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The Castle ® SPOR-TEST PA Biological Indicator Kit is only intended to monitor the Steris System 1 liquid chemical sterilization system, with the Steris 20 sterilant. Use in monitoring other sterilization processes is contraindicated.

Castle SPOR-TEST PA Biological Indicators are qualified using Castle Culture Media. When tested at 1,000 ppm peracetic acid, 50°C, the Castle SPOR-TEST PA Biological Indicator will survive at 41 seconds and will be killed at 6 minutes.

The Castle® SPOR-TEST PA Biological Indicator Kit is exclusively intended to monitor the Steris® System 1 peracetic acid sterilization process, with Steris 20 sterilant. The product contains chromatography paper strips that are inoculated with Bacillus stearothermophilus (or G. stearothermophilus) spores at a nominal population of 105 per strip. Sterile tubes of Castle Culture Media (modified soybean casein broth) and a transfer clip are included. The materials of construction are equivalent to the Unispore® product. The product is intended to be used in an identical manner as the Steris® Process Biological Indicator Kit.

The provided document is a 510(k) summary for the Castle® SPOR-TEST PA Biological Indicator Kit. This type of document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device. As such, it does not contain details of a clinical study with human subjects, test sets, training sets, or expert evaluations in the typical sense of AI/ML device studies.

Instead, the "study" described herein refers to the performance testing of the biological indicator in a laboratory setting to demonstrate its efficacy in monitoring a sterilization process compared to a predicate device.

Here's the information extracted and interpreted based on the context of a biological indicator's regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for biological indicators are usually defined in terms of their D-value (decimal reduction time) and population count. However, this submission focuses on specific "survival" and "kill" times under defined conditions.

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

• Sample Size: Not explicitly stated as a number of individual biological indicators tested. For this type of device, testing would involve multiple runs under controlled conditions to ensure consistency and reliability. The submission focuses on the performance parameters (survival/kill times) rather than a statistical sample size in the clinical trial sense.
• Data Provenance: The testing would have been conducted in a laboratory environment by Getinge/Castle Inc. to demonstrate the device's performance characteristics. This is a prospective test for the device's performance against established criteria, not a retrospective analysis of patient data. There is no mention of country of origin for test data, but it would typically be from the manufacturer's R&D facilities.

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

• Not applicable in the context of this device. Biological indicator testing involves laboratory measurements and observation of microbial growth (or lack thereof), not expert interpretation of images or clinical data. The "ground truth" is established by the clear presence or absence of spore viability after exposure to the sterilant under controlled conditions.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" are relevant for subjective interpretations (e.g., radiology reads). For a biological indicator, the result is objective: either the spores grow (failure to sterilize) or they do not (successful sterilization).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is for evaluating human performance, often with and without AI assistance, in interpreting medical information. Biological indicators are objective tests, not subject to human interpretation in the same way.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, in spirit. The performance described is inherently "standalone" for the biological indicator. It functions mechanically and biologically without human "in-the-loop" interpretation beyond observing the color change in the culture medium. There is no algorithm, but the device's performance parameters (survival and kill times) are tested directly and objectively.

7. The Type of Ground Truth Used

• Microbial Viability/Inviability: The ground truth is the confirmed presence or absence of viable Bacillus stearothermophilus spores after exposure to the sterilant under specified conditions, as indicated by growth in the culture media (color change).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product whose performance is inherent to its design and manufacturing.

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

• Not applicable. No training set is involved for this type of device.

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The Model 733HC Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

The 733HC Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates a medium sized chamber and has the same control system and offers similar overall features as those on the 400HC/500HC Series Steam Sterilizers. These include: additional functionality, ease of use to the end user, large color display that will allow the user to choose from the entire list of available cycles, allows renaming and re-sequencing of sterilization cycles.

Here's a breakdown of the acceptance criteria and study information for the Model 733HC Vacuum/Gravity Steam Sterilizer based on the provided text:

Acceptance Criteria and Device Performance Table:

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It doesn't present "acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, the "acceptance criteria" for a steam sterilizer are its ability to effectively sterilize the specified loads under the given cycle parameters, as demonstrated by compliance with recognized standards. The "reported device performance" is essentially the listed cycle parameters and load configurations that the device claims to achieve.

Study Information:

This 510(k) summary does not describe a study that "proves the device meets acceptance criteria" in the way one might expect for a diagnostic or AI-driven device. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Castle® 400HC/500HC Series Steam Sterilizer [K012573]). For devices like sterilizers, substantial equivalence is typically shown through engineering testing, comparison of technical specifications, and compliance with recognized industry standards. No clinical data was required or submitted.

Therefore, most of the specific questions about sample sizes, experts, adjudication, MRMC studies, standalone performance, and training sets are not applicable to this type of submission.

Here's a breakdown of what is available based on the provided text:

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

   • Not applicable / Not explicitly stated. This summary doesn't detail specific testing data like a clinical trial. The device's performance is asserted to comply with AAMI, CSA, and GGS standards, which implies various engineering and microbiological tests would have been performed during design validation, but the details of these tests (sample sizes, specific data provenance) are not provided in this 510(k) summary. These would typically be found in the full 510(k) submission, not the summary.

2. 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. There is no "ground truth" established by experts in the context of a clinical test set in this submission. Compliance with sterilization standards (AAMI, CSA) serves as the "truth" or benchmark for non-clinical performance.

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

   • Not applicable. No test set or human adjudication process is described.

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

   • No. This is a steam sterilizer, not an AI or diagnostic device. MRMC studies are not relevant.

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

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

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

   • The "ground truth" for a sterilizer is confirmed sterility. This is achieved through adherence to validated cycle parameters derived from physical and biological indicator testing against industry standards (AAMI ST8, CSA-Z314.7, GGS-1340A, GGS-1343A). This is more akin to engineering validation and microbiological testing against defined performance specifications rather than a "clinical ground truth" established by expert review of patient data.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; there is no "training set."

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

   • Not applicable. As above, no training set.

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Castle® 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids to be used to tienties mappes contact) by means of pressurized steam.

The 400HC/500HC Series Steam Sterilizer is intended for use in hospital and health care facilities. The product incorporates an update to the control system that provides additional functionality and ease of use to the end user. It includes a larger color display that will allow the user to choose from the entire list of available cycles. Similar features to those on the Series 100HC include renaming and re-sequencing of sterilization cycles. The full lists of available cycles are provided in Table 1 for vacuum sterilizers (Models 433HC and 533HC) and Table 2 for gravity sterilizers (Models 422HC and 522HC).

Here's an analysis of the provided text regarding the Castle® 400HC/500HC Series Steam Sterilizer, focusing on acceptance criteria and the study proving its performance.

Please note: This document is a 510(k) summary for a medical device (steam sterilizer), not a study report for a human-AI effectiveness study. Therefore, many of the requested fields related to AI, human readers, and ground truth in a clinical context are not applicable. The information provided heavily focuses on the device's functional specifications and equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by its functional specifications, regulatory standards, and claimed equivalence to a predicate device. The performance is reported in terms of its ability to achieve sterilization under specific cycle parameters and load configurations.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data for AI systems. For a physical device like a sterilizer, testing would involve multiple runs under various conditions. The exact number of test runs or items processed during validation is not provided in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data. The validation of a sterilizer typically involves engineering and microbiological challenge tests performed in a laboratory or factory setting. The specific country of origin for these tests is not mentioned, but the submitting company is "Getinge/Castle Inc." located in Rochester, NY, USA. The testing would be considered prospective as it validates the device's performance against its specifications.

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

• Number of Experts: Not applicable. For a sterilizer, the "ground truth" for sterilization efficacy is typically established through standardized microbiological challenge tests (e.g., using biological indicators or thermocouples to verify physical parameters) rather than expert consensus on images or clinical outcomes.
• Qualifications of Experts: If experts (e.g., microbiologists, sterilization specialists) were involved in validating the test methodologies or interpreting results for sterilization, their qualifications are not provided in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used in clinical studies, often for image interpretation tasks, to resolve discrepancies between readers. For a sterilizer, validation relies on objective physical and biological measurements.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive tools, not for a physical device like a steam sterilizer.

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

• Standalone Performance: Not applicable. The "device" is a physical sterilizer, not an algorithm. Its performance is inherent to its design and function. While it has an updated control system and software, these are integral to the sterilizer's operation, not a separate standalone AI algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For a steam sterilizer, the ground truth for sterilization efficacy is established through:

  • Microbiological challenge tests: Using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) to demonstrate a sterility assurance level (SAL).
  • Physical parameter monitoring: Measuring and confirming that critical parameters (temperature, pressure, time, steam penetration) are met throughout the sterilization cycle using calibrated sensors (e.g., thermocouples).
  • Chemical indicators: Used as process indicators but not primary ground truth for sterility.
  • Industry Standards: Compliance with recognized national and international sterilization standards (e.g., AAMI, ISO).

  The document explicitly mentions adherence to AAMI standards (ST8, ST46, ST37) and CSA-Z314.7, GGS-1340A, and GGS-1343A Standards, implying these are the basis for validating "ground truth" performance.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This summary is for a physical steam sterilizer, not an AI or machine learning model that requires a training set of data. The device's "training" refers to its design, engineering, and manufacturing process.

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

• Ground Truth for Training Set: Not applicable. As mentioned, this is not an AI/ML device. For a physical device, its "ground truth" (i.e., its intended design specifications and performance parameters) is established through design controls, engineering principles, and adherence to relevant industry standards and regulatory requirements. These designs are then validated through testing.

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Castle® Series 100HC Steam Sterilizers are intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids (liquids not intended for direct patient contact) by means of pressurized steam.

The 100HC Steam Sterilizers represent a series of sterilizers intended for use in hospital and health care facilities. The product provides an update to the control system that provides additional functionality and ease of use to the end user that includes the added flexibility to adjust cycle parameters (as on previous sterilizer models), rename, and reassign (re-sequence) the designated sterilization cycles.

Here's an analysis of the provided text regarding the Castle® Series 100HC Steam Sterilizers, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the way one might expect for software or diagnostic devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device (steam sterilizer) are tied to its ability to meet established industry standards for sterilization and its substantial equivalence to a predicate device.

The reported device performance is described by its various sterilization cycles, which are designed to achieve specific sterilization parameters for different load configurations. The implicit acceptance criteria are that these cycles, when executed by the device, achieve the necessary conditions for sterility.

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

This document does not describe a "test set" in the context of data for an algorithm or diagnostic. The device in question is a steam sterilizer, a piece of hardware designed to perform a physical process.

• Sample Size: Not applicable in the context of data for an algorithm. The testing would involve physical load configurations and sterility assurance levels, typically standardized by regulatory bodies and industry rather than a statistical "test set" of data.
• Data Provenance: Not applicable. The document refers to compliance with standards (e.g., AAMI, CSA) which represent established scientific and industry best practices for sterilization, not data collected from a specific patient population or geographical region.
• Retrospective/Prospective: Not applicable. Testing for a sterilizer's efficacy is typically conducted through controlled laboratory and real-world simulations to ensure it meets performance standards.

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

This information is not applicable to this type of device submission. For a steam sterilizer, "ground truth" is established by scientific principles of microbiology and engineering, and validated through standardized testing protocols (e.g., using biological indicators, thermocouples) that demonstrate the destruction of microorganisms. The document refers to compliance with standards established by organizations like AAMI, which involve experts in sterilization, microbiology, and healthcare, but does not detail the specific experts or their qualifications for this particular submission's ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication process described for the performance of a steam sterilizer. The performance is assessed against physical and biological parameters defined by recognized 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 not an AI-assisted diagnostic or imaging device. It is a steam sterilizer.

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

Not applicable. This device does not involve an algorithm for diagnostic or interpretative purposes. The "algorithms" in this context refer to the programming of the sterilization cycles, which operate autonomously once initiated according to pre-validated parameters.

7. The Type of Ground Truth Used

The ground truth for the efficacy of the sterilizer is based on:

• Scientific Principles of Sterilization: The complete destruction of all viable microorganisms, typically confirmed through biological indicators (spores) and physical monitoring (temperature, pressure, time).
• Industry Standards: Compliance with established sterilization standards and guidelines such as AAMI ST8, ST37, ST46, CSA-Z314.7, and GGS-1340A. These standards define the parameters (temperature, pressure, time exposures for specific loads) required to achieve sterilization.
• Engineering Validation: Verification that the device can consistently deliver the specified physical conditions (temperature, pressure, vacuum) within the sterilization chamber.

8. The Sample Size for the Training Set

Not applicable. This device does not use an "AI" training set. Its operational parameters (cycles) are designed based on scientific principles and extensive validation testing of sterilization processes, not machine learning from a dataset.

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

Not applicable, as there is no training set in the AI sense. The "ground truth" for developing the sterilizer's parameters (temperature, time, pressure for various loads) would be established through a combination of:

• Microbiological Studies: Determining the D-value (decimal reduction time) of highly resistant microorganisms (e.g., Geobacillus stearothermophilus) at specific temperatures and humidities.
• Engineering and Thermal Mapping Studies: Extensive testing with thermocouples and biological indicators within simulated load configurations to ensure that every point within the load reaches and maintains the required sterilizing conditions for the specified duration.
• Compliance with Recognized Sterilization Standards: These standards (e.g., AAMI, ISO) provide scientifically validated guidelines for effective sterilization cycles.

In summary, this document describes a traditional medical device (a steam sterilizer) where performance is evaluated against established physical and biological standards for sterilization, rather than through empirical data analysis of an algorithm's output or human reader performance.

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The Castle 3000 Surgical Lamp is to be used to provide illumination appropriate for examination, trauma, and surgical procedures.

Getinge/Castle, Inc. 3000 Series surgical lamps are designed to provide the high quality lighting required in an operating room environment. The standard configuration shall be a two lamp head system. Two sizes of lamp head will be offered, a 24" diameter and a 32" diameter. There are four major considerations in the design of the surgical lamp systems: Infra-red and Ultra-violet filtration will exceed the specifications as set forth by IEC 601-2-41. Color Representation, as measured by Color Rendering Index and color temperature, will meet or exceed the specifications of IEC 601-2-41. Light delivery, upon failure of one bulb, will continue to be > 70% intensity . Electromagnetic and Bacteriological Neutrality - The product has been designed, and will be tested, to comply with the electromagnetic compatibility requirements of the European Medical Device Directive. The sealed optical unit, the flat smooth surfaces, and the touch-controls provide for an aseptic interface. The lamp head is designed to provide limited interruption of laminar air flow. The lighting systems are supported by specifically designed, steel and aluminum, load bearing drop tubes, yokes, and counterbalance arms. These assemblies are either covered with chemically resistant plastic, or coated with epoxy resin paint. The structures are mechanically connected at pivot points housing fiber optic connection joints. The lamp heads are able to be positioned in virtually any orientation, with no drift once positioned. The light source is an assembly comprised of eight metal halide light bulbs, a dichroic reflective surface to absorb ultra-violet and infra-red radiation, and fiber optic bundle connection points. Color correction is provided by Light Emitting Diode bundles which are mixed with the feed line. These bundles are controlled through an electronic sensor/comparator loop to provide constant, correct color temperature.

The provided text describes a 510(k) submission for a surgical lamp, focusing on its design considerations and regulatory approval. It does not contain information about a study proving the device meets acceptance criteria in the way described in the prompt (e.g., sample size, expert ground truth, MRMC studies, training sets, etc.). The document is a 510(k) summary and approval letter, which typically focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and design rather than clinical performance studies.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in the context of clinical studies).
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The document does list design considerations which can be interpreted as acceptance criteria for the device's technical specifications, and states that the design will meet or exceed these specifications, implying performance. However, it does not provide reported device performance results from a study, nor does it detail the methodology of how these performance claims were verified in a study format.

Here's what can be extracted and inferred from the text regarding technical specifications/design goals, which act as acceptance criteria:

Regarding the other points you requested:

1. Sample size used for the test set and data provenance: Not mentioned.
2. Number of experts used to establish the ground truth for the test set and qualifications: Not mentioned.
3. Adjudication method for the test set: Not mentioned.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: Not mentioned, and highly unlikely for a surgical lamp. MRMC studies are typically for diagnostic imaging devices.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a medical device (surgical lamp), not an algorithm.
6. The type of ground truth used: Not applicable in the context of clinical "ground truth." The stated "acceptance criteria" are technical specifications based on industry standards (IEC 601-2-41) and design goals.
7. The sample size for the training set: Not applicable, as this is a medical device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval notice for a medical device (surgical lamp) and details its design considerations. It does not include information about clinical studies with human readers, performance against "ground truth" derived from expert consensus or pathology, or machine learning model training. The "acceptance criteria" are technical specifications that the device's design is stated to meet or exceed, implying compliance through engineering and testing rather than a clinical performance study as typically seen with diagnostic AI.

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THE PRODUCT WILL BE USED TO ILLUMINATE SURGICAL PROCEDURES WITH COLOR CORRECTED WHITE LIGHT AND HEAT FILTERING (IR). DESIGNED TO ELIMINATE SHADOWS AND ILLUMINATE DEEP CAVITY WOUNDS WITH ADEQUATE PENETRATION. IT IS INTENDED TO BE USED BY SURGEONS AND OTHER MEDICAL CARE PRACTITIONERS IN A SURGICAL SETTING. THERE ARE NO CONTRA-INDICATIONS FOR USE.

The Getinge/Castle OptiView® surgical lights are designed to provide the high quality light required in an operating room setting. There are four major considerations that the lights have been designed for: 1. Shadow Elimination. 144 radial dioptric lenses, disposed equally on the lens glass, are used to broaden the light beam such that a 10 X 20 cm patch of light is produced on the surgical site from each lens. Should one or several of the lenses become obstructed by the surgeon or from equipment, a constant quantity of light is subtracted from each point of the light field. This virtually eliminates shadows and provides for optimum visibility. 2. Optimal Depth of Field. A central toric lens and conic mirror is used to produce very broad beams whose intersection are not points but are volumes. In some cases the volume can measure up to 70 cm in height and 20 cm across the center. The design also allows the volume of light to be moved in the axis of the beam, this is called variable focusing. 3. Heat Elimination and High Color Rendition. Through the use of a special type of glass, the emitted light is corrected for color (towards the model for broadband sunlight) and filtered for infrared. This eliminates the thermal effect of the beam and allows a color rendition index of Ra = 95 or greater. 4. Electromagnetic and Bacteriologic Neutrality. The product have been designed and tested to comply with the strictest electromagnetic compatibility standards. Also, the sealed optical unit, the flat, smooth surfaces and sensitive touch-controls provide for an extremely aseptic environment. The mechanical aspects of the lights are that they are constructed of specifically designed steel load-bearing drop tubes, yokes and suspension assemblies that are coated with a strong epoxy resin paint. These structures are mechanically connected at pivot points that incorporate counter-balances for ease of movement as well as specially designed wire-runs and fully pivoting electrical connectors. The electrical aspects of the lights are designed to comply with international safety standards such as: Low Voltage Directive (LVD) 72/23/CEE, Decree No. 95-1081 Electromagnetic Compatibility Directive (EMC) 89/336/CEE, Decree No. 95-587 Medical Device Directive (MDD) 93/42/CEE. Power Supply Units, NF EN 60-4391 (IEC 433-1), NF EN 60-439-Operating Theatre Lighting, NF EN 60-601-1 (IEC 601). The design will also be examined to UL 544 and certified by either Underwriters Laboratory or Intertek Testing Services (ITS) which should result in the UL or ETL mark. The lights were previously CE marked, while marketed in Europe, by the original manufacturer: Scialityque Industrie. The lights are electrically controlled via pressure sensitive touch controls that may be located on the lights or at remote locations. The controls allow the lights to be energized, the light level to be adjusted and the focus mechanisms to be operated. The light beam is achieved through the use of one or two (dependent upon model) tungsten-halogen 24 VDC bulbs that are contained in a sealed optical unit. The emitted light is focused through a toroidial lens and is reflected off of a conic, polished aluminum reflector and through 144 radial dioptric lenses which allows for a radial-focused broad-beam light pattern on the surgical surface. This eliminates shadows while concurrently extending the true depth of field of the beam.

The provided document is a 510(k) premarket notification for the Getinge/Castle OptiView® Surgical Light. It details the device's description, intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not include a formal study with acceptance criteria and reported device performance in the way a clinical trial or performance validation study would typically present it for an AI/ML device.

Instead, the "acceptance criteria" can be inferred from the comparison tables which demonstrate that the OptiView® surgical lights meet or exceed the specifications of the predicate devices for key performance characteristics. The "study" proving this is implicitly the comparison itself, showing that the new device's specifications are within acceptable ranges relative to already-marketed and cleared devices.

Here's an analysis based on the provided text, addressing the requested points:

Acceptance Criteria and Device Performance for Getinge/Castle OptiView® Surgical Light

The "acceptance criteria" for this device are implicitly defined by its substantial equivalence to predicate devices, particularly in key performance specifications relevant to surgical lighting. The study proving conformance is a direct comparison of these specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-AI surgical light, formal acceptance criteria as typically seen for AI/ML devices (e.g., sensitivity, specificity thresholds) are not explicitly stated. Instead, the acceptance criteria are satisfied by demonstrating that the OptiView® series lights perform comparably or better than the predicate devices across relevant technical specifications.

The tables below present selected specifications for the OptiView® 500 series and 700 series alongside their predicate devices. The "Acceptance Criteria" column represents the range or value observed in the predicate devices within which the new device should fall to demonstrate substantial equivalence. The "Reported Device Performance" column shows how the OptiView® series lights meet these implicit criteria.

OptiView® 500 series vs. Predicate Devices (ALM PRC 7001 series, Berchtold C-570 series)

Note on Field Size and Depth of Field for OptiView® 500 series: While the reported values are sometimes outside the predicate range, the narrative emphasizes benefits like "optimal depth of field" (up to 70cm in some cases) and variable focusing, suggesting these differences are part of an equivalent or improved design aimed at specific functional benefits such as shadow elimination and deep cavity penetration.

OptiView® 700 series vs. Predicate Devices (ALM PRC 9001 series, AMSCO SQ240)

Note for OptiView® 700 series: similar to the 500 series, specific values like bulb life (500 min hrs vs 1000 hrs for predicates) might differ, but the overall functional equivalence and safety are argued through the 510(k) process, emphasizing design features like "true depth of field of the beam."

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

This is not a study involving a "test set" in the context of AI/ML. The "test" consists of comparing the specifications of the new device to existing predicate devices. The data provenance is from the technical specifications provided by Getinge/Castle and the manufacturers of the predicate devices. The data is based on engineering specifications and likely internal testing, not patient data.

• Sample Size for Test Set: Not applicable in the context of an AI/ML device test set. The "test" is a comparison of product specifications.
• Data Provenance: Technical specifications of manufactured surgical lights (OptiView series and predicate devices). Implicitly, this data is from the respective manufacturers, likely based on engineering designs and performance testing. The country of origin for Getinge/Castle is the USA (North Charleston, SC). For predicate devices, ALM, AMSCO, and Berchtold are mentioned, which are international manufacturers. The data is retrospective in the sense that it reflects established specifications of existing devices.

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

Not applicable. "Ground truth" in this context is established by the documented technical specifications of the surgical lights themselves, which are derived from engineering and manufacturing standards, not expert medical opinion on a dataset.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" as this is not a diagnostic device with ambiguous outputs requiring clinical interpretation.

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

No. This is a medical device (surgical light), not a diagnostic algorithm, and therefore an MRMC study is not relevant or performed in this submission.

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

This is a physical surgical lighting device, not an AI algorithm. "Standalone" performance testing would refer to the device's technical specifications and functionality (e.g., light intensity, color temperature, heat dissipation) as reported in the tables, independent of human interaction during those measurements. The information provided demonstrates this by listing the device's inherent performance characteristics.

7. The type of ground truth used

The "ground truth" implicitly used for comparison is the published performance specifications of legally marketed predicate surgical lights, which represent accepted performance benchmarks for such devices in a clinical setting.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a "training set."

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

Not applicable.

Summary of the "Study" (510(k) Premarket Notification):

The "study" in this submission is the comprehensive comparison of the Getinge/Castle OptiView® Surgical Light (including its 200, 500, and 700 series) with predicate devices (ALM Prismatic models, AMSCO SQ240, Berchtold Chromophare models). This comparison is based on detailed technical specifications across numerous parameters, including:

• Physical dimensions (diameter, weight)
• Electrical specifications (supply voltage, power, bulb type, volts, life)
• Optical performance (color temperature, field size, depth, focal length, illumination level)
• Control features (dimmer, focus, field size, rotation)
• Material composition (heat filtering, filter material, reflector material)
• Mounting types and ceiling height requirements

The premise of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, and either has the same technological characteristics as the predicate, or has different technological characteristics but does not raise new questions of safety and effectiveness and is as safe and effective as the predicate device.

The provided tables and descriptive text fulfill this requirement by showing that the OptiView® series lights meet or exceed the performance metrics of the predicate devices for critical elements like illumination, color rendition, heat filtering, and shadow elimination, indicating that they are at least as safe and effective. The narrative explicitly states: "We are not introducing new technology. The OptiView® lights and the predicate devices use very similar technology to achieve the same basic goal..." and "We are not introducing any new indications for use." These statements, backed by the comparative data, serve as the "proof" that the device meets the implicit acceptance criteria of substantial equivalence.

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Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam stenlization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C)

Model 233: The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F (121°C to 135°C).

Model 223: The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C).

All Models: Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterlity assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.

The Castle Series 200 Sterilizers (Powerclave) is a control system upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 200 (Powerclave) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc for use in health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, hard goods, and linens. The difference between the predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with a more modern microprocessor, software, and an interactive operator interface. The piping remains relatively unchanged, with the addition of a chamber drain float switch to signal possible water-in-chamber conditions and a thermostatic drain discharge temperature control. A minor change on each chamber vessel size has changed the interior chamber width from 24 inches to 26 inches; the length on the mid-sized vessel has changed from 49 inches to 50 inches.

Here's a breakdown of the acceptance criteria and the study information for the Castle Series 200 Steam Sterilizers (Powerclave) based on the provided text, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the sterilizer's performance are the established sterilization cycles and their effectiveness in achieving a specified sterility assurance level (SAL). The reported device performance is that these cycles were validated to meet a SAL of at least $10^{-6}$.

*Exposure times listed are actual times of the cycles to be cleared and are not half times.

Beyond sterilization efficacy, the device also meets the following requirements:

• Safety Standards: UL544 and CSA C22.2 Nº 151 product safety standards for medical devices.
• Pressure Vessel Code: Section VIII of the ASME pressure vessel code.

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

• Sample Size for Test Set: The document mentions "Evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped)". However, it does not specify the exact number or sample size of these loads used for the validation testing.
• Data Provenance: The studies were conducted internally by Getinge/Castle, Inc. and are retrospective in nature (testing of the developed device). The country of origin of the data is implicitly the USA, where Getinge/Castle, Inc. is located.

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

• The document does not mention the use of experts to establish the ground truth for the sterilization testing. Sterilization efficacy is typically validated through microbiological challenge tests and physical measurements, rather than expert consensus on images or diagnoses.

4. Adjudication Method for the Test Set:

• Given that the validation relied on established industrial standards and the measurement of sterility assurance levels through "half cycle analysis," no human adjudication method (like 2+1, 3+1) was used or is relevant for this type of device testing.

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 relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance. This document pertains to a steam sterilizer, which is a therapeutic/device processing tool, not a diagnostic one.

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

• This question is not applicable to a steam sterilizer. The "device" in question is the sterilizer itself, which operates autonomously to sterilize items based on pre-programmed cycles. Its performance is inherent to the machine, not an algorithm that assists human interpretation.

7. The Type of Ground Truth Used:

• The ground truth for the sterilization efficacy was established through microbiological challenge tests resulting in a sterility assurance level (SAL) of at least $10^{-6}$. This is inferred from the statement "Validation testing was performed using accepted half cycle analysis and results consistent with a sterility assurance level of at least $10^{-6}$ were obtained." This type of ground truth is based on a quantifiable reduction of microbial life, a standard method for sterilizer validation.

8. The Sample Size for the Training Set:

• This question is not applicable to this device. A steam sterilizer does not involve a "training set" in the context of machine learning or AI algorithms. The sterilizer operates based on engineered physics, control systems, and pre-defined parameters, not learned data sets.

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

• This question is not applicable for the same reasons as #8. There is no training set or corresponding ground truth in the context of this traditional medical device. The "ground truth" for its operation is the established science of sterilization (heat, pressure, time) and the engineering principles applied in its design.

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The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls an intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16" x 16" x 26" chamber having a volume 3.9 cubic feet and a 20" x 20" x 38" chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows:

For the Model 122

• P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
• P2 GRAV WRAP 2 Gravity Cycle 10 minute exposure at 275°F and 30 minute dry
• P3 FLASH 3+ Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry
• P4 FLASH 10+ Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry

For the Model 123

• P 1 GRAV WRAP 1 Gravity Cycle 30 minute exposure at 250°F and 30 minute dry
• P4 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and o minutes dry

For the Model 133

• P1 PREVA WRAP Prevacuum Cycle 3 minute exposure at 275°F and 16 minute dry
• P2 PREVA WRP1 Prevacuum Cycle 3 minute exposure at 275°F and 3 minute dry
• P3 FLASH 3+ Gravity Cycle 3 minute exposure at 275°F and 0 minute dry
• P4 FLASH 10+ Gravity Cycle 10 minute exposure at 275°F and 0 minute dry
• P5 VAC LEAK TST Air leak Test 3 minute exposure at 268°F and 15 min. leak test

The Castle Series 100 Sterilizers (Straightline) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, PACS 2000 controls applied to the Series 100 (Straightline) Steam Sterilizer are to be used with "Castle" brand sterilizers manufactured by Getinge/Castle, Inc. for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact)

The difference between predicate sterilizer controls and the PACS 2000 controls is that the PACS 2000 controls are provided with more modern microprocessor/software, and interactive operator interface. The chamber vessel and piping remain unchanged.

This is a submission for a steam sterilizer, which is a physical device, not an AI/ML powered device. Therefore, many of the requested categories are not applicable.

Here's the information about acceptance criteria and study as requested, with explanations of why some categories are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Castle Series 100 Steam Sterilizers are primarily derived from established industry standards for steam sterilization. The reported performance is the established sterilization cycles.

• Wrapped Linen Packs: 30 min @ 250°F, 30 min dry
• Wrapped Hard Goods: 10 min @ 275°F, 30 min dry
• Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry
• Unwrapped Porous Instruments (Flash): 10 min @ 275°F, 0 min dry

Model 123 (Gravity):

• Wrapped Linen Packs and Hard Goods: 30 min @ 250°F, 30 min dry
• Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry

Model 133 (Prevacuum):

• Wrapped Hard Goods: 3 min @ 275°F, 16 min dry
• Linen Packs & Single Wrapped Hard Goods: 3 min @ 275°F, 3 min dry
• Unwrapped Nonporous Instruments (Flash): 3 min @ 275°F, 0 min dry
• Unwrapped Porous Instruments (Flash): 10 min @ 275°F, 0 min dry
• Air Leak Test: 3 min @ 268°F, 15 min leak test |
  | AAMI ST37-1996: Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use | Cycles as described above for "Flash" sterilization (e.g., 3 min @ 275°F for unwrapped nonporous instruments). |
  | CAN/CSA-Z314.7-M91: Effective Sterilization in Hospitals by the Steam Process (ref. AAMI ST8-1988) | Cycles as described above, demonstrating effective steam sterilization. |
  | GGS-1340A: Federal Specification Sterilizer, Surgical Instrument and Supply Gravity Air Removal, Non-Portable (Heat and Moisture Stable) | Cycles as described above, demonstrating compliance with federal specifications for sterilizers. |
  | Sterility Assurance Level (SAL) of at least 10⁻⁶ | Achieved through "half cycle analysis" validation testing. |
  | UL544 and CSA C22.2 No. 151: Product safety standards for medical devices | The product has been designed to meet these safety requirements. (Compliance is stated, specific performance metrics are not detailed in this summary for these standards.) |
  | ASME pressure vessel code, Section VIII | The vessel is designed, constructed, and certified to this code. (Compliance is stated, specific performance metrics are not detailed in this summary.) |

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

The study involved "evaluation studies consisting of fabric and instrument loads (wrapped and unwrapped)". No specific numerical sample size (e.g., number of test runs, number of biological indicators) is provided in this summary.

Data Provenance: The studies were performed by Getinge/Castle, Inc. as part of the device validation. The location is not specified beyond the company's US address. This is a prospective study as it involves specific validation testing of the device.

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

Not applicable. For a steam sterilizer, the "ground truth" for sterilization effectiveness is established through standardized microbiological testing (e.g., biological indicators, half-cycle analysis) that demonstrates a sterility assurance level (SAL). This does not typically involve human experts establishing a "ground truth" in the same way as, for example, image interpretation. The standards themselves are developed by experts in the field of sterilization.

The report mentions "accepted half cycle analysis," which refers to a standard method of validating sterilization cycles using biological indicators.

4. Adjudication method for the test set

Not applicable. The validation of a steam sterilizer's performance involves objective microbiological testing and physical parameter measurement, not subjective interpretation requiring adjudication among experts.

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 device is a steam sterilizer, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device does not involve an algorithm providing standalone interpretations. The device itself performs the sterilization process.

7. The type of ground truth used

The type of ground truth used is microbiological sterility (demonstrated by a Sterility Assurance Level (SAL) of at least 10⁻⁶), as determined by "half cycle analysis" and adherence to the performance requirements of the cited industry standards (e.g., ANSI/AAMI ST-8, AAMI ST37). This typically involves:

• Biological Indicators (BIs): Spore strips or suspensions containing a known number of highly resistant bacterial spores, which are processed through the sterilizer and then cultured to confirm their inactivation.
• Physical Monitoring: Temperature, pressure, and time readouts from the sterilizer to ensure parameters meet the cycle specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no "training set." The development of the device's control system and cycles would be based on engineering principles and knowledge of sterilization science.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's design and development would be based on the scientific principles of microbial inactivation and the requirements outlined in the relevant sterilization standards.

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