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510(k) Data Aggregation
(77 days)
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System).
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.
Here's a breakdown of the acceptance criteria and study information for the Tecomet Global Unite Short Stem Instrumentation, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Type of Testing | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Pre-vacuum sterilization efficacy | 10⁻⁶ SAL (Sterility Assurance Level) | PASSED |
| Pre-vacuum dry time (3 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Pre-vacuum dry time (4 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Design Validation | Acceptable performance for reverse and anatomic shoulder preparation | PASSED |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the sterilization efficacy, dry time, or design validation testing. Specifically:
- Sterilization and Dry Time: No sample size is mentioned for these tests.
- Design Validation: "N/A design validation cadaver testing" is mentioned, implying cadavers were used, but the quantity is not specified.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests.
4. Adjudication Method
- The document does not specify any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is surgical instrumentation, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- This question is not applicable. The device is surgical instrumentation, not an algorithm or software.
7. Type of Ground Truth Used
- Sterilization Efficacy: The ground truth is the demonstration of a 10⁻⁶ SAL, which is a microbiological standard.
- Pre-vacuum Dry Time: The ground truth is the established minimum dry time achieved necessary for effective sterilization.
- Design Validation: The ground truth is "acceptable performance" during cadaver testing, likely assessed by surgeons or qualified personnel evaluating the functionality and usability of the instruments in a simulated surgical environment.
8. Sample Size for the Training Set
- This question is not applicable as the device is surgical instrumentation and does not involve a training set as would be found in machine learning models.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this type of device.
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(269 days)
FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
FlashPak® Model/Maximum Instrument Load Weight Recommendation:
9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg)
9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg)
9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg)
9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)
The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.
Here's a breakdown of the acceptance criteria and study information for the FlashPak® Sterilization Container System, based on the provided document:
This document is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "study" described is a validation of additional sterilization parameters rather than a comparative effectiveness study in the typical sense of AI/human reader performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for this submission are based on the successful demonstration of sterilization efficacy for the newly added sterilization cycles. The existing acceptance criteria for the device's physical and chemical properties, material compatibility, and microbial barrier properties are implicitly met because the device itself is physically identical to the previously cleared predicate.
| Acceptance Criteria (for added sterilization cycles) | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Gravity-displacement Cycle - 3 min): | No microbial growth observed in three half-cycle runs. Achieved SAL of 10⁻⁶. |
| Sterilization Efficacy (Dynamic-air-removal Cycle - 3 min): | No microbial growth observed in three half-cycle runs. Achieved SAL of 10⁻⁶. |
| Sterilant Penetration: | Three thermal mapping studies for each of the two sterilization modes demonstrating a precise match (within seconds) between the chamber and container temperature profiles. |
| Microbial Barrier (Packaging Integrity): | The current container design and its performance were deemed acceptable, as it's the same as the predicate device which passed a microbial aerosol challenge test. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set: Biological indicators (BIs) with Geobacillus Stearothermophilus were used for efficacy testing. The document states "Half cycles were run three times for each sterilization mode, gravity displacement and dynamic-air removal." This means a total of 6 half-cycle runs were performed (3 for gravity-displacement, 3 for dynamic-air-removal). The number of BIs per run is not explicitly stated, but they were placed "throughout the container among the devices and four devices were directly inoculated."
- Data Provenance: The study was conducted by Symmetry Surgical, Inc. (the manufacturer) for their device. The provenance is internal, prospective testing conducted to validate the new sterilization parameters. No country of origin is specified for the data itself, but the company is located in Antioch, TN, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable in the context of this device and study. The "ground truth" for sterilization efficacy is the sterility assurance level (SAL) achieved, which is a microbiological outcome determined through standardized laboratory testing, not expert consensus.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Sterilization efficacy is an objective outcome based on microbial growth, not a subjective interpretation requiring adjudication. Positive and negative controls were concurrently processed and passed, indicating proper test execution.
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. This device is a sterilization container, not a diagnostic imaging device or an AI-powered tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth: Microbiological outcome data, specifically the absence of microbial growth on biological indicators after sterilization and incubation, demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶. Thermal mapping data provided evidence of sterilant penetration.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is a physical device; there is no "training set" in the context of machine learning. The device was developed and validated through engineering design, material science, and microbiological testing, not machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment for Training Set: Not applicable. As there is no training set, there is no corresponding ground truth to establish in that context.
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(63 days)
The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French
Symmetry Surgical Single Use Cuffed Catheter Removal devices are sold as sterile, single use devices, unless otherwise noted. The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a tool for minimizing surgical trauma associated with catheter removal. The device jaws are normally in the closed position. The device is equipped with a trigger, a button located on the handle, actuated feature that opens the jaws. Upon release of the trigger, the jaws return to the normally closed position with a spring assist mechanism. The Single Use Cuffed Catheter Removal Device has no locking mechanism. During use the jaws are opened outside the patient and allowed to close around the catheter. The catheter then serves as a guide for moving the closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.
The provided text describes a 510(k) submission for the Symmetry Surgical Single Use Cuffed Catheter Removal Device. This submission primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and performance testing. Crucially, clinical data was not required for this device, and therefore, the information typically associated with studies proving device performance against acceptance criteria for AI/ML devices is not present.
The document outlines an animal study and biocompatibility testing as the basis for substantial equivalence, but it does not detail specific acceptance criteria or performance metrics in a way that aligns with the request for AI/ML device evaluations.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it pertains to a physical medical device that did not require clinical trials for its 510(k) clearance due to its classification and the nature of its equivalence claim.
However, I can extract the available information that relates to performance assessment, even if it doesn't fit the typical "acceptance criteria" and "device performance" format for AI/ML.
1. Table of Acceptance Criteria and Reported Device Performance
As clinical data was not required and this is not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the performance assessment focused on demonstrating safety and functional equivalence through non-clinical testing.
| Acceptance Criteria (Proxy) | Reported Device Performance (Proxy) |
|---|---|
| Biocompatibility with recognized standards (ISO 10993, CFR Title 21 Part 58, etc.) | Device passed biocompatibility testing as per listed standards (implied by "biocompatibility testing includes performance assessment"). |
| Functional equivalence to predicate device | Design does not alter the fundamental technology or intended use of the predicate. Device shown to be substantially equivalent in terms of function, operating principles, surgical application, indications for use, material, classification, device description, performance, and sterility. |
| Minimizing surgical trauma | Device described as a "tool for minimizing surgical trauma associated with catheter removal." |
| Jaws operation within design limits | Jaws open and close as designed, constrained by tissue tunnel, with a maximum angle of 57° (design limit, implied acceptance criteria). |
| Compatibility with specified catheter sizes | Indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French (design specification, implied acceptance criteria). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified for any specific performance test in the document. The document mentions "animal study and biocompatibility testing," but doesn't provide the number of animals or samples used.
- Data Provenance: The studies were non-clinical (animal study and biocompatibility testing). No country of origin for data is stated, but the submission is to the US FDA. The studies were likely prospective experimental tests, not retrospective analyses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth as typically understood for AI/ML models (e.g., expert consensus on image interpretation, pathology reports) was not established for this device. Performance was assessed through engineering and biocompatibility testing, not human expert evaluations of diagnostic output.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication process is described as clinical data or human interpretive tasks were not required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical surgical instrument, not an AI/ML diagnostic aid. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device would be based on physical and biological standards and measurements as opposed to clinical outcomes or expert labels. This includes:
- Physical measurements against design specifications (e.g., jaw opening angle, compatibility with catheter sizes).
- Biocompatibility test results against established safety thresholds (e.g., cytotoxicity, sensitization, irritation as per ISO 10993).
- Animal physiological responses during the animal study, likely assessing tissue response, ease of removal, or absence of adverse events, compared to a control or predicate device (though specific outcomes are not detailed).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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(230 days)
FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).
The FlashPak Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging method for surgical instruments requiring flash steam sterilization. Each FlashPak system is comprised of an upper lid that seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.
This is not an AI-enabled device. This is a medical device, specifically a sterilization container system, for which the submitted information confirms its substantial equivalence to a predicate device.
Therefore, questions regarding AI-specific elements such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established are not applicable.
Here's the relevant information based on the provided text for the FlashPak® Sterilization Container System:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are established by demonstrating that it functions as intended and is substantially equivalent to a legally marketed predicate device (K871202) by meeting applicable standards, specifically ANSI/AAMI ST77:2006 "Containment Devices for Reusable Medical Device Sterilization".
The "performance" section of the 510(k) summary (page 2) outlines the key performance aspects that were evaluated.
| Acceptance Criteria (Performance Aspect) | Reported Device Performance (New Device) | Discussion (Comparison to Predicate) |
|---|---|---|
| Sterilant Penetration (Sterilization Efficacy) | Gravity-displacement Cycle: 10 minutes at 132°C (270°F) for porous and cannulated devices. Dynamic-air-removal Cycle: 4 minutes at 132°C (270°F) for porous and cannulated devices. Thermal mapping studies demonstrating container temperature closely matches sterilizer chamber. | Equivalent (to predicate's 10 min gravity, 5 min dynamic-air-removal cycles, and thermal mapping performance). The new device has a shorter dynamic-air-removal cycle. |
| Microbial Barrier Properties (Packaging Integrity) | The container completely encapsulates the items sterilized inside and prevents recontamination during transport to the point of use immediately after sterilization. | Same as predicate |
| Material Compatibility | Materials used are compatible with the recommended sterilization method and cleansers. | Same as predicate |
| Toxicological Properties (Biocompatibility) | Cytotoxicity per ISO 10993-5. Irritation per ISO 10993-10. | Equivalent (to predicate which used medical grade polymers or stainless steel, with no patient contact). |
| Drying Time | Intended for flash sterilization and immediate use, implying no specific drying time acceptance criterion for a separate dry storage period. | Same as predicate |
Study Information
The study demonstrating the device meets the acceptance criteria is a series of performance tests and validations adhering to the ANSI/AAMI ST77:2006 standard.
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Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., number of containers tested, number of sterilization cycles). It states that "Testing to applicable standard, ANSVAAMI ST77:2006... has been completed with acceptable outcomes."
- Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing conducted by Symmetry Medical Inc. (the device manufacturer). This would typically be prospective testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is defined by passing specific physical, chemical, and biological performance tests according to established standards. This is not a diagnostic device requiring expert interpretation of results.
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Adjudication method for the test set: Not applicable. Test results are objectively measured against predefined criteria in the standard.
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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-enabled device and does not involve human readers interpreting data.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
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The type of ground truth used:
- Performance against established standards: The ground truth is determined by objective measurements and biological indicators (e.g., sterility assurance level for sterilization validation, absence of cytotoxicity/irritation for biocompatibility, physical integrity for handle strength/valve life) as defined in ANSI/AAMI ST77:2006 and ISO 10993 standards.
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The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and manufacturing process for the physical device are based on engineering principles and material science.
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How the ground truth for the training set was established: Not applicable. No training set is used for a physical medical device like this.
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(263 days)
PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap.
PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use.
The Delivery Systems are designed using plastic and metal materials that can be reused with steam or Ethylene Oxide sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
Here's an analysis of the provided text regarding the PolyVac Surgical Instrument Delivery System's acceptance criteria and the supporting study:
The provided text describes a 510(k) premarket notification for the "PolyVac Surgical Instrument Delivery System" seeking to add Ethylene Oxide (EO) sterilization as an approved method.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a performance study aimed at demonstrating equivalence and efficacy for the new sterilization method. The implicit acceptance criterion is that the device successfully achieves sterilization in the specified Ethylene Oxide process.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Ethylene Oxide Sterilization Efficacy: Achieve a six-log reduction in microbial load (sterility assurance). | Ethylene Oxide Qualification: "The system was successfully sterilized in a 60 minute ETO half cycle. The sterilization tests demonstrate a six log reduction capability of all spores strips and inoculated devices." |
| Ethylene Oxide Residual Evaluation: Residual concentrations of EO, ECH, and EGly must be within acceptable limits after aeration. | Ethylene Oxide Residual Evaluation: "Radel-R materials were exposed to full Ethylene Oxide Cycles and aerated for 11 hr. and 35 min. Residual concentrations of EO, ECH, and EGly, were all within acceptable limits." (Note: The document does not specify what these acceptable limits are, only that they were met). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the number of PolyVac Delivery Systems (or individual materials/components) used for the Ethylene Oxide Qualification and Residual Evaluation tests. It refers to "test articles" and "Radel-R materials."
- Data Provenance: The data is likely prospective, generated specifically for this 510(k) submission to demonstrate the new sterilization method. The country of origin of the data is not specified, but given the company's location (Warsaw, Indiana) and submission to the FDA, it's presumed to be from the USA or a recognized testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not involve experts establishing ground truth in the way a diagnostic AI study would (e.g., radiologists reviewing images). Instead, the "ground truth" is established by validated biological and chemical indicators.
- Ethylene Oxide Qualification: The "ground truth" for sterilization efficacy is the sterility of the devices, determined by the absence of growth from spore strips and biological indicator organisms after processing. This is an objective, laboratory-based assessment, not reliant on expert review.
- Ethylene Oxide Residual Evaluation: The "ground truth" for chemical residuals is determined by analytical chemistry techniques, measured against predefined acceptable limits.
Therefore, the concept of "number of experts" and "qualifications of those experts" for ground truth establishment does not apply in this context.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are relevant for studies where multiple human readers interpret data, and discrepancies need to be resolved for ground truth. This is not applicable here as the "ground truth" is determined by objective laboratory assays (biological indicator tests, chemical analyses).
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 used for diagnostic devices involving human interpretation (e.g., comparing human performance with and without AI assistance). The PolyVac system is a surgical instrument delivery system, and its performance is evaluated through material compatibility and sterilization efficacy, not diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The PolyVac system is a physical medical device, not a software algorithm. Its performance is inherent in its physical and material properties and its interaction with the sterilization process, not through an algorithm.
7. The Type of Ground Truth Used
- Ethylene Oxide Qualification: The ground truth is biological indicator sterility (absence of microbial growth) corroborated by chemical indicators. This is an objective, laboratory-based measurement of sterilization efficacy.
- Ethylene Oxide Residual Evaluation: The ground truth is objective chemical concentration measurements (EO, ECH, EGly) compared against predefined safety limits.
8. The Sample Size for the Training Set
The concept of a "training set" is applicable to machine learning algorithms. The PolyVac system is a physical device, not an AI, so there is no training set. Its performance relies on its physical design and materials, which are validated through specific testing.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this physical device, this question is not applicable.
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(393 days)
PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum; Gravity Steam: 132°C - 30 minutes minimum; Gravity Steam: 121°C - 55 minutes minimum
PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.
The PolyVac Surgical Instrument Delivery System is intended to protect medical device instrumentation and facilitate the sterilization process. The acceptance criteria and the study proving the device meets these criteria are detailed below. It's important to note that this document outlines safety and biocompatibility tests and sterilization efficacy, rather than performance in the sense of accuracy, sensitivity, or specificity, as seen in diagnostic AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Acute Systemic Toxicity (USP) | No significantly greater systemic reaction than blank extractant. | Extracts of the test article injected into mice did not produce a significantly greater systemic reaction than the blank extractant. |
| Intracutaneous Toxicity (USP) | No significantly greater tissue reaction than blank extractant. | Extracts of the test article injected intracutaneously into rabbits did not produce a significantly greater tissue reaction than the blank extractant. | |
| Implantation Test (USP) | Macroscopic reaction not significant compared to USP negative control plastic. | The macroscopic reaction of the test article implanted for 7 days was not significant as compared to the USP negative control plastic. | |
| Sterilization Efficacy | Prevacuum Steam Sterilization (132°C, 4 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. |
| Gravity Air Displacement Steam Sterilization (132°C, 30 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. | |
| Gravity Air Displacement Steam Sterilization (121°C, 55 min) | Six-log reduction of spores; excellent steam penetration. | Successfully sterilized with a six-log reduction of all spore strips and inoculated devices. Thermocouple data indicated excellent steam penetration within wrapped packages. |
2. Sample Size Used for the Test Set and Data Provenance
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Biocompatibility Tests: The exact number of mice and rabbits used for the Acute Systemic Toxicity and Intracutaneous Toxicity tests, respectively, is not specified. For the Implantation Test, the number of implanted test articles is not specified. The provenance of the data is not explicitly stated (e.g., country of origin, specific lab), but these are standard USP (United States Pharmacopeia) tests, implying a controlled laboratory setting. The tests were likely conducted prospectively.
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Sterilization Qualification: The document refers to "test articles" that were inoculated with a biological indicator organism. The exact number of test articles (PolyVac Delivery Systems) used for each sterilization cycle is not specified. This testing would have been conducted prospectively in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device and testing does not typically involve "experts" in the sense of clinical specialists like radiologists establishing ground truth. The "ground truth" for these tests is based on objective, quantifiable biological and physical measurements:
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Biocompatibility: The assessment of systemic and tissue reactions, and macroscopic reactions, would be performed by trained laboratory personnel (e.g., toxicologists, histopathologists) following USP protocols. The document does not specify the number or qualifications of these individuals but implies adherence to established scientific standards.
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Sterilization Qualification: The "ground truth" for sterilization efficacy is the demonstrable six-log reduction of biological indicator spores and successful steam penetration, as measured by thermocouples. This is determined empirically by laboratory technicians following validated sterilization protocols. The "experts" in this context are those who design, execute, and interpret the microbiology and engineering aspects of sterilization studies, whose qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessments by multiple human readers (e.g., in medical image analysis). For the objective tests described here:
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Biocompatibility: The results (e.g., presence/absence of significant reaction) are based on direct observation and measurement by trained laboratory personnel, often against a control. Any ambiguous findings would typically be resolved by internal laboratory procedures or re-testing, rather than an "adjudication" process in the diagnostic sense.
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Sterilization Qualification: The outcomes (six-log reduction, steam penetration) are determined by quantitative laboratory methods. The results are binary (pass/fail) based on predefined criteria. No expert adjudication method is relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to compare the performance of different diagnostic methods or to assess the impact of AI assistance on human reader performance. The PolyVac Surgical Instrument Delivery System is a medical device for sterilization and protection of instruments, not a diagnostic tool or AI system that involves human interpretation. Therefore, this type of study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable. The PolyVac Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used
The ground truth used for these studies is empirical and objective:
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Biocompatibility: The ground truth is based on biological response (e.g., observed systemic reactions in mice, tissue reactions in rabbits, macroscopic reactions in implant sites) against established USP standards and control samples.
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Sterilization Qualification: The ground truth is based on microbiological sterility (demonstrated by a six-log reduction of biological indicator spores) and physical parameters (successful steam penetration confirmed by thermocouple data) according to validated sterilization cycle parameters.
8. The Sample Size for the Training Set
No training set is applicable. This device is not an AI algorithm or a diagnostic model that requires a training set. The tests conducted are empirical performance validations of a physical product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device.
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