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The InnerDyne, Inc., Radially Expanding Vascular Access System is intended to provide percutaneous access to the vasculature. The Radially Expanding Vascular Access System is indicated for the following usages: Percutaneous vascular access.

The Radially Expanding Vascular Access System consists of an expandable sleeve assembly: The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected vessel over a previously placed guidewire. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments.

This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the lumen of the sleeve while leaving the sleve inserted in the vessel. A larger diameter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments.

The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The provided text describes a 510(k) premarket notification for a medical device, the InnerDyne Radially Expanding Vascular Access System, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, performance studies with reported metrics, sample sizes, expert involvement, or any of the other specific study design elements requested in the prompt.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

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

• Acceptance Criteria: Not explicitly stated. The device is determined to be "substantially equivalent" to a predicate device (K931489). This implies that its performance is expected to be comparable to the predicate device, but specific quantitative criteria are not listed.
• Reported Device Performance: Not provided in quantitative terms. The document concludes that the device is "as safe and effective as currently marketed devices for the stated indications." This is a qualitative statement of equivalence, not a report of specific performance metrics.

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

• No information on test set sample size or data provenance is provided.

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. This type of study (e.g., clinical trial, diagnostic accuracy study) is not described. The submission is based on substantial equivalence.

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

• Not applicable. No test set or ground truth establishment 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

• No MRMC or AI-related study is mentioned. This is a 1997 submission for a mechanical medical device, not an AI-powered diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable. Ground truth for a clinical study is not described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. This is not a machine learning device, so there is no "training set."

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

• Not applicable.

Summary of Substantial Equivalence Basis:

The core of the submission (K972684) relies on demonstrating substantial equivalence to a previously cleared predicate device: the InnerDyne, Inc., Radially Expanding Dilating Introducer device (K931489).

The key arguments for substantial equivalence are:

• Similarities in Design Principles: "basic design principles... are similar, and remain essentially unchanged."
• Similarities in Configuration, Composition, Materials: "product configuration, composition, and utilized materials are similar."
• Similar Principles of Operation: "each of these products employs a similar insertion technique, indications for use, contraindications for use, warnings and precautions."
• Minor Differences: The subject device differs only in "changes to the materials used in the construction of the expanding sleeve portion and the presentation style of the product. Alternative locations and methods of sterilization are being included."
• Validation of New Materials/Sterilization: The new material and alternative sterilization methods are stated to be "similar to those used in the InnerDyne Step™ family of products" which likely have their own history of FDA clearance (K943253, K940232, K950632, and K950658). This implies these components/processes have been previously deemed safe and effective in similar contexts.

In essence, the "study" proving the device meets acceptance criteria is the argument that the new device is fundamentally the same as a device already on the market and cleared by the FDA, with only minor changes that do not alter its safety or effectiveness profile. This is typical for a 510(k) submission where a device is not entirely novel but rather a modification or evolution of an existing product.

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The Step®family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach.

The subject Open-Step® system configuration allows the user to access the desired region through open laparoscopic surgical techniques for passage of small diagnostic instruments accomplished without a radially expanding sheath. An incision is made at the target insertion site using standard technique. The surgeon places a finger into the previously created incision to ensure that a free cavity has been entered. The Open-Step®access device is inserted into the incision with the adjustable cone secured against the bottom of the cannula/dilator. The adjustable cone is slid down the cannula assembly and into the incision, helping to form an adequate seal. Position the desired cannula depth into the cavity by advancing or retracting the cannula assembly. The dilator cannula can then be removed from the lumen of the cannula while leaving the cannula inserted through the tissues creating an access/passage route for operative instruments.

The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

This document is a 510(k) submission for a medical device (InnerDyne Open-Step®), which focuses on demonstrating substantial equivalence to existing devices rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way a clinical trial or algorithm validation study would for a diagnostic or AI device.

Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable in this context. The document does not describe a study to prove the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, etc., as it's a device for surgical access, not a diagnostic tool or an AI algorithm.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

(This is a high-level conclusion based on substantial equivalence, not detailed quantitative metrics.) |
| Material Quality | "Assembled from medical grade materials under GMP and ISO conditions."

"Components are molded and machined by qualified suppliers." |
| Design Principles | "Similar basic design principles for the subject InnerDyne, Inc., Open-Step® device and the predicate Step® devices... remain essentially unchanged." |
| Product Configuration, Composition, Materials | "Similar in each of the products [subject and predicate devices]." |
| Principles of Operation | "Similar insertion technique, indications for use, contraindications for use, warnings and precautions" to predicate devices. |
| Function, Product Dimensions, General Indications for Use | "Similar to the referenced predicates." |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not applicable. No specific test set in the sense of a clinical or observational study is described. The demonstration of safety and effectiveness relies on substantial equivalence to existing devices through comparison of design, materials, and intended use.
• Data Provenance: Not applicable. No specific data set is mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. Ground truth, in the context of device performance testing, is not established through expert consensus as there's no diagnostic or measurement outcome to evaluate this way.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring adjudication is described.

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

• MRMC Study: No. This is not
  the type of device or regulatory submission that would typically involve an MRMC study.

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

• Standalone Performance Study: Not applicable. This device is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is the established safety and effectiveness profile of the predicate devices. The submission asserts that the Open-Step® device is substantially equivalent to these predicates, implying it shares their safety and effectiveness characteristics. This isn't a "ground truth" derived from patient outcomes or pathology in a study specific to the Open-Step® device.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This document does not describe an AI/ML algorithm or a dataset used for training.

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

• Ground Truth Establishment: Not applicable. As there is no training set mentioned, this question is irrelevant to the provided text.

Summary of the Document's Approach:

The document leverages the concept of substantial equivalence to existing, legally marketed predicate devices (K943253, K940232, K950632, K950658, and others). The "study" here is essentially a comparison of the new Open-Step® device to these predicates based on:

• Similarities in Design Principles: The fundamental way the device is constructed and intended to operate.
• Similarities in Function, Product Dimensions, and General Indications for Use: What it does, its size, and its intended applications.
• Similarities in Material Composition: The types of materials used.
• Similarities in Operating Principles: How it's used, including insertion technique, indications, contraindications, warnings, and precautions.
• Minor Differences: Identifying that the differences (e.g., elimination of reducer cap, expandable sleeve, access needle, and adoption of a locking adjustable cone) do not raise new questions of safety or effectiveness.

The conclusion is that, because of these similarities and the nature of the differences, the Open-Step® device is as safe and effective as the predicate devices already on the market. This is a common pathway for regulatory clearance of medical devices, especially for those that are evolutions of existing designs, rather than novel technologies requiring extensive clinical trial data for initial clearance.

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