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The Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

Device Description

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. The Medtronic StrataMR™ valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMR™ valve can by modified by means of a magnetic adjustment tool.

AI/ML Overview

The provided document describes the Medtronic StrataMR™ Valves and Shunts and details the testing performed to demonstrate its substantial equivalence to a predicate device (Medtronic PS Medical Strata Type Valve (K060681)). The information focuses on bench testing and biocompatibility testing, rather than a study involving AI performance or human reader studies.

Therefore, many of the requested criteria regarding AI performance, human reader studies, and large-scale data sets (like training or test sets for AI) are not applicable to this device's submission and the testing described. The device is a physical medical device (a shunt valve), not a software or AI-driven diagnostic tool.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent/not applicable:

Analysis of Acceptance Criteria and Proving Device Performance

The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device. This means the acceptance criteria are largely tied to meeting performance benchmarks that are comparable to or better than the predicate, as well as showing the new design changes (primarily for improved MR resistance) do not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a summary of bench tests with their methods and results. The "acceptance criteria" are implied by the "Results" column stating "All valves met acceptance criteria," or by explicitly stating values (e.g., for biocompatibility).

Test	Test Method Summary	Acceptance Criteria Implied/Stated	Reported Device Performance
Bench Testing
Resistance to leakage	Measured using air. Required no leakage for 5 minutes with a differential pressure of 1 m H2O.	No leakage for 5 minutes with 1 m H2O differential pressure.	All valves met acceptance criteria, demonstrating no concerns regarding valve integrity/leakage relative to the predicate device.
Reservoir dome needle puncture	Show no leakage when repeatedly punctured with a non-coring needle under pressure.	No leakage after repeated punctures.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Dynamic breaking strength	Tension applied in flow direction (10% elongation or 5 N max force). No break, rupture, or disconnection after 100,000 cycles at 1.0 ± 0.2 Hz.	No break, rupture, or disconnection after 100,000 cycles.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Pressure/flow	Tested according to ISO 7197:2006. Measured pressure to remain inside manufacturer's specifications.	Measured pressure must be within manufacturer's specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Siphon control device casing effect	Compared valve pressure at -50 cm hydrostatic pressure with 0 cm. Difference to meet manufacturer's specifications.	Difference in pressure must meet manufacturer's specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Ability to withstand overpressure	After application of positive pressure (1 m water per ISO 7197:2006), valves to meet pre-established pressure/flow specifications.	Valves must meet pre-established pressure/flow specifications.	All valves met acceptance criteria, demonstrating no concerns regarding pressure/flow performance relative to the predicate device.
Bursting pressure	After application of positive pressure (2 m water per ISO 7197:2006), valves to meet pre-established pressure/flow specifications.	Valves must meet pre-established pressure/flow specifications.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Long term stability	Valves in water bath (37°C ± 5) with pumping water (20 mL/h) for 28 days. Valves to maintain pre-established pressure/flow specifications.	Valves must maintain pre-established pressure/flow specifications after 28 days.	Results not explicitly stated as "met acceptance criteria" in table, but overall conclusion states "all cases, the results of bench testing met applicable pre-established acceptance criteria."
Identification of shunts in vivo	X-ray imaging. Valve identification markers must be visible and valve setting readable.	Valve identification markers visible and valve setting readable in X-ray images.	All valves met acceptance criteria, demonstrating no concerns regarding identification of the valve via X-ray relative to the predicate device.
Post-MRI functional testing	Exposed to multiple MRI exposures in clinically relevant orientation. Valves to maintain pre-conditioning pressure setting, be readable and adjustable, and meet pre-established pressure/flow specifications.	Maintain pre-conditioning pressure setting, be readable/adjustable, and meet pre-established pressure/flow specifications after MRI.	All valves met acceptance criteria, demonstrating no concerns regarding valve performance after MRI exposure relative to the predicate device.
Design validation testing	Surgeon evaluators read and adjusted valves, pre- and post-implantation in cadavers.	Evaluators must be able to successfully read and adjust valves.	In all cases evaluators were able to successfully read and adjust the valves, demonstrating no concerns related to valve readability/adjustability relative to the predicate device.
MRI safety testing	Magnetically induced displacement force (ASTM F2052-15), magnetically induced torque (ASTM F2213-06), radio frequency induced heating (ASTM F2182-11a), image artifact testing (ASTM F2119-07).	Test results demonstrated MR conditional and no MRI safety concerns relative to predicate when scanned per labeling conditions.	Test results demonstrated that StrataMR valves are MR conditional and that there are not MRI safety concerns relative to the predicate device when scanned according to the MR conditions specified in the labeling.
Biocompatibility Testing (Shunt)
Cytotoxicity	ISO MEM Elution. Incubated at 37°C for 48 hr. Examined microscopically for abnormal cell morphology and cellular degeneration.	Extract must show no evidence of causing cell lysis or toxicity (score = 0). Test article must meet requirements (score ≤ 2).	Pass. Extract showed no evidence of causing cell lysis or toxicity (score = 0). Test article met requirements of the test (score ≤ 2).
Irritation	ISO Intracutaneous Study in Rabbits. Extracted separately in saline and sesame oil. Observations for erythema and edema at 24, 48, and 72 hr.	Scores ≤ 1.0.	Pass. Scores = 0.0 for saline and 0.1 for oil. Extracts met requirements of the test (score of 1.0 or less).
Acute systemic toxicity	ISO Systemic Toxicity Study in Mice. Extracted separately in saline and sesame oil. Observations for signs of systemic toxicity at 0, 4, 24, 48, and 72 hrs.	No mortality or evidence of systemic toxicity.	Pass. No mortality or evidence of systemic toxicity from extracts. Extracts met requirements of the test.
Material-mediated pyrogenicity study	USP Material-Mediated Pyrogen Study. Extracted in saline. Rectal temperatures measured prior to injection and at 30 min intervals between 1 and 3 hours.	Total temperature rise during 3 hr period ≤ 0.5°C (max rise of 0.2°, 0.2°, and 0.1°C for three rabbits). No single animal showed rise of ≥0.5°C and total temp rise

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