Search Results

To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors.

Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

Klarity Vacuum Cushions: The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment.

Klarity Mold Cushions: The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.

The provided text describes two medical devices, Klarity Vacuum Cushions and Klarity Mold Cushions, and their 510(k) submission for substantial equivalence. It does not contain information about specific acceptance criteria, performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as requested in the prompt. The submission focuses on demonstrating equivalence to predicate devices based on design, construction, intended use, and functioning, rather than presenting new performance data against statistical acceptance criteria.

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

Here's a summary of what can be extracted and what is missing:

Klarity Patient Immobilization Devices: Acceptance Criteria and Study Information

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified. The submission relies on a comparison to predicate devices rather than independent testing of a specific sample size.
• Data Provenance: Not applicable, as no new performance data or clinical study results are presented. The claims are based on the similarity to previously cleared devices.

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

• Not applicable. No ground truth was established by experts for a test set, as no independent performance study was conducted. The equivalence is established by comparing device characteristics to predicate devices.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication was used.

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

• No MRMC comparative effectiveness study was done. The submission is not focused on demonstrating an improvement in human reader performance with AI assistance, as these are physical immobilization devices without an AI component.

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

• Not applicable. These are physical patient immobilization devices, not algorithms. The concept of "standalone performance" as it relates to AI algorithms does not apply here.

7. Type of Ground Truth Used:

• Not applicable. The basis for clearance is substantial equivalence to predicate devices. This means the device is deemed safe and effective because it shares similar technological characteristics and intended use with devices already on the market (Klarity Vacuum Cushions to Bionix SecureVac Immobilization System, and Klarity Mold Cushions to Civco MoldCare/AccuForm™). No "ground truth" in the clinical performance sense was established for these specific Klarity devices.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets.

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

• Not applicable. No training set was used.

Summary of Device Equivalence Justification provided in the 510(k) submission:

• Klarity Vacuum Cushions:

  • Predicate Device: The SecureVac Immobilization System (K040773) manufactured by Bionix Development Corporation.
  • Basis for Equivalence:
    • Similar Construction: Both use polyurethane coated nylon material and are filled with small polystyrene spheres.
    • Similar Function: Both are sealed airtight with self-closing valves. Both work by evacuating air, causing the cushion to contract and hold a rigid, patient-conforming shape.
    • Similar Clinical Use: Both are used for positioning and repositioning patients during external-beam radiation therapy in the same manner.
    • Conclusion: Based on similarity in design, construction, and function, it is reasonable to expect similar properties, attenuation factors, and performance regarding use, safety, and effectiveness.

• Klarity Mold Cushions:

  • Predicate Device: The MoldCare head and neck cushion (K982624) marketed by Civco (now AccuForm™).
  • Basis for Equivalence:
    • Similar Intended Use: Both are designed for positioning and repositioning patients receiving external-beam radiation therapy.
    • Similar Outcome: Both harden to create a firm, patient-conforming support cushion.
    • Differing Mechanism (but achieving similar function):
      • Predicate (MoldCare): Polystyrene spheres mixed with a water-activated resin, hardening after water application (approx. 10 minutes).
      • Klarity Mold Cushions: Polystyrene spheres surrounded by a 1/16" layer of polycaprolactone thermoplastic. This material softens at 150°F (using oven or hot water bath) and becomes moldable for 5-8 minutes as it cools, then hardens. The thermoplastic technology is noted as commonly used in other radiation therapy devices (e.g., Klarity thermoplastic masks, 510(k)#022708).
    • Conclusion: Despite a different hardening mechanism, the devices achieve the same clinical function of conforming to and stabilizing the patient for radiation therapy, leading to a conclusion of substantial equivalence in use, safety, and effectiveness.

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