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The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Twinheads® TH-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device, a lithotripter, and its clearance process through a 510(k) submission.

Here's a breakdown of why the requested information is absent and what the document does say:

1. A table of acceptance criteria and the reported device performance

• Not applicable to this document. This document is for a physical medical device (Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter), not an AI/ML device. Acceptance criteria for such a device would typically involve mechanical specifications, safety features, energy delivery parameters, and clinical efficacy (e.g., stone-free rates, re-treatment rates), which are not explicitly detailed as acceptance criteria in this summary. The "reported device performance" would typically be derived from clinical studies or non-clinical tests, neither of which are extensively detailed or used to establish "acceptance criteria" in this 510k summary.

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable to this document. No test set in the context of AI/ML validation is mentioned.

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 to this document. No ground truth for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No adjudication method for an AI/ML test set is mentioned.

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 to this document. No MRMC study or AI assistance is mentioned.

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

• Not applicable to this document. The device is a physical lithotripter, not an algorithm.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

8. The sample size for the training set

• Not applicable to this document. No training set for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

What the document does state regarding acceptance criteria and studies:

The document explicitly states:

• "No clinical studies were performed."
• The premise for clearance is substantial equivalence to a predicate device (Twinheads® TH-101 ESWL, K030346).
• The Twinheads® TH-103 ESWL is described as a "modification" of the predicate device, having the "same fundamental scientific technology and intended use."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the FDA's "substantial equivalence" determination, based on the device having similar technological characteristics and intended use to a previously cleared device, without the need for new clinical data. The "proof" is the comparison to the predicate device and the claim that the modifications do not change the fundamental scientific technology.

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The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Twinheads® TH-101 ESWL is a spark gap dual head shock wave lithotripter with an integrated fluoroscopy system for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-101 delivers a pair of shock waves, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing the fluoroscopy system via two orientations. A rapid current pulse discharges through a small gap in each of the two heads. The pulse discharge creates a shock wave, which radiates outward. Two identical ellipsoid reflectors serve to reflect and focus the shock waves, which are transmitted into the patient by a water cushion through a membrane and contact gel. There are two shockwave sources and two cushions in the Twinheads® TH-101 ESWL. Also included are an accurate motorized table and U-arm movements, high resolution fluoroscopy, and efficient shock wave energy sources.

The provided document describes a 510(k) premarket notification for the Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter. The acceptance criteria and the study proving the device meets them are outlined in section 7, "Clinical study."

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to the special controls guidance for ESWL devices as the acceptance criteria. The specific performance metrics assessed in human clinical trials for a new ESWL device would typically include:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 20 patients.
• Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin, but given the 510(k) submission to the FDA, it is highly probable the data was collected in the United States.
• Retrospective or Prospective: Prospective, as it states "20 patients were treated" indicating a clinical trial was performed.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). In a clinical study for a lithotripsy device, the success of "stone fragmentation" would typically be assessed by the treating urologists or other medical specialists involved in post-procedure imaging and patient follow-up.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1) for assessing the outcomes of the clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this summary. The study described is a confirmatory clinical study to demonstrate the device's functionality, safety, and effectiveness, not a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI algorithm. The study described assesses the device's ability to fragment stones in patients.

7. Type of Ground Truth Used:

The ground truth used was based on clinical outcomes (successful stone fragmentation) and safety assessments (absence of unanticipated adverse effects) in treated patients. While not explicitly detailed, these assessments would involve post-treatment imaging and clinical evaluation by medical professionals.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of an AI/ML algorithm. This device is a physical lithotripsy machine; therefore, the concept of a training set for an algorithm is not applicable here. The "clinical study" described serves as the primary evidence for its intended use, rather than a separate training and test set distinction typically associated with AI.

9. How Ground Truth for Training Set Was Established:

As there is no training set for an AI algorithm, this question is not applicable. The device's fundamental design and technological characteristics (Section 6) are based on established physics and engineering principles, and its performance is validated through the clinical study.

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