(114 days)
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:
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not specified | Not specified | The 510(k) submission demonstrates substantial equivalence to predicate devices based on design and intended use, not through specific performance metrics and acceptance criteria. No quantitative performance data, such as precision, accuracy, or stability over time, is provided for either Klarity Vacuum Cushions or Klarity Mold Cushions. |
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.