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Powder Free Surgical gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.

These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy:

"WARNING: Do not use with Carmustine and Thiotepa"

It is the powder-free variation of the class I sterile latex surgical gloves made on-line by surface treatment on the outside and polymer coating on inner surface.

The provided text is related to the 510(k) premarket notification for surgical gloves and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment as it pertains to an AI/ML device.

The document details the substantial equivalence of new surgical gloves to a legally marketed predicate device based on various physical, chemical, and biocompatibility tests, as well as their resistance to chemotherapy drugs. It explicitly states that "Clinical testing is not applicable to this device." This confirms that there was no study involving human readers or AI in the way your prompt describes.

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A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The device has been tested for use with chemotherapy drugs.

The Encore Acclaim Sterile Powder-Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim

The document is a 510(k) summary for the Encore® Acclaim® Sterile Powder-Free Latex Surgical Gloves. It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here’s a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (e.g., dimensions, physical properties, freedom from holes, powder-free, protein content, biocompatibility, or chemotherapy drug permeation). It mentions that the device was "tested against the ASTM standards," which would implicitly define sample size requirements within those standards, but the specific numbers are not provided in this summary.

The data provenance is from non-clinical performance data conducted by Ansell Healthcare Products LLC. There is no information provided about the country of origin of the data or whether it was retrospective or prospective, though performance testing is typically prospective.

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

This type of information is generally not applicable to the performance testing of medical devices like surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted, standardized testing protocols (e.g., ASTM standards) rather than expert consensus on individual cases. The results are objective measurements.

4. Adjudication method for the test set

Not applicable. The tests performed are objective, measurable outcomes based on ASTM standards. There is no subjective interpretation requiring an adjudication method.

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

Not applicable. This is a medical device for personal protection, not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies and AI improvement effect sizes are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm or software.

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

The ground truth used for demonstrating device performance consists of established, objective measurements specified by recognized industry standards (ASTM standards). For example, the ground truth for protein content is "Maximum 50 µg/dm²" as specified in ASTM D3577-09e1 and ASTM D5712. For chemotherapy drug permeation, the ground truth is the measured breakthrough time according to ASTM D6978-05.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

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

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The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.

Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.

The Acclaim™ Total Elbow System is intended for cemented use only.

The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.

The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components.

Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.

This document describes a 510(k) premarket notification for a medical device – the Acclaim™ Total Elbow System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria as you've outlined.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be found in this document because:

• This is a 510(k) summary for a medical implant (prosthesis), not a software device or AI algorithm. The questions you've posed are typically relevant for the assessment of AI/ML-based medical devices or diagnostic tools.
• 510(k) submissions focus on substantial equivalence. The primary goal is to show the new device is as safe and effective as a predicate device already on the market, not to meet pre-defined performance metrics against a "ground truth" using statistical studies as would be done for novel devices or AI.
• The "study" referenced here is the comparison to predicate devices and conformance to voluntary performance standards, not a clinical trial or performance study against an adjudicated ground truth in the way your questions are framed.

Here's a breakdown of what the document does provide in relation to your questions, and what it does not provide:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:

• Does NOT Provide: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or specific device performance metrics in numerical terms. It's a regulatory submission demonstrating substantial equivalence, not a performance study report for an AI.
• Does Provide (Implicitly): The "performance" is implicitly tied to the performance and safety record of the predicate devices (Acclaim™ Total Elbow System - K992656, Mark II Elbow System - K872084). The submission states, "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards." This implies the new device performs at least as well as the predicate devices and meets relevant industry standards, but no new empirical performance data or specific criteria are listed.

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

• Does NOT Provide: This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on a specific dataset. Therefore, there's no mention of sample size or data provenance in that regard.
• Does Provide (Indirectly): The "test" for substantial equivalence involved comparing the new device's design, materials, sterilization, and packaging to the predicate devices. This isn't a data-driven test set as you've implied.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Does NOT Provide: Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is not an AI/diagnostic device.

4. Adjudication Method:

• Does NOT Provide: Not applicable. There is no adjudication method described as there's no ground truth to establish for a test set.

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

• Does NOT Provide: This is a mechanical prosthetic device, not a diagnostic imaging tool or AI. Therefore, an MRMC study is completely irrelevant to this submission and is not mentioned.

7. The Type of Ground Truth Used:

• Does NOT Provide: No "ground truth" as a reference standard (like pathology, expert consensus, or outcomes data) is used because this is an orthopedic implant, not a diagnostic tool requiring such validation. The "truth" in this context is that the device is substantially equivalent to a legally marketed predicate device.

8. Sample Size for the Training Set & 9. How Ground Truth for Training Set was Established:

• Does NOT Provide: These concepts are entirely irrelevant to a 510(k) submission for a mechanical implant. There is no AI model, no training set, and no ground truth for a training set in this context.

In summary, the provided document is a 510(k) summary for an elbow prosthesis aiming to demonstrate substantial equivalence to existing devices. It does not contain the type of AI/ML performance study information you are requesting.

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The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.

Not Found

This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.

The key information provided is:

• Trade/Device Name: Acclaim
• Regulation Number: 21 CFR 872.6640
• Regulation Name: Dental Operative Unit and Accessories
• Regulatory Class: I
• Product Codes: NRD and EAY
• 510(k) Number: K042266
• Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.

Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.

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1064 nm: The Cynosure YAG Family laser is intended for the coagulation and hemostasis of bonion vascular lesions such as, but not limited to, port winc stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, stiae and psoriasis. The laser is also intended for the treatment of bonign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café' au lait macules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or black tattoos) and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).

1320 nm The Cynosure YAG Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.

The Cynosure YAG Family Laser is a Nd: Y AG laser, having a Nd: Y AG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm and 1,320 nm. Laser activation is by foot switch or finger switch. Overall weight of the laser is 81 Kg, and the size is 112x48x71 cm (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.

The provided document is a 510(k) Summary for the Cynosure YAG Family Laser. It describes a medical device, but it does not contain any information about acceptance criteria or a study proving its performance against such criteria.

The 510(k) Summary explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

This means that no performance data, clinical or nonclinical, was submitted or reviewed for this 510(k) application to demonstrate the device meets any specific acceptance criteria. The device's approval is based on its substantial equivalence to predicate devices. The review process for substantial equivalence does not typically require new clinical or non-clinical performance data if the device is deemed sufficiently similar to already approved predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.

The Acclaim is a pulsed solid state laser, emitting at the near intra-red wavelength of 1064nm. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x19"x24" (HxWxD). Electrical requirement is 110 VAC or 220 VAC, 20A, 50-60 Hz, single phase.

This document is a 510(k) summary for the Cynosure Acclaim Dermatology Laser, submitted in 2001. It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern medical AI device submission would. This is because the device is a laser system, not an AI or software as a medical device (SaMD), and the regulatory requirements and types of performance studies were fundamentally different in 2001.

Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence to predicate laser devices based on intended use, principle of operation, wavelength, and pulse energy range, rather than on detailed performance metrics from a clinical study with acceptance criteria.

Here's why the requested information is not present:

• Acceptance Criteria and Reported Device Performance (Table): This type of detailed performance data with specific numerical acceptance criteria is typical for clinical studies of new drug efficacy, diagnostic accuracy for IVD/imaging devices, or AI/SaMD performance. For a laser system in 2001, "performance" was largely assessed by comparing technical specifications and intended use to existing, legally marketed devices.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set Details: These items are all highly relevant to the evaluation of AI/ML-based medical devices or complex diagnostic systems. A laser device like the Acclaim Dermatology Laser does not involve these types of evaluations. Its effectiveness is based on the known biophysical interaction of laser light with tissue, which was established through a long history of use for similar devices. The regulatory pathway in 2001 for this type of device primarily required demonstrating technical similarity and safe operation compared to predicates.

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The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

Abbott LifeCare Standard Tubing Pump (Acclaim)

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a detailed study description. The document is a 510(k) clearance letter from the FDA for a device called "Acclaim™ Infusion Pump."

This type of document typically:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the intended use and regulatory class of the device.
• Outlines general regulatory obligations.
• Does not include the specific results of performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

To answer your questions, I would need access to the actual 510(k) submission or a summary of safety and effectiveness (SSE) document, which would contain the details of the studies performed to demonstrate substantial equivalence.

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