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Elcam Stopcocks and Manifolds are indicated for fluid flow directional control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration and transfusion.

Elcam Stopcocks and Manifolds are composed of a body with two or three ports and a handle. Each port has either a male or female connector. Male connectors also include a nut for locking over the female connector of another component. A small amount of lubricant is applied between the stopcock body and handle. Elcam Stopcocks and Manifolds will be available in a wide variety of configurations for use according to the particular situation and the clinician's preference.

This document is a 510(k) summary for Elcam Stopcocks and Manifolds, a medical device. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria for the Elcam Stopcocks and Manifolds device. Instead, it relies on demonstrating substantial equivalence to a predicate device and satisfactory results from standard performance and biocompatibility testing. Since no explicit numerical criteria are offered, a table cannot be constructed with "reported device performance" against those criteria.

However, we can infer the general acceptance conditions from the information provided:

Study Details

Based on the provided text, the following information can be extracted regarding any "study" conducted:

1. Sample size used for the test set and the data provenance:

   • Sample size: Not specified. The document uses phrases like "Standard testing" and "A biocompatibility assessment was performed," but does not provide any numerical sample sizes for these tests (e.g., number of stopcocks tested, number of material samples).
   • Data provenance: Not explicitly stated. The manufacturer is Elcam Plastic Kibbutz BarAm Merom Hagalil 13860 Israel. The testing was conducted as part of their submission to the US FDA. The nature of the testing (bench, in-vitro, etc.) is implied rather than explicitly detailed as retrospective or prospective clinical data.

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

   • Not applicable/Not specified. For mechanical devices like stopcocks and manifolds, "ground truth" is typically established by engineering specifications, validated test methods, and industry standards, rather than expert clinical consensus in the way it would be for diagnostic algorithms. The "satisfactory results" mentioned for performance and biocompatibility testing imply that the results met predefined engineering and safety standards, but no expert panel is detailed.

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

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth for diagnostic imaging algorithms where there's subjectivity. For performance and biocompatibility testing of a simple medical device, results are usually objectively measured against predefined criteria.

4. 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, an MRMC study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this device (stopcocks and manifolds for fluid control).

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

   • Not applicable. This device is a manual, mechanical component. There is no algorithm involved.

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

   • For performance testing: Ground truth would be defined by engineering specifications, established industry standards (e.g., for luer fittings, pressure resistance, flow rates), and regulatory requirements for fluid administration devices.
   • For biocompatibility: Ground truth would be established by validated toxicology and material safety standards (e.g., ISO 10993 series).

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not applicable, as there is no training set for this type of device.

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The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.

MASTER Handpiece: The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.

3.2 mm Probe: The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.

The provided text describes a 510(k) summary for the ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and 3.2 mm Probe, seeking clearance based on substantial equivalence to predicate devices. The submission details various tests performed to support this claim for both the handpiece and the probe.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it describes various tests performed to demonstrate substantial equivalence to existing predicate devices. The implication is that the performance of the new device (MASTER Handpiece and 3.2 mm Probe) was considered acceptable if it performed comparably to, or improved upon, the predicate devices in the specific tests mentioned.

Here's an interpretation of the performance and implied criteria based on the text:

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 specify sample sizes for any of the tests performed (lifetime, displacement, velocity, impact pressure, disintegration efficiency, in-vitro tissue impact studies).

The data provenance (country of origin, retrospective/prospective) is also not mentioned in this summary. It's likely these were in-house laboratory tests conducted by ELECTRO MEDICAL SYSTEMS SA, which is based in Nyon, Switzerland.

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)

This section is not applicable to this submission. The tests described are bench or in-vitro performance studies, not clinical studies involving expert interpretation of patient data to establish ground truth.

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

This section is not applicable. No human interpretation or adjudication of results is mentioned for these performance tests.

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

There is no MRMC study mentioned, as this is a device for fragmenting kidney stones, not an AI-assisted diagnostic tool where human readers would be involved.

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

This is not applicable in the context of an AI algorithm. The device itself (handpiece and probe) is the standalone entity, and its performance was evaluated in various bench and in-vitro tests without human assistance during the actual fragmentation process, although a surgeon would operate it.

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

For the performance tests mentioned, the "ground truth" would be established by:

• Measurement of physical parameters: For "lifetime," "probe displacement," "probe velocity," and "impact pressure," the ground truth would be directly measured physical quantities using appropriate sensors and equipment.
• Quantitative results of efficacy: For "disintegration efficiency," the ground truth would be objectively measurable outcomes like the extent of stone fragmentation or reduction in stone mass.
• Observable effects: For "in-vitro tissue impact studies," the ground truth would involve observable or measurable effects on the tissue, often compared against a control or predicate device's effects.

8. The sample size for the training set

This is not applicable. This is a hardware medical device clearance, not an AI/machine learning application requiring a training set.

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

This is not applicable for the same reason as above.

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