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Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized for Immediate Use and/or Pre Vacuum Sterilization. Pre Vacuum sterilized devices may be stored in protective storage (temperature, humidity, air filtration etc. controlled hospital storage room conditions) for up to 6 months provided integrity of container is not compromised. Bahadir Pre Vacuum sterilization containers may be stacked during storage, one on top of one another, the heavier container being on the bottom. Pre Vacuum sterilization containers may be stacked up to 18 inches during the sterilization process with no more than THREE containers as part of the 18" maximum configuration. Containers are marked as to their height to facilitate this process.

• 3 containers MAXIMUM can be stacked.
• Stacked containers may not exceed a maximum of 18 inches

Immediate Use only intended for non-stacked configurations during the sterilization process. Immediate Use sterilized devices cannot be stored.

The devices included in this submission are to be used with a pre-vacuum, three pulse of 4 minutes at 270 degrees F with a dry time of 20 minutes or Immediate Use sterilization.

The devices (natural aluminum color containers with colored lids as follows: green, yellow/golden orange, red, deep black and natural aluminum) subject to this submission are as follows:

The devices are composed of anodized aluminum alloy with lid colors as follows: green, yellow/ qolden orange, red, black and natural aluminum.

The provided document describes the acceptance criteria and the studies performed for the Bahadir Sterilization Containers. Here's a breakdown of the requested information:

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

The document doesn't explicitly list "acceptance criteria" in a formal table with corresponding performance metrics in a way that typically applies to AI/software performance (e.g., sensitivity, specificity, AUC). Instead, it describes various validation tests for the physical sterilization containers. The "acceptance criterion" for each test is implicitly that the "Test Passed."

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

The document is a 510(k) summary for a physical medical device (sterilization containers), not an AI/software device. Therefore, the concepts of "test set sample size" and "data provenance" (like country of origin of data, retrospective/prospective) as they apply to clinical studies for AI are not directly relevant or reported. The "samples" in this context refer to the physical containers themselves and the items sterilized within them. The specific number of containers tested for each validation is not provided in this summary but is implied to be sufficient for a "Test Passed" conclusion. The provenance of the testing (where the tests were conducted) is not explicitly stated, but it would typically be in a certified testing laboratory.

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

This information is not applicable to this document. The "ground truth" for a sterilization container is assessed through validated physical and microbiological testing methods, not through expert consensus or interpretation in the way it would be for an AI diagnostic device.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of medical data (e.g., radiology images) is being compared or refined.

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

This information is not applicable. MRMC studies are relevant for AI/software devices that assist human readers (e.g., radiologists, pathologists). This document concerns a physical sterilization container.

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

This information is not applicable. A standalone algorithm performance study applies to AI/software, not physical sterilization containers.

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

The "ground truth" for the performance of the sterilization containers is established through physical and microbiological validation testing. This includes:

• Sterility testing: Ensuring no microbial growth after sterilization and storage.
• Aging studies: Demonstrating maintained integrity over time.
• Microbial barrier integrity studies: Confirming the container prevents microbial ingress.
• Air impermeability testing: Verifying the container's seals and filters function correctly.
• Stacking validation: Confirming structural integrity and sterilization effectiveness when stacked.

8. The sample size for the training set

This information is not applicable. The device is a physical product and does not involve AI or machine learning models that require a "training set."

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

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

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Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices (natural aluminum color containers and lids) subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

(Full Size Max Load Wt. 24.75 Ibs including basket & instruments) Lumen Size min 1mm diameter X 300mm length

% Size Y211.10W % Size Y211.13W % Size Y211.15W

(% Max Load Wt. 12.5 Ibs

including basket & instruments)

Lumen Size min 1mm diameter

½ Size Y311.26W

(½ Size Max Load Wt. 9.25 Ibs including basket & instruments) Lumen size min 1mm diameter X 200mm length

½ Size Y311.10W

½ Size Y311.13W

½ Size Y311.15W

1/2 Size Y311.20W

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices subject to this submission are as follows:

Full Size Y111.10W Full Size Y111.13W Full Size Y111.15W Full Size Y111.20W Full Size Y111.26W Full Size Y110.62W Full Size Y110.68W Full Size Y111.62W Full Size Y111.68W

% Size Y211.10W % Size Y211.13W % Size Y211.15W ½ Size Y311.10W ½ Size Y311.13W ½ Size Y311.15W ½ Size Y311.20W ½ Size Y311.26W

The devices are composed of anodized aluminum (this does not include colored anodized lids).

The provided document K112090 is a 510(k) Pre-market Notification for Sterilization Trays. It primarily discusses the substantial equivalence of the new Bahadir USA Sterilization Trays (including wide body versions) to their previously cleared predicate device (K102146).

This document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. Instead, it outlines the device's intended use, materials, sterilization method, and dimensions, focusing on comparing these aspects to a predicate device to establish substantial equivalence for medical hardware.

Therefore, I cannot provide the requested information in a table or structured format as the submission does not pertain to AI/ML device performance or clinical studies of that nature.

Here's why the requested information cannot be extracted from this document:

• Type of Device: The device described is a "STERILIZATION TRAY," which is a physical container used for sterilizing medical instruments. It is explicitly classified as "Sterilization Wraps, Trays, Containers Class 2 - KCT." This is a medical device hardware, not an AI/ML software device.
• Purpose of the Submission: The 510(k) submission's goal is to demonstrate "substantial equivalence" of the new sterilization trays to a previously cleared sterilization tray (predicate device K102146). This involves comparing features like materials, dimensions, intended use, and sterilization compatibility.
• Nature of the "Non-Clinical Tests Performed": The document states "The subject devices were subjected to sterility testing and performance testing." However, no details on acceptance criteria, specific test results (e.g., in a table), sample sizes, ground truth, expert involvement, or any form of multi-reader/multi-case (MRMC) study are provided within this summary for these tests. The statement is very high-level and does not offer the granular detail required for your request. It's safe to assume these "sterility and performance tests" would pertain to the effectiveness of the tray in allowing sterilization and maintaining sterility, not to an algorithm's diagnostic or predictive performance.

In summary, this 510(k) document is for a traditional medical device (sterilization trays) and does not describe acceptance criteria or a study related to an AI/ML device's performance, human reader improvement with AI, or standalone algorithm performance.

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Intended for use in hospitals and healthcare facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices using steam sterilizers. Sterilized devices may be stored and transferred in the container.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes.

The devices (natural aluminum color containers and lids) subject to this submission are as follows:

Full Size 1/1 Y110.20 Full Size 1/1 Y110.15 Full Size 1/1 Y110.13 Full Size 1/1 Y110.10 3/4 Size Y210.10 34 Size Y210.15 3/4 Size Y210.13 1/2 Size Y310.20 1/2 Size Y310.15 1/2 Size Y310.13 1/2 Size Y310.10

The maximum load weight is 24.75 lbs for full size, 12.5 lbs for 34 size, and 9.25 Ibs for 1/2 size. The sterilization validation included three types of loads, empty, full load of textiles, and full load of surgical instruments.

The subject trays are not validated for use with lumened devices, air driven instruments, power systems, or cannulized instruments.

The devices included in this submission are to be used with a pre-vacuum cycle of 4 minutes at 270 degrees F with a dry time of 20 minutes. Stacking during sterilization is not recommended.

The devices subject to this submission are as follows:

Full Size 1/1 Y110.20 (580 x 280 x 200mm) Full Size 1/1 Y110.15 (580 x 280 x 150mm) Full Size 1/1 Y110.13 (580 x 280 x 135mm) Full Size 1/1 Y110.10 (580 x 280 x 100mm) 3/4 Size Y210.15 (465 x 280 x 150mm) 3/4 Size Y210.13 (465 x 280 x 135mm) 3/4 Size Y210.10 (465 x 280 x 100mm) 1/2 Size Y310.20 (285 x 280 x 200mm) 1/2 Size Y310.15 (285 x 280 x 150mm) 1/2 Size Y310.13 (285 x 280 x 135mm) 1/2 Size Y310.10 (285 x 280 x 100mm)

The maximum load weight is 24.75 lbs for full size, 12.5 lbs for ¾ size, and 9.25 lbs for 1/2 size.

The devices are composed of anodized aluminum (this does not include colored anodized lids).

Here's a breakdown of the acceptance criteria and study information for the Bahadir USA STERILIZATION TRAYS, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details non-clinical tests performed rather than specific quantitative acceptance criteria or their corresponding performance results in a structured format. However, based on the types of tests performed and the ultimate goal of substantial equivalence for sterilization trays, we can infer the implied acceptance criteria.

• Pass steam sterilization (pre-vacuum cycle: 4 min at 270°F, 20 min dry time).
• Effective sterilization of various loads (empty, full textile, full surgical instruments).
• Prevention of microbial migration during storage. | The devices were subjected to "sterility testing" and "half cycle" tests.
  Validation included three types of loads: empty, full load of textiles, and full load of surgical instruments.
  The trays "Permits entry of sterilization agent and prevents microbial migration during storage." |
  | Cleaning Effectiveness:
• Device can be effectively cleaned. | The devices were subjected to "cleaning validation." |
  | Material Durability/Aging:
• Device maintains integrity and function over time/usage. | The devices were subjected to "aging studies." |
  | Product Performance/Integrity:
• Device physically holds contents.
• Maintains seal integrity.
• Withstands sterilization cycle conditions. | The devices were subjected to "performance testing."
  Features like "Sealed: Yes" and "Gasket: Silicone Based" indicate an expectation of seal integrity. |
  | Biocompatibility/Safety (Implied):
• Materials are safe for medical device contact. | The main material is anodized aluminum (with stainless steel handles, silicone seal, paper filter). Substantial equivalence to predicate devices (also aluminum alloy with similar components) implies material safety. |

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

• Sample Size: Not explicitly stated. The document mentions "The devices were subjected to cleaning validation, aging studies, half cycle, sterility testing and performance testing." It refers to "the devices included in this submission" as a set of specific models (11 different sizes). It does not specify how many units of each model, or total units, were tested for each type of study.
• Data Provenance: Not explicitly stated. It's unclear if the testing was done by the manufacturer, an independent lab, or in a specific country. Given the manufacturer's address in New York, USA, it is likely the testing was conducted in the USA or supervised from there. The study appears to be prospective in nature, as it describes tests performed on the physical devices to support the 510(k) submission.

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

Not applicable. This device is a physical sterilization tray, and the "ground truth" for its performance is established through objective physical, biological, and chemical tests (e.g., sterility indicators, microbial challenge tests, physical integrity checks, material degradation analysis). There were no human experts establishing a "ground truth" through interpretation or consensus, unlike in studies involving diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" for this type of device is based on objective scientific testing, not expert consensus or adjudication. Test results would be interpreted against predefined pass/fail criteria.

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. This type of study is typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases, and the AI's impact on their performance is evaluated. Sterilization trays do not involve human interpretation in this manner.

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

Yes, in essence, the studies performed (cleaning validation, aging studies, half cycle, sterility testing, performance testing) represent a "standalone" evaluation of the device's physical and functional properties, without human interaction as an integral part of its direct performance (beyond setup and monitoring). The device itself, independent of human interpretive input during use, was tested for its intended function.

7. The Type of Ground Truth Used

The ground truth used for these studies would be based on:

• Biological Indicators/Chemical Indicators: For sterility testing, the absence of viable microorganisms after sterilization, often confirmed by biological indicator sterility (e.g., spore strips showing no growth) and chemical indicator changes.
• Physical Measurements/Observation: For cleaning validation (absence of residual soil), aging studies (material integrity, absence of cracks/corrosion), and performance testing (device remaining intact, seals functional, filters allowing air passage while trapping microbes).
• Adherence to Standards: Compliance with relevant industry standards (e.g., AAMI ST77, as mentioned).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense.

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

Not applicable. As there is no AI algorithm or training set, this question is not relevant.

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