(88 days)
The TLC Pediatric Frame is intended for use as a stereotactic platform for fractionated (multiple, lower dose) LINAC-based radiation treatments and related CT and angiographic imaging in the cranium for the treatment of pediatric patients.
The TLC Pediatric Frame is a Re-locatable Head Holder System. The device consists of a base frame that combines the attachment of various sized plastic occipital head cups, left and right earplug tips, and a mold of the patient's frontal, nasion and lateral of eyes. The Radionics' Depth Helmet attaches to the frame and depth measurements are maintained to allow the operator to re-locate the patient for each radiation therapy treatment.
The provided text describes the 510(k) summary for the Radionics TLC Pediatric Frame, a re-locatable head holder system for pediatric radiation therapy. However, it does not contain a specific study with detailed acceptance criteria and reported device performance metrics in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Radionics Gill-Thomas-Cosman (GTC) Re-locatable Head Holder System, K934523), rather than presenting a standalone performance study with quantitative acceptance criteria.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the TLC Pediatric Frame. Instead, it relies on demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated, inferred from 'substantial equivalence') | Reported Device Performance |
|---|---|---|
| Relocatable Accuracy | (Implied to be comparable to predicate's established accuracy for LINAC-based radiation treatments and imaging) | Not Quantified |
| Patient Comfort/Fit | (Implied acceptability for pediatric use, similar to predicate's adult use with pediatric adaptations) | Not Quantified |
| Image Compatibility | (Implied compatibility with CT and angiographic imaging, similar to predicate) | Not Quantified |
| Safety | (Implied to be safe, with "quality assurance equipment and procedures to verify, prior to patient treatment, that the TLC Frame is accurately positioned".) | Not Quantified |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements." However, it does not specify the sample size used for these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a mechanical device like a head frame, the "test set" would likely refer to a series of physical measurements and experiments conducted in a lab setting, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for the "test set" in the context of clinical accuracy or diagnosis. The testing described appears to be engineering verification and validation against product requirements, likely performed by the manufacturer's internal engineering team.
4. Adjudication Method:
Since no expert input for ground truth is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic AI tools where human readers interpret images. The TLC Pediatric Frame is a physical medical device.
6. Standalone Performance Study:
The document states: "Non-clinical tests were conducted to demonstrate that the TLC Pediatric Frame meets all product requirements." This implies a standalone (algorithm only, though in this case, device only) performance assessment against pre-defined engineering requirements. However, no quantitative performance metrics from such a study are provided in the summary. The focus is on substantial equivalence to the predicate device.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" would be the engineering specifications and design requirements for the device (e.g., dimensional accuracy, stability, material properties, repeatability of positioning). There is no mention of clinical ground truth derived from pathology, outcomes data, or expert consensus in this summary.
8. Sample Size for the Training Set:
Not applicable. The TLC Pediatric Frame is a physical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. (See point 8).
In summary:
The provided 510(k) summary for the Radionics TLC Pediatric Frame is focused on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and non-clinical performance testing. It does not provide the detailed quantitative acceptance criteria and study results typically found in performance studies for diagnostic or AI-driven medical devices. The "study" mentioned is general non-clinical testing to ensure the device meets its product requirements and is comparable to the predicate.
§ 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.