" or "Meets requirements."

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify the exact sample sizes used for each test. It states that "The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll" and "The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll."
   • Data Provenance: The manufacturer is Sigma Medical Supplies Corp. located in Taiwan (R.O.C.). The testing (non-clinical) would likely have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but given it's a premarket notification for a new device (albeit similar to a predicate), it would be prospective data generated specifically for this submission.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • This document describes performance testing of a medical device (sterilization pouches and rolls) against established standards (ISO, ASTM). It does not involve human interpretation of images or other data for which "ground truth" would be established by experts in a clinical sense (e.g., radiologists for diagnostic AI).
   • The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., attainment of SAL 10^-6^ for sterilization, specified physical properties, color change of chemical indicators).
   • Therefore, the concept of "ground truth" established by a panel of human experts in the way it's used for AI/clinical diagnostic studies is not directly applicable here. The validity of the tests themselves is based on adherence to the referenced standards.

3. Adjudication Method for the Test Set:

   • Not applicable in this context. Adjudication is typically used for reconciling disagreements among human readers or evaluators in clinical studies. Here, the tests are objective measurements against defined standards.

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

   • No, an MRMC study was not done. This type of study is relevant for assessing the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its reported testing.

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

   • Yes, implicitly. All the described tests (Sterilant Penetration, Package Integrity, Biocompatibility, Chemical Indicator Efficacy, etc.) are evaluating the physical and functional properties of the device itself, independent of human interaction during its use (beyond following instructions). These are "algorithm only" in the sense that the device's performance is measured against objective criteria, not as part of a human-AI system.

6. The Type of Ground Truth Used:

   • The ground truth is based on industry-recognized technical standards (e.g., ISO, ASTM) for sterilant efficacy, package integrity, biocompatibility, and chemical indicator performance. For example, "SAL 10^-6^" or physical property thresholds defined by the standards.

7. The Sample Size for the Training Set:

   • This document describes premarket notification for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications and then tested.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by prior engineering knowledge and adherence to quality systems for medical device production.

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The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.

The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly state quantitative "acceptance criteria" for the device's imaging performance (e.g., specific resolution, penetration depth, or diagnostic accuracy metrics). Instead, it primarily establishes substantial equivalence to a predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System) by demonstrating similar technological characteristics and compliance with relevant safety and performance standards.

The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets the general safety and performance standards for diagnostic ultrasound systems.

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

The document explicitly states: "Non-clinical testing," and references "results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner." The testing focuses on compliance with international and national safety and performance standards (e.g., IEC 60601, NEMA UD 2, ISO 10993).

• Sample Size: Not specified in terms of patient or imaging data. The testing appears to be primarily device-centric (e.g., electrical safety, acoustic output, biocompatibility) rather than a clinical performance study using patient data.
• Data Provenance: The nature of the "non-clinical test results" suggests they are derived from laboratory and engineering tests of the device itself. There is no indication of patient data being used for the "test set" in the context of clinical performance. The manufacturer is "Beijing East Whale Imaging Technology Co., Ltd." in CHINA.

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

This information is not provided because the testing described is non-clinical and related to device compliance with engineering and safety standards, not a clinical performance study requiring expert ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as the document describes non-clinical engineering and safety compliance testing, not a clinical study involving human readers and adjudicated ground truth.

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. The device described is an ultrasound diagnostic scanner, and the submission is for its substantial equivalence to a predicate ultrasound system based on technological similarities and compliance with standards. It is not an AI-powered diagnostic device, nor does the document mention any MRMC studies or AI assistance for human readers.

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

Not applicable. This is not an algorithm-only device. It's a complete ultrasound diagnostic scanner intended for use by a physician.

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

The type of "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced standards (e.g., maximum acoustic output levels, electrical impedance, biocompatibility test results). There is no clinical "ground truth" (like pathology or expert consensus on diagnoses) discussed in this document.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound scanner, not an AI/machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for an AI/machine learning model discussed in this document.

Summary of the Study (as described in the 510(k) Summary):

The study described is a non-clinical performance and compliance testing program. It aims to demonstrate that the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner (and its various probe configurations) is substantially equivalent to a legally marketed predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System).

The primary evidence presented for this substantial equivalence is:

• Compliance with recognized safety and performance standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993-5, and ISO 10993-10.
• Similar intended use: The indications for use broadly overlap with the predicate device across various anatomical regions and clinical applications.
• Similar technological characteristics: The document details a side-by-side comparison (table on pages 11-12) showing that the proposed device shares the same classification, product codes, regulation numbers, panel, class, probe types (though specific model names differ, the general categories are similar), acoustic track, imaging modes, power supply, acoustic output limits, electrical safety, EMC, performance standards, biocompatibility standards, software level of concern, and design with the predicate.

The conclusion is that "the differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the proposed device. And no new risk is raised regarding to effectiveness and safety. The proposed device is substantial with the predicated device." This means the "study" effectively demonstrates that the device functions within established safety parameters and has similar capabilities to an already-approved device, thus meeting the requirements for 510(k) clearance by proving substantial equivalence.

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The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 5 types:

• Self-sealing sterilization pouches .
• . Sterilization pouches, Flat
• . Sterilization pouches, Gusseted
• . Sterilization rolls, Flat
• . Sterilization rolls, Gusseted

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121 ℃. The recommended EO sterilization cycle is 4 hours at 55 C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 5 types:

• Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
• Sterilization pouches, Flat: These pouches has the same components with the Self-sealing . sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
• Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, . except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
• Sterilization rolls, Flat: These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
• Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The SIGMA Sterilization Pouch and Roll underwent numerous validation studies to demonstrate its effectiveness and safety, confirming its substantial equivalence to predicate devices. These studies adhered to recommended practices, standards, and guidelines from organizations such as AAMI, ISO, and ASTM.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the validation studies. The studies reference adherence to international standards (AAMI, ISO, ASTM), which typically define appropriate sample sizes for such tests.
The data provenance can be inferred as originating from testing laboratories in connection with Sigma Medical Supplies Corp., which is based in Taiwan. The studies appear to be prospective, as they were conducted specifically for the validation of the SIGMA Sterilization Pouch and Roll.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The studies rely on established international standards and laboratory testing rather than expert-based ground truth for the performance criteria of sterilization pouches and chemical indicators.

4. Adjudication Method for the Test Set:
This information is not provided in the document. The validation methods described are primarily objective physical and chemical tests, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or clinical data. The SIGMA Sterilization Pouch and Roll is a Class II device for sterilization wraps and indicators, and its performance is evaluated through laboratory testing against established physical and chemical standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance evaluations of the device itself (the pouches and their integrated chemical indicators). This is inherent to the nature of testing sterilization packaging and chemical indicators, which are designed to function independently based on physical and chemical principles, without human interpretation of "algorithm-only" performance in the context of AI.

7. The Type of Ground Truth Used:
The ground truth used for these studies is based on established scientific and engineering principles codified in international consensus standards (AAMI, ISO, ASTM). These standards define the acceptable performance parameters for sterilant penetration, drying time, aeration, biocompatibility, package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy. The "ground truth" is therefore the successful compliance with these predefined objective criteria.

8. The Sample Size for the Training Set:
This is not applicable. The device is a physical product (sterilization pouch and roll) and does not involve AI or machine learning algorithms that require a training set. The validation studies focused on testing the manufactured product's compliance with performance standards.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for this device.

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The SIGMA Elite 34, 36 and 40 Monoplace Hyperbaric Chambers are intended for use for the following clinical medical conditions in accordance with guidelines established by the Undersea and Hyperbaric Medical Society, as follows: Air or Gas Embolism; Carbon Monoxide / Smoke Inhalation; Compromised Skin Grafts and Flaps; Crush Injuries / Acute Traumatic Ischemia; Decompression Sickness; Enhanced Healing in Selected Problem Wounds; Exceptional Blood Loss (Anemia); Gas Gangrene (Clostridia Myonecrosis); Intracranial Abscess; Necrotizing Soft Tissue Infections; Radiation Tissue Damage (Osteoradionecrosis); Refractory Osteomyelitis; Thermal Burns.

The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have the same intended use; as a prescription device intended for the whole body administration of oxygen to a patient at pressures not exceeding 3 ATA. The SIGMA Elite Series Hyperbaric Chambers and their predicate devices have very similar general principles of operation. All of these chambers are pressurized and ventilated continuously with pure oxygen, and the patient breathes the chamber atmosphere. Also, in each of the chambers, the pressure-time profile (i.e. the rate and direction of pressure change and the time held at any particular pressure), as well as the oxygen ventilation rate of any treatment, are controlled by the chamber's operator, either directly by means of a pneumatic or an automatic electronic system. The purpose of such controls are to be able to conduct the particular hyperbaric oxygen treatment prescribed by the physician in a way that is safe and comfortable for the patient, and to be able to respond appropriately and effectively to any contingency circumstance.

The provided text is for a 510(k) submission for a hyperbaric chamber, which is a medical device, and does not involve AI or algorithms that would have a "reported device performance" in the typical sense of diagnostic metrics like sensitivity or specificity.

Therefore, the specific information requested in the prompt, such as "reported device performance," "sample size," "ground truth," "MRMC study," and "training set," is not applicable to this type of device submission.

Instead, the acceptance criteria for this device are demonstrated by its compliance with recognized industry standards for design, manufacturing, and safety. The "study" that proves the device meets these criteria is a series of engineering and safety tests to ensure it adheres to these standards.

Here's an analysis of the provided information, framed as closely as possible to your request, but acknowledging the difference in device type:

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

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

This information is not applicable and therefore not provided in the document. As a physical medical device (hyperbaric chamber), the "test set" would refer to the chambers themselves undergoing engineering and safety testing, not a dataset of patient information or images. The "provenance" would be the manufacturing location and standard compliance testing, not data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the submission for a hyperbaric chamber. The "ground truth" for this device is compliance with engineering and safety standards, validated through testing by qualified engineers and technicians, not by medical experts interpreting results from the device.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review for diagnostic performance. For a hyperbaric chamber, it's about meeting quantifiable engineering and safety standards through documented testing, not subjective assessment.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This submission is for a physical medical device (hyperbaric chamber) and does not involve AI or human readers in the context of diagnostic interpretation.

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

This is not applicable. The device is a hyperbaric chamber, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness relies on adherence to established engineering, safety, and medical device standards (ASME, NFPA, CAN/CSA, EN standards). These standards themselves represent a form of "ground truth" in terms of what constitutes a safe and functional hyperbaric chamber, based on collective expert consensus in engineering and healthcare safety fields.

8. The sample size for the training set

This is not applicable. There is no "training set" for a hyperbaric chamber in the context of an algorithm or AI.

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

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

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The Sigma 5000 series, Imagic is a medical diagnostic ultrasound imaging system. This submission adds an Adult Cephalic (Adult Transcranial) indication for use to the system, which was previously cleared with other diagnostic ultrasound investigations including Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes several transducers for use with the system.

I am unable to provide a description of the acceptance criteria and study proving device performance because the provided text is a premarket notification for an ultrasound system, not a study report. It states that clinical tests are "not required" for the device as it uses the "same technology and principles as existing devices", and thus does not contain the information needed to answer the request.

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The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is designed to enrich the fresh gas flow of a continuous flow anaesthesia machine, when the vaporizer is connected directly between the flowmeter and the common gas outlet of the machine. The device has been developed in close co-operation with clinicians and the anaesthetic agent manufacturer.

This document is a 510(k) summary for the Sigma Alpha Vaporizer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML-based medical devices.

Therefore, many of the requested items related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not present in this document.

Here’s an analysis based on the provided text, addressing what can be extracted:

Acceptance Criteria and Device Performance Study for Sigma Alpha Vaporizer

This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a detailed clinical study with quantifiable metrics as one would expect for a novel AI/ML device.

The "study" in this context refers to the comparison of the Sigma Alpha Vaporizer's technological characteristics, intended use, and indications for use against predicate devices. The implicit acceptance criterion is that the new device is "as safe and effective" as the predicates, and that its technological characteristics are "very similar" without any "minor differences" making it "any less safe and effective."

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implicit)	Reported Device Performance (as per 510(k))
   Substantial Equivalence (Overall Safety & Effectiveness to Predicates): The device must be "as safe and effective" as analogous legally marketed predicate devices. This implies meeting performance standards for anesthetic vaporizers in terms of vaporizing specific agents and delivering controlled concentrations.	The document concludes: "From the above information it is concluded that the Penlon Sigma Alpha Vaporizer is substantially equivalent to the above named predicate devices." It explicitly states that "any minor differences do not make the Sigma Alpha any less safe and effective than the predicate devices."
   Intended Use & Indications for Use Match Predicates: The device's intended use and indications for use should align with the predicate devices.	"The intended use and indications for use apply equally to the above named predicate devices." The device is intended to vaporize Suprane® (Desflurane) and deliver controlled concentrations to patients (adult and pediatric).
   Technological Characteristics Similarity: The device's technological characteristics must be very similar to predicate devices.	"The technological characteristics of the Sigma Alpha and the predicate Devices... are very similar."

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

   • N/A. This is a 510(k) for a medical device (anesthetic vaporizer), not an AI/ML diagnostic or predictive tool. There is no "test set" of observational data in the AI/ML sense mentioned in this document. The evaluation is based on device design, engineering specifications, and comparison to predicate devices.

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

   • N/A. No "ground truth" establishment in the AI/ML sense. The approval process relies on regulatory review by FDA experts based on the device's documentation and demonstrated substantial equivalence, rather than expert consensus on a dataset.

4. Adjudication method for the test set:

   • N/A.

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:

   • N/A. This device is an anesthetic vaporizer, not an AI-assisted diagnostic tool.

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

   • N/A. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used:

   • N/A. For this type of device, "ground truth" would relate to engineering measurements verifying the vaporizer's output accuracy against its calibrated settings under various operating conditions. Such detailed test results are typically presented in the full 510(k) submission, but only the summary is provided here, which focuses on substantial equivalence. The summary does not provide specific performance data beyond the claim of substantial equivalence.

8. The sample size for the training set:

   • N/A. There is no "training set" in the AI/ML sense for this device.

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

   • N/A.

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