(52 days)
The Encompass™ SRS Headframe provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning, and immobilization. The Encompass™ SRS Headframe allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.
Qfix, has made a modification to its previously cleared Encompass™ SRS Immobilization System (cleared in K152321). In this modified variant of the Encompass™ SRS Immobilization System, the essential geometry of the head portion of the Encompass™ SRS Standalone Device is isolated to create a separate attachment which can be affixed to patient positioning devices that accept S-type thermoplastic masks, such as Qfix's Portrait™ Intracranial, Head and Neck Device (a device for use with S-type thermoplastics). Ofix intends to initially market the subject device for use with the Encompass™ SRS Fibreplast® System with optional IntegraBite™ (also cleared in K152321) and its devices which share a hole pattern and geometry with its Portrait™ Intracranial, Head and Neck Device. Examples of such devices include the kVue™ Portrait™ Intracranial. Head and Neck Insert and the Symphony® Portrait™ Transfer Device (cleared in K160627). This creates a flexible solution for a variety of imaging and radiotherapy treatment applications using stereotactic radiosurgery, such as radiation oncology and the treatment of noncancerous conditions and malformations such as trigeminal neuralgia.
The provided text is a 510(k) summary for the Qfix Encompass™ SRS Headframe, a medical device for patient immobilization during radiation therapy. It claims substantial equivalence to a previously cleared predicate device rather than presenting a novel AI/software-as-a-medical-device (SaMD) study. Therefore, the information typically requested about AI/SaMD acceptance criteria, test set details, expert ground truth, MRMC studies, and training set information is not present in this document.
However, I can extract information related to the device's performance claims and general testing.
Here's a breakdown of what can be extracted based on the provided text, and what cannot be extracted because it's not an AI/SaMD submission:
Acceptance Criteria and Device Performance (General Device Performance):
The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance data in the typical sense of a SaMD validation study. Instead, it makes a general claim about performance relative to its predicate device.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Accuracy/Immobilization | Provides sub-millimetric immobilization for imaging and radiotherapy, including SRS. |
| Limiting motion to less than 1 mm in most clinical applications using stereotactic radiosurgery. | |
| Compatibility | Compatible with radiation therapy environments, including stereotactic radiosurgery. |
| Accepts the same Encompass™ SRS Fibreplast® System patient immobilization masks. | |
| Intended for use with patient positioning devices that accept S-type thermoplastic masks (e.g., Qfix's Portrait™ Intracranial, Head and Neck Device). | |
| MR compatible variants (Encompass™ SRS MR Headframe is MR Safe per ASTM F2503-13). | |
| Safety & Effectiveness | No new questions of safety or effectiveness. |
| Risk management in compliance with ISO 14971:2007. | |
| Adheres to recognized and established industry practices and standards. | |
| Non-Clinical Bench Testing & Validation | Met all acceptance criteria for testing conducted and was appropriately validated per its intended use based on: |
- Verification of hardware specifications
- Accuracy validation via motion studies
- Ease of use/ergonomics assessments
- Verification of aluminum equivalence
- Verification of compatibility with optical tracking systems |
Information NOT available in the provided text (typical for AI/SaMD studies):
- Sample size used for the test set and the data provenance: Not applicable to this device type and submission. The document mentions "testing using healthy volunteers" for non-clinical bench testing but does not specify a sample size for these volunteers.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical immobilization device is typically established through direct measurement (e.g., motion studies, calibration) rather than expert interpretation of images or data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted device for diagnostic interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, ground truth for accuracy claims would be based on physical measurements (e.g., displacement measurements during motion studies) rather than expert interpretation or pathological findings.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.
Summary of Device and Study Type:
This 510(k) submission is for a physical medical device (Encompass™ SRS Headframe) used for patient immobilization during radiation therapy. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Encompass™ SRS Immobilization System, K152321). Therefore, the "study" described is primarily non-clinical bench testing and testing with healthy volunteers to ensure the modified device maintains the performance characteristics (e.g., sub-millimetric accuracy, compatibility) and safety profile of the predicate device, rather than a clinical trial or AI/SaMD validation study with diagnostic endpoints.
§ 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.