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The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

The FridaMom Anti-nausea Bands are adjustable wrist bands which apply pressure to the Neiguan (P6) acupressure point to relive symptoms of nausea. The bands consist of an adjustable strap with a hemi-spherical button which applies pressure to the acupressure point.

The FridaMom Anti-Nausea Bands do not involve AI; therefore, many of the requested categories are not applicable. The device is a physical acupressure band.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This device is not an AI/software device that uses a test set in the traditional sense. The "test" involved pre-clinical force measurements on human wrists and biocompatibility testing of materials.
• Data Provenance: The pre-clinical testing involved measurements on the 1st, 50th, and 99th percentile size female wrists to assess the force applied. The biocompatibility testing followed ISO standards, suggesting laboratory testing. No information on country of origin is specified for these tests. The study is best described as pre-clinical testing for equivalence.

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

• Not applicable. The ground truth for this device is based on physical properties (force applied, material biocompatibility) and comparison to predicate devices, not expert human assessment of diagnostic output.

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

• Not applicable. This is not a study that involves human readers or adjudication.

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 not an AI device.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" equivalent for acceptability in this submission primarily relies on:
  • Substantial Equivalence: Comparison to legally marketed predicate devices (TumEase Acupressure Bracelets and Acu-strap Travel and Motion Sickness Band) in terms of intended use, technological characteristics (pressure application, materials, dimensions), and safety/efficacy.
  • Pre-clinical Testing Results: Measurements of force applied to the Neiguan (P6) acupressure point on human wrists and biocompatibility testing of the device materials.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that uses a training set.

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

• Not applicable. This is not an AI/machine learning device that uses a training set.

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Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/ Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

Bonine Acupressure Bands are acupressure devices made of comfortable fabric band straps with Velcro closures and a dome on the buckle. Bonine Acupressure Band's acupressure dome provides gentle pressure on the Nei-Kuan or P6 pressure point in the wrist. The amount of pressure applied is fully adjustable and allows the user to increase or decrease as needed. Bonine Acupressure Bands are provided for over-the-counter use to be worn directly as desired on the consumer's wrists.

This document pertains to the 510(k) premarket notification for the Bonine Acupressure Bands (K211823), intending to demonstrate its substantial equivalence to legally marketed predicate devices. It focuses on the device's ability to reduce symptoms of nausea by applying pressure to the Nei-Kuan (P6) acupressure point on the wrist.

Crucially, no clinical testing was conducted for this device. The demonstration of substantial equivalence relies primarily on:

• Comparison of Indications for Use: The Bonine Acupressure Bands share the same intended use (reduction of nausea symptoms) as the predicate devices (TumEase Acupressure Bracelets and Sea-Band).
• Comparison of Technological Features: The device operates on the same principle as the predicates, i.e., acupressure on the P6 point for nausea relief.
• Bench Performance Testing: The primary and only performance testing reported is non-clinical/bench testing to compare the contact pressure of the Bonine Acupressure Bands to the predicate device.

Given that no clinical study was performed, the typical elements of acceptance criteria and study design (such as sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in this context. The acceptance criteria here are implicitly met by demonstrating comparable physical properties to the predicate.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study was performed, the acceptance criteria are not in the format of clinical efficacy targets (e.g., sensitivity, specificity). Instead, the "acceptance criteria" revolve around demonstrating comparable physical characteristics to the predicate devices.

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

• Test Set Sample Size: Not applicable. No clinical test set data was used.
• Data Provenance: Not applicable. The performance data is from non-clinical bench testing.

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

• Not applicable. No expert ground truth was established as no clinical data was analyzed.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set to adjudicate.

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

• No MRMC study was done. This type of study evaluates human reader performance, which is not relevant for a device cleared based on substantial equivalence to physical properties and intended use.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This is a physical, non-electronic device; there is no "algorithm" to evaluate in standalone performance.

7. Type of Ground Truth Used:

• Not applicable. No clinical ground truth (expert consensus, pathology, outcomes data) was used. The basis for equivalence is the physical and functional similarity to predicate devices already cleared for the same indications.

8. Sample Size for the Training Set:

• Not applicable. This device does not involve a "training set" in the machine learning sense. Its design is based on the known, effective principles of acupressure and the established designs of predicate devices.

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

• Not applicable. No training set ground truth was established.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is the non-clinical bench performance testing and the comparison of device characteristics (intended use, technological principle, materials, how supplied, application method, and dimensions) to the legally marketed predicate devices.

The key finding from the performance testing was that the Bonine Acupressure Bands were "comparable to the predicate device and was able to provide a similar average contact pressure in the pressure point bench testing." This demonstrates that the device physically functions similarly to the predicate in applying pressure.

The entire 510(k) submission, by definition, aims to prove "substantial equivalence" to existing legally marketed devices, rather than proving de novo clinical efficacy. The FDA's clearance (K211823) indicates their acceptance of this demonstration based on the provided non-clinical data and comparisons to predicate devices.

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The acupressure bracelets are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the bracelet. This small bump is manually aligned with the P6 (Neiguan or Pericardium) acupressure point. The bracelet is affixed using a Velcro strap and the desire amount of pressure is applied. One key design feature is the ability to adjust the pressure level using the "tightness" of the Velcro strap. More pressure generally increases the desired anti-nausea affect. The functionality of the Veloro strap allows each patient the ability to find the right amount of pressure for themselves based on their condition and needs. In addition, the TumEase bracelets are designed to be cosmetically attractive. It is supplied to the counter (non-sterile). The acupressure bracelets are intended to be worn over a thin fabric. It can be used as frequently as needed by the patient.

The provided document is a 510(k) summary for the TumEase Acupressure Bracelets, which is a regulatory submission to the FDA. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical performance metrics for clinical outcomes. Instead, it focuses on establishing substantial equivalence to predicate devices based on various specifications, and the "performance testing" section describes bench testing related to force applied.

Here's a breakdown of the comparison to predicate devices, which serves as the basis for demonstrating equivalence:

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

• Test Set Sample Size: The document only describes bench testing for "Performance Testing." It does not provide a specific sample size for this bench test, nor does it detail the number of units tested.
• Data Provenance: The bench testing involved comparing the TumEase product to the "Acu-Strap product." The origin of the Acu-Strap product or the environment of the test is not specified, but it's understood to be a controlled laboratory or engineering environment for mechanical testing. No patient data or clinical data provenance is mentioned as no clinical studies were conducted for this submission.

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. The "test set" described is for mechanical/bench testing of physical properties (force applied), not clinical performance requiring expert ground truth establishment.

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

Not applicable. This concept is relevant for clinical studies where multiple experts independently evaluate data and consensus is needed. The testing performed was bench testing of physical attributes.

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. The device is a physical acupressure bracelet, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

Not applicable. The device is a physical product, not an algorithm.

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

For the bench testing, the "ground truth" was based on measured physical properties (force applied) of the TumEase device and a predicate device (Acu-Strap). The fixed pressure of the Acu-Strap served as a reference point.

8. The sample size for the training set

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

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

Not applicable, as there is no training set for this device.

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Pressure Right® is a drug-free, Single-Use, Pressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

The Pressure Right device is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right device has a three-quarter wrist size design (5.50″ long X 1.0″ wide) with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

This document describes a 510(k) submission for the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip" (K142471). The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, particularly the Sea-Band® (K033268) for over-the-counter (OTC) use and an earlier version of the Pressure Right® (K110563) for prescription use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly based on demonstrating performance equivalence to already cleared predicate devices, specifically regarding the pressure exerted and overall functionality. Since this is a 510(k) for an acupressure device, the primary performance measure highlighted is the typical contact pressure.

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

For the specific 510(k) submission K142471 describing the "Pressure Right® Acupressure, Pressure-Sensitive Wrist Strip," no clinical testing was performed. The non-clinical performance data relied on bench testing to evaluate the pressure equivalence between the Pressure Right device and the marketed predicate Sea-Band device. Therefore, there is no specified "test set" in terms of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective status for this submission.

The document states: "There was no new clinical testing required to support the medical device as bench testing was performed to evaluate the pressure equivalence of the Pressure Right acupressure device compared to the marketed predicate (Sea-Band) device."

However, it does mention that the predicate device, Pressure Right (K110563), was clinically tested, and that clinical data was included in its original submission (K110563). The details of the sample size and provenance for that predicate study are not provided in this document.

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

Not applicable, as no clinical test set was used for this specific submission (K142471). Bench testing was conducted to assess physical attributes.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for this specific submission.

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

No. A MRMC comparative effectiveness study was not conducted for this submission. The submission primarily relies on demonstrating substantial equivalence through non-clinical bench testing and comparison to predicate devices, including their existing clinical data.

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

Yes, in a sense. The "device" in question is a physical acupressure wrist strip. The performance evaluation was essentially a standalone assessment of its physical characteristics (primarily pressure output) compared to a predicate device, without a human-in-the-loop performance study for this specific submission.

7. The Type of Ground Truth Used

For this specific submission (K142471), the "ground truth" for the non-clinical bench testing was the measured typical contact pressure of the predicate Sea-Band device (5-7 lbs/sq. in). The new Pressure Right device was expected to demonstrate equivalent pressure.

For the predicate Pressure Right device (K110563), the document states it was "clinically tested" and had "proven safety and efficacy for the use of the device." This implies an existing body of clinical outcomes data (e.g., reduction in nausea symptoms) served as the ground truth for that prior submission, but the specifics are not detailed here.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set. The device is a physical acupressure wrist strip.

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

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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The Barf Band is indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example: pregnancy (morning sickness), motion sickness, anesthesia and chemotherapy.

The Barf Band is a wristband with adjustable properties that operates by putting pressure on Nei Kuan acupressure point (also known as the P6 point) on each wrist by means of a plastic dome/stud. Barf Bands are made from PVC free polyurethane, ABS plastic covered with Santoprene and 100% cotton. The band itself is composed of polyurethane. The ABS plastic covered with Santoprene is used to construct the plastic dome/stud that applies the pressure to the P6 point. The cotton is used inside the band to make the band comfortable to the end user.

The provided text is a 510(k) summary for the "Barf Band" and a subsequent FDA letter of substantial equivalence. This type of document, particularly for an acupressure device, focuses primarily on establishing substantial equivalence to predicate devices rather than presenting detailed clinical study data with specific acceptance criteria, statistical analyses for performance, or ground truth establishment as would be seen for a more complex diagnostic or therapeutic device.

Therefore, many of the requested elements for a study proving acceptance criteria are not applicable or not present in this document. The submission relies on demonstrating similarity in intended use, technological characteristics, and principle of operation to existing approved devices (PSI Band and Sea Band), along with performance testing to show the applied force falls within the range of the predicates.

Here's an attempt to address your request based on the available information, indicating when information is not present:

Description of Acceptance Criteria and Study Proving Device Meets Criteria

Overview: The Barf Band's acceptance criteria and proof of meeting them are established primarily through demonstrating substantial equivalence to predicate devices (PSI Band and Sea Band). The key performance metric evaluated was the force applied by the wristband, which was shown to fall within the range established by the predicate devices. This approach is common for lower-risk devices where direct head-to-head clinical efficacy studies against specific criteria are not typically required for 510(k) clearance if substantial equivalence can be shown.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for performance testing. The document refers to "Performance testing conducted on the Barf Band and the predicate devices," implying a comparison. It does not appear to be a clinical trial with a "test set" in the traditional sense of patient data.
• Data Provenance: Not applicable. The testing described appears to be bench testing of the device's physical properties (force application) and a comparison of those properties to predicate devices, rather than clinical patient data.
• Retrospective/Prospective: Not applicable based on the nature of the described testing.

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

• Number of Experts: Not applicable. The "ground truth" for this submission revolves around the characteristics of the device itself and its comparison to predicate devices, not expert interpretation of clinical data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was not a study involving expert adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission is for a physical acupressure device, not an AI-assisted diagnostic or therapeutic tool for which such a study would be relevant.

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

• Standalone Performance: Not applicable. The Barf Band is a physical device, designed for human use, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the physical properties and performance characteristics of the predicate devices (PSI Band and Sea Band) regarding the force applied to the acupressure point. The Barf Band's performance was compared to this established range.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device submission.

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The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is indicated for the relief of emetic (nausea and vomiting) symptoms associated with Post-Operative Anesthesia.

The Pressure Right®, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip is a single-use, disposable acupressure strip that operates by exerting pressure on the Nei-Kuan (acupuncture) or (P6) pressure point.

The Pressure Right® device has a three-quarter wrist size design (5.50″ long X 1.0″ with an affixed hard plastic button. Its pressure stimulation effect to the P6 acupressure point provides nausea and vomiting relief for surgical patients. Pressure Right® device is intended for use by adults, 18 years and older and intended to be worn on each wrist. The Pressure Right® device also comes with a P6 locator template to accurately determine an individual's P6 pressure point.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Pressure Right® device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for clinical performance. Instead, it frames the evaluation in terms of "substantial equivalence" to a predicate device and "reducing postoperative nausea and vomiting." Therefore, the table below reflects the general claims and the study's aim rather than precise, pre-defined thresholds.

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

• Test Set Sample Size: The document does not specify the exact sample size for the clinical study. It only mentions "Use of disposable acupressure device as part of a multi-model antiemetic strategy for reducing postoperative nausea and vomiting."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not available in the provided text. The document refers to a "clinical study" but does not detail how "ground truth" (e.g., actual presence/severity of nausea/vomiting) was established or by whom.

4. Adjudication Method for the Test Set

This information is not available in the provided text.

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

• Was an MRMC study done? No, the device is a physical acupressure strip, not an AI or imaging device that would typically involve human readers interpreting cases.
• Effect size of human readers with AI vs. without AI assistance: Not applicable.

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

• Was a standalone study done? No, the device is a physical medical device. The "clinical study" would inherently involve human subjects using the device.

7. The Type of Ground Truth Used

The type of "ground truth" for the clinical study would likely relate to the subjective experience of nausea and vomiting reported by patients, potentially measured through standardized scales. However, the document does not explicitly state the method for establishing ground truth or the specific outcome measures used to assess "nausea and vomiting relief."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The Pressure Right® device is a physical device, not an AI algorithm that requires a training set in the typical sense.

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

• How ground truth was established: Not applicable. As it's not an AI device, there is no "training set" or corresponding ground truth establishment process in this context.

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Psi Bands are indicated for the relief of nausea. Nausea is a symptom that may be experienced due to a variety of causes, for example:

• pregnancy (morning sickness)
• motion sickness
• anesthesia
• chemotherapy.
  Psi Bands are intended for over-the-counter use.

Psi Bands, acupressure (pressure stimulation) wrist bands, consist of a plastic orb that applies pressure to the Nei-kuan (P6) acupressure point, the area that provides nausea relief. Psi Bands may be worn on both wrists at the same time and may be adjusted at two areas: 1) around the wrist like a watch, and 2) at the acupressure point by turning a plastic dial clock-wise. The plastic dial allows the user to apply different degrees of pressure at the acupressure point for maximum comfort and effectiveness. Select from one of three settings (mild nausea = low pressure; moderate nausea = medium pressure; troublesome nausea = high pressure). By turning the dial past the highest setting, the dial will automatically return to its neutral, or lowest, setting so that it cannot be overtightened.
Psi Bands are made from synthetic rubber, specifically medical grade Santoprene™ thermoplastic rubber and food grade ABS plastic which does not directly contact the patient after adjustment.
Components of the system include:
Strap and collar made of medical grade Santoprene™ thermoplastic rubber
Button is composed of three parts; the dial, the nut and the ring all made of food grade ABS plastic and which reside inside the button itself which is part of the Santoprene™strap

The Psi Bands 510(k) summary (K070766) indicates that no clinical tests were performed to establish the device's performance against acceptance criteria. Instead, the device's substantial equivalence to a predicate device (Acuband Acupressure Wrist Band Device, K053509) was determined through a comparison of their technical characteristics and non-clinical bench testing.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, the focus is on demonstrating equivalence in technical characteristics and performance outputs with the predicate device.

Study Information:

The document explicitly states: "Not applicable. No clinical tests were performed." This means that many of the requested points related to clinical studies and test sets are not directly addressed in this 510(k) summary.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical tests were performed. Bench testing was performed to compare performance outputs, but details on sample size for this are not provided beyond the comparison of "performance outputs."
2. 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 no clinical tests were performed requiring direct expert-established ground truth for a test set.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical tests were performed.
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. The device is not an AI-assisted diagnostic tool; it is a physical acupressure wrist band.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical product, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the purpose of substantial equivalence, the "ground truth" for the Psi Band was the established performance and characteristics of the predicate device. For the non-clinical comparison, the ground truth was derived from bench testing to measure physical properties like contact area and pressure.
7. The sample size for the training set: Not applicable, as no clinical studies or machine learning algorithms were involved in this submission.
8. How the ground truth for the training set was established: Not applicable, as no clinical studies or machine learning algorithms were involved.

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Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post-operative from anesthesia.

The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior side of the band. The Acubands are made of hook and loop fabric which allows the wrist band to be fully adjustable. The Acuband wrist bands enable the button to apply gentle pressure on the acupressure point, the P6 or Nei-Kuan, point on the inner wrist. This action interrupts the signal that triggers nauses.

This submission primarily focuses on establishing substantial equivalence for the Acuband device based on technological characteristics and intended use compared to predicate devices, rather than presenting a performance study with acceptance criteria. As such, the input document does not contain the information required to populate most of the sections in your request. The device is an acupressure wristband, and the review by the FDA (in 2006) for this type of device typically relied on comparison to previously approved devices of similar design and function, not on extensive performance studies with specific acceptance criteria in the same way a diagnostic or therapeutic medical device might.

Here's an attempt to address the points based on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The submission focuses on substantial equivalence to predicate devices based on design and intended use, not on quantifiable performance metrics with associated acceptance criteria.

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

Not applicable. No performance study data is presented.

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

Not applicable. No performance study data is presented.

4. Adjudication method for the test set

Not applicable. No performance study data is presented.

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 acupressure wristband, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted or is relevant here.

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

Not applicable. This device is an acupressure wristband, not an algorithm.

7. The type of ground truth used

Not applicable. No performance study was conducted that would require a "ground truth" in the typical sense for a medical device performance evaluation. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This device is an acupressure wristband, not a machine learning algorithm.

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

Not applicable. This device is an acupressure wristband, not a machine learning algorithm.

Summary based on the provided text:

The provided document is a 510(k) summary for the Acuband, an acupressure wristband. The submission establishes substantial equivalence to previously cleared predicate devices (BioBands, Acu-Strap, Sea-Band, Ezy-Travel Band) based primarily on:

• Intended Use: Both the Acuband and the predicate devices are indicated for the relief of nausea due to various causes (motion sickness, morning sickness, chemotherapy, post-operative from anesthesia).
• Technological Characteristics: The Acuband is described as being constructed in the same manner as the Bio-Bands (K051397). It uses hook and loop fabric for adjustability and features a plastic button to apply pressure to the P6 or Nei-Kuan acupressure point on the inner wrist. The button's dimensions and composition are stated to be similar to those of the predicate devices.

The FDA's review in 2006 concluded that the device was substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market under general controls provisions. This type of submission does not typically include a detailed performance study with quantifiable acceptance criteria for a physical device like an acupressure band.

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BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.

BioBands is an adjustable wristband that fits on either wrist. The device is composed from nylon and polyester fabric, and features a Velcro closure for easy adjustment. The BioBands wristband has a wooden bead or button sewn into the band's underside. When BioBands is worn by users, the wooden bead applies pressure to the P6 or "nei-kuan" acupuncture point. The gentle pressure applied by the bead to the P6 interrupts the signals that trigger nausea.

The provided text is a 510(k) summary for the BioBands device, which is an acupressure wristband. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data in the way a de novo or PMA submission would.

Therefore, much of the requested information (such as specific acceptance criteria based on performance metrics like sensitivity/specificity, detailed study designs, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document. The document's purpose is to establish equivalence, not to prove specific performance against quantitative criteria in a new study.

Here's what can be extracted and what cannot:

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

This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in nausea scores) from a new clinical study. The basis for acceptance is substantial equivalence to predicate devices, which implies that if the predicate devices were considered safe and effective for the stated indications, then BioBands, being "similarly constructed" and using the "same principal of operation" for the "same indications for use," would also be considered safe and effective.

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

• Sample size for test set: Not applicable and not mentioned. No specific test set for BioBands performance is described.
• Data provenance: Not applicable. The document relies on the regulatory clearance of predicate devices rather than new clinical data.

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):

• Number of experts/qualifications: Not applicable and not mentioned. No specific ground truth establishment for a test set is described.

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

• Adjudication method: Not applicable and not mentioned. No test set requiring expert adjudication is described.

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:

• MRMC study: No. This device is a physical acupressure band, not an AI or imaging device, so an MRMC study is not relevant.

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

• Standalone study: No. This is a physical device, not an algorithm.

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

• Type of ground truth: Not applicable. The "ground truth" here is effectively the prior regulatory clearance of the predicate devices based on their established safety and efficacy, or public domain knowledge about acupressure for nausea. The document doesn't describe establishing new ground truth for BioBands through clinical outcomes or expert consensus.

8. The sample size for the training set:

• Sample size for training set: Not applicable and not mentioned. There is no algorithm or model described that would require a training set.

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

• How ground truth was established: Not applicable and not mentioned. No training set or ground truth for it is described.

Summary of Study Information based on the provided document:

The provided 510(k) summary does not describe a new clinical study to establish acceptance criteria or device performance. Instead, it relies on demonstrating substantial equivalence to two legally marketed predicate devices: K033268 ("Sea-Band" wristband) and K041877 (Acu-Strap Motion Sickness Band).

• Basis for Substantial Equivalence: BioBands is described as "similarly constructed" to the predicates, utilizes the "same principal of operation" (applying pressure to the P6 or "nei-kuan" acupuncture point), and is "marketed for the same indications for use" (relief of nausea due to Travel, Pregnancy, Anesthesia, or Chemotherapy).
• No new clinical data/studies presented: The document does not provide details of any specific clinical trials, performance studies, sample sizes, expert-adjudicated ground truth, or statistical analysis for the BioBands device itself. The regulatory acceptance is based on its similarity to already cleared devices.

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For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for the "Ezy-Travel Wristbands," an acupressure device. This letter indicates a finding of substantial equivalence to a legally marketed predicate device for the stated indications for use (relief of nausea).

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the device. The letter solely states that the device is substantially equivalent and can be marketed.

Therefore, I cannot provide the requested information from the given text. The document does not describe the acceptance criteria or a study that proves the device meets them.

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