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The CSS Cannulated Screw System will be indicated for use in long and small bone fracture fixation, which includes the following;

• Fractures of the tarsals and metatarsals
• Fractures of the olecranon, distal humerous
• Fractures of the radius and ulna
• Patella fractures
• Distal tibia and pilon fractures
• Fractures of the fibula, medial malleolus, os calcis
• Tarso-metatarsal and metatarsal phalangeal arthrodesis
• Metatarsal and phalangeal osteotomies
• Osteochondritis dissecans
• Ligament fixation
• Other small fragment, cancellous bone fractures and osteotomies

The CSS Cannulated Screw System consists of cannulated screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which are optional, as well as guide wire and various instruments.
The cannulated screws are self tapping. They are made from made from Titanium Ti-6Al-4V ELI Alloy in conformance with ASTM F-136 Standard Specification for Wrought Titanium 6Al-4V ELI Alloy for Surgical Implant Applications.
The CSS System includes (4) different types of washers. These are; Flat Washers, Contoured Washers, Partial Contoured Washers, and Domed Washers. The various styles are intended to offer the surgeon a variety of anatomical fit to the bone in certain applications.

The provided text describes the CSS Cannulated Screw System and its substantial equivalence to a predicate device, the Howmedica Asnis III Cannulated Screw System (K000080).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a separate "test set" in the context of clinical data for the device's performance. The performance evaluation was primarily mechanical and computational.

• Sample size for test set: Not applicable in the context of human data. For the mechanical and computational analysis, the "samples" would refer to the designs modeled and tested. The document implies a comparison of the CSS Cannulated Screw System against the predicate device.
• Data provenance: Not applicable. The data is from in-vitro mechanical testing and computational modeling (Finite Element Analysis) performed by the manufacturer, OrthoHelix Surgical Designs, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. Ground truth in this context refers to mechanical properties and substantial equivalence, not clinical diagnostic accuracy or efficacy requiring expert consensus for a test set.

4. Adjudication Method for the Test Set:

Not applicable. This concept pertains to resolving discrepancies in expert interpretations of clinical data, which is not relevant to this type of device submission.

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. The CSS Cannulated Screw System is a physical medical device (cannulated screws) for orthopedic fixation, not a software or AI-driven diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. As noted above, this device is not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for demonstrating substantial equivalence was the known mechanical performance and design specifications of the legally marketed predicate device, the Howmedica Asnis III Cannulated Screw System. This served as the benchmark against which the CSS Cannulated Screw System's performance (via FEA and performance testing) was compared.

8. The Sample Size for the Training Set:

Not applicable. The concept of a "training set" typically refers to data used to train machine learning models and is not relevant to the evaluation of this physical medical device. The design and materials are based on established engineering principles and materials science for medical implants.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set in the context of machine learning, no ground truth was established for it. The design and manufacturing process would adhere to established standards (e.g., ASTM F-136) and engineering best practices for orthopedic implants.

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The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.

The provided text describes a 510(k) summary for the "CSS" (Coagulation Device) a modification to the MSI Bipolar Sheath. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• Specific quantitative or qualitative acceptance criteria beyond "substantially equivalent" and "no new safety/efficacy concerns."
• Detailed performance metrics (e.g., coagulation time, tissue effect, safety margins for specific power differences).
• Actual data demonstrating how the device met these criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified. It's bench testing, so likely conducted in a lab setting, but no country of origin is mentioned. The testing is retrospective, as it's for verification of a device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. The study involved bench testing, not human interpretation or clinical data requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set:

• Not applicable. As this was bench testing, there's no mention of an adjudication method among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This device is an accessory for surgical procedures, and the testing described is bench testing, not a clinical study involving human readers interpreting cases.

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

• Yes, in a way. The "bench testing" can be considered a standalone performance evaluation of the device itself (not an algorithm), without human-in-the-loop performance influencing the device's basic functionality. However, it's not "algorithm only" as there's no explicit algorithm described.

7. The Type of Ground Truth Used:

• For the bench testing, the "ground truth" would be engineering specifications and design input requirements for functionality, materials, and power characteristics. This is based on engineering/design specifications for the device.

8. The Sample Size for the Training Set:

• Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as no training set is mentioned.

In summary, the provided document describes a 510(k) submission for a medical device accessory (CSS) that relies on demonstrating substantial equivalence through bench testing to established predicate devices. It does not provide the detailed study design, specific acceptance criteria, or quantitative results typical of studies for novel devices or AI/software as a medical device (SaMD).

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The Medtronic CSS™ Cardioplegia Safety System is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures.

The Medtronic CSS Cardioplegia Safety System Model 990 consists of an electro-mechanical instrument and disposable Cardioplegia Sets. The instrument delivers cardioplegia solution through dual peristaltic independently operated pumps (one for blood, one for crystalloid). It monitors volume delivered, flow rate (adjustable from 0 - 990 ml/min), and pressure (line and external). It also includes temperature monitoring capabilities, gross air detection using ultrasonic technology, and two independent elapsed timers. The instrument has a color central information display and a two-stage alert-alarm process. It has battery backup for 60 minutes of "On" time and 15 minutes of pumping time. The disposable sets are single use, sterile, and nonpyrogenic, designed to mix arterial blood and asanguineous cardioplegia solution at various ratios. The sets include silicone tubing and polycarbonate connectors and are available in four configurations, with or without a heat exchanger and with standard or dual lumen patient lines.

The Medtronic CSS Cardioplegia Safety System Model 990 is intended for use as a cardioplegia delivery system which controls, monitors, and delivers oxygenated blood and/or asanguineous solutions during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than fully detailing a study against specific acceptance criteria for novel performance claims. However, it does present performance data for various features of the device as part of the substantial equivalence argument, which can be interpreted as meeting certain "acceptance criteria" by comparing them to predicate devices or manufacturer's specifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparative table where the Medtronic CSS's features and performance specifications are listed alongside those of predicate devices (Sorin BCC, Quest MPS, Sarns 9000). While it doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical claims, the comparison table implicitly defines the acceptable performance range by demonstrating equivalence to already cleared devices or meeting internal specifications.

* "Based on customer input this accuracy is sufficient for this application"

2. Sample Size Used for the Test Set and Data Provenance

The document describes "In-Vitro Bench Testing" and "Biocompatibility Testing."

• Test Set Sample Size: Not explicitly stated for any of the individual bench tests. The document only lists the types of tests conducted. For biocompatibility, it states "these devices were tested," implying a sample was used but no number is provided.
• Data Provenance: The tests described are "In-Vitro Bench Testing" and "Biocompatibility Testing." This indicates the data is from retrospective laboratory experiments conducted by the manufacturer, Medtronic Bio-Medicus, Inc. There is no mention of human subject data or data from specific countries of origin beyond the company's location in Eden Prairie, MN, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a cardioplegia delivery system, and the studies performed are bench tests and biocompatibility tests. There is no diagnostic component requiring human expert ground truth for interpretation of medical images or patient conditions. The "ground truth" for these tests would be the established engineering specifications, chemical/biological standards, and physical measurements.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not relevant for bench or biocompatibility testing. The "adjudication" would involve comparing test results against predefined engineering specifications and regulatory standards.

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

No, a Multi-Reader Multi-Case comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and their performance with and without AI assistance is compared. The Medtronic CSS Cardioplegia Safety System is a therapeutic delivery system with monitoring capabilities, so an MRMC study is not relevant to its function and claims.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the "In-Vitro Bench Testing" and "Biocompatibility Testing" can be considered standalone performance evaluations. These tests assess the device's intrinsic mechanical, electrical, and material properties and performance against specifications without direct human-in-the-loop interaction for the specific performance endpoint being measured (e.g., pump flow accuracy, pressure detection, air bubble detection). The control system (microprocessor, software) within the instrument operates autonomously during these tests to fulfill its functions.

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

• Engineering Specifications: For parameters like flow accuracy, pressure accuracy, temperature accuracy, timer accuracy, and constant pressure mode performance, the ground truth is the device's designed operational specifications and performance limits. These are then compared to the measured performance.
• Physical Measurements: Directly measured flow rates, pressures, temperatures, and times.
• Biological/Chemical Standards: For biocompatibility, the ground truth is established by recognized international standards (ISO 10993-1, USP XXIII) and FDA guidelines. For EtO residuals, it's ANSI/AAMI/ISO 10993-7:1995. For pyrogen testing, it's FDA guidelines.
• Visual/Physical Detection: For gross air detection, the ground truth would be the presence of a known air bubble of a specified size.

8. Sample Size for the Training Set

Not explicitly stated. As this is a 510(k) for a hardware device with embedded software (not a machine learning/AI diagnostic system generating models from data), the concept of a "training set" in the context of statistical modeling or AI development is not directly applicable in the way it is for imaging algorithms. Any "training" or calibration would likely refer to internal iterative development and testing against specifications, rather than data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the typical AI/ML sense. For hardware and embedded software development, the "ground truth" during development (if we were to loosely interpret "training set" as development data) would be established by engineering design specifications, safety standards, and performance targets derived from clinical requirements and predicate device performance. This would involve rigorous internal testing, debugging, and verification to ensure the device performs as designed.

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