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Miltex Sterilization Cassettes (Miltex®, Thompson™) are general dental/surgical instrument cassettes indicated to hold instruments and accessories in place during storage and the sterilization cycle. Suitable for Gravity Steam and Pre-Vacuum Steam, the cassettes are intended to be used in conjunction with sterilization wrap in order to maintain sterility.

Miltex® Thompson™ Cassettes are sterilization cassettes made of surgical-grade passivated stainless steel to provide protection, storage and organization for all types of instruments. Miltex® Thompson™ Cassettes may be used in dental, surgical or veterinary procedures. Cassettes are available in a variety of configurations and are designed to fit standard autoclaves.

The provided text describes Miltex® Thompson™ Cassettes, which are sterilization cassettes used for dental/surgical instruments. The document focuses on their indications for use, contraindications, warnings, precautions, instructions for use (cleaning and sterilization), and validated sterilization parameters. It also includes information about the product's 510(k) clearance (K101653) with the FDA.

Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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 states: "Miltex® Thompson™ cassettes have been tested with no adverse effects under the following sterilization parameters." and "Miltex® Thompson™ cassettes have been validated to withstand up to 50 sterilization cycles with no evidence of deterioration."

• Sample Size: The document does not explicitly state the numerical sample size (number of cassettes or tests) used for the sterilization and durability testing. It indicates that testing and validation were performed, but not the specific quantity of units involved.
• Data Provenance: The document does not specify the country of origin where the testing was conducted. Given the manufacturer's address (York, PA, USA) and FDA 510(k) clearance, it is highly likely the testing was conducted in the US or by a facility adhering to US regulatory standards. The data would be considered prospective as it involves controlled testing to validate device performance.

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 type of information is generally not applicable to a medical device like a sterilization cassette, which undergoes performance testing (e.g., sterilization efficacy, material durability, functional design). The "ground truth" for such a device is established through scientific and engineering standards and validated laboratory testing, not expert consensus on interpretations of images or clinical outcomes. Therefore, no experts in the sense of medical specialists interpreting data are explicitly mentioned as establishing a "ground truth" here. The validation would be performed by qualified engineers, microbiologists, and technicians.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of ambiguous data requires consensus. For the performance testing of a sterilization cassette, the "adjudication" is based on objective measurements and established pass/fail criteria according to validated protocols and standards (e.g., microbial kill, material integrity, functional checks). There is no mention of an adjudication method involving multiple human readers for consensus.

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

An MRMC comparative effectiveness study is not applicable as this device is a physical instrument for sterilization, not an AI-powered diagnostic tool requiring human interpretation improvement.

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

This refers to AI algorithm performance and is not applicable to a physical sterilization cassette.

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

The ground truth for this device is established by:

• Sterilization Efficacy: Meeting established sterility assurance levels (SAL) for steam sterilization, likely demonstrated through biological indicator studies (e.g., killing of specified microorganisms like Geobacillus stearothermophilus) and physical parameters (temperature, pressure, time). This would fall under microbiological testing/standards compliance.
• Durability: Physical integrity and functionality of the cassette after a specified number of sterilization cycles, assessed through visual inspection and functional testing, falling under engineering and material performance standards.
• Functional Design: The ability to hold instruments, fit standard autoclaves, and be used with sterilization wrap, as per the device description and indications.

8. The sample size for the training set

The concept of a "training set" is relevant for machine learning algorithms. This device is a physical medical device, not an algorithm. Therefore, there is no training set in the AI sense. The design and manufacturing process would involve extensive engineering, material testing, and quality control, but this is distinct from "training data."

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

As there is no training set for an AI algorithm, this question is not applicable. The "ground truth" for the device's design and manufacturing is derived from engineering specifications, industry standards for medical device materials, sterilization guidelines (e.g., AAMI, ISO), and regulatory requirements for instrument sterilization.

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Miltex® Membrane Tack Kit is intended to fixate or stabilize guided tissue regeneration membranes to bone at the surgical site.

The Miltex® Membrane Tack Kit consists of non-sterile, single use titanium alloy tacks available in 3 mm or 5 mm lengths. Membrane Tacks are used in conjunction with the following accessories and reusable stainless steel instruments for implantation: Tack Membrane Probe, Tack Applicator, Perforation Raspatory, Kirsch Sinus 7 Double-ended Spoon and Plugger, Sinus Elevator, Mixing Cup with Plastic Lid, Tack Storage Box for 15 Tacks and Tack Wash Tray with Lid.

The provided text is a 510(k) Summary for the Miltex® Membrane Tack Kit. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the basis for 510(k) clearance. This process relies on demonstrating that the new device has the same intended use, fundamental technology, design, and material as legally marketed predicate devices, rather than on specific performance metrics or clinical studies with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text only establishes the device's identity, intended use, and substantial equivalence to existing devices.

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Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.

This document is a 510(k) summary for the Miltex® Dental Aspirating Syringes, which is a traditional medical device (not an AI/ML powered device). Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies or standalone algorithm performance) is not applicable or available in this submission.

The 510(k) summary establishes substantial equivalence to predicate devices based on:

• Intended Use: "Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity." This is the same as the predicate devices.
• Fundamental Technology, Design, and Materials: The document states the Miltex® syringes are substantially equivalent to the legally marketed predicate devices in these aspects. The devices consist of chrome-plated brass and stainless steel (and aluminum for one specific model), are reusable and sterilizable, and are packaged non-sterile, consistent with standard dental aspirating syringes.

The FDA's review confirms substantial equivalence, allowing the device to be marketed, subject to general controls and applicable additional controls for Class II devices.

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The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using gravity steam sterilizers. The recommended gravity steam sterilization cycle parameters are 45 minutes exposure at 121 deg C and a 20 minute dry time. 2 metal lumens 3-mm in diameter and up to 200-mm in length were validated. The container is intended for use with non-porous materials such as stainless steel surgical instruments.

For effective sterilization and drying, the weight of the single container, basket and basket contents should not exceed the following: 16 lbs for the one-half size container, 20 Ibs for the three-quarter size container, and 25 Ibs for the full size container.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility for a maximum of 60 days as long as the integrity of the container has not been compromised.

Containers should not be stacked when used within gravity steam sterilizers.

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

• Container bottoms (perforated versions) .
• . Container baskets,
• . Container lids (perforated only)

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., number of sterilization cycles, number of containers tested for sterility maintenance). It only states that tests were performed for various parameters.
• Data Provenance: The document implies that the data was generated by the manufacturer, Miltex, Incorporated, as part of their 510(k) submission. The country of origin for the data is not explicitly stated but is implicitly the United States given the submission to the FDA. The study is prospective as it involves the testing and validation of the Miltex device.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for the performance testing of the device (e.g., for interpreting sterilization efficacy, sterility maintenance, or thermal profiles). Performance criteria are likely based on established industry standards (AAMI) and direct laboratory measurements rather than expert consensus on individual "cases."

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method as it does not involve subjective interpretations of "cases" by multiple reviewers. The performance testing appears to involve objective measurements and adherence to predefined protocols and standards.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of data (e.g., medical images), not for sterilization containers whose performance is assessed through objective physical and microbiological testing.

6. Standalone Performance Study:

• Yes, a standalone performance study was done. The "Performance Data" section directly reports the performance of the Miltex System for various properties and validation tests (Gravity Steam Efficacy Testing, Thermal Profile Study, Sterility Maintenance, Load, Test Organisms/Inoculated Product). This evaluation is based on the algorithm/device's own performance against established criteria and the predicate device.

7. Type of Ground Truth Used:

• The ground truth used for the performance evaluation is based on objective experimental results and adherence to recognized industry standards. This includes:
  • Microbiological testing: Efficacy of sterilization based on inactivation of test organisms (e.g., in inoculated lumens and stainless steel medical devices).
  • Physical measurements: Thermal profiles to confirm sterilant penetration, weight load capacity tests.
  • Time-based validation: Sterility maintenance over a specified duration (30 days in real-time with handling events).
  • Conformance to standards: Meeting the requirements of AAMI ST 77 Draft.

8. Sample Size for the Training Set:

• The concept of a "training set" is relevant to machine learning or AI algorithms. As this device is a physical rigid sterilization container system, there is no training set in the context of AI or machine learning. Performance is verified through physical and microbiological validation testing.

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

• Since there is no "training set" as defined in machine learning contexts, this question is not applicable. The "ground truth" for the device's performance was established through rigorous, standardized laboratory and engineering tests designed to directly measure its efficacy and adherence to performance specifications.

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The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. Metal lumens 3-mm in diameter and length up to 200-mm in length were validated. The container intended for use with non-porous materials such as stainless steel surgical instruments.

Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.

Containers should not be stacked when used within cthylene oxide sterilizers

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

• Container bottoms (both perforated and non-perforated versions)
• Container baskets,
• Container lids (perforated only), and .
• u Container color-coding "labels."

The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using ethylene oxide gas sterilizers. The container is intended for use with non-porous materials such as stainless steel surgical instruments. Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the medical devices within it until used.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

| Acceptance Criteria / Performance Standard | Miltex System Reported Performance | Predicate Device Performance
(for comparison but not direct acceptance) |
| :----------------------------------------- | :-------------------------------------------------------------------------- | :------------------------------------------------------------------------------------------- |
| Conformance to appropriate AAMI standards | Yes, conforms to AAMI ST 77 Draft- Containment Devices for Reusable Medical Device Sterilization | Yes, conforms to AAMI ST 33- Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for ETO Sterilization and Steam Sterilization in Health Care Facilities |
| Ethylene Oxide Sterile Efficacy Testing | Yes | Yes |
| Aeration Time and EO Residuals | 8-hours/ below maximum acceptable levels | 12-hours/ below maximum acceptable levels |
| Sterility Maintenance (Duration) | 30-day real time w/ weekly handling events | 90-day real time w/ weekly handling events. 30-day real time w/ daily handling events. |
| Load Capacity (Small container) | Up to 16-lbs. | Up to 22-lbs. |
| Load Capacity (Medium container) | Up to 20-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Load Capacity (Large container) | Up to 25-lbs. | (Implied: up to 22-lbs for all sizes if not specified otherwise) |
| Inoculated Lumens (Dimensions) | Yes--3-mm I.D. x 200-mm, metal | Yes-- 2.2-mm I.D. x 457-mm, metal |
| Inoculated Stainless Steel Medical Devices Location | Yes (hinge area of medical pliers and knurled instruments) | Yes (blades) |

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "Validation Testing" which usually implies a pre-defined sample size for each test. However, the exact number of containers or tests performed is not detailed.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, as it involves "Validation Testing" and "real-time" sterility maintenance, implying active testing of the Miltex system.

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

• This information is not provided in the document. The studies described are performance tests of the device itself (e.g., sterile efficacy, sterility maintenance, load capacity), not studies requiring human expert assessment or ground truth establishment in the way it would be for, say, an AI-powered diagnostic device. The "ground truth" for these tests would typically be established by validated laboratory methods for sterilization effectiveness and sterility.

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

• This information is not applicable to the type of studies described. Adjudication methods are typically used in studies involving human interpretation or subjective assessment (e.g., medical image reading) where multiple experts might disagree. The performance tests for a sterilization container are objective and measured against pre-defined physical and biological parameters.

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 is not applicable. An MRMC study is relevant for evaluating diagnostic or interpretive AI systems where human readers interact with the AI. The Miltex Rigid Sterilization Container System is a physical medical device, not an AI or software-as-a-medical-device (SaMD).

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

• This is not applicable. As stated above, this is a physical medical device, not an algorithm. The "standalone" performance refers to the device's ability to sterilize and maintain sterility based on its design and materials, which is what the validation testing evaluates.

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

• The ground truth for the performance tests would be established through laboratory testing and microbiological methods. For example:
  • Ethylene Oxide Sterile Efficacy Testing: Ground truth would be the complete kill (sterilization) of specified resistant microorganisms (e.g., Bacillus atrophaeus spores) inoculated onto test articles within the container, followed by incubation and verification of no growth.
  • Aeration Time and EO Residuals: Ground truth would be the measurement of residual EO levels below acceptable safety thresholds using standardized analytical chemistry techniques.
  • Sterility Maintenance: Ground truth would be the absence of microbial ingress after specified handling events and storage times, verified by microbiological culture methods.
  • Load Capacity: Ground truth would be the ability of the container to hold the specified weight without structural failure or compromise to its function.

8. The sample size for the training set:

• This is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The development of the device would involve engineering design, prototyping, and iterative testing, but not a data-driven training process in the AI sense.

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

• This is not applicable for the same reason as point 8.

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The Miltex Ligating Clip is an extra-vascular, implanted device intended to occlude by compression blood flow within small, non-intracranial vessels. The clip is available in several sizes and the practitioner chooses the size of clip to fit the procedure, insuring that the tissue to be occluded fits completely within the clip.

The Miltex Ligating Clip is constructed exclusively of CP Grade 1 titanium wire having a heart-shaped cross-section. The clip is chevron-shaped. The inside (tissue-engaging) surfaccs of the clip legs have a longitudinal groove intersected by a number of angled transverse grooves. The longitudinal grooves do not extend fully to the distal ends of the legs, but leave distal flat surfaces at the ends of the legs. When the clip is closed, tissue will fill in the grooves, providing secure retention on the vessel. This feature also improves the occluding functions of the clip. The distal flat ends of the legs provide surfaces that will contact each other initially as the clip is closed. The contact of the distal flat surfaces will cause the legs to straighten in alignment with cach other, thereby minimizing the possibility of scissoring. Clips are available in 4 sizes: small, medium, medium-large, and large. The clips are packaged six per disposable cartridge holder. The clips and cartridge holder are supplied sterile. Cartridge holders are color-coded using the industry standard color-coding system.

The provided document, a 510(k) Pre-Market Notification for the Miltex Ligating Clip, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria or a study proving those criteria are met. Therefore, much of the requested information cannot be found in the provided text.

Here is what can be extracted and inferred:

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

The document states that the Miltex Ligating Clip functions "in the same manner as the predicate device" and is "as safe, as effective, and performs as well as the Horizon Ligation System (K982313)."

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

This information is not provided in the document. The submission relies on a comparison to a predicate device rather than a new clinical study.

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

This information is not provided as there's no mention of a test set or ground truth established by experts in this context. The claim is based on substantial equivalence to the predicate device.

4. Adjudication method for the test set:

This information is not provided as there's no mention of a test set.

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 is not applicable. The device is a physical ligating clip, not an AI-powered diagnostic or assistive technology.

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

This is not applicable. The device is a physical ligating clip, not an algorithm.

7. The type of ground truth used:

This information is not explicitly stated in the context of a "ground truth" for a study. The "truth" in this submission relies on demonstrating the physical and functional similarity to a legally marketed predicate device. This is a regulatory pathway of "substantial equivalence" rather than proving new efficacy from scratch.

8. The sample size for the training set:

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

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

This information is not provided as it is not relevant for this type of device submission. There is no training set for a machine learning model.

In summary, the Miltex Ligating Clip's acceptance relies not on a clinical trial with specific performance criteria and ground truth, but on demonstrating "substantial equivalence" to a legally marketed predicate device (Horizon™ Ligation System by Weck Closure Systems, K982313) based on material, design, dimensions, and intended use. The document asserts that due to these similarities, the Miltex Ligating Clip is "as safe, as effective, and performs as well" as the predicate.

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The Miltex Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized and to allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers. The containers have been validated for sterilization of instruments with lumens up to 3 mm I.D. by 400 mm length, for the Full (large) size container and up to 3mm I.D. by 200mm length for the ½ (small) and ¼ (medium) size containers. Sterilized devices may be stored and transported within the container.

The Miltex Rigid Sterilization Container System consists of a family of rigid, re-usable, sealed containers that provides an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. The system is composed of the following components:

• Container bottoms (both perforated and non-perforated versions)
• Container baskets,
• Container lids (perforated only), and
• Container color-coding "labels."
  The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated.

The provided text describes a 510(k) premarket notification for the Miltex Rigid Sterilization Container System. It does not describe an AI or algorithm-based device, but rather a medical device designed for sterilizing other medical instruments. Therefore, many of the requested details, such as those related to AI performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes, are not applicable to this document.

However, I can extract information related to the device's performance against relevant standards and the nature of the study conducted, which is a validation study demonstrating the device's sterilization capabilities.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Miltex Rigid Sterilization Container System are based on conformance to AAMI standards and successful validation testing for steam sterilization.

(These are fundamental design and functional requirements inherent to the product category, and the "Yes" confirms they are met for the Miltex system). |

Study Information (as applicable for a non-AI medical device):

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

   • The document does not explicitly state a sample size in terms of number of containers or tests in a statistical sense for the validation. Rather, it describes the conditions and types of loads tested.
   • The "test set" in this context refers to the conditions and materials used during the validation testing: "inoculated lumens" (3-mm I.D. x 400-mm, metal, and 3-mm I.D. x 200-mm, metal) and "inoculated stainless steel medical devices."
   • Data provenance: Not specified, but likely laboratory-based (in-vitro) testing conducted by the manufacturer or a contracted lab to demonstrate efficacy for regulatory submission. It is prospective in the sense that the testing was performed specifically to validate the device's performance prior to market approval.

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

   • This concept is not applicable to this type of device validation. Ground truth for sterilization efficacy is established through scientific methods like spore-kill assays and sterility testing, not expert consensus interpretation. The "ground truth" here is the absence of viable microorganisms after the sterilization cycle.

3. Adjudication method for the test set:

   • Not applicable. Sterilization efficacy is typically determined by objective biological and physical indicators (e.g., biological indicators showing no growth, chemical indicators showing proper sterilant exposure, physical parameters like temperature and pressure).

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:

   • Not applicable. This study is for a physical medical device (sterilization container), not an AI algorithm.

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:

   • The ground truth for adequate sterilization is based on microbiological sterility (absence of viable microorganisms) for the inoculated test pieces (lumens and stainless steel devices), confirmed by appropriate biological indicators and sterility testing methods. This aligns with scientific and regulatory standards (like AAMI) for sterilization efficacy.

7. The sample size for the training set:

   • Not applicable. This is not an AI or algorithm-based device that requires a training set. The "training" here would refer to the developmental process of the container design and manufacturing.

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

   • Not applicable.

In summary, the provided document details the conformance and validation testing of a physical medical device (sterilization container) against established performance standards and functional requirements. It does not pertain to software, AI, or diagnostic algorithms, and therefore, many of the requested categories related to such technologies are not relevant.

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The devices are intended to manipulate tissue, organs, or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate tissue.

These devices represent a family of monopolar laparoscopic instruments that consist of:

• Stainless Steel Handle (non-ratcheted)
• Stainless Steel Pull Rod attached to a stainless steel jaw
• Insulation material composed of PPSU (PolyPhenylSulfone)
  Various configurations of the jaw (graspers, cutters, dissectors, and punches) exist to meet the needs of the surgical procedure. The instruments have the capability for monopolar electrocautery to allow for the cutting and coagulation of soft tissue.
  These reusable instruments are sold non-sterile. The instruments are packaged in a labeled plastic bag.

The provided text describes a 510(k) pre-market notification for Miltex Laparoscopic Instruments, which primarily focuses on establishing substantial equivalence to a predicate device. This type of submission generally does not include extensive performance studies with detailed acceptance criteria as would be expected for novel or high-risk devices requiring clinical trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not applicable/Not provided. This submission is for laparoscopic instruments, and performance is demonstrated through material compliance and comparison to a predicate device, not typically through a test set of data with a specific sample size as would be found in an AI/software device.
• Data Provenance: Not applicable/Not provided. The data provided relates to material specifications and compliance with standards, not patient data.

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

• Not applicable/Not provided. Ground truth establishment with experts is not relevant for this type of device submission.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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/Not provided. This is a physical medical instrument, not an AI/software device.

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

• Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.

7. The type of ground truth used:

• Not applicable/Not provided. The "ground truth" in this context is based on engineering specifications, material standards, and functional comparison to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.

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

• Not applicable/Not provided. This is a physical medical instrument, not an AI/software device.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) submission is based on the following:

• Material Biocompatibility: "The patient contact materials are commonly used in medical materials. The stainless steel 420 is compliant with the long history of biocompatibility." This indicates reliance on established knowledge and historical use of the material.
• Compliance with Safety Standards: "The subject devices can withstand EN 60601-2-18: Type 2: Particular requirements for the safety of endoscopic equipment." This demonstrates the device's adherence to relevant international safety standards for endoscopic equipment.
• Substantial Equivalence to Predicate Device: The core of a 510(k) submission. The applicant states: "The subject devices have the same indications for use as the predicate devices, have stainless steel jaws, are both sold non-sterile, and have monopolar electrocautery capability." The main difference (handle material) is presented as a minor change that does not affect safety or effectiveness. The conclusion explicitly states that "the subject devices are as safe and effective as the predicate devices."

In summary, for these laparoscopic instruments, the "acceptance criteria" are met by demonstrating that the device uses biocompatible materials, complies with relevant safety standards, and is substantially equivalent in design, function, and intended use to an already legally marketed device (the predicate device). There are no clinical studies or AI performance metrics involved in this type of submission document.

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1. It is the intention of Miltex Inc. to introduce into the marketplace a line of Fixation/Steinmann Pins both Smooth and Threaded.
2. The material is 316LVM, Stainless Steel and the Pins are to be utilized for internal fixation of bone fractures.
3. The Pins are used specifically for fractures of the proximal or distal end of long bones such as intracapsular intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur.
4. The device(s) may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Steinmann and Fixation Pins, Smooth and Threaded. The material is 316LVM, Stainless Steel.

The provided text describes a 510(k) summary for Steinmann and Fixation Pins and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or benchmark study.

Instead, the submission relies on the concept of Substantial Equivalence to legally marketed predicate devices.

Therefore, most of the requested information cannot be extracted from this document, specifically:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance study
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Here's what can be extracted, based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document states:

• "Miltex Inc. will assure that product will be manufactured as indicated above and with the further confirmation that the Pins will meet all parameters of our print specifications and current ISO standards referenced under Performance Standards, Miltex Inc. then hereby claims that these Steinmann/Fixation Pins are Substantially Equivalent."
• "The above attestation therefore deems this product as being Safe and Effective. Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."

There are no explicit quantitative acceptance criteria or reported device performance metrics in the provided text. The acceptance criteria are implicitly linked to manufacturing consistency, adherence to print specifications, and current ISO standards. Device performance is not quantitatively reported but is inferred from the substantial equivalence claim and prior use in veterinary medicine.

2. Study that proves the device meets the acceptance criteria:

The primary "proof" for regulatory clearance is based on the claim of Substantial Equivalence to legally marketed predicate devices, rather than a clinical study evaluating specific performance criteria against predefined acceptance thresholds.

The relevant statements are:

• "Miltex Inc. is claiming Substantial Equivalence for our Fixation Pins, Smooth and Threaded based upon the cross referenced information as presented in the Spread Sheet, pages 5-2 and 5-3, which clearly indicates a large representation of other manufacturers. Their similar products have been utilized in the medical device market for many years."
• "The subject Pins have already been assigned Product Codes of 87HTY and 87JDW by the FDA. The FDA in these classifications has already issued 510(k) numbers to manufacturers who sell and or distribute these product lines."
• "Our (5) plus years in which Miltex Inc. has already sold Steinmann/Fixation Pins in the Veterinary marketplace, serves as additional confirmation of the Safety and Effectiveness of this new product line. Miltex Quality records for these products support our claim."

Summary of available information:

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