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This closed suction system is indicated for endotracheal / tracheostomy suction of adult and pediatric intubated patients (including neonates). This device is intended for single use only.

Ty-Care is a suction catheter system that is designed to connect to the endotracheal tube or tracheostomy tube of the patient and remains in place up to 48 hours ("fixed" version). Ty-Care exel is a detachable system and features a suction catheter that must be replaced after 24 hours while the angled connector (elbow) may be replaced after 72 hours of use. If the patient is on mechanical ventilation, this device allows the attending health professional to suction the patient's tracheobronchial secretions without disconnecting the ventilator. Ty-Care exel offers all the advantages of Ty-Care system with the added feature of a rotating patient-access valve.

The provided text describes the 510(k) summary for the MALLINCKRODT DAR Ty-Care™ / Ty-Care™ exel Closed Suction System, claiming substantial equivalence to predicate devices. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a study that proves the device meets those criteria, specifically regarding performance metrics, sample sizes, expert involvement, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence based on intended use, design, operational characteristics, and materials of construction compared to predicate devices. It briefly mentions "Biocompatibility and performance testing demonstrate that MALLINCKRODT DAR Ty-Care™ / Ty-Care Closed Suction System complies with designated voluntary standards and fulfills product specifications. Verification and validation testing demonstrates that the increased duration of use raises no new issues of safety or effectiveness." This is a general statement and lacks the specific details requested in your prompt.

Therefore, most of the requested information cannot be extracted from this document.

Here's how much of your request can be answered based solely on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document does not mention experts involved in establishing ground truth for performance testing.

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

• Not specified.

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. This is a medical device (closed suction system), not an AI-powered diagnostic or imaging device for which MRMC studies comparing human readers with and without AI assistance would be relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Not specified. The document only generally mentions "biocompatibility and performance testing" and "verification and validation testing" against "designated voluntary standards and product specifications." It does not detail how the "truth" or success of these tests was established.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would have a "training set."

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

• Not applicable.

Summary:
The provided 510(k) summary is designed to demonstrate substantial equivalence to predicate devices based on design and intended use, rather than presenting a detailed performance study with specific acceptance criteria and results in the format requested. Information regarding specific testing methodologies, sample sizes, ground truth establishment, or expert involvement in performance criteria is absent from this document.

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The CD HORIZON® system is intended for the following indications:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/Jumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEX™ Reconstruction System.

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal Svstem implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the manner of a new AI/software device. Therefore, many of the requested elements (like sample size for test/training, number of experts, adjudication, MRMC, standalone performance, specific acceptance criteria with reported device performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to what it is trying to prove and the mechanism used.

Here's a breakdown of what can be inferred and what cannot:

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

• Inapplicable. This document is not a clinical trial report with pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and reported performance metrics against those criteria. Instead, it's a regulatory submission demonstrating "substantial equivalence" of a medical device (spinal fixation system) to previously cleared devices. The "acceptance criteria" here are broad regulatory requirements for substantial equivalence, satisfied by comparing indications for use and technological characteristics.

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/Not Provided. No test set or patient data is mentioned in this summary. The review is based on comparisons of product descriptions, indications for use, and technological characteristics to predicate devices.

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/Not Provided. The concept of "ground truth" established by experts for a test set doesn't apply to this type of device submission. The "truth" in this context is established by the regulatory body (FDA) based on documentation of substantial equivalence.

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

• Not Applicable/Not Provided. No test set or adjudication process is described.

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. This document concerns a physical spinal implant system, not an AI or software device that would involve human "readers" or AI assistance.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable. As mentioned, "ground truth" in the context of typical AI/diagnostic device studies isn't relevant here. The "truth" is whether the device is substantially equivalent to a predicate device, which is a regulatory and engineering assessment.

8. The sample size for the training set

• Not Applicable/Not Provided. No training set for an algorithm is mentioned.

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

• Not Applicable/Not Provided. No training set or associated ground truth establishment is mentioned.

What can be extracted from the document regarding "acceptance" and "proof":

This document is a 510(k) Premarket Notification, which seeks to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "acceptance criteria" are the regulatory standards for substantial equivalence, primarily focusing on comparable Indications for Use and technological characteristics.

Device: CD HORIZON® Spinal System - Addition of Screw w/ Dual Rod Channel

Regulatory Approval Mechanism/Study: 510(k) Premarket Notification, demonstrating Substantial Equivalence.

Predicate Device(s): The document states: "Documentation was provided which demonstrated the CD HORIZON® SPINOUS PROCESS Plate to be substantially equivalent to pre-amendment devices, as well as to the previously cleared CD HORIZON® Spinal System." This implies the predicate device is a combination of pre-amendment devices and/or the existing CD HORIZON® Spinal System.

Table: "Acceptance Criteria" (Regulatory Requirements for Substantial Equivalence) and "Reported Device Performance" (Claimed Equivalence)

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