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aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.

The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient's skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.

Here's a breakdown of the acceptance criteria and study information for the aBSI device, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly define a table of "acceptance criteria" with specific performance thresholds. Instead, it refers to the device's performance through verification testing and clinical studies, demonstrating its ability to quantify the Bone Scan Index (BSI) and its association with clinical outcomes.

However, based on the performance data presented, here's an inferred table of performance aspects and reported findings:

Study Details

2. Sample size(s) used for the test set and the data provenance:

• Study I (Clinical Data):
  • Sample Size: 721 evaluable patients.
  • Data Provenance: Prospective, multi-site, international (241 sites in 37 countries, including the US). Part of a Phase 3 study (10TASQ10) for metastatic castration-resistant prostate cancer (mCRPC).
• Study II (Clinical Data):
  • Sample Size: 169 patients with bone scans available for aBSI analysis (from an initial 257 assessed patients).
  • Data Provenance: Retrospective study at Memorial Sloan Kettering Cancer Center (MSKCC) – single site, from Phase II/II clinical trials of agents targeting the androgen receptor (AR) signaling axis for metastatic prostate cancer.
• Bench Testing: No specific sample sizes for "test sets" are provided for linearity, accuracy, precision, or reproducibility studies. These are implied to be laboratory-based validation efforts, likely using standardized phantoms or controlled datasets that don't involve human patients as a "test set" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test sets in the clinical studies.

• Study I: Ground truth for overall survival, progression-free survival, and opioid-induced survival would typically be established by clinical follow-up and documented patient outcomes, not directly by image review experts for the aBSI.
• Study II: The comparison was against PCWG (Prostate Cancer Working Group) criteria for radiographic progression. PCWG criteria involve clinical interpretation, but the specific number of human readers or their qualifications used to apply these criteria for the 169-patient test set is not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies. For the clinical outcomes (e.g., overall survival), these are typically determined by the course of the disease and patient records, not through an adjudication process by image readers. For PCWG criteria, it's not detailed how consensus or disagreement was handled.

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 involving human readers with and without AI assistance is mentioned in the provided text. The clinical studies focused on the performance of the aBSI algorithm itself in relation to clinical outcomes and PCWG criteria, rather than comparing human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, standalone performance was assessed. The reported clinical studies (Study I and Study II) evaluate the aBSI algorithm's performance (its quantitative assessment of BSI) as a standalone predictor or correlate of clinical outcomes (OS, progression, opiate use) and against PCWG criteria. The device is a "software-only medical device that provides a fully quantitative assessment."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Study I: The "ground truth" was clinical outcomes data (overall survival, progression-free survival, opioid-induced survival) rather than a direct image-based expert consensus.
• Study II: The "ground truth" for comparison was PCWG criteria for radiographic progression (which represents consensus clinical guidelines for assessing progression) and overall survival (outcomes data).

8. The sample size for the training set:

The document does not provide any information about the sample size used for training the aBSI algorithm. It only details the studies used for clinical evaluation and verification.

9. How the ground truth for the training set was established:

The document does not provide any information on how ground truth was established for the training set, as details about the training process are not included in this 510(k) summary.

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