Search Results

The TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation is intended to be used for repeat positioning and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.
It is intended to be used by or under the direction of a licensed physician.

The TruGuard Custom Tongue and Jaw Positioner consists of two dental bite trays composed of rigid plastic and connected at the base of their arcs in a bivalve fashion so as to allow the upper and lower bite trays to open and close in similar fashion as the upper and lower jaws of the patient. The two bite trays are each lined with an insert of low-temperature EVA (ethylene vinyl acetate) thermoplastic material similar to that used in commercial mouth guards. Projections on the lower and upper bite trays mate securely to a plastic indexing tab component that has holes at pre-set locations. When the plastic indexing tab is joined to the upper and lower bite trays the jaw is held open at pre-set angles, depending on the hole selected. This allows the mouth to be positioned and repositioned as needed, and ensures unrestricted air flow to the patient. An optional tongue depressor interlocks with the lower bite tray to restrict the tongue position to the lower portion of the oral cavity.

The provided document describes the TruGuard Custom Tongue and Jaw Positioner from Bionix Development Corporation and its substantial equivalence to a predicate device. It primarily focuses on comparing the new device against an existing one, the Dental Tray for use with the Gill-Thomas-Cosman Relocatable Head Holder, manufactured by Integra.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for the TruGuard device in terms of performance metrics like accuracy, specificity, or recall. Instead, it demonstrates "substantial equivalence" to a predicate device, focusing on similar design, features, composition, and function, particularly concerning reproducible patient positioning and shielding efficacy.

The key performance described is related to shielding efficacy against backscatter radiation.

Study Information

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

   • Sample Size: The bench testing involved a "phantom (teeth with amalgam fillings)". The number of phantoms or trials is not specified beyond this.
   • Data Provenance: The study was a bench test, so no human patient data was used. The provenance is internal Bionix Development Corporation testing.

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):

   • This information is not provided. Given it was a bench test, expert consensus for ground truth might not be directly applicable in the same way as clinical studies. The ground truth for backscatter radiation was measured using Gafchromic EBT3 film.

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

   • This information is not applicable as the test was a bench test measuring physical properties (radiation dose), not a clinical study requiring human adjudication of results.

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:

   • An MRMC study was not done. This device is a physical medical device (positioner/immobilizer) for radiation therapy, not an AI software device.

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

   • A standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

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

   • For the shielding efficacy test, the ground truth was quantitative measurement of radiation dose using "industry standard Gafchromic EBT3 film." This is a physical and objective measurement.

7. The sample size for the training set:

   • This information is not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

   • This information is not applicable as there is no training set for a physical device.

Ask a specific question about this device

The Little Angels Swaddling Blanket developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.

It is intended to be used by or under the direction of a licensed physician.

The Little Angels Swaddling Blanket is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting. The Little Angels Swaddling Blanket is similar in composition and function to other devices used as adjuncts to current neonatal phototherapy systems used to treat neonatal hyperbilirubinemia.

The Little Angels Swaddling Blanket is comprised of a sheet of spun bond polypropylene material that is die-cut and heat welded in a pattern that allows an infant undergoing phototherapy for hyperbilirubinemia to be tightly swaddled in a fashion such that only a single layer of material is ever interposed between the infant and the phototherapy source.

Spun bond polypropylene is a commonly used fabric in medical products and garments. Spun bond polypropylene is non-irritating to the skin. soft, and has a good drape that allows it to easily conform to body contours. Spun bond polypropylene is available in different fabric weights, depending on the tightness of the weave and fabric density. Light-weight spun bond polypropylene fabric is used in the Little Angels Swaddling Blanket to ensure maximum light transmittance from the phototherapy source to the patient's skin. {See section on "Bench Testing".)

In use, an infant undergoing phototherapy for hyperbilirubinemia is first laid atop the Little Angels Swaddling Blanket, and the blanket is then folded around the infant in a prescribed fashion that ensures the infant is tightly swaddled and that only a single layer of fabric lies between the phototherapy source and the infant's skin. When an overhead phototherapy source is used, the swaddled infant is then placed under the light source in the usual fashion in order to receive the phototherapy treatment. The Little Angels Swaddling Blanket also has a pocket formed in its rear panel (under the infant). If a light emitting pad type phototherapy source is to be used, the light emitting pad is placed in this pocket and phototherapy is administered to the swaddled infant in the usual fashion. Also, double phototherapy can be administered to an infant swaddled using the Little Angels Swaddling Blanket by combining an overhead phototherapy source together with a light emitting pad type phototherapy source, each used as described above.

The provided text describes a 510(k) summary for the "Little Angels Swaddling Blanket". The primary acceptance criterion investigated here is light transmittance, specifically comparing it to a predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for the new device are implicitly that it should perform at least as well as the predicate device, or ideally, better, in relevant metrics like light transmittance for effective phototherapy. The table shows the new device significantly surpasses the predicate device in light transmittance.

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

• Sample Size: For light transmittance testing, 2 samples of the "Little Angels Swaddling Blanket" material and 2 samples of the "BiliSoft Cover" material were tested for each phototherapy light source (GE Giraffe SPOT PT LITE and Drager PT 4000). This means a total of 4 material samples were tested.
• Data Provenance: This was "Bench Testing" conducted on material samples, not patient data. The origin of the material samples (e.g., country of manufacture) is not specified. It is a retrospective analysis of material properties.

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

• Not applicable. This device is not an AI/ML device, and no human experts were involved in establishing ground truth for the light transmittance bench testing. The ground truth (actual light transmittance values) was established by direct physical measurement using a light meter.

4. Adjudication Method for the Test Set

• Not applicable. There was no need for adjudication as the testing involved direct physical measurements of light transmittance and fabric weight.

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

• No. This is not an AI/ML device requiring human reader interaction or MRMC studies.

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

• No. This is not an AI/ML algorithm; it is a physical medical device (a swaddling blanket).

7. The Type of Ground Truth Used

• Direct Physical Measurement: The ground truth for light transmittance and fabric weight was established through direct physical measurements using a light meter and standard laboratory methods (not explicitly detailed but implied by "Fabric weights of the materials used in each device were also determined").

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device, so there is no training set in the AI/ML sense.

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

• Not applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device

Embrace Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

Silhouette Thermoplastic from Bionix Development Corporation is intended to be used for the external support and immobilization of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

Embrace Thermoplastic from Bionix Development Corporation is a moldable lowtemperature thermoplastic comprised of polycaprolactone, a biodegradable thermoplastic polymer that has been approved by the Food and Drug Administration for other medical device applications.

Embrace Thermoplastic becomes pliable and moldable by hand at temperatures of about 160 to 170 degrees Fahrenheit. This heating is most often done by immersion in hot water. To improve the ease of handling the polycaprolactone material in its heated, softened state, the Embrace Thermoplastic sheets will be bonded to a non-low temperature rigid thermoplastic frame. These frames also serve as convenient points to affix the Embrace Thermoplastic to an underlying patient support device.

Embrace Thermoplastic will be supplied in a variety of configurations and sizes, depending on the size and location of the body part to be immobilized, and to enable compatibility with other radiation therapy immobilization devices already in use. The Embrace Thermoplastic sheets may be perforated to enhance an even stretch over anatomical protuberances such as the nose and chin. This improves the conformity and rigidity of the resulting mask by preventing over-stretching and thinning in these areas. Perforation patterns may be uniform (as in a sheet intended to be used over a limb) or variable (such as in a sheet intended to be used with the head), all designed to enhance the even stretch of the material and the rigidity of the resultant mask.

The typical application of Embrace Thermoplastic is to create a conformal "mask" of an anatomical body part, such as the head, by stretching the pliable heated polycaprolactone sheet over the body part and allowing it to cool and become rigid. The resulting conformal "mask" can then be used to position and reposition a patient undergoing a course of external beam radiation therapy with a high degree of accuracy and reproducibility.

Here's a breakdown of the acceptance criteria and study information for the Embrace Thermoplastic, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is marketed as substantially equivalent to predicate devices, meaning its performance is considered acceptable if it is comparable to these devices. The acceptance criteria are implicitly defined by the performance characteristics of the predicate devices.

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

• Test Set Sample Size: The document does not specify a distinct "test set" in the context of typical machine learning or diagnostic device studies. Instead, samples of each thermoplastic material (Embrace, Klarity, Aquaplast) were used for bench testing. The exact number of individual samples tested for each attribute (e.g., number of rigidity measurements) is not provided, but it implies a sufficient number for representative physical and radiation attenuation measurements.
• Data Provenance: The data is generated from bench testing of the actual materials. No mention of geographical origin or retrospective/prospective nature is applicable as it's not human subject data.

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

Not applicable. The ground truth for physical properties (rigidity, shrinkage, melting point, etc.) and radiation attenuation for this type of medical device is established through instrumental measurements and standardized testing methods, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as the "ground truth" is derived from direct instrumental measurements, not human interpretation requiring adjudication.

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

No. This study is focused on the physical and radiation-attenuation properties of a thermoplastic material used for patient immobilization. It does not involve human readers interpreting medical images or making diagnoses, thus an MRMC study is not relevant.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical product (a thermoplastic), not an algorithm or software. Therefore, there is no standalone algorithm performance to evaluate.

7. Type of Ground Truth Used

The ground truth used in this study is based on direct physical measurements and instrumental radiation attenuation measurements. These are objective, quantifiable properties of the material itself.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and the study involves bench testing of its properties. There is no machine learning model being trained, and therefore no "training set."

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

Not applicable, as there is no training set.

Ask a specific question about this device

The Omni V SBRT Positioning System from Bionix Development Corporation is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

The Bionix Omni V stereotactic body radiation therapy (SBRT) positioning system is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. This device has been most likely classified as Class II by the FDA Panel on Radiology, falling under CFR 892.5050.

The Omni V SBRT positioning system from Bionix Development Corporation has several component parts that are designed to work together to provide an easy to use means of reproducibly positioning a patient undergoing external beam stereotactic radiation therapy. The system includes a thermoformed base, body support vacuum cushion, upper arm support, thigh and foot bolster, breath-suppression arch, and fiducial arch. These components work together to immobilize the patient and provide an external reference system for stereotactic localization.

The provided text is a 510(k) summary for the Bionix Omni V SBRT Positioning System. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific acceptance criteria through quantitative performance metrics.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set sizes) cannot be fully extracted from this document because it is not typically included in a 510(k) summary for a device of this nature (a patient positioning system).

Here's what can be gathered and why other information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria" for this device:

For this type of device (a patient positioning system, classified as an accessory to an accelerator), the "acceptance criteria" for 510(k) clearance are primarily demonstrating substantial equivalence to legally marketed predicate devices. This means showing that the new device is as safe and effective as the predicate. The FDA does not have voluntary standards for this specific device type, meaning there are no pre-defined numerical thresholds the device needs to meet.

The document demonstrates equivalence by comparing:

• Intended Use: Identical.
• Design and Function: Similar components (base-plate, vacuum cushions, fixation/immobilization methods, reference systems).
• Materials: Both use radiolucent materials (carbon fiber/foam composite for BodyFix, acrylic sheet for BodyLoc, acrylic/PVC alloy for Omni V).
• Performance (qualitative): The Omni V is designed to achieve reproducible patient positioning and localization, minimize organ movement (via breath-suppression), and provide an external reference system, similar to the predicate devices.

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

• Sample Size: Not applicable/Not provided. The 510(k) summary does not describe a performance study with a test set of patients or medical images.
• Data Provenance: Not applicable/Not provided.

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

• Number of Experts: Not applicable/Not provided. No ground truth establishment is described for a performance study.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/Not provided. No test set adjudication is described.

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

• MRMC Study: No. This type of study is typically done for diagnostic imaging devices where human readers interpret results, comparing performance with and without AI assistance. This device is a physical positioning system, not an imaging interpretation algorithm.
• Effect Size of Human Reader Improvement: Not applicable.

6. Standalone Performance Study (Algorithm Only):

• Standalone Study: No. This device is physical hardware, not a software algorithm used for standalone performance assessment. The "performance" is implicitly tied to its physical properties and design, verified through comparison to predicate devices, rather than a standalone algorithm test.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable/Not provided. No performance study requiring ground truth is described. For this device, "ground truth" would relate to its physical properties (e.g., attenuation, rigidity, reproducibility of indexing), which are assessed through engineering design and comparison to existing products, rather than clinical outcomes or pathology from a dataset.

8. Sample Size for the Training Set:

• Sample Size: Not applicable/Not provided. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

• How Ground Truth Established: Not applicable/Not provided. As above, no training set or associated ground truth is relevant for this device type.

In summary: The provided 510(k) summary is for a physical medical device (patient positioning system) demonstrating substantial equivalence to predicate devices using design, function, and material comparisons. It does not contain information about studies involving patient data, expert reviews, or algorithm performance metrics, as these are not typically required for this classification of device seeking 510(k) clearance by this method. The "acceptance criteria" are met by demonstrating the device is as safe and effective as the already-marketed predicate devices.

Ask a specific question about this device

The Bionix T-Form Extremities Immobilizer patient positioning system, developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The Bionix T-Form Extremity Immobilizer is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

The T-Form Extremity Immobilizer from Bionix Development Corp. consists of a thermoformed patient support device with attachment areas for accessories. The T-Form Extremity Immobilizer is thermoformed from an ABS plastic material so that the resulting contoured shell is lightweight and thin-walled, providing low attenuation for unobstructed passage of the radiation therapy beam. The T-Form Extremity Immobilizer is specifically designed for immobilization of the upper and lower extremities.

The T-Form Extremity Immobilizer has a generally rectangular shape, with pre-formed areas that allows,the device to be securely attached to the treatment couch tabletop. Specifically, there are pre-formed depressions with threaded holes that allow the T-Form Extremity Immobilizer to screw onto an attachment bar that can lock onto the treatment couch tabletop. These pre-formed areas can be found on both the top and side of the device, allowing the T-Form Extremity Immobilizer to be used in either a longitudinal or transverse orientation to allow greater flexibility in patient positioning. This allows the T-Form Extremity Immobilizer to be repeatedly located in the same position on the treatment couch tabletop for each therapy session.

The T-Form Extremity Immobilizer has a central thermoformed depression to allow the use of optional vacuum cushions as part of the patient immobilization process. Vacuum cushions contain expanded polystyrene beads in an airtight vinyl bag, with a valve for attachment to a vacuum pump. In practice, the patient's extremity is positioned on the bag which is then evacuated using the vacuum pump. As the bag is evacuated, the polystyrene beads form a rigid cushion that accurately conforms to the contours of the patient's extremity, and also to the sides of the thermoformed depression. The latter allows the vacuum cushion to locate reproducibly onto the board, while the patient's extremity can be reproducibly located into the pocket formed into the vacuum cushion.

Attachment points for standard low-melt thermoplastic (used to restrain patients undergoing radiation therapy) are provided for use in immobilizing the patient's extremities. A simple mechanical interlocking system allows the attachment of the lowmelt thermoplastic to the T-Form Extremity Immobilizer. Low-melt thermoplastic has the property of becoming soft and pliable when warm so that it can be stretched over and molded to the contoured shape of an object, in this case the patient. As it cools, it becomes rigid, and retains the object's shape. For the T-Form Extremity Immobilizer two non-adherent plastic handles are used to hold the low-melt thermoplastic. Simple screwtightened clamps mounted on the surface of the T-Form Extremity Immobilizer are used to secure the non-adherent plastic handles to the board. The low-melt thermoplastic sheet is stretched over the patient's extremity in its pliable form; once molded to the patient's anatomy, the customized low-melt thermoplastic sheet can be placed over the patient and "locked down" to the T-Form Extremity Immobilizer to ensure proper positioning for every therapy session.

The Bionix T-Form Extremity Immobilizer has a thermoformed ABS shell that displays minimal attenuation of the radiotherapy beam. This is due primarily to the fact that the thermoformed shell is relatively thin. The device has an open, air filled core that is radiolucent. The resulting structure provides strength and rigidity, and is ideal for producing a device that reproducibly positions patients and yet does not interfere with the administration of therapeutic radiation. Patient positioning devices with this type of structure are common in radiation therapy. They come in many varieties and are manufactured by several companies; examples including Civco Medical Solutions.

In clinical practice, the Bionix T-Form Extremity Immobilizer is secured to the therapy couch tabletop by attachment to a lock-down bar. The patient's extremity is positioned on the T-Form Extremity Immobilizer as desired, either directly onto the board or with the use of a vacuum cushion that has been evacuated to conform to the patient's anatomy. Low-melt thermoplastic is heated, and then draped in its warm, pliable state over the patient's extremity, and then secured to the T-Form Extremity Immobilizer using the screw-down clamps. When it cools, the low-melt thermoplastic becomes rigid and retains the shape of the patient's extremity, allowing it to be positioned and re-positioned securely during the radiation therapy regimen. Radiation therapy is then administered in the usual fashion.

The provided document is a 510(k) summary for the Bionix T-Form Extremities Immobilizer. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria, as typically seen in clinical performance studies for diagnostic or AI-powered devices.

This document is a submission for a Class II medical device accessory (Extremity Immobilizer for radiation therapy), and its clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, not on a clinical performance study with specific quantifiable metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

Summary of Device Comparison (from document):

The justification for acceptance appears to be based on the following comparison points to predicate devices (Multifix and HipFix by Civco Medical Solutions):

• Intended Use: The T-Form Extremities Immobilizer is for "positioning and re-positioning of patients for receiving external beam radiation therapy," which is identical to the predicate devices.
• Design Similarity:
  • Uses a base-plate-like structure (thermoformed ABS plastic shell) for attachment to the treatment couch tabletop via a lock-down bar.
  • Allows for reproducible positioning.
  • Incorporates features for securing patient extremities.
  • Allows use of vacuum cushions (optional for T-Form, integrated for HipFix).
  • Utilizes low-melt thermoplastic sheets to conform to the patient's extremity for immobilization and proper positioning, similar to both predicate devices.
• Radiolucency: The T-Form's thermoformed ABS plastic shell is described as lightweight, thin-walled, and having low attenuation for the radiation therapy beam, achieving radiolucency similar to the carbon fiber/foam composite materials used in the predicate devices. The open, air-filled core also contributes to radiolucency.
• Function: The document states that the "similarity of design, features, radiolucency, and function indicate that the T-Form Extremity Immobilizer... will perform as well as the legally marketed Multifix and HipFix immobilization devices."

In essence, for this type of medical device clearance, the "proof" the device meets acceptance criteria is the demonstration of substantial equivalence to already cleared devices based on design, materials, and intended function. There isn't a "study" in the traditional sense of a clinical trial or performance evaluation with quantifiable metrics against a defined acceptance threshold for algorithms or diagnostic tools.

Ask a specific question about this device

The Bionix Thigh and Foot Positioner patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio) is intended to be used for the positioning and re-positioning of patients for receiving external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The SuProne Plus from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy.

Thigh Bolster and Foot Positioner: The Thigh Bolster and Foot Positioner consist of two parts, a thigh support and a footrest. The thigh support portion has a generally tent-like shape, with formed contours to support the thighs and calves. The thigh support portion is designed to interface with the Bionix Secure-Bar, allowing it to be secured to the radiation therapy treatment couch in an index-able fashion. The thigh support portion also has attachment points for interlocks that allow the use of low-melt thermoplastic during the patient immobilization procedure. The Thigh Bolster and Foot Positioner are constructed of a thermoformed thermoplastic ABS shell with an air core. The Thigh Bolster and Foot Positioner also have simple mechanical interlocks that allows the individual parts to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the Thigh Bolster and Foot Positioner during the patient positioning process.

SuProne Plus: The SuProne Plus consists of a flat "headboard" comprised of a material with a carbon fiber/epoxy skin and a foam core that rests on a base-plate comprised of similar carbon fiber/epoxy composite material without the foam core. The headboard is designed to hold a patient's head in either the supine or prone position during treatment. An open area in the center of the headboard allows for prone positioning of the patient; during treatment, the patient's forehead and cheekbones rests on a foam cushion for support and comfort. For supine positioning, the patient's head rests on a thin plastic headrest for comfort. With both prone and supine positioning, low-melt thermoplastic may be used to further constrain patient movement. The headboard has clamps or other locking mechanisms that allow the low-melt thermoplastic to attach firmly to the device. The headboard rests on a base-plate made from a carbon fiber/epoxy resin composite material. This base-plate has three main elements: a base, side supports, and an upper frame that mates with the headboard. The base-plate base has simple mechanical interlocking systems that allow the device to be securely attached to the treatment couch tabletop using an attachment bar or similar device. The side supports of the base-plate provide rigidity and have semi-circular slots milled into the side support of the bas a rigid, open box-like design, and has locating pins that mate with the underside of the headboard. The sides of the upper frame have threaded pins that mate with the semi-circular slots in the side supports. These threaded pins allow the upper frame to move in an arcing fashion, following the semi-circular slots in the side supports. Tightening the threaded pins locks the upper frame at desired angle.

The provided document is a 510(k) Premarket Notification for two medical devices: the Thigh Bolster and Foot Positioner, and the SuProne Plus. This submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through a study with detailed quantitative outcomes.

Therefore, the document does not contain the information requested in sections 1-9 of your query, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria, sample sizes, expert adjudication, or MRMC studies.

Here's why the requested information is absent:

• No Acceptance Criteria or Reported Performance (Section 1): The document claims "similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam." However, these are qualitative statements of expected similarity to predicates, not specific measurable acceptance criteria with reported performance values as would be found in a performance study.
• No Test Set Sample Size or Provenance (Section 2): Since no performance study is detailed, there is no test set, sample size, or data provenance mentioned.
• No Experts for Ground Truth (Section 3): The submission relies on a comparison to existing devices, not on the generation of new ground truth for a test set.
• No Adjudication Method (Section 4): Not applicable as there's no diagnostic study requiring adjudication.
• No MRMC Study (Section 5): The document focuses on the physical characteristics and intended use of the devices, not on effects on human reader performance.
• No Standalone Performance Study (Section 6): The devices are patient positioning systems, not algorithms. Their performance is described in terms of their intended function (positioning and re-positioning patients for radiation therapy) and comparison to predicate devices, not as standalone diagnostic performance.
• No Ground Truth Type (Section 7): The "ground truth" here is the established safety and effectiveness of the predicate devices based on their long-term clinical use and FDA clearance. No new clinical ground truth is established for these devices in this submission.
• No Training Set Sample Size (Section 8): These are physical devices, not AI/ML algorithms that require training sets.
• No Ground Truth Establishment for Training Set (Section 9): Not applicable for the same reason as above.

The core of this 510(k) submission is the argument that the new devices are "substantially equivalent" to legally marketed predicate devices. This is achieved by comparing their design, materials, function, and intended use. The document repeatedly states:

• "This product is similar in design and function to existing patient positioning devices currently in use..."
• "The Bionix Thigh Bolster and Foot Positioner is substantially equivalent to the Med-Tec Dual Leg Positioner and Knee-and-Foot Lok in design, form, and function."
• "Based on the almost identical design and similar features...it is reasonable to expect that the two devices will have similar properties as regards to stiffness, support strength, and minimal attenuation of the radiotherapy beam, and should function in a substantially equivalent fashion..."

In summary, this document does not contain the information you requested because it's a regulatory submission demonstrating substantial equivalence through comparison, not a clinical trial or performance study with detailed acceptance criteria and quantitative results.

Ask a specific question about this device

The Bionix Pelvis BellyBoard PLUS patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Bionix SecureVac patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Bionix SecureFoam patient positioning system developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Bionix SecureFit Bar patient positioning device developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and repositioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Bionix Extended Butterfly Armboard patient positioning device, developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.

The Pelvis BellyBoard PLUS from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix Pelvis BellyBoard PLUS is flat and has a similar, generally rounded rectangular-shaped contour, with areas specifically designed for the head, abdomen, and thighs. Specially designed cushions that fit in these areas of the Pelvis BellyBoard PLUS are used to position and support the patient. The head cushion has a contoured opening so that the patient may rest his/her head comfortably in the prone position during the treatment process. The abdominal cushion is also designed with an open, contoured cutout region. The patient is positioned over the abdominal cushion such that the belly drops into the cutout region during the radiation therapy session. Contoured thigh cushions are provided for patient comfort and support. The cushions are affixed to the thermoplastic shell of the Pelvis BellyBoard PLUS using Velcro strips in the usual fashion. The Bionix Pelvis BellyBoard PLUS is constructed in a manner similar to the Advanced Belly board System from Med-Tec, having a thermoformed thermoplastic Kydex® shell with an air core that is an accepted standard in radiation therapy. The thermoformed Kydex® shell again provides stiffness and strength, while the air core allows for almost no attenuation of the radiation beam during the treatment process. The Pelvis BellyBoard PLUS also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow lowmelt thermoplastic to be attached to the Pelvis BellyBoard PLUS during the patient positioning process.

The SecureVac Immobilization System from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The SecureVac bags are constructed from strong, vinyl coated nylon material that is filled with small polystyrene spheres to immobilize the patient. Each bag is double sealed airtight and fitted with a self-closing valve for ease of use. It also features a pinch clamp system for more security. Once evacuated, the Secure Vac cushion holds a rigid shape over the course of the radiation therapy treatment regimen. The Bionix SecureVac Immobilization System is constructed in a manner similar to the Vac-Lok Immobilization System from Med-Tec, having a plastic nylon/vinyl film skin and filled with small polystyrene beads. The bag is sealed to be airtight, and an integral check valve is used to deflate and re-inflate the bag, and to maintain the bag in an evacuated state.

The SecureFoam from Bionix Development Corporation is designed to be used for the positioning and re-positioning of patients for receiving radiation therapy. The Bionix SecureFoam is a two-part foaming system comprised of Part B (polyol) and Part A (diisocyanate) components. The reaction of the polyol and diisocyanate components produces a water-blown polyurethane foam that hardens to rigidity as it cures. The polyurethane foam produced by this process is mostly air-filled, and thus has an air-equivalent radiolucency similar to that of the Med-Tec RediFoam.

The SecureFit Bar from Bionix Development Corporation is designed to be used for the indexing of patient immobilization devices to a treatment couch top. The Bionix SecureFit Bar is comprised of either aluminum or a rigid carbon fiber/epoxy laminate material. The SecureFit Bar has an engagement pin on one end and a cam-type pivot on its other end that allows it to lock into these indentations and securely hold the bar in position on the treatment couch top. Locator pins on the SecureFit Bar engage matching openings on the underside of the immobilization device, in this case the Bionix Pelvis BellyBoard PLUS, allowing the immobilization device to be reproducibly indexed to the treatment couch top.

The Extended Butterfly Armboard from Bionix Development Corporation is designed to be used for the positioning and repositioning of patients for receiving radiation therapy. The Bionix Extended Butterfly Armboard is constructed of a single piece of polycarbonate plastic material that is machined and thermoformed to achieve the final product design. The Extended Butterfly Board has elevated thermoformed "wings" on either side to support the patient's upper arms and facilitate patient positioning and comfort. An adjustable T-Bar handgrip is attached to the board. The T-Bar handgrip adjusts in both the horizontal and vertical direction to facilitate patient positioning and repositioning. Various headrests and cushions may be used to assist in patient positioning and improve patient comfort. The Bionix Extended Butterfly Armboard may be used alone or in conjunction with other patient positioning devices such as the Bionix Pelvis BellyBoard.

The provided document is a 510(k) Premarket Notification submission for the Pelvis BellyBoard PLUS and accessory products. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing a study proving the device meets specific performance acceptance criteria.

The document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or ground truth establishment for a test set.
• Number of experts or their qualifications, or adjudication methods for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Sample size for a training set or how ground truth for a training set was established.

Instead, the submission relies on the concept of substantial equivalence. It argues that the Bionix devices (Pelvis BellyBoard PLUS, SecureVac System, SecureFoam System, SecureFit Bar, Extended Butterfly Armboard) are so similar in design, construction, function, and intended use to existing, legally marketed predicate devices that they should be considered substantially equivalent.

The "study" that proves the device meets the acceptance criteria (interpreted here as demonstrating substantial equivalence) is the comparison presented in the 510(k) submission itself.

Here's a breakdown of the claims of substantial equivalence for each product:

1. Pelvis BellyBoard PLUS

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate devices, and function in a clinically identical fashion.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec Advanced Belly board System (K023293): Thermoformed plastic shell with a foam core, generally rectangular, specific areas for head, abdominal, and leg cushions (Velcro affixed), mechanical interlocking for couch attachment and low-melt thermoplastic masks. Minimal attenuation due to foam core (mostly air).
    • AccuFix IMRT Quick-fix Carbon Fiber Pelvis System (WFR/Aquaplast Corp.): Carbon fiber/epoxy skin with a foam core, provides strength, stiffness, and minimal attenuation. Can be indexed to treatment tabletops, used with low-melt thermoplastic for positioning.
  • Bionix Pelvis BellyBoard PLUS: Flat, similar rounded rectangular contour, areas for head, abdomen, thighs. Specially designed cushions (Velcro affixed), head cushion with contoured opening, abdominal cushion with open contoured cutout. Constructed with thermoformed Kydex® shell with an air core, providing stiffness, strength, and almost no radiation beam attenuation. Simple mechanical interlocks for couch attachment and low-melt thermoplastic. Can be used prone (with belly falling into cutout) or supine (with standard or custom SecureVac/SecureFoam cushions).
• Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Advanced Belly board System and similar design and intended use to the AccuFix IMRT Quick-fix Carbon Fiber Pelvis System, it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

2. SecureVac System

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec Vac-Lok System (K935300): Nylon-reinforced blue urethane bags filled with tiny polystyrene beads, airtight, closeable check valve. Air-equivalent radiolucency. Bags are evacuated to conform to anatomy, forming a rigid, re-positionable mold.
    • S&S Par Scientific Vac Fix System (K895697): Urethane film bag filled with polystyrene beads, check valve, airtight. Functions by evacuation to conform to patient anatomy.
  • Bionix SecureVac Immobilization System: Constructed from strong, vinyl-coated nylon material filled with small polystyrene spheres. Double-sealed airtight, self-closing valve, pinch clamp system for security. Evacuated bags form a rigid shape conforming to patient anatomy for re-positioning.
• Conclusion of Substantial Equivalence: Based on almost identical design, construction, and function to the Med-Tec Vac-Lok Immobilization System and the S&S Par Scientific Vac Fix System, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

3. SecureFoam System

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties and attenuation factors as the predicate devices, and function in a clinically identical fashion for patient positioning and repositioning.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Devices:
    • Med-Tec RediFoam (K951808): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown polyurethane foam. Mostly air-filled, effectively air-equivalent for minimal attenuation. Poured into a plastic bag, placed on immobilization device, expands around patient, cures to rigid, re-positionable mold.
    • Soule, Inc. Rapid-Foam (K952457): Two-part foaming agent (diisocyanate and polyol) reacting to form water-blown rigid polyurethane foam. Mostly air-filled, air-equivalent radiolucency. Functions by expanding around patient and curing to a rigid, re-positionable mold conforming to patient and immobilization device.
  • Bionix SecureFoam: Two-part foaming system (Part B polyol, Part A diisocyanate) reacting to produce water-blown polyurethane foam. Hardens to rigidity, mostly air-filled, air-equivalent radiolucency similar to Med-Tec RediFoam. Used in the same fashion as predicate devices: reacted components poured into a plastic bag, placed over patient immobilization device (e.g., Pelvis BellyBoard PLUS), expands around patient, rapidly cures to rigidity, forming a custom, re-positionable mold.
• Conclusion of Substantial Equivalence: Based on almost identical composition and mixing process to the Med-Tec RediFoam and Soule, Inc. Rapid-Foam, it is "reasonable to expect" similar properties and attenuation factors, and clinically identical function.

4. SecureFit Bar

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness and support strength as the predicate devices, and function in a clinically identical fashion for indexing patient immobilization devices.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Device:
    • Med-Tec Exact Lok-Bar (K973842): Rigid aluminum bar machined to couch width, engagement pins on underside for couch indentations. Cam-like pivot for tightening to couch. Locator pins on surface for corresponding holes on immobilization device. Not intended to be radiolucent as it's outside the treatment field.
  • Bionix SecureFit Bar: Comprised of either aluminum or rigid carbon fiber/epoxy laminate material. Engagement pin on one end and cam-type pivot on other end for locking into couch indentations. Locator pins engage matching openings on the underside of immobilization devices (e.g., Pelvis BellyBoard PLUS) for reproducible indexing.
• Conclusion of Substantial Equivalence: Based on almost identical design and construction to the Med-Tec Exact Lok-Bar, it is "reasonable to expect" similar properties (stiffness, support strength) and clinically identical function for reproductively indexing immobilization devices.

5. Extended Butterfly Armboard

• Acceptance Criteria (Implied by Substantial Equivalence): The device should have similar properties in terms of stiffness, support strength, and minimal attenuation of the radiotherapy beam as the predicate device (when positioned flat), and function in a clinically identical fashion.
• Reported Device Performance (as demonstrated by comparison):
  • Predicate Device:
    • Med-Tec MT-200 Acrylic Breastboard (K935412): Two pieces of machined acrylic plastic hinged to form a device. Upper piece for patient support (can be angled), lower piece as base. Notched rod for angle adjustment. Threaded rods serve as adjustable handgrips to elevate arms out of the treatment field. Used with cushions/headrests for comfort.
  • Bionix Extended Butterfly Armboard: Single piece of machined and thermoformed polycarbonate plastic. Elevated thermoformed "wings" to support upper arms. Adjustable T-Bar handgrip (horizontal and vertical adjustment) for patient positioning and repositioning, to keep arms elevated. Can use various headrests/cushions. Mounting holes for use with other devices.
• Conclusion of Substantial Equivalence: Based on similar design, composition, and construction to the Med-Tec MT-200 Acrylic Breastboard (specifically when the predicate is in the flat, true supine position), it is "reasonable to expect" similar properties (stiffness, support strength, minimal attenuation) and clinically identical function.

In summary, the "study" for these devices is the detailed comparison to predicate devices, asserting that the new devices share fundamental technological characteristics and intended use, and therefore can be expected to perform equivalently. No experimental studies with specific acceptance criteria, sample sizes, expert ground truth, or MRMC/standalone performance data are presented in this 510(k) submission.

Ask a specific question about this device

The VersaBoard patient positioning system developed and manufactured by Bionix Development Corporation, Toledo, Ohio, is intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

The Bionix VersaBoard is substantially equivalent to the Med-Tec S-Type Baseplate in design, construction, and function. The VersaBoard is flat and has a similar, generally torso-shaped contour. with an area specifically for the head, shoulders, and back. The head portion has a central open area where a thin plate of carbon fiber/epoxy is placed. This thin plate may have a waffle-like cutout, or a more sophisticated design that allows for the prone as well as supine positioning of the patient. The Bionix VersaBoard is manufactured according to the FDA Good Manufacturing Practice guidelines using standard methods and practices. The VersaBoard is constructed in the same manner as the S-Type Baseplate from Med-Tec, having a carbon fiber/epoxy/foam core composite structure) that is an accepted standard in radiation therapy. The carbon fiber/epoxy again provides stiffness and strength, while the foam core allows for almost no attenuation of the radiation beam during the treatment process. The VersaBoard also has simple mechanical interlocks that allow the board to be secured to the tabletop of the therapy couch. Other interlocks or clamps allow low-melt thermoplastic to be attached to the VersaBoard during the patient positioning process.

The provided document is a 510(k) Premarket Notification Summary for the VersaBoard Patient Positioning System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and studies as might be found in a De Novo submission or a PMA.

Therefore, many of the requested elements regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included or required in a 510(k) summary focused on substantial equivalence for a device like a patient positioning system.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not define specific, quantifiable acceptance criteria or provide a table of reported device performance in the way a clinical study would for a novel therapeutic or diagnostic device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The key "performance" metrics for patient positioning systems like the VersaBoard relate to their physical properties (strength, stiffness, minimal radiation attenuation) and their ability to reproducibly position patients without interfering with radiation therapy.

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

• Test Set Sample Size: Not applicable. The submission does not describe a clinical "test set" in the context of a performance study with patient data. It is a comparison of design and function of the device itself to predicate devices.
• Data Provenance: Not applicable. The "data" presented comprises descriptions of the device's design, construction materials, and intended use, along with comparisons to existing predicate devices. No patient or clinical data is provided or referenced from a specific country of origin, nor is it described as retrospective or prospective.

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

• Not applicable. No ground truth was established by experts for a test set in the context of this 510(k) submission. The submission relies on the established safety and effectiveness of the predicate devices. The submitter, James Huttner M.D., Ph.D., as Vice President, New Product Development, is an expert in the field.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set requiring adjudication in the context of a clinical study.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices to assess reader performance. The VersaBoard is a patient positioning system, not a diagnostic device.

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

• Not applicable. The VersaBoard is a physical medical device, not an algorithm. Therefore, "standalone" performance in the AI context does not apply. The device's function is inherently "with human-in-the-loop" as it is used by clinicians to position patients.

7. The Type of Ground Truth Used:

• Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices (Med-Tec S-Type Baseplate, Med-Tec Carbon Fiber Breast Board, Bionix Max 2 Deluxe TorsoBoard) as recognized by the FDA through prior clearances (K933227, K974703, K905007). The submission argues that since the VersaBoard is substantially equivalent in design, materials, and intended use, it inherently shares the "ground truth" of safety and effectiveness with these predicates.

8. The Sample Size for the Training Set:

• Not applicable. There is no concept of a "training set" for this type of physical medical device in a 510(k) submission.

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

• Not applicable, as there was no training set.

Ask a specific question about this device