(90 days)
The PTW T31006 and T31007 Pinpoint type ionization chambers are intended to be used for the collection of beam data in water, air, or other suitable solid state phantom material from radiation therapy treatment machines. This data is used to completely document the beam characteristics of treatment machines and to establish and maintain an on going treatment machine quality assurance program.
The PTW T31006 and T31007 are classical waterproof ionization chambers that differ only in the lengths of their respective active volumes. The T31006 is a 0.015 cc ionization chamber with a 5 mm active length and the T31007 is a 0.005 cc ionization chamber with a 2 mm active length. Both chamber volumes are open to the atmosphere, they are waterproof, and they are vented via their connectors. These chambers are constructed of precisely the same materials, are available with a 1 m or 10 m cable for connection to an electrometer, and may be terminated in a variety of standard electrometer connectors (BNT, TNC, PTW M, or BNC banana.
Here's an analysis of the provided text regarding the PTW T31006 and T31007 Pinpoint type ionization chambers for their acceptance criteria and study information:
This submission is a 510(k) Premarket Notification for ionization chambers, which are measurement devices. As such, the concept of "device performance" in terms of clinical outcomes or diagnostic accuracy doesn't directly apply in the same way it would to an imaging or therapeutic device for patients. Instead, the "performance" here relates to their measurement accuracy, precision, and adherence to established specifications compared to predicate devices.
The document primarily demonstrates substantial equivalence to predicate devices rather than a standalone clinical study. Therefore, many of the requested fields regarding a clinical study will not be explicitly present.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Indications for Use: Same as predicate devices (PTW T31002, T31003). | Met: Intended for collecting radiation beam data in water, air, or solid-state phantoms from radiation therapy treatment machines to document beam characteristics and for QA programs. |
| Design: Same as predicate devices. | Met: Classical waterproof ionization chambers, differing only in active volume lengths. |
| Manufacturing and Testing Processes/Procedures: Same as predicate devices. | Met: Manufacturing and testing processes are identical. |
| Materials: Same as predicate devices, except for the steel electrode. | Met: Similar materials, with a noted difference in the electrode material but deemed equivalent in safety and effectiveness. |
| Specifications: Same as predicate devices. | Met: The submission states specifications are the same, implying they meet the same performance benchmarks as the predicate devices. |
| Safety and Effectiveness: No new issues raised compared to predicate devices. | Met: The manufacturer states no issues regarding safety and effectiveness are raised by the T31006 and T31007. |
Explanation of "Acceptance Criteria" for this device:
Since this is a 510(k) submission for a measurement device, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to already cleared predicate devices. The primary acceptance criterion is that the new devices do not raise new questions of safety or effectiveness and are equivalent in indications for use, technological characteristics, and performance to the predicate devices. The study, in this context, is the comparison to the predicate device and the assertion of equivalence.
Study Information (Based on 510(k) Submission)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not describe a traditional clinical study with a "test set" of patient data.
- The "test" here involves the characterization and comparison of the new devices (PTW T31006 and T31007) against the predicate devices (PTW T31002 and T31003) and their known specifications. The sample size would refer to the number of units tested, but this information is not provided in the summary.
- Data provenance (country of origin, retrospective/prospective) is not applicable or stated for this type of submission.
3. 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)
- Not applicable. This is not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for an ionization chamber's performance would be its physical measurement accuracy against traceable standards, which is not detailed in this summary, but would be part of the internal manufacturing and testing processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical adjudication method is described. The "adjudication" is internal to the manufacturer's quality control and testing processes demonstrating adherence to specifications and equivalence.
5. 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. This is not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a passive measurement device, not an algorithm. Its operation is standalone in the sense that it collects data without human interpretation during the collection, but the interpretation of the collected data is done by humans.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For a measurement device like an ionization chamber, the "ground truth" would typically be established by comparison to primary or secondary standards in a metrology laboratory, ensuring the device accurately measures radiation dose. This is not explicitly detailed in the 510(k) summary but is implied by the assertion of "specifications are the same as the predicate devices" and "routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision."
8. The sample size for the training set
- Not applicable. There is no machine learning or AI algorithm involved, so no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set.
§ 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.