(88 days)
The NOMOS Motorized CRANE II is intended to be used as an accessory to powered radiation therapy patient support tables. The NOMOS Motorized CRANE II verifies and describes, via a set of Z and X coordinates, the set-up of the table/patient prior to treatment.
The NOMOS Motorized CRANE II is a powered version of the manual NOMOS CRANE II. It is an accessory to radiation therapy patient support tables. Like the NOMOS CRANE II, the Motorized CRANE II attaches to the stationary base Elle the NOWOO OF through a permanently installed interface plate and clamps to the accessory rails of the moveable table top. The Motorized CRANE II can be the acod from the treatment table when its use is not required, leaving only the interface plate remaining on the stationary base of the treatment table. The Motorized CRANE II uses precision ball screw drive positioning mechanisms (one for the Z-axis and one for the X-axis) to position the table top relative to the stationary base of the treatment table. While these positioning mechanisms retain the small hand cranks employed in the predicate CRANE II to allow manual operation when needed, the primary drive force is provided by two electric motors – one for each axis of movement. These motors le provided and operator interface is provided through two touch screen are ooltware oon. One located on the device and one remote panel that can be placed in the treatment control room. The control panels display the position of the patient treatment table, and allow the operator to specify and initiate movement in the Z and X axes. Using the NOMOS CRANE II, the operator can move the treatment table over a range of 300 mm in each axis. When attached to a treatment table loaded to a maximum weight of 300 ounds, the NOMOS Motorized Crane II is capable of +/- 0.1 mm accuracy in the Zaxis, and +/- 0.4 mm accuracy in the X-axis. The Motorized CRANE II retains the battery-powered digital scales from the Crane II as an independent means of position verification.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NOMOS Motorized CRANE II:
The document provided (K013036) is a 510(k) summary for the NOMOS Motorized CRANE II, which focuses on demonstrating substantial equivalence to a predicate device (NOMOS CRANE II). Crucially, this document does not contain a detailed study report with methods, results, or statistical analysis. Instead, it states the specifications and claims equivalence.
Therefore, I cannot populate all the requested fields with specific study details. I will extract the available information and explicitly state when information is not provided in the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Expectation) | Reported Device Performance (Claimed Performance) |
|---|---|
| Accuracy in Z-axis: +/- 0.1 mm (when attached to a treatment table loaded to a maximum weight of 300 pounds) | Accuracy in Z-axis: +/- 0.1 mm (The document states the device is capable of this accuracy. It doesn't present data to prove it, but rather claims this as its specification, mirroring the predicate.) |
| Accuracy in X-axis: +/- 0.4 mm (when attached to a treatment table loaded to a maximum weight of 300 pounds) | Accuracy in X-axis: +/- 0.4 mm (The document states the device is capable of this accuracy. It doesn't present data to prove it, but rather claims this as its specification, mirroring the predicate.) |
| Range of Movement (Z-axis): 300 mm | Range of Movement (Z-axis): 300 mm |
| Range of Movement (X-axis): 300 mm | Range of Movement (X-axis): 300 mm |
| Independent Position Verification: Retains battery-powered digital scales | Independent Position Verification: Retains battery-powered digital scales |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "When attached to a treatment table loaded to a maximum weight of 300 pounds," implying a specific loading condition for testing, but does not detail the number of tests performed or readings taken.
- Data Provenance: Not specified. As this is a 510(k) summary focusing on equivalence, it doesn't describe originating data, but rather claims to meet specifications. It's likely internal engineering testing by NOMOS Corporation. The country of origin would presumable be USA, given the applicant's address.
- Retrospective or Prospective: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This device's performance is objective (positional accuracy), not subjective (like image interpretation). Ground truth would be established by high-precision measurement tools (e.g., laser interferometers, precision calipers, etc.), not human experts.
- Qualifications of Experts: Not applicable.
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Adjudication method for the test set:
- Adjudication method: Not applicable. As the ground truth is objective measurement of mechanical precision, human adjudication is not relevant.
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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:
- MRMC Study: No. This is a mechanical positioning device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The claims regarding +/- 0.1 mm and +/- 0.4 mm accuracy are standalone specifications of the device's mechanical and control system performance. While operators control the movement, the inherent accuracy is a characteristic of the device itself. The document does not describe a formal "standalone study" with methodology, but rather states the device "is capable of" this performance. No algorithm performance is described beyond the basic controls for movement.
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The type of ground truth used:
- Type of Ground Truth: Objective mechanical measurement using high-precision metrology tools (e.g., highly accurate encoders, laser measurement systems, etc.) to verify the actual position of the table.
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The sample size for the training set:
- Sample Size: Not applicable. This device utilizes electric motors and software controls for mechanical movement, not a machine learning or AI algorithm that requires a "training set" in the typical sense. The software would be developed and tested through traditional software engineering verification and validation (V&V) processes.
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How the ground truth for the training set was established:
- How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's control system development would be the desired mechanical behavior and accuracy specifications, which are translated into software requirements and tested against using established engineering principles.
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.