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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

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

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

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

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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Autoclave Indicator Tape is designed for use by a health care provider to demonstrate that the unit or load has been exposed to a steam sterilization process and to distinguish between processed units or loads. After steam sterilization, the chemical indicator lines will show a visual color change from yellow to Black. This is a single use, disposable device(s), and provided non-sterile.

The Autoclave Indicator Tape can be used in the following steam sterilization cycles:

1. Gravity: 121°C, 30 minutes

2. Vacuum assisted (pre-vacuum): 134°C, 4 minutes

EO Indicator Tape is designed for use by a healthcare provider to demonstrate that the unit or load has been exposed to an EO gas sterilization process and to distinguish between processed units or loads. The chemical indicator lines turn from Orange to Green when exposed to EO gas sterilization conditions. This is a single use, disposable device(s), and provided non-sterile.

The EO Indicator Tape can be used in the following EO sterilization cycle:

55°C, 762mg/l EO, 40~80%RH, 4 hours exposure

Autoclave Indicator Tape is a single chemical indicator designed for steam sterilizing monitoring. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial yellow color of the indicator ink on the autoclave indicator tape changes to Black. If no color change occurs, it may indicate that the autoclave indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

EO Indicator Tape is single chemical indicator designed for use in ethylene oxide sterilizing processes. The diagonal strips are printed along the length of the tape using chemical indicator ink. During the sterilization cycle, the initial orange color of the indicator ink on the EO indicator tape changes to green. If no color change occurs, it may indicate that the EO indicator tape was not exposed to the sterilization process due to equipment malfunctions or procedural errors during the sterilization process. This is a single use, disposable device(s), and provided non-sterile.

1. Table of Acceptance Criteria and Reported Device Performance:

Autoclave Indicator Tape

EO Indicator Tape

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

The document does not explicitly state the sample sizes used for each specific test within the non-clinical testing. However, the tests are performed according to recognized international standards (ISO 11140-1:2014, ISO 10993 series) and FDA guidance, which typically involve specific sample sizes to ensure statistical validity.

The data provenance is not specified beyond "non-clinical testing" conducted by the applicant, Jiangmen New Era External Use Drug Co., Ltd. Given the nature of these tests (e.g., sterilization cycle performance, biocompatibility, adhesion), they are most likely conducted in a controlled laboratory environment. The document does not indicate if the data is retrospective or prospective, but performance testing for regulatory submission is typically prospective.

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

This section is not applicable. The tests performed are objective chemical and physical performance tests against established international standards and regulatory guidance, rather than subjective evaluations that would require expert human interpretation to establish ground truth.

4. Adjudication Method for the Test Set:

This section is not applicable. The tests performed are objective, with clearly defined pass/fail criteria based on physical and chemical reactions or measurements. There is no indication of an adjudication method being necessary for these types of tests.

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

No MRMC comparative effectiveness study was done. The submission focuses on non-clinical performance testing of the sterilization indicators themselves, not on their use by human readers in a diagnostic capacity or with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was done. The entirety of the "Summary of Non-Clinical Testing" section describes the standalone performance of the Autoclave Indicator Tape and EO Indicator Tape against established standards and criteria for their chemical indicator function. The device itself is the "algorithm" in this context, where it is designed to change color based on exposure to specific sterilization conditions. The tests evaluate this color change and other physical properties directly.

7. Type of Ground Truth Used:

The ground truth used for these studies is based on:

• Established International Standards: ISO 11140-1:2014 for chemical indicators for sterilization.
• Regulatory Guidance: FDA guidance for industry and FDA staff, "Premarket Notification [510(k)] Submissions for Chemical Indicators."
• Defined Physical and Chemical Parameters: Specific temperature, time, and concentration parameters for steam and EO sterilization cycles that should induce a color change, and absence of color change under non-sterilizing conditions or dry heat.
• Biocompatibility Standards: ISO 10993-5, ISO 10993-10, and ISO 10993-23 for evaluating biological effects of medical devices.
• Material Science Specifications: Criteria for adhesion, offset/transference, and shelf-life.

8. Sample Size for the Training Set:

This information is not provided. The document describes premarket notification (510(k)) testing, which evaluates the final device product against performance criteria. It does not detail any "training set" in the context of machine learning, as these are chemical indicators, not AI/ML-based devices. The "training" for such devices is inherent in the chemical formulation and manufacturing process development.

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

This section is not applicable as the device is not an AI/ML-based system requiring a training set with established ground truth in that context. The "ground truth" for the development of these chemical indicators would have been established through extensive chemical research, formulation, and iterative testing to achieve the desired color change properties in response to specific sterilization parameters, guided by the ISO standards and regulatory requirements.

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Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.

Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

The provided text does not contain information about acceptance criteria for a medical device's performance (such as sensitivity, specificity, or accuracy) or details about a study designed to prove the device meets these criteria. The document is an FDA 510(k) clearance letter for sterilization process indicators, not a performance study report for a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. How ground truth for the training set was established.

The document focuses on the regulatory clearance for biological and chemical indicators used to monitor sterilization processes, confirming their substantial equivalence to predicate devices, and outlining applicable regulations. It does not describe a clinical performance study as one would typically find for a diagnostic or AI device.

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The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX, maX 2, 60, and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALL Clear Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾'' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The provided document is a 510(k) premarket notification for a medical device called "CELERITY HP Indicator Tape (PCC077)". It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document states, "No testing was required to verify the labeling change," and clarifies that "The revised labeling is in accordance with recommendations in 'User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry'' April 1, 2003." This implies that the current submission (K242189) is for a labeling change on an existing device, and therefore, no new performance testing was conducted for this specific submission.

The document also refers to the predicate device, K240760, and states that the proposed and predicate devices have "Identical" technological characteristics and performance limitations. This suggests that the performance criteria and related studies would have been established and demonstrated for the predicate device, and since the current device is identical in these aspects (apart from labeling), no new studies are needed.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted from this document, as this submission primarily addresses a labeling change.

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The STERRAD™ Chemical Indicator (CI) Strip is a process indicator per ISO 11140-1:2014 [Type 1] (to differentiate processed from unprocessed packages) and is intended for use with medical device packages to be sterilized in the following STERRAD™ Sterilization Systems:

• · STERRAD™ 100S Sterilization System
• · STERRAD NXTM Sterilization System
  o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology
• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear Technology o ULTRA GITM Cycle with Integrated ALLClear Technology

STERRAD™ SEALSURE™ Chemical Indicator Tape is a process indicator (ISO 11140-1:2014 [Type 1]) intended for use by health care providers to secure non-woven sterilization packs and wraps to be sterilized in the STERRAD™ Sterilization Systems:
· STERRAD™ 100S Sterilization System
· STERRAD NXTM Sterilization System
o STANDARD AND ADVANCED Cycles with and without ALLClear™ Technology

• · STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology o ULTRA GI™ Cycle with Integrated ALLClear™ Technology
  The color of the STERRAD SEALSURE Chemical Indicator Tape changes from red to gold (or lighter) indicated by comparator bar when exposed to hydrogen peroxide and is intended to differentiate between processed loads.

The STERRAD VELOCITY™ Biological Indicator (BI)/Process Challenge Device (PCD), in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring and/or periodic testing of the following STERRAD™ Systems:

• . STERRAD™ 100NX Sterilization System
  o STANDARD, FLEX, EXPRESS, and DUO Cycles with and without ALLClear™ Technology
  o ULTRA GI™ Cycle with Integrated ALLClear Technology (for frequent monitoring only).
• . STERRAD NX™ Sterilization System
  o (STANDARD AND ADVANCED Cycles) with and without ALLClear™ Technology
  · STERRAD™ 100S Sterilization System

The ULTRA GI™ Process Challenge Device (PCD) Vial is used with the STERRAD VELOCITY™ Biological Indicator (BI) for periodic testing and frequent monitoring of the ULTRA GI™ Cycle in the STERRAD™ 100NX Sterilization System with ALLClear™ Technology.

The STERRAD™ Chemical Indicator (Cl) Strip consists of chemically reactive ink, a clear overcoat ink, a yellow comparator bar, and black ink for copy printed on a strip of white styrene. This device is a through-put process indicator to be used with ASP's STERRAD™ Sterilization Systems. The STERRAD Sterilization System utilizes hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. When in the presence of hydrogen peroxide, the indicator will change from red to yellow as indicated by the comparator bar to indicate that the load has been exposed to hydrogen peroxide.

The STERRAD™ SEALSURE™ Chemical Indicator Tape is a through-put process indicator tape to be used with ASP's STERRAD™ Sterilization Systems that utilize hydrogen peroxide gas plasma to achieve rapid, low-temperature sterilization of medical devices. The Chemical Indicator Tape reacts with hydrogen peroxide as it is introduced into the sterilization chamber. The chemical reaction between the indicator ink and the hydrogen peroxide causes the dye of the indicator ink on the diagonal STERRAD logos and the chemical indicator square on the tape to change color, indicating that the load has been exposed to hydrogen peroxide.

The STERRAD VELOCITY Biological Indicator (BI) is a self-contained biological indicator, used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring and/or periodic testing in STERRAD Sterilization Systems.

The assembled ULTRA GI PCD is composed of a vial that encapsulates the STERRAD VELOCITY Biological Indicator (BI). The vial creates a stronger resistance to the ULTRA GI Cycle. At the end of the Bl is removed from the vial and used in conjunction with the STERRAD VELOCITY Reader (software version 1139260417 or newer) to verify the effectiveness of the ULTRA GI PCD Vial is only used for the ULTRA GI Cycle in STERRAD 100NX Sterilizers.

The provided document describes the acceptance criteria and the studies conducted for several sterilization process indicators and related devices (Chemical Indicator Strip, Chemical Indicator Tape, Biological Indicator, Biological Indicator Reader, and Process Challenge Device Vial). The studies aim to demonstrate the substantial equivalence of these devices to their legally marketed predicates, particularly with the inclusion of the new ULTRA GI Cycle.

Here's a breakdown of the requested information for each device where available:

1. STERRAD™ Chemical Indicator (CI) Strip (14100)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

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

• No. This is not applicable for chemical indicators.

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

• Yes, the studies described are standalone performance tests of the chemical indicator strip itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

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

• Not applicable.

2. STERRAD™ SEALSURE™ Chemical Indicator (CI) Tape (14202NL)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable for these types of physical/chemical indicators. Ground truth is based on physical/chemical properties and adherence to ISO standards.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective chemical reactions and physical changes.

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

• No. This is not applicable for chemical indicators.

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

• Yes, the studies described are standalone performance tests of the chemical indicator tape itself.

7. Type of ground truth used:

• Objective physical/chemical change (color change due to hydrogen peroxide exposure) and physical properties (adhesion strength) validated against ISO 11140-1:2014 Type 1 requirements.

8. Sample size for the training set:

• Not applicable. These are physical/chemical indicators, not AI/ML devices with training sets.

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

• Not applicable.

3. STERRAD VELOCITY™ Biological Indicator (BI) and STERRAD VELOCITY™ Reader (43210, 43210-30, 43220)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable. Ground truth for biological indicators is based on microbiological growth/no growth and fluorescence detection, which are objective measures.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

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

• No. This is not applicable for biological indicators and their readers.

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

• Yes, the studies described are for the standalone performance of the biological indicator and the reader. The reader's "algorithm" interprets the fluorescence, but it's not described as an AI/ML system requiring typical training/test sets.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus ATCC 7953) and fluorescence detection, which correlates to enzymatic activity of the organism.

8. Sample size for the training set:

• Not applicable. While the reader processes data, it's not described as an AI/ML system with a separate training set.

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

• Not applicable.

4. ULTRA GI™ Process Challenge Device (PCD) Vial (43400)

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated. The studies are referred to as "this study" without specific numbers of units tested.
• Data Provenance: Not explicitly stated. The document implies these are internal company studies conducted to support the 510(k) submission.

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

• Not applicable. Ground truth for PCDs is based on the resistance they provide to the sterilization process, measured using biological indicator growth/no growth and fluorescence detection.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective microbiological and fluorescence readings.

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

• No. This is not applicable for PCDs.

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

• Yes, the studies described are for the standalone performance of the PCD vial in conjunction with the biological indicator and reader.

7. Type of ground truth used:

• Microbiological growth (absence or presence of Geobacillus stearothermophilus) and fluorescence detection, demonstrating the designed resistance to the sterilization process.

8. Sample size for the training set:

• Not applicable.

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

• Not applicable.

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The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterlization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items.

The EO Chex indicator tape can be used in the following EO sterilization cycles:

1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure
2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure
3. 54℃, 600 mg/ L EO, 40-60% RH, 45 min or longer
4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure
5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure

The EO Chex "1" indicator tape is a single-use, beige color pressure-sensitive adhesive tape with pink stripes that can be used to secure packages for Ethylene Oxide Gas (EO) sterilization.

The pink stripes are process chemical indicators for monitoring of exposure to Ethylene Oxide sterilization. After sterilization exposure the pink stripes turn to orange-brown.

The EO Chex indicator tape is made in rolls ¾ inch and 1 inch wide and 55-60 yards long. Each roll has a core with 3-inch internal diameter that allows for use with any standard tape dispenser.

The indicator responds to the critical parameters of an EO sterilization cycle: exposure time, temperature, relative humidity, and concentration of Ethylene Oxide gas. During EO sterilization process indicator ink chemicals react forming an orange-brown compound. The degree of the reaction depends on the sterilization exposure. When the parameters achieve the required level, the indicator ink chemistry changes color from pink to orange-brown. If the parameters do not achieve the required level, the indicator color remains as any shade of pink.

This FDA 510(k) summary describes the acceptance criteria and the study proving the device (EO Chex™ Indicator Tape) meets these criteria. Since this is for a physical/chemical sterilization process indicator, the "study" is a series of non-clinical performance tests rather than a clinical trial with human subjects. Thus, many of the typical questions for AI medical devices (e.g., sample size for test set, number of experts, MRMC studies) are not applicable.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the EO Chex™ Indicator Tape is its conformance to the ANSI/AAMI/ISO 11140-1:2014 standard for Type 1 process indicators, along with successful performance in typical EO sterilization cycles, biocompatibility, endpoint stability, shelf-life, and adhesive tests.

Table of Acceptance Criteria and Reported Device Performance:

• 37°C, RH 60%, EO 600mg/L, 25 min: orange-brown
• 54°C, RH 60%, EO 600mg/L, 20 min: orange-brown
  Specific Fail Conditions (no color change or markedly different):
• 37°C, RH 60%, EO 600mg/L, 3 min
• 54°C, RH 60%, EO 600mg/L, 2 min
• 60°C, RH ≥85%, EO - none, 90 min | Passed |
  | Testing in EO cycles typical for healthcare use | To demonstrate that EO Chex indicator tape achieves specified end color in typical cycles. | Color change from pink to orange-brown (in specified cycles: 38°C, 736 mg/L EO, 40-80% RH, 4.5 hrs; 38°C, 759 mg/L EO, 40-80% RH, 4.5 hrs; 54°C, 600 mg/L EO, 40-60% RH, 45 min+; 55°C, 736 mg/L EO, 40-80% RH, 1 hr; 55°C, 759 mg/L EO, 40-80% RH, 1 hr). | Passed |
  | Biocompatibility study and ink transfer test | To demonstrate that the indicator does not create biocompatibility issues for healthcare professionals and patients; and to confirm no ink transfer. | Evaluation of individual components for biocompatibility and indicators with similar formulation with long history on the market.
  Ink Transfer Requirement (ISO 11140-1:2014, 6.2.2): No ink transfer should be observed on unprocessed and EO processed samples. | Passed |
  | End point stability and shelf-life study | To confirm acceptable stability of color after processing (passed/failed conditions) and to demonstrate performance parameters are met throughout the declared shelf-life using real-time exposure. | Endpoint Stability: EO Chex indicator tape processed in Pass and Fail cycles at various time points after production and at the end of shelf-life should demonstrate stable color for 180 days.
  Shelf-Life: Met specifications after 24 months of real-time shelf-life exposure. | Passed |
  | Adhesive test healthcare applications | To evaluate if the adhesive is suitable for its function and does not deteriorate during the sterilization process. | The test is considered a pass if at least 95% of the indicators at different stages of shelf life remain on surfaces of sterilization packaging materials before and after EO processing. | Passed |

Study Details (Non-Clinical Performance Testing):

This section addresses the specific points requested, noting their applicability to a physical/chemical indicator.

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

   • The document does not explicitly state the numerical sample size for each test (e.g., number of indicator strips tested). However, the testing was conducted according to specified industrial standards (ANSI/AAMI/ISO 11140-1:2014), which implicitly define the required sample sizes and methodologies for such performance evaluations.
   • Data Provenance: Not explicitly stated, but typical for 510(k) submissions, the testing would have been conducted by the manufacturer (Propper Manufacturing Co., Inc.) or a qualified testing lab, likely within the US, as the submitter is based in New York. The data is retrospective in the sense that it was collected prior to the 510(k) submission for the purpose of demonstrating substantial equivalence.

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

   • This question is not applicable in the context of this device. Ground truth for a chemical indicator is established by physical/chemical reactions under controlled conditions (e.g., color change based on precise exposure to sterilant). It does not involve expert human interpretation of complex data like medical images. The "ground truth" is defined by the physical/chemical properties and the specified color change according to the ISO standard.

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

   • This is not applicable as the evaluation relies on objective color change criteria and physical performance metrics rather than subjective human interpretation requiring adjudication.

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

   • This is not applicable as the device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers.

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

   • This is not applicable. The device is a physical indicator. Its "performance" is its ability to change color as designed, which is a standalone function in itself, but not an "algorithm."

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

   • The ground truth is established by objective physical and chemical criteria, specifically:
     • Defined color changes: Pink to orange-brown under specific EO sterilization conditions (Pass).
     • Absence of color change or markedly different color: Under defined challenging or insufficient sterilization conditions (Fail).
     • Adherence/physical integrity standards: For the adhesive and ink transfer.
     • Biocompatibility standards: Related to material safety.
   • These are based on the requirements of ANSI/AAMI/ISO 11140-1:2014 and the manufacturer's internal specifications derived from these standards.

7. The sample size for the training set:

   • This is not applicable. The device is a chemical indicator that operates based on material properties and chemical reactions. There is no "training set" in the machine learning sense. The development of the indicator chemistry and manufacturing process would involve internal R&D and optimization, but this is not analogous to training an AI model.

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

   • This is not applicable for the reasons stated above.

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BioHorizons Tapered Pro Conical dental implants are intended for use in the mandible or maxilla for use as an artificial root structure for single tooth replacement or for fixed bridgework and dental implants may be restored immediately (1) with a temporary prosthesis that is not in functional occlusion or (2) when splinted together for multiple tooth replacement or when stabilized with an overdenture supported by multiple implants.

BioHorizons Tapered Short Conical dental implants are intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. These dental implants must be restored using delayed loading, for single tooth replacement, or may be used with a terminal or intermediate abutment for fixed or removable bridgework or for overdentures. Tapered Short Conical implants should be used only when there is not enough space for a longer implant. If the ratio of crown length is unfavorable, the biomechanical risk factors have to be considered and appropriate measures have to be taken by the dental professional.

BioHorizons conical dental prosthetic components connected to the endosseous dental implants are intended for use as an aid in prosthetic rehabilitations of the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed abutments for use with Conical CAD/CAM Ti Blanks and Ti Bases are to be sent to a BioHorizons validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system, Tapered Pro Conical Implant System, from BioHorizons Implant Systems Inc. The Tapered Pro Conical Implant System includes a range of ental implants and prosthetic components, BioHorizons Tapered Pro Conical implants feature a tapered screw-shaped design with a reverse buttress thread. Cutting flutes are incorporated into the thread to be self-tapping when placed into the prepared surgical site. The outer surface of the implant has been roughened with resorbable blast texturing (RBT) using a hydroxyapatite blast media. Internally, the implant features a deep conical prosthetic connection between implants and abutments with six anti-rotation cams at the base of the connection, intended to interface with the three cams of the prosthetic components. It is available with or without Laser-Lok treatment applied to the collar of the implant.

Tapered Pro Conical Implants are available in a range of implant diameters and lengths with two prosthetic platform (implant/abutment connection) sizes, as shown below. Internal surfaces of the Tapered Pro Conical Regular platform implants are anodized yellow to distinguish them from Narrow platform implants.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations. The Conical Ti-Base abutments are a two-piece abutment composed of a pre-manufactured Ti Base component and a CAD/CAM patient-matched mesostructure (superstructure) composed of sagemax® NexxZr zirconia (K130991).

The provided text is a 510(k) premarket notification summary for a dental implant system. It does not describe a study to prove the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it contain information on the performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies typically associated with such devices.

The document focuses on demonstrating substantial equivalence to predicate dental implants and their components. The "PERFORMANCE DATA" section (page 7 of the PDF, starting on page 8 of the transcription) lists non-clinical data such as validation of sterilization, bacterial endotoxin testing, shelf-life testing, biocompatibility, MRI compatibility, and mechanical testing, which are standard for dental implants.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about acceptance criteria and a study proving the device meets those criteria, specifically for an AI/ML medical device.

To be explicit, the document states:

• "No clinical data were included in this submission." (Page 7)
• The performance data discussed are entirely non-clinical and relate to the physical and material properties of the dental implants, not an AI or software component assessing images or providing diagnostic assistance.

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The Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink/magenta) to orange, yellow or lighter. The Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

· Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible, and Specialty Cycles of the V-PRO: 1, 1 Plus, maX 2, 60, and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX Sterilizer with or without ALLClear

· Standard, Flex Scope, Express and DUO Cycles of the STERRAD® 100NX Sterilizer with or without ALLClear.

The CELERITY HP Indicator Tape (Indicator Tape) is a ¾' wide crepe paper tape printed with diagonal stripes of a vaporized hydrogen peroxide (VHP) reactive ink. The ink is sealed with a varnish, the function of which is to inhibit removal of the ink via transference or by the adhesive (as the tape is dispensed). The reactive ink meets the performance specifications for a Type 1 process indicator for vaporized hydrogen peroxide as defined in ANSI/AAMI/ISO 11140-1:2014.

The STERIS CELERITY HP Indicator Tape is a chemical indicator designed to distinguish between processed and unprocessed units in various low-temperature sterilization systems using vaporized hydrogen peroxide (VHP).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of indicator tapes per cycle, number of cycles tested). However, it mentions that "Performance testing was completed using well established methods such as those described in ISO 11140-1 and those used to verify the predicate design." This suggests that standard testing methodologies, which typically include specific sample size requirements, were followed.

The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a medical device to be marketed in the US, the studies were likely conducted to meet US regulatory requirements.

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

This information is not provided in the document. For chemical indicators like the CELERITY HP Indicator Tape, the "ground truth" for successful processing is typically defined by the objective color change criteria specified by the manufacturer and validated against known sterilization conditions (full cycle vs. partial cycle). The interpretation of the color change might be assessed by trained personnel rather than "experts" in the traditional sense, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided in the document. For a chemical indicator, the color change itself is a direct visual output. Adjudication, if any, would likely involve confirmation that the observed color change aligns with the expected outcome (e.g., full color change for a successful cycle, incomplete for a partial cycle). However, the specific method (e.g., consensus among multiple observers) is not detailed.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with diagnostic imaging devices or algorithms where human readers interpret complex data, and the AI's impact on their performance is measured. The CELERITY HP Indicator Tape is a passive chemical indicator with a direct visual output, making an MRMC study irrelevant to its evaluation.

6. Standalone Performance Study:

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. The performance testing (Simulated Use Testing, ISO 11140-1 Testing, Light Stability, Endpoint Stability, Shelf Life) described in the document evaluates the intrinsic behavior and response of the CELERITY HP Indicator Tape itself, independent of human interpretation or assistance beyond observing the color change. The device's performance is determined by its physical and chemical properties and its reaction to sterilization conditions.

7. Type of Ground Truth Used:

The ground truth used for the performance testing is based on:

• Known Sterilization Conditions: The indicators are exposed to "full cycle" and "partial cycle" conditions within specified sterilization systems. A full cycle represents effective sterilization, while a partial cycle represents an insufficient process.
• Adherence to Standards: The "Meets requirement of Type 1 VHP Indicator" for ISO 11140-1 Testing implies that the ground truth for this aspect is defined by the objective performance criteria outlined in the ISO 11140-1 standard for Class 1 chemical indicators. These standards specify how the indicator should react to critical process variables.
• Stability over Time: For light stability and endpoint stability, the ground truth is the expectation that the ink's performance and the endpoint color remain consistent for the labeled period under specified environmental conditions.

8. Sample Size for the Training Set:

This information is not applicable and is not provided in the document. The CELERITY HP Indicator Tape is a chemical indicator, not an AI/ML algorithm that requires a training set. Its design and behavior are based on chemical formulations and physical characteristics, not on learned patterns from a dataset.

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

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

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Terragene® Chemdye® Multivariable Chemical Indicator (CD40) is a multivariable chemical indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
  The chemical indicator changes from purple to green to indicate that the conditions of the cycle have been met.

Terragene® Chemical Process Indicator (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advanced cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.

Terragene® Cintape® Chemical Process Indicator Tape (CT40) is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® NX Sterilization System (Standard and Advance cycles).
• · Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced cycles).
• · Sterrad® 100NX Sterilization System (Standard, Flex, Express and Duo cycles).
• · Sterrad® 100NX with ALLCrear® Technology Sterilization System (Standard, Flex, Express and Duo cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer (Cycle 1).
  The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or the ground truth used for any of the Terragene products (Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)).

The document is an FDA 510(k) clearance letter, which confirms that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices for their stated indications. It outlines regulatory requirements and general information about FDA processes but does not detail the specific studies, testing methodologies, or results that demonstrate the devices meet performance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The DynaNail Mini Tapered Hybrid is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

The proposed DynaNail Mini Tapered Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.

The proposed DynaNail Mini Tapered Hybrid™ is available in identical diameters and lengths to the predicate device, and to accommodate variations in patient anatomy. The proposed device differs from the predicate device only in the threaded component major diameter, which is tapered. The DynaNail Mini Tapered Hybrid™ is implanted with the same driver/ deployment frame and fixation screws as the predicate. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation identical to the predicate.

This document is a 510(k) Summary for a medical device called the "DynaNail Mini Tapered Hybrid." It details the manufacturer's claim that this new device is substantially equivalent to a previously cleared predicate device.

Based on the provided document, there is NO study information available that proves the device meets acceptance criteria related to AI/software performance or human reader improvement.

The document discusses the substantial equivalence of a physical medical device (an orthopedic nail) to a predicate device. The acceptance criteria and "study" information provided refer to mechanical and material testing of the physical implant, not to the performance of a software or AI algorithm.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria, data provenance, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details because this document does not contain information about an AI/software device.

The "studies" conducted and described are non-clinical (mechanical) tests to demonstrate that the physical device performs equivalently to its predicate.

Here's what I can extract related to the physical device's "acceptance criteria" and "performance," as inferred from the mechanical testing, but please note this is not for an AI device:

Acceptance Criteria and Device Performance (for the physical medical device - Orthopedic Nail)

This section outlines the non-clinical (mechanical) testing performed to demonstrate the substantial equivalence of the DynaNail Mini Tapered Hybrid to its predicate device. The "acceptance criteria" are implicitly met if the proposed device's performance is "substantially equivalent" or "superior" to the predicate or relevant standards.

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

Regarding the other points of your request as they apply to an AI device (since this document is not about AI):

• 2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" consists of physical devices subjected to mechanical testing. No patient data or clinical imagery is involved.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is established by published test standards and engineering measurements, not by human experts.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No human readers or AI assistance involved.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical measurements obtained according to validated standard test methods (e.g., ASTM standards).
• 8. The sample size for the training set: Not applicable. This is not an AI/software device.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical orthopedic implant, demonstrating its substantial equivalence through mechanical and material testing, not through AI performance studies.

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