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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves are available with finger textured surface. Sizes; Extra Small and XX-Large.

Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XS, Model SNAEFT-240OR-XS Midas Touch-Nitrile Examination Gloves - Powder free, Orange, XXL, Model SNAEFT-240OR-XXL

This is a 510(k) premarket notification for "Midas Touch-Nitrile Examination Gloves". This document does not describe a study involving device performance metrics, algorithms, human readers, or ground truth as would be found in a submission for an AI/ML-based medical device. Instead, it is an administrative letter from the FDA confirming substantial equivalence for a physical medical device (examination gloves) to predicate devices.

Therefore, I cannot provide the information requested in your prompt as it is not present in the provided text. The prompt's questions pertain to acceptance criteria and studies for AI/ML device performance, which are not relevant to this document.

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The container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Sharpsology 2 is a reusable plastic sharps disposal container. The container is a nonsterile device for nonsterile applications. The container is intended to be used in an appropriate wall mount unit, wall bracket or stand alone tray. It features a canteen style, vertical drop lid and a mailbox style, vertical drop lid for safe and easy disposal of sharps. Simply deposit syringes vertically into the opening of the lid, and they are deposited automatically into the container. Container is easily identified as full by looking at both the fill line on the container and biohazard label attached to container. When the canteen style lid is being used and the container is full, the supplied cap is attached to the lid by turning clockwise until it snaps into place for transport. When using the mailbox style lid and the container is full, pull the rotating portion of lid forward and snap lock the rotating portion into the two locking tabs located on the front of the lid. The Sharpsology 2 has a hole in one end of the lid and container that match, a plastic cable wire tie is inserted to look the lid to the container for transportation. Then just replace it with a clean sanitized unit, Using proper cleaning and sterilizing equipment, cleaning facility will empty and sanitize the unit and return it to the user facility to use for the next switch out. The durable high-density polypropylene specialty impact copolymer construction of the Sharpsology 2 makes it leak resistant, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives. The projected life expectancy of the device is at least (5) five years. Other sharps containers using the same material for the same purpose have remained in use over (5) five years without showing failure. The container is intended to be used in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Sharpsology 2 container is inserted into a wall mount unit available from Industrial Water Solutions, Inc. that is lockable and allows access to the opening of the lid of the Sharpsology 2 container for needle disposal. Healthcare personnel drop used sharps into the opening of the lid of the container, Sharps drop to the bottom of the container. When the container is full or up to the "Fill Line" of the container, the container is then taken out of the wall mount or bracket on the wall. The label on the container has very visible "Fill Line" imprinted on the outside. The container also has a very visible fill line, as well. A new container or one that has been sanitized for reuse is then put back into the wall mount or bracket for use. The container is then ready for transport to the cleaning facility for sanitation.

A label will be attached to the container specifying the intended use of the container. A sample of this label is attached at the end of this document. (See Attachment 1)

The Sharpsology 2 container is a reusable two gallon sharps container used for the collection of sharps at the healthcare facility. The container is housed in a wall mount or bracket attached to the wall. Healthcare personnel simply drop used sharps into the vertical drop opening on top of the lid and release. The used sharps deposited into the container and drop to the bottom of the container. The container is used until it is deemed to be full by visually inspecting to see if the sharps level is up to the "Fill Line". Once the container is deemed to be full, it is then removed from the wall mount or bracket and gotten ready for transport. A new container or a used, sanitized container is then placed in the wall mount or bracket for use, The Sharpsology 2 container has no handles, but is easily picked up by placing hands on either side of the container and lifting. The average weight of the container plus sharps inside a full container will average five and seven pounds. The used or full containers are then transported to the cleaning and sanitizing facility for sanitation, inspection, packaging, and made ready for reuse. The container is lockable. Each container has a bayonet style lid closure that horizontally slides into place and is removed mechanically for emptying and cleaning. The lid features a wire tie to further help hold the lid in place.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Simulated Life-Use Test: 30 containers (15 with canteen-style lids, 15 with mailbox-style lids). The containers were red-colored Sharpsology 2 containers from the same lot tested by Arama Package and Container Testing Services, Inc. in July 2013 (Test report dated July 24, 2013). This appears to be prospective testing conducted by the manufacturer or a contracted lab.
• Free Fall Drop Test: Five (5) filled packages.
• Vibration Test: Three (3) samples.
• Stacking Test: Three (3) containers.
• Leak Resistance: Three (3) containers.
• Puncture Resistance: "A sample of several sections of containers," including the thinnest areas.
• Freestanding Capability: Not explicitly stated but implied to be sufficient for assessment.

The data provenance for most tests appears to be from laboratory testing conducted specifically for the 510(k) submission, likely in the United States, given the reference to U.S. regulations (49 CFR, OSHA) and a U.S. testing laboratory (Container Testing Laboratory, Inc.).

3. Number of Experts and Qualifications:

Not applicable. This device is a reusable sharps disposal container, and the tests performed are physical and mechanical performance tests, not clinical evaluations requiring expert interpretation of results (e.g., medical image analysis).

4. Adjudication Method:

Not applicable, as the tests involve objective physical measurements and observations (e.g., presence of leakage, damage, puncture force, stability) rather than subjective assessments requiring adjudication.

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

Not applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical device; there is no embedded algorithm.

7. Type of Ground Truth Used:

The ground truth for these tests is defined by the objective pass/fail criteria established by the referenced standards and regulations (e.g., 49 CFR 178.603, 49 CFR 178.606, 49 CFR 178.608, Health Devices 22, OSHA specifications). These are engineering and performance standards for packaging and safe handling of hazardous materials.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning model.

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

Not applicable. There is no training set for a physical device.

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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Midas TouchTM - Nitrile Examination Gloves - Powder free, Green

This is a 510(k) premarket notification for "Midas Touch 191 - Nitrile Examination Gloves - Powder Free. Green." This document does not describe a study that proves the device meets specific acceptance criteria in the manner that a medical imaging AI or diagnostic device would. Instead, it is an FDA clearance letter based on substantial equivalence to a predicate device.

Therefore, many of the requested items (sample sizes, expert qualifications, MRMC studies, standalone performance, training data, etc.) are not applicable to this type of regulatory submission.

However, I can extract the relevant information regarding the device and its indications for use.

Here's a breakdown of the available information:

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

For examination gloves, the "acceptance criteria" are typically defined by recognized consensus standards, which include physical properties and barrier integrity. The FDA letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the relevant performance standards for patient examination gloves. However, the specific performance data against these standards are not included in this clearance letter. This letter is the outcome of the review, not the detailed submission itself.

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

• Not Applicable. This is not a study involving a test set of data in the context of an AI or diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device, which typically involves testing the physical properties of the glove according to recognized standards. The sample sizes for these physical tests would be defined by the specific test methods (e.g., ASTM standards) but are not detailed in this clearance letter.

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)

• Not Applicable. As above, there is no "ground truth" establishment in the context of image interpretation or diagnosis for this type of device. The quality and performance of the gloves are assessed through standardized physical and chemical tests, not expert consensus on medical images.

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

• Not Applicable.

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

• Not Applicable. This device is an examination glove, not an AI or diagnostic tool that assists human readers.

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

• Not Applicable.

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

• The "ground truth" for examination gloves typically refers to the objective measurements of their physical and barrier properties against established, internationally recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves). These standards define acceptable performance ranges for attributes like tensile strength, elongation, and freedom from holes.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no training set.

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

• Not Applicable.

Summary of Device and Indication for Use:

• Device Name: Midas Touch™ - Nitrile Examination Gloves - Powder free, Green
• Manufacturer: Industrial Clothings Ltd., Prime Polymers Division
• 510(k) Number: K130846
• Indications for Use: "A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large."
• Regulatory Class: I
• Product Code: LZA (Patient Examination Glove)

This clearance indicates that the FDA has determined the device is "substantially equivalent" to currently marketed devices and can be legally marketed, based on fulfilling the general controls provisions of the Act and likely meeting relevant consensus standards. The detailed engineering and performance data are part of the original 510(k) submission, which is not fully included here.

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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Not Found

The provided text is a 510(k) premarket notification for "Midas Touch™ Nitrile Examination Gloves - Powder-Free, Orange." This document is a regulatory submission for a medical device and does not contain information about a study proving the device meets acceptance criteria in the format typically found for AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices like gloves. It confirms that the device is intended for medical purposes, to be worn on the hand or finger to prevent contamination between patient and examiner.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, as this document pertains to a physical medical device (gloves).

Here's why the requested information categories are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). For gloves, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), tensile strength, elongation, etc., which are not detailed here beyond the general claim of being "powder-free" and available in sizes.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth, in the AI/ML sense, is not established for gloves.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to examination gloves.
6. Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There's no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval for examination gloves and does not contain the kind of study data requested for AI/ML device performance.

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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Not Found

This document describes the 510(k) premarket notification for "Midas Touch™ - Nitrile Examination Gloves - Powder Free, Grey." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically seen for complex medical devices with quantitative diagnostic or performance metrics (e.g., sensitivity, specificity, accuracy).

However, for patient examination gloves, the primary acceptance criteria revolve around meeting established ASTM standards for physical properties and barrier integrity. The "Premarket Notification (510k) Summary" (which is typically part of an FDA submission but not fully contained in the provided letter and Indications for Use) would detail these.

Based on the context of FDA substantial equivalence for examination gloves, the implied acceptance criteria are that the Midas Touch™ gloves meet the relevant ASTM standards. The "study that proves the device meets the acceptance criteria" would be the testing conducted by the manufacturer according to these standards.

Here's a hypothetical table based on typical glove testing for a 510(k) submission, as these are the "performance" aspects a glove device would need to demonstrate:

Note: The specific ASTM standards and target values would be detailed in the applicant's 510(k) submission. This table is illustrative of the types of criteria and performance typically required for examination gloves.

The "Study That Proves the Device Meets the Acceptance Criteria":

The "study" confirming the device meets the acceptance criteria would be a series of bench tests and laboratory assays conducted by the manufacturer, Industrial Clothings Limited, Prime Polymers Division. These tests would involve:

• Physical Property Testing: Measuring tensile strength and elongation using methods like ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) and ASTM D573 (Standard Test Method for Rubber—Deterioration in an Air Oven). These tests would be performed on samples of the finished gloves, both before and after accelerated aging to simulate shelf life.
• Barrier Integrity Testing: Primarily through the water leak test according to ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves). This involves filling gloves with water and observing for leaks within a specified time, and reporting results based on Acceptable Quality Limits (AQL). An AQL of 2.5 is common for examination gloves, meaning a certain percentage of defects is acceptable. The applicant likely tested to an AQL of 1.5 as is commonly done.
• Biocompatibility Testing: Performing dermal irritation and sensitization tests on Guinea pigs (or other suitable models) according to standards like ASTM F719/F720 or ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization).
• Powder Residue Testing: For powder-free gloves, testing according to ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) to ensure powder levels are below the specified maximum.

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

• Test Set Sample Sizes: The document does not explicitly state the sample sizes used for each test. These details would be contained within the engineering and testing reports submitted as part of the 510(k). For glove testing:
  • For physical properties, sample sizes are usually quite small (e.g., 5-10 gloves per batch per test condition).
  • For the water leak test (AQL testing), sample sizes are determined by statistical sampling plans based on the batch size, as outlined in ASTM D5151 (e.g., ANSI/ASQ Z1.4). For a large batch, this could be hundreds of gloves.
  • For biocompatibility, sample sizes are typically defined by regulatory toxicology guidelines (e.g., 3-5 animals per test group for irritation/sensitization).
• Data Provenance: The manufacturing entity is Industrial Clothings Limited, Prime Polymers Division, located in Sri Lanka. Therefore, the testing data would originate from their facilities or contracted testing laboratories, likely in Sri Lanka or elsewhere as required by testing standards. The data would be prospective as it's generated specifically for the 510(k) submission.

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

This question is not directly applicable in the context of examination gloves. "Ground truth" (in the sense of expert consensus on diagnostic findings) is relevant for diagnostic imaging or AI algorithms. For a physical device like a glove, the "ground truth" is established by adherence to universally accepted engineering and material science standards (e.g., tensile strength values in ASTM, AQL limits in D5151). The "experts" would be the testing technicians, quality engineers, and regulatory specialists who conduct and verify the adherence to these standards. Their qualifications would be expertise in materials testing, quality control, and relevant ASTM/ISO standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (2+1, 3+1) are used for resolving disagreements among multiple human readers on diagnostic tasks, typically in AI/imaging studies. For physical device performance, tests yield objective quantitative or pass/fail results, not subjective interpretations requiring adjudication.

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

Not applicable. MRMC studies compare the performance of human readers (with or without AI assistance) on diagnostic cases. This device is a disposable medical glove, not a diagnostic AI system.

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

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. Type of Ground Truth Used

As mentioned, "ground truth" for this device is based on established engineering and material science standards (e.g., ASTM standards) rather than pathology, outcomes data, or expert consensus on clinical findings. For example:

• The "ground truth" for tensile strength is the minimum value specified in the relevant ASTM standard.
• The "ground truth" for barrier integrity is the AQL level specified in ASTM D5151.
• The "ground truth" for biocompatibility is the absence of a significant irritative or sensitizing response according to recognized toxicology protocols.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning or AI. The term "training set" refers to data used to train an algorithm. For a physical device, the equivalent concept might be the data from process validation runs or initial manufacturing batches used to optimize the production process, but this is distinct from an AI training set.

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

Not applicable for the same reasons as point 8.

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A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Midas Touch™ - Nitrile Examination Gloves Powder free, Pink

The provided text is a 510(k) premarket notification letter from the FDA for medical gloves, specifically "Midas Touch 101 - Nitrile Examination Gloves-Powder Free, Pink."

This document does not contain information about acceptance criteria and a study proving a device's performance in the sense of an AI/ML or diagnostic device. Instead, it concerns the FDA's determination of substantial equivalence for a patient examination glove to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as the document does not pertain to such a study or device.

The document primarily focuses on:

• Regulatory Clearance: K122465, indicating the FDA has reviewed the submission and determined substantial equivalence.
• Device Type: Nitrile Examination Gloves, Powder Free, Pink.
• Intended Use: "A powder-free examination glove is a disposable device intended for medical purposes, that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
• Regulatory Classification: Class I, Product Code LZA (Patient Examination Glove).
• Manufacturing Information: Industrial Clothings, Limited, Prime Polymers Division, from Sri Lanka.

For a medical glove, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from pinholes, viral penetration), sterility (if applicable), and biocompatibility. The "study" proving these would be laboratory testing against recognized standards (e.g., ASTM standards for medical gloves). This specific FDA letter, however, only states that substantial equivalence has been determined, implying that such testing was submitted and found acceptable by the FDA, but it does not detail the tests, methodology, or results within the letter itself.

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The container is intended for use by healthcare providers, such as hospitals, laboratories, medical clinics, veterinary clinics and other facilities where needles are generated. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.

The Enviro Sharp Solutions 3 is a reusable plastic sharps disposal container. It features a mail drop, torturous path tumbler lid for safe and easy disposal of sharps. Simply deposit syringes horizontally into the opening of the lid, and they are deposited automatically into the container. When the container is full, the tumbler will indicate that it is time to replace the unit. Just insert the locking tabs to secure the container in a closed position and replace it with a clean sanitized unit. Using our proprietary equipment, Sci-Med Waste employees will empty and sanitize the unit and return it to the facility to use for the next switch out. The durable high-density polyethylene construction of the Enviro Sharp Solutions 3 makes it leakproof, puncture resistant and stable. It meets or exceeds all OSHA recommendations for sharps containers, and because it is reusable, it is more environmentally friendly and less expensive than disposable alternatives.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Enviro Sharp Solutions 3 device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a precise numerical sample size for the "random sampling" of containers subjected to simulated life-use or for the individual performance tests (Puncture, Leak, Vibration, Free Fall Drop, Stacking). It refers to "all components of a random sampling" for the simulated life-use.
• Data Provenance: The data is retrospective, generated from testing performed on the device components. The country of origin is not explicitly stated but is implied to be within the US given the FDA submission and US regulatory standards cited (e.g., OSHA, CFR). The testing occurred over "a two-day period from November 5, 2008 to November 7, 2008."

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

• The document does not describe the use of human experts to establish ground truth for the performance tests. The "ground truth" for these tests is based on objective measurements and observations against established engineering and regulatory standards (Health Devices 22, 49 CFR).
• The final assessment for the performance tests is reported by "Container Testing Laboratory, Inc.," indicating an accredited testing facility, but individual expert qualifications are not detailed.

4. Adjudication Method for the Test Set

• No human adjudication method (like 2+1 or 3+1) is mentioned or implied for the performance tests. The tests involve objective measurements against pass/fail criteria from regulatory standards.

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

• No, an MRMC comparative effectiveness study was not done. This device is a physical sharps disposal container and not an AI-assisted diagnostic or decision support tool that would involve human readers.

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

• This question is not applicable. The device is a physical product, not an algorithm or software. The performance tests are by definition "standalone" in the sense that they evaluate the physical product's characteristics against objective criteria.

7. The Type of Ground Truth Used

• The ground truth used for the performance tests is derived from established engineering and regulatory standards. For example, the "Pass" for Puncture, Leak, Vibration, Free Fall Drop, and Stacking implies that the device performance met the quantitative or qualitative criteria specified within Health Devices 22 and various sections of 49 CFR. For the simulated life-use, the ground truth was the absence of visible signs of failure.

8. The Sample Size for the Training Set

• This question is not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

• This question is not applicable, as there is no training set for this device.

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The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.

The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.

The provided text is a 510(k) summary for an Aspiration Pump and a letter from the FDA. It details the device's identification, description, intended use, and its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The document states:

• Device: Aspiration Pump
• Intended Use: "The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures."
• Predicate Device: Medela AG, Basic 30 (510(k) K021368)
• Rationale for Substantial Equivalence: "The Aspiration Pump shares the same general indications for use, similar design features, and functional features as predicated device. Therefore, the technological differences between Aspiration Pump and predicated device do not raise any new issues of safety, effectiveness, or performance of the product. We believe that Aspiration is substantially equivalent to the above legally marketed predicate device."

To address the specific points of your request:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance: This information is not available in the provided text. No specific performance testing or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not available in the provided text. No ground truth establishment is described.
4. Adjudication method for the test set: This information is not available in the provided text.
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 and not available. The device is an Aspiration Pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not applicable and not available. The device is an Aspiration Pump, not an algorithm.
7. The type of ground truth used: This information is not available in the provided text, as no specific performance testing or clinical study is detailed.
8. The sample size for the training set: This information is not available in the provided text. No machine learning model or training set is mentioned.
9. How the ground truth for the training set was established: This information is not available in the provided text.

In summary, the provided document is a regulatory submission for a medical device (an Aspiration Pump) based on substantial equivalence. It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical for an AI/ML device or a device requiring specific performance claims beyond general functional equivalence.

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The LucentLite Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology:

1064 nm:

• To effect stable long-term, or permanent* hair reduction through selective targeting of melanin in hair follicles.
• For the removal of unwanted hair.
• For coagulation and hemostasis of vascular lesions.
• For Incision/excision of soft body tissues in dermatology.
• For soft tissue general surgery applications: skin incision; tissue dissection; excision of external turnors and lesions; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation.

• Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after treatment regimen.

1320 nm:

• For the treatment of periorbital and perioral wrinkles.

The LucentLite Laser is comprised of the following main components:

• Console (including laser, electronics, cooling system, and software);
• Control panel;
• Permanently attached fiberoptic-coupled handpiece;
• Skin cooling device;
• Foot pedal;
• Remote interlock connector.

The provided text is a 510(k) summary for the LucentLite Laser, a medical device. This document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed clinical study results with acceptance criteria and specific performance metrics for the LucentLite device itself.

Therefore, many of the requested details about acceptance criteria, study methodologies, sample sizes, and ground truth establishment cannot be found in this document. The 510(k) process for this type of device typically relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria.

Here's the information that can be extracted or inferred based on the provided text:

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

Based on the provided 510(k) summary, specific acceptance criteria and detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative measurements for efficacy) are not reported. The document focuses on demonstrating substantial equivalence to predicate devices, implying that the device achieves performance comparable to those predicates for its stated indications for use.

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

Not provided. The document does not describe a "test set" in the context of an evaluative study with specific performance metrics. The 510(k) summary relies on comparison to predicate devices, not on a new clinical study with a specified test set patient cohort.

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

Not applicable/Not provided. Since no specific test set and associated ground truth establishment process are described, this information is not available.

4. Adjudication method for the test set

Not applicable/Not provided. Since no specific test set and associated ground truth establishment process are described, this information is not available.

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

No. This document describes a laser surgical instrument, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not performed.

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

Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

Not applicable/Not provided. As there's no described new clinical study with a test set, the concept of "ground truth" for a new dataset is not discussed. The device's safety and effectiveness are established by demonstrating substantial equivalence to predicate devices, for which the "truth" of their efficacy would have been established through a combination of scientific understanding, previous clinical data, and regulatory clearance.

8. The sample size for the training set

Not applicable/Not provided. This document does not describe a machine learning algorithm or a "training set."

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

Not applicable/Not provided. This document does not describe a machine learning algorithm or a "training set."

Summary of what the document does provide:

• Device Name: LucentLite Laser
• Intended Use: Surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in general and plastic surgery and dermatology. Specific indications for 1064 nm (hair reduction, vascular lesions, incision/excision of soft tissue) and 1320 nm (treatment of periorbital and perioral wrinkles).
• Predicate Devices:
  • Altus Medical, Inc. - Family of Altus Medical CoolGlide Aesthetic Lasers (K022226, K003202)
  • CoolTouch Corporation - CoolTouch Nd: Y AG Laser System (K014035)
  • Sciton, Inc. - Profile 1320 Laser System (K022466)
• Rationale for Substantial Equivalence: The LucentLite Laser shares the same general indications for use, similar design features, and functional features as the predicate devices. The technological differences do not raise any new issues of safety, effectiveness, or performance.

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Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for Midas Touch Blue Latex Examination Gloves, confirming substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and marketing permissions. Therefore, I cannot fulfill your request based on the given input.

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