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Master Caution Device (MCD) is intended to condition an electrocardiographic signal, so that it can be transmitted digitally via Bluetooth technology and cell-phone or communication device to a remote location. The Master Caution Device (MCD) is designed to be used by a patient to transmit a 12 lead ECG, posture and motion , respiration and skin temperature (IR) signals, in near real-time to enable review at a physician's office, hospital or other remote medical receiving center. Master Caution Device (MCD) target population is adults above the age of 21.

The HealthWatch Master Caution Device (MCD) is a personal, hand-held battery powered, ECG device that can be connected to any approved and market cleared, ten standard ECG electrodes, configuring a 12-lead ECG device.

The MCD is a miniature ECG device with an embedded processor containing data acquisition, data storage, data processing accelerometers, respiration, skin temperature (IR) and BT (Bluetooth) capabilities. The HealthWatch Master Caution Device (MCD) acquires ECG data via the connected electrodes. The HealthWatch Master Caution Device (MCD) transmits the data in near real time to a suitable Bluetooth communication device for forwarding to a remote location for professional review.

A communication device is defined as any device that is capable of receiving the ECG data via Bluetooth and forwarding it via WIFI or cellular network (3G/4G). Communication devices can be cellphones, computers or other dedicated communication modems.

The provided document is a 510(k) premarket notification for the Healthwatch Master Caution Device (MCD). It asserts substantial equivalence to predicate devices rather than providing a detailed study proving device performance against specific acceptance criteria. Therefore, several of the requested sections cannot be fully populated as the information is not present in the document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a readily extractable table. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards.

The document mentions that "Bench testing demonstrated that the HealthWatch Master Caution Device (MCD™) is as safe and effective as the cleared predicate device." This is a general statement rather than specific performance data.

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

The document does not detail a specific test set or data provenance for performance evaluation of the MCD itself. It states that for the MCD, performance bench tests were conducted to demonstrate equivalence to the predicate device. However, no sample sizes or data provenance are provided for these bench tests.

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 the document does not describe a clinical study with a ground truth established by experts for the MCD directly.

4. Adjudication method for the test set

This information is not provided as the document does not describe a clinical study with an adjudication method for the MCD directly.

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 such MRMC comparative effectiveness study is mentioned for the Master Caution Device (MCD). The MCD is described as a device that conditions and transmits ECG signals, not an AI-assisted diagnostic tool.

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

This is not applicable as the MCD is a hardware device for signal acquisition and transmission, not an algorithm, and its intended use is for review by a physician.

7. The type of ground truth used

For the MCD, the document does not indicate the use of specific ground truth types (e.g., pathology, outcomes data) in a clinical study. The device's performance is gauged against its ability to acquire and transmit physiological signals accurately, and its equivalence to predicate devices through bench testing and compliance with standards.

8. The sample size for the training set

This information is not applicable. The MCD is a hardware device for signal acquisition and transmission 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 information is not applicable for the same reasons as above.

Summary based on the document:

The HealthWatch Master Caution Device (MCD) received 510(k) clearance based on demonstrating substantial equivalence to legally marketed predicate devices. The primary arguments for equivalence are:

• Same Intended Use: The MCD's intended use is to condition and transmit electrocardiographic signals and other physiological data (posture, motion, respiration, skin temperature) for remote review.
• Similar Technology: It utilizes the same transmission method (Bluetooth) as its predicate devices.
• Performance Bench Tests: Bench testing was conducted to verify that the MCD is "as safe and effective" as the cleared predicate device, without raising new safety or effectiveness concerns. These tests presumably assessed the device's ability to acquire and transmit the specified signals correctly and reliably. However, specific performance metrics or detailed results from these bench tests are not provided in this summary.
• Compliance with Standards: The device complies with several international and US standards related to medical electrical equipment safety, electromagnetic compatibility, software life cycle processes, risk management, and labeling (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ISO 62304, ISO 14971, ISO 15223-1, ASTM D4169).
• Reliance on Predicate Device Studies: The document explicitly states, "Due to the comprehensive clinical studies already performed by the predicate and other devices, published in scientific literature, and since the performance testing shows its substantial equivalence, HealthWatch believes that animal and clinical studies are not necessary to determine the substantial equivalence of the HealthWatch Master Caution Device (MCDTM)." This indicates that no new clinical studies or detailed performance studies with human subjects were conducted for the MCD itself to prove its effectiveness beyond substantial equivalence.

Therefore, the document emphasizes regulatory compliance and comparison to existing devices rather than a detailed performance study with specific acceptance criteria and outcome measurements for the MCD as a standalone product.

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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Master Guard Disposable Nitrile Powdered Blue Examination Gloves

This FDA 510(k) clearance letter for "Master Guard Disposable Nitrile Powdered Blue Examination Gloves" does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way requested.

The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device, which means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976.

Specifically, the document does not provide any information for the following requested items:

1. A table of acceptance criteria and the reported device performance: This type of data is typically found in a summary of safety and effectiveness or a test report, not in the clearance letter itself.
2. Sample size used for the test set and the data provenance: There is no mention of specific test sets or their size/origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no such test is described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable (this is a physical glove, not an AI algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is a physical glove, not an AI algorithm).
9. How the ground truth for the training set was established: Not applicable.

The document does state the Indications for Use:
"A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

To find information on acceptance criteria and performance data for this type of device, one would typically need to refer to:

• Voluntary consensus standards: Such as ASTM standards for medical examination gloves (e.g., ASTM D6319 for nitrile examination gloves), which define performance requirements for properties like tensile strength, elongation, puncture resistance, and barrier integrity (e.g., AQL for pinholes).
• The 510(k) submission itself: The actual submission would contain the test reports and data that demonstrate the device meets these standards and any other specific performance claims, enabling the FDA to determine substantial equivalence.

Without access to the actual 510(k) submission, the requested information cannot be extracted from the provided text.

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A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

Here's an analysis of the provided FDA document regarding the acceptance criteria and study details for the Nitrile Blue Powder Free Examination Glove:

This document is a 510(k) clearance letter for a medical device (Nitrile Blue Powder Free Examination Glove). It does not contain the acceptance criteria or results of a study designed to prove the device meets specific performance criteria, especially not in the context of an AI/ML powered device.

Instead, this document is a regulatory approval letter stating that the device is "substantially equivalent" to a legally marketed predicate device. This means the manufacturer demonstrated that their device performs similarly to an existing device for its intended use, rather than conducting a de novo study against a set of predefined acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information from the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve rigorous testing against performance metrics. This document pertains to a Class I medical device for which the primary regulatory pathway is demonstrating substantial equivalence.

However, to illustrate what specific elements are missing and why the provided document does not fulfill the request, let's address each point as if this were an AI/ML device submission, explaining why the information is absent:

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

• Missing: This document does not specify any quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) or corresponding acceptance criteria needed for an AI/ML device. For a glove, the "performance" would relate to barrier integrity, tensile strength, and freedom from holes, but these types of metrics are not detailed here.

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

• Missing: No test set is described, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.

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)

• Missing: Not applicable for this type of device and submission.

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

• Missing: 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

• Missing: Not applicable. This device is not an AI algorithm intended to assist human readers.

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

• Missing: Not applicable. This is a physical product, not an algorithm.

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

• Missing: Not applicable. For a glove, "ground truth" might relate to physical properties meeting standards, but this is not detailed.

8. The sample size for the training set

• Missing: Not applicable. There is no training set for a physical device like a glove.

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

• Missing: Not applicable.

Conclusion:

The provided FDA letter (K071208) is a clearance for a Nitrile Blue Powder Free Examination Glove based on substantial equivalence. It does not contain the detailed performance metrics, study designs, or data provenance information that would be requested for an AI/ML device's acceptance criteria and validation study. The letter confirms market clearance, but not specific test results or acceptance criteria in the manner you've outlined for software/algorithm performance.

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A patient examination Latex Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Powder Free Examination Gloves

This document is an FDA 510(k) clearance letter for "Latex Powder Free Examination Gloves". It does not contain information about acceptance criteria and a study proving a device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Lube Free Low Speed Handpiece line comprises a family of air driven low speed dental motors, FDA classification code EFB, for use in dental non-surgical operatory and laboratory procedures by licensed practitioners. The dental motors are known as: Master Classic 5K Low Speed Handpiece Master Classic 20K Low Speed Handpiece Master TM5 5K Low Speed Handpiece Master TM20 20K Low Speed Handpiece The following are examples for which the motors can be utilized. Note that these are just examples and not limitations of the procedures for which the handpieces can be used. - . Grinding and trimming on dentures and bridge work. - Polishing and finishing of natural dentition . - Endodontio abcess procedures . - Cavity preparation. t - Crown and cap preparation . - Post and pin setting . - Implant setting .

The Master line of air driven handpieces are intended for use in a variety of non-surgical dental laboratory and operatory applications. They are typically coupled with a selection of attachments and angle heads to provide the licensed practitioner with the correct range of torque and speed to perform the desired procedure.

This 510(k) submission document pertains to a Class I medical device, the "Master line of air driven handpieces" for dental applications. Class I devices are subject to general controls and typically do not require extensive clinical studies or robust acceptance criteria demonstrations like those needed for higher-risk devices. Therefore, the information you've requested regarding detailed acceptance criteria and a study proving performance against them is not present in this type of submission for a Class I device.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate.

Here's an analysis based on the provided document, addressing your questions where applicable and explaining why certain information is absent:

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

This information is not provided in the document. For Class I devices like dental handpieces, the "acceptance criteria" are generally tied to demonstrating equivalence in functionality, materials, and sterilization to existing predicate devices, rather than specific quantitative performance metrics tested against pre-defined thresholds. The submission asserts that the device utilizes "materials commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization," which implies meeting common industry standards for device durability and reusability, but no specific performance data or acceptance targets are listed.

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

This information is not provided. As explained above, for Class I devices seeking 510(k) clearance through substantial equivalence, a formal "test set" in the context of a robust performance study (like for AI/diagnostic devices) is generally not required or performed for a device like a dental handpiece. The evaluation is often based on engineering specifications, material properties, and comparison to the predicate device.

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

This information is not applicable/not provided. There is no "ground truth" establishment as would be required for a diagnostic device or an AI algorithm. The device's function is mechanical, and its intended uses are well-established dental procedures.

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

This information is not applicable/not provided. There is no "test set" and no "adjudication" in the context of expert review for this type of device submission.

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/not provided. This device is a mechanical dental handpiece, not an AI or diagnostic tool. Therefore, an MRMC study is entirely irrelevant to its submission.

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

This information is not applicable/not provided. This is a mechanical device, not an algorithm.

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

This information is not applicable/not provided. As a mechanical device for dental procedures, the concept of "ground truth" as used in diagnostic or AI device evaluations does not apply. The device's effectiveness relies on its ability to perform its mechanical functions (e.g., rotation, torque, speed) reliably and safely, analogous to the predicate device.

8. The sample size for the training set

This information is not applicable/not provided. There is no AI component or "training set" for a mechanical dental handpiece.

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

This information is not applicable/not provided. As there is no AI component or "training set," there's no ground truth to establish for it.

Summary of what the document does provide:

• Predicate Devices: The document clearly identifies the predicate device as "Lynx Classic 5K / Classic Air Motor," "Lynx TM5 - 5K," and "Lynx TM20 - 20K" (K940261).
• Intended Use & Indications for Use: The document clearly states the intended use for "dental laboratory and operatory non-surgical procedures by licensed practitioners" and provides examples like grinding, polishing, cavity preparation, etc.
• Device Description: It describes the device as "air driven handpieces" coupled with attachments for various dental procedures, emphasizing the use of materials "commonly known for their ability to withstand many exposures to common cleaning and disinfecting agents and steam sterilization."
• Substantial Equivalence: The primary objective of this 510(k) submission is to demonstrate substantial equivalence to the predicate devices, thereby ensuring the new device is as safe and effective as devices already on the market. The FDA's letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."

In conclusion, for a Class I mechanical device like a dental handpiece, the regulatory pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies with detailed acceptance criteria and ground truth establishment typically found for novel, higher-risk, or AI-driven devices.

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Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..

Master & Frank Surgical Drapes (Sterile), is manufactured from nonwoven fabric , PE & Reinforce layer. The Surgical Drapes includes (3) basic configurations of SPLIT DRAPE , THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes is supplied sterile and for single use only.

The provided document is a 510(k) summary for the Master & Frank Surgical Drapes (Sterile). It describes the device, its intended use, and a performance summary. However, it does not contain a detailed study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific types of studies (MRMC or standalone) as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Medline Disposable Surgical Drapes & Gowns K964142) by stating that the device meets applicable standards.

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

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

• Acceptance Criteria (Implicit via Standards Met): The document states: "In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards .."
  • This implies that the acceptance criteria are adherence to these specific standards for physical properties, biological safety, and sterilization.
• Reported Device Performance: The document only generically states that the device is "designed to meet applicable standards." It does not provide specific numerical or qualitative results for each standard (e.g., actual tensile strength measurements, specific flammability ratings, or detailed biocompatibility test reports).

The following information is NOT available in the provided text:

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

• The document mentions "bench testing contained in this submission" but provides no details on sample sizes or data provenance.

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 not relevant or included for a physical device like a surgical drape. Ground truth is established by adherence to documented standards and test methods.

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

• Not applicable as no human adjudication is described for the physical and biological testing of a surgical drape.

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

• Not applicable. This is a physical medical device (surgical drape), not an AI/software product requiring human reader studies.

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

• Not applicable, as this is not an AI/software algorithm.

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

• For this device, the "ground truth" would be established by the specifications defined in the referenced ASTM, NFPA, and ISO standards, and the results of laboratory tests performed according to those standards. The document only confirms the device "is designed to meet applicable standards."

8. The sample size for the training set:

• Not applicable as this is not a machine learning/AI model that requires a training set. The "design" for a physical device is not "trained" in this context.

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

• Not applicable for the same reason as point 8.

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Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven fabric. This surgical Gown is supplied sterile and for single use only.

The provided text is a 510(k) summary for a medical device, specifically Master & Frank Surgical Gowns (Sterile). It outlines the device description, intended use, and a performance summary. However, it does not describe an AI medical device, but rather a physical sterile surgical gown.

Therefore, the requested information regarding acceptance criteria and a study proving a digital device meets those criteria (which would typically involve performance metrics like accuracy, sensitivity, specificity, statistical analysis of a test set, expert adjudication, etc.) is not applicable to this submission.

The "Performance Summary" section of the 510(k) states:

"In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards----etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards.."

This indicates that the acceptance criteria for this physical device are based on compliance with established industry standards for physical properties (like tear strength, tensile strength, flammability), biological safety (biocompatibility), and sterilization. The "study" proving it meets these criteria would typically involve bench testing against these specific material and sterilization standards, rather than the types of studies performed for AI software (e.g., test set evaluations with ground truth derived from expert consensus or pathology).

Since the submission is not for an AI device, I cannot provide the requested details regarding AI-specific criteria.

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This product is an air compressor that when used in conjunction with a hand held nebulizer, produces the nebulization of a liquid prescribed medication. The compressor produces an air source that is channeled through tubing into the hand held nebulizer. The nebulizer creates an aerosol mist by forcing the compressed air through the nebulizer baffle. This creates negative pressure in which the liquid medication is vacuumed into the air, creating the aerosol mist.

This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices.

The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various hand held nebulizers that are currently in distribution in the United States and Europe.

The components found within this product are common items. The product consists of a thermally protected motor, a cylinder and piston assembly (the compressor) attached to the motor, the case, a switch, an electrical cord, and a printed circuit board. The circuit board makes the wiring more stable and organized, thus ensuring higher quality and safety.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device called "Master Neb II" from 1997. It describes the device's intended use and states its substantial equivalence to previously marketed devices. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any information related to AI or MRMC studies.

Therefore, I cannot extract any of the requested information to fill in the table or answer the specific questions about device performance and studies.

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