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UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema). It is to be used on intact skin only. Patients shall use it at home under the guidance of the physician.

UV phototherapy device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and eczema. It is to be used on intact skin only. Patients shall use it at home under the quidance of the doctor.

Users can set UV irradiation dose through the controller, and confirm the light emission by pressing the start button. The controller will control the light emitting time of the set dose. The light emission will stop automatically after the UV irradiation dose reaches the set value.

The provided text is a 510(k) Summary for a UV Phototherapy Device. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria.

The document states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It then lists several international standards (IEC and ISO) with which the device complies. However, it does not provide:

• A table of actual acceptance criteria (e.g., minimum efficacy rates, safety thresholds) for the device's clinical performance.
• The reported device performance against such criteria.
• Details about specific studies (clinical or non-clinical) that "prove" the device meets these criteria in terms of clinical outcomes for psoriasis, vitiligo, and atopic dermatitis.
• Information on sample sizes for test sets or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document focuses on substantiating equivalence to predicate devices primarily through technological comparison and compliance with electrical safety, EMC, and biocompatibility standards, rather than direct evidence of clinical efficacy meeting predefined acceptance criteria for the treatment of dermatologic conditions.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the studies and ground truth, as this information is not present in the provided text.

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InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.

• · in the context of a treatment of fenestration defects
• · in case of dehiscence defects
• · after apicoectomy and resection of retained teeth
• · in extraction sockets after tooth extractions
• · in case of immediate or delayed augmentation around implants in extraction sockets

InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.

This FDA 510(k) summary describes the InterCollagen® Guide, a resorbable collagen membrane. The submission seeks to prove substantial equivalence to a predicate device, the Straumann Jason Membrane, rather than demonstrate strict acceptance criteria and performance against those criteria. Therefore, the response will be structured to extract relevant performance claims and the study details provided, even if they don't explicitly fit a "table of acceptance criteria" format with numerical targets.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission seeking substantial equivalence, explicit numerical "acceptance criteria" with defined thresholds are not typically presented in the same way as a de novo or PMA submission. Instead, the focus is on demonstrating similar performance to a legally marketed predicate device. The following table summarizes the key performance aspects that were evaluated and the results presented, which essentially serve as the "reported device performance" against the implicitly accepted standard of the predicate device's performance.

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

The primary "test set" for performance evaluation was the canine two-wall intrabony defect model.

• Sample Size: Not explicitly stated in terms of the number of animals or defects. The document mentions "End points for pathology, histology, histomorphology and micro-CT were taken after 2, 6, and 13 weeks," implying a longitudinal study.
• Data Provenance: Conducted as an animal study (canine model). The country of origin is not specified in the provided text. The study design was a comparison between the test article (InterCollagen® Guide), a predicate device (Jason membrane), and an empty control. This is a prospective study design for evaluating the device's performance post-implantation.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the animal study. Histology, histomorphology, and pathology evaluations are typically conducted by trained veterinary pathologists or researchers specialized in bone regeneration, but specific details are not provided.

4. Adjudication method for the test set

The document does not specify any adjudication method for establishing ground truth in the animal study. Evaluations of pathology, histology, histomorphology, and micro-CT are usually performed by experts, but whether independent reviews or consensus methods were used is not mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a resorbable collagen membrane for guided bone and tissue regeneration, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

A standalone performance study of an algorithm was not performed. This is a medical device (collagen membrane), not a software or AI/ML algorithm.

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

For the animal study:

• Pathology: Evaluation of pathological changes in tissues.
• Histology: Microscopic examination of tissue samples.
• Histomorphology: Quantitative analysis of tissue morphology (e.g., bone formation).
• Micro-CT: Three-dimensional imaging for bone volume and structure analysis.

These are considered objective biological and imaging endpoints, typically interpreted by experts, to establish the "ground truth" regarding the device's in-vivo performance and tissue response.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set."

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 medical device.

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InterOss® Collagen is indicated for filling of extraction sockets to enhance preservation of the alveolar ridge. InterOss Collagen is recommended for:

Filling of extraction sockets to enhance preservation of the alveolar ridge

Filling of periodontal defects in extraction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss Collagen is a combination of InterOss®, an anorganic hydroxyapatite bone substitute, and collagen fibers for use in periodontal, oral and maxillofacial surgery. This product is a composite of 90% InterOss® (granules of size 0.25-1mm) and 10% porcine collagen fibers. InterOss®, which is already a cleared device by the FDA (K151209), is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps InterOss® acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process. The collagen component facilitates the adaptation of Inter Osse to the allowing easier handling. The product is non-pyrogenic, single use only, and terminally sterilized via gamma-irradiation.

The product is available in the following shapes and sizes:

| Type | Weight
(mg) | Dimension
(mm) | Ref# |
|-------|----------------|-------------------|----------|
| Block | 50 | 6 x 6 x 3 | IOC-50 |
| Block | 100 | 6 x 6 x 6 | IOC-100 |
| Block | 250 | 7 x 9 x 8 | IOC-250 |
| Block | 350 | 8 x 10 x 9 | IOC-350 |
| Block | 500 | 10 x 12 x 10 | IOC-500 |
| Plug | 150 | 6 x 10 | IOC-P150 |
| Plug | 250 | 8 x 10 | IOC-P250 |
| Plug | 400 | 11 x 9 | IOC-P400 |
| Plug | 450 | 10 x 12 | IOC-P450 |

The provided document is a 510(k) premarket notification for the InterOss® Collagen bone grafting material. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence.

However, the document does not contain information about a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning device. The "acceptance criteria" and "device performance" in the tables are for the physical and chemical properties and biocompatibility of the bone grafting material itself, not for an AI-powered system evaluating its efficacy or providing diagnostic information.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone performance (algorithm only).
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a traditional medical device (bone grafting material), not an AI/ML medical device, and thus the requested AI-specific information is not present.

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MediLab is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. MediLab displays and manages diagnostic quality DICOM images. MediLab is not intended for diagnostic use with mammography images. Usage for mammography is for referral only. MediLab is not intended for diagnostic use on mobile devices.

Contraindications: MediLab is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.

The MediLab is a DICOM medical image viewer that allows downloading, reviewing, manipulating, visualizing and printing medical multi-modality image data in DICOM format, from a client machine. MediLab is a server-based solution that connects to any PACS and displays DICOM images within the hospital, securely from remote locations, or as an integrated part of an EHR or portal. MediLab enables health professionals to access, manipulate, measure DICOM images and collaborate real-time over full quality medical images using any web-browser without installing client software.

The provided text describes the MediLab device, its intended use, and compares it to predicate devices. However, it does not explicitly state acceptance criteria in a quantitative manner or detail a specific study proving the device meets said criteria for diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (ZeeroMED View, IMPLANTER DENTAL PLANNING SOFTWARE, and aPROMISE X) based on intended use, technical characteristics, and functionalities as a medical image management and processing system.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide specific quantitative acceptance criteria or diagnostic performance metrics for the MediLab device. The comparison focuses on feature similarity with predicate devices. The closest to "performance" mentioned is "Performance Testing (Measurement Accuracy) was conducted on the MediLab system to determine measurement accuracy when performing the various distance and area measurements." However, the results of this testing, or any specific acceptance criteria for these measurements, are not provided.

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 provided in the text. The document mentions "Non-clinical product evaluation to demonstrate safety and effectiveness was conducted" and "Performance Testing (Measurement Accuracy) was conducted," but it does not specify the details of the test data (sample size, origin, retrospective/prospective nature).

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 information is not provided in the text. The document does not mention any expert review or ground truth establishment process for diagnostic performance validation.

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

This information is not provided in the text, as no details of a diagnostic performance study are given.

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 is no indication in the text that an MRMC comparative effectiveness study was conducted. The MediLab device is described as a medical image management and processing system and a diagnostic/analysis tool, not specifically an AI-assisted diagnostic tool.

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

There is no indication in the text that a standalone algorithm performance study was conducted. The device is presented as a medical image viewer and management system for use by qualified medical personnel.

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

This information is not provided in the text, as no diagnostic performance study details are given.

8. The sample size for the training set

The document describes "Software Verification and Validation" and mentions "software requirements and specifications, design architecture, risk analysis and software validation and verification." However, it does not mention a "training set" or "training data" in the context of an AI/ML device. The MediLab is described as a DICOM image viewer and processor, not as a device utilizing machine learning for diagnostic interpretations.

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

As there is no mention of a training set in the context of an AI/ML algorithm, this information is not applicable and therefore not provided in the text.

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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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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilizer.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

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

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/Roll maintains 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 sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® 100S Sterilization System.

The pouches are constructed from Tyvek®/plastic films, with H2O2 Chemical Indicator printed onto the Tyvek® film. 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 STERRAD® Sterilization Systems.

The H2O2 Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

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

The provided text describes the regulatory submission for a medical device (Sterilization Pouch/Roll Made with Tyvek®) seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI/software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria and study design for AI/SaMD devices (like sample size for test/training sets, data provenance, expert
qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this submission. This device is a physical product, and its performance is evaluated through material science, sterility, and packaging tests.

However, I can extract the acceptance criteria and reported performance for the physical device based on the non-clinical testing summaries.

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

For the following points, as explained, they are not applicable because this is a 510(k) submission for a physical medical device (sterilization pouches) based on substantial equivalence, not an AI/SaMD (Software as a Medical Device). The evaluation focuses on material properties and performance under sterilization conditions rather than algorithmic performance on complex data (like images or medical records).

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests performed are engineering and material-science based, using samples of the device and specific test setups, not patient-derived data. The document does not specify a "test set" in the context of an AI algorithm, nor "data provenance" (e.g., country of origin) relevant to patient data. The non-clinical tests were likely conducted in a controlled laboratory environment.

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 as typically defined for AI/SaMD (e.g., disease diagnosis from medical images) is not relevant here. The "ground truth" for these tests are objective measurements against established engineering and biological standards (e.g., quantitative measures of tensile strength, observable microbial growth, or chemical indicator color change).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human annotators/experts for ground truth establishment in AI/SaMD; this is not relevant for materials testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance evaluations are based on established industry standards and scientific principles for material properties (e.g., ASTM standards for mechanical properties), biological efficacy (e.g., 6-log reduction for sterilization), and chemical reactivity (e.g., color change of indicators). No human expert consensus or outcomes data in a clinical context is used as "ground truth" for this device's acceptance.

8. The sample size for the training set: Not applicable. There is no AI training set involved.

9. How the ground truth for the training set was established: Not applicable. There is no AI training set involved.

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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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InterOss® small granules are recommended for:

• Augmentation or reconstructive treatment of the alveolar ridge .
• . Filling of infrabony periodontal defects
• . Filling of defects after root resection, apicocectomy, and cystectomy
• . Filling of extraction sockets to enhance preservation of the alveolar ridge
• . Elevation of the maxillary sinus floor
• . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
• . Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

InterOss® large granules are recommended for:

• . Augmentation or reconstructive treatment of the alveolar ridge
• . Elevation of the maxillary sinus floor
• . Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.

InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.

InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).

InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).

The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.

During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.

All InterOss® products are supplied sterile and are intended for single use only.

The provided text describes the regulatory clearance of a bone grafting material called InterOss® and does not contain information about a medical device that relies on AI or offers performance metrics that would typically be described with acceptance criteria like sensitivity, specificity, or AUC, as commonly seen in AI/ML device descriptions.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons. The "acceptance criteria" here are implied by the standards for bone grafting materials and the equivalence to the predicate devices.

Here's an attempt to structure the information based on the request, reinterpreting "acceptance criteria" as the properties and test outcomes required for substantial equivalence in this context:

1. Table of Acceptance Criteria and Reported Device Performance

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The Sterilization Pouch/Roll Made with Tyvek® are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. 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 sterilization.

The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140-1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® Sterilization Systems. The recommended Gas Plasma sterilization cycle parameter is 6 minutes (Injection volume: 2880µ L) at 50°C. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 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 sterilization.

The Pouch/Roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERRAD® Sterilization System.

The proposed pouches are constructed from Tyvek® plastic films, with H2O2 Chemical Indicator printed onto the Tyvek" film. 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 STERRAD® Sterilization Systems.

The H2O2 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. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:

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

This document is a 510(k) premarket notification for a medical device called "Sterilization Pouch/Roll Made with Tyvek®". It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence, which is the basis for its FDA clearance.

Here's a breakdown of the requested information:

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

The document presents performance data primarily in a comparative table (Table 5-2, continued on subsequent pages in the original document) comparing the new device against its predicate. It also lists the standards used for testing throughout the "Effectiveness and Safety" section.

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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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