(84 days)
The Prone Breast Positioning Board, model number 37-018 is to be used as a positioning device in patient set-up for primary breast irradiation.
The Prone Breast Positioning Board is a linear accelerator couch-mounted platform which enables the breast to hang in a comfortable, gravity-dependent fashion for treatment with opposed tangential photon beams.
The provided document, K971382, describes a Premarket Notification [510(k)] for the "Prone Breast Positioning Board, Model #37-018." This submission primarily focuses on establishing substantial equivalence to a predicate device, rather than proving a novel device meets specific performance acceptance criteria through an independent study.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable (N/A) in the context of this 510(k) submission. This is because the 510(k) pathway is designed to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically require extensive novel clinical studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) pathway might.
However, based on the information provided, we can extract details related to the comparison performed to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are implicitly tied to demonstrating that the new device is as safe and effective as the predicate device. The performance is reported through a comparative analysis rather than meeting predefined quantitative metrics for a new claim.
| Criterion Type (Implicit for 510(k)) | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (positioning in primary breast irradiation) | "To be used as a positioning device in patient set-up for primary breast irradiation." |
| Safety | No new issues relating to safety compared to predicate device | "The conclusions drawn... demonstrate that the Prone Breast Board... presents no new issues relating to safety and effectiveness..." |
| Effectiveness | No new issues relating to effectiveness compared to predicate device; Clinical and Dosimetric advantages demonstrated | "...and is substantially equivalent to the legally marketed predicate device..." Clinical benefits (large/pendulous breasts, lung/heart avoidance, reduced skin reaction, simplifies breast boosts) and Dosimetric benefits (reduced internal scatter, minimized scatter to contralateral breast, no wedges needed). Sample treatment plans showed uniform dose distribution vs. hot spots in supine treatment. |
| Technological Characteristics | Differences do not raise new questions of safety/effectiveness | Differs from predicate in prone vs. supine positioning, with claimed advantages supported by literature and sample treatment plans. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The document explicitly mentions "Two sample treatment plans (exhibits F and G) labeled 'Jones, Pearl' are attached." This indicates a sample size of one patient with two treatment plans (prone and supine for comparison) were used for the non-clinical performance data portion.
- For the clinical study/test data, the submission references two external articles (Exhibits "H" and "I"). The sample sizes for these articles are not provided in this 510(k) document.
- Data Provenance:
- The "Jones, Pearl" treatment plans are presented as internal data to the submission, likely from the manufacturer or an affiliated institution. Country of origin is not explicitly stated but implied to be the US, given the submission to the FDA. The nature (retrospective/prospective) of these specific plans is not stated.
- The external articles (Exhibits "H" and "I") would have their own data provenance, which is not detailed in this 510(k) summary. One article is from "The Official Journal," suggesting a peer-reviewed publication.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Jones, Pearl" sample treatment plans: The creation and interpretation of these treatment plans would typically be performed by medical physicists and/or radiation oncologists. The document references the expertise of the authors of the referenced articles ("Thomas E. Merchant, D.O., and Beryl McCormick, M.D."). These are medical doctors, likely radiation oncologists, but the exact number of experts involved in the "ground truth" for the submitted sample plans is not specified.
- For the referenced articles (Exhibits H and I): The ground truth would be established by the authors and peer reviewers of those respective studies, whose qualifications are not detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None explicitly stated for the "Jones, Pearl" treatment plans. It appears to be an internal comparison exercise rather than a multi-reader, adjudicated study.
- The referenced articles (Exhibits H and I) would have their own research methodologies which are not detailed here.
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:
- No MRMC comparative effectiveness study was done. This device is a physical positioning board, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (breast positioning board), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "Jones, Pearl" sample treatment plans: The "ground truth" for demonstrating dosimetric advantages is based on medical physics calculations and interpretation of dose distributions, which represents an expert-driven simulation and analysis, possibly reflecting accepted clinical practice for judging treatment plan quality.
- For the referenced articles: The ground truth would be based on the methodologies specific to those studies (e.g., clinical outcomes, dosimetric measurements, simulated patient data), but this is not specified within the 510(k) document.
8. The sample size for the training set:
- Not applicable. This submission focuses on demonstrating substantial equivalence of a physical device. There is no AI algorithm being "trained" in this context. The "training data" for the concept of prone breast positioning would be general medical knowledge and the body of scientific literature, implicitly represented by the referenced articles.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no discrete "training set" in the AI sense for this physical device. The information supporting the benefits of prone breast positioning is derived from established medical literature and clinical understanding, as evidenced by the cited articles.
§ 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.