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The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use: Percutaneous vascular access.

The REVAS product 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 according to the techniques of Seldinger. (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 sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the 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 lumion the sleeve while leaving the sleeve inserted in the vessel. A larger dirmeter 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 medical device, the InnerDyne, Inc., Radially Expanding Vascular Access System (REVAS™), and its 510(k) submission for market clearance. However, it does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the format requested.

Here's why and what information is missing:

• No Acceptance Criteria Table or Reported Performance: The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating "substantial equivalence" to a predicate device. It doesn't present specific acceptance criteria (e.g., success rates, complication rates, force required, etc.) or a quantitative performance report against such criteria.
• No Study Details: The text states, "The subject InnerDyne, Inc., REVAS product is as safe and effective as currently marketed devices for the stated indications," and "The FDA finding of substantial equivalence... permits your device to proceed to the market." This indicates that the primary method for demonstrating safety and effectiveness was through comparison to existing, legally marketed devices (predicates), not through a new, independent clinical trial or bench study with specific performance endpoints.
• Lack of detailed ground truth, sample sizes, expert qualifications, adjudication, or MRMC studies: These elements are typically part of a comprehensive clinical or performance study report, which is not present in this 510(k) summary. The 510(k) pathway often relies on demonstrating similarity to established devices rather than new performance benchmarks.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document's purpose is to establish substantial equivalence, not to report on a detailed performance study with acceptance criteria.

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The InnerDyne, Inc., RED® device is intended for use during minimally invasive surgery to provide temporary dilation access to the abdominal/peritoneal cavity and to the lumen of specified internal organs to establish a port of entry for diagnostic, therapeutic, and operative instruments. Typical procedures for product use include:

• Laparoscopic access to the abdominal/peritoneal cavity; .
• Percutaneous gastrostomy; .
• Percutaneous enterostomy; ●
• Percutaneous cystostomy; .
• . Percutaneous cholescystostomy; and
• . Dilation of biliary and urethral strictures.

The RED® device is an expandable dilator sheath assembly, consisting of a radially expanding sleeve, inflation syringe, cannula (with integral valve system), dilator, and insertion instrument (either an access needle or guidewire). The tubular member of the expandable sleeve is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the dilator assembly is inserted through the radially expandable sleeve, penetrating the tissue into the target cavity (e.g., abdominal/peritoneal) or hollow organ.

The provided text describes a medical device, the InnerDyne, Inc., Radially Expanding Dilation "RED®" Device, and its intended use. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

This document is a Summary of Safety & Effectiveness Information (510(k) submission) to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results with specific acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on this input. The document explicitly states:

"From the foregoing, we conclude that the subject RED® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications."

This statement highlights that the submission is based on a claim of substantial equivalence to existing devices, meaning its safety and effectiveness are established by comparison to already approved devices, rather than through independent studies with explicit acceptance criteria provided in this document.

To answer your questions, I would need a different type of document, such as a clinical study report or a detailed device validation plan.

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The InnerDyne, Inc., G-RED® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.

• Percutaneous urological access, for typical procedures such as:
  • Percutaneous nephroscopy
  • Percutaneous bladder access (suprapubic)
• Percutaneous laparoscopic access to primary body cavities (i.e., abdominal and thoracic), both primary and secondary punctures; and
• Percutaneous access into hollow body organs.

The G-RED® device consists of an expandable dilator sheath assembly deployable via standard needle or cather/guidewire (Seldinger or similar) placement technique. The tubular member of the dilator assembly is configured so as to be axially compressed to reduce the outside than of the mandable sheath, penetrating the tissue into the target cavity (e.g., abdominal) or hollow organ. Upon use, the dilator assembly radially expands the walls of the surrounding tissue. This technique allows the user to benefit from the unique safety features and controllability of radial dilation by going from a less traumatic initial stick, followed by radial dilation to the dosire working channel. Once the working channel is established, the expandable should the working cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments. This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments. The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The G-RED® device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product may be supplied in both disposable forms.

The provided text is a 510(k) premarket notification for a medical device called the "InnerDyne, Inc., Generic Radially Expanding Dilation, 'G-RED®' Device." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics.

Therefore, the document does not contain the kind of information typically found in a study demonstrating device performance against predefined acceptance criteria, especially not for AI/ML-based devices.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Device Performance: This document does not present explicit acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity, or surgical outcomes with numerical targets) nor does it provide a table of reported device performance in those terms. Instead, it argues for substantial equivalence to predicate devices.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Info: These are all concepts related to clinical performance studies, particularly for diagnostic or AI/ML devices. Since this is a 510(k) for a mechanical dilation device, such studies are not typically required or presented. The focus is on design, materials, function, and safety, demonstrating they are similar to already approved devices.

Information that can be extracted from the provided text:

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

   • Acceptance Criteria/Goal: To demonstrate substantial equivalence in terms of basic design, product configuration, composition, utilized materials, function, deployment, warnings, precautions, contraindications, and intended use as compared to predicate devices.
   • Reported Device Performance: The document states that the G-RED® device is "as safe and effective as named predicates and currently marketed competitive devices for the stated indications." It does not provide quantitative performance data.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data/cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established for this type of submission.

4. Adjudication method for the test set: Not applicable.

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 is not an AI-assisted device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.

7. The type of ground truth used: Not applicable in the context of a typical performance study. The "ground truth" for this submission is essentially the proven safety and effectiveness history of the predicate devices.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Equivalence Argument (based on the provided text):

• Device Name: InnerDyne, Inc., Generic Radially Expanding Dilation, "G-RED®" Device
• Intended Use: Temporary dilation access for laparoscopic procedures (diagnostic, therapeutic, operative), percutaneous urological access (nephroscopy, suprapubic bladder access), percutaneous laparoscopic access to primary body cavities (abdominal and thoracic), and percutaneous access into hollow body organs.
• Substantial Equivalence Claimed Against:
  • InnerDyne, Inc., Step® device versions (for basic design, product configuration, composition, materials, function, deployment, warnings, precautions, contraindications, and intended use for access to abdominal/thoracic cavities).
  • InnerDyne, Inc., R.E.D.® device versions (for access to hollow body organs).
  • A number of currently marketed products with removable sheath design.
• Basis for Equivalence: Similarities in basic design, product configuration, composition, utilized materials, function, deployment, warnings and precautions, contraindications, and intended use.
• Manufacturing: Assembled from medical grade materials under GMP conditions; components molded and machined by qualified suppliers; assembled and secured by adhesives, welds, and mechanical interlocks.
• Conclusion: The submitter concludes the G-RED® device is "as safe and effective as named predicates and currently marketed competitive devices for the stated indications."

This document serves as a regulatory submission for market clearance based on substantial equivalence, not a clinical trial report with performance acceptance criteria.

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The InnerDyne, Inc., Step® device is intended to provide dilation access for the performance of laparoscopic procedures to establish a port of entry for diagnostic, therapeutic, and operative procedures.

• Laparoscopic access to the abdominal region, both primary and secondary punctures;
• Thoracoscopic access to the thoracic cavity, both primary and secondary punctures; and
• Percutaneous access into hollow body organs with typical use in such procedures as percutaneous gastrostomy, percutaneous enterostomy, cholecystostomy, and dilation of biliary and urethral strictures.

The Step Trocar Expandable Port Step® device consists of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the target cavity or hollow organ.

For laparoscopic access to the abdominal/thoracic cavities, the following instructions should be utilized. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic, therapeutic, and/or surgical instruments.

For access to hollow body organs (e.g., intragastric placement viewed as typical), the following instructions should be utilized. If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the access device. The sheath/needle assembly, is advanced into the stomach. The access needle is removed, leaving the expandable sheath in place. The dilator cannula assembly is inserted through the lumen of the dilator sheath which expands radially to accommodate it. Following dilation the dilator is removed, leaving the expandable sheath and dilator cannula in place to provide a sealed port for passage of the selected instruments. Once the desired instruments are placed, the access device cannula and expanding sheath are removed, allowing the stomach and abdominal wall to contract/relax. (Access to hollow organs other than the stomach, can be achieved following general laparoscopic technique and the access methodology described above.)

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

The device is assembled from medical grade materials under GMP conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks. The Step® radially expanding access device is available in various lengths and working diameters to accommodate the selected size of indicated medical instruments. The subject product shall be available in both disposable and reusable forms.

The provided text is a 510(k) premarket notification for the InnerDyne Step Trocar Expandable Port, "Step®". It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a diagnostic or AI-powered device.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be directly extracted or are not applicable to this type of submission.

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

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

• Acceptance Criteria (Inferred from Substantial Equivalence Claim): The device is deemed acceptable if it is "substantially equivalent" to predicate devices in:
  • Basic design
  • Product configuration
  • Composition
  • Utilized materials
  • Function
  • Deployment
  • Warnings and precautions
  • Contraindications
  • Intended use
  • Safety and effectiveness for stated indications.
• Reported Device Performance: The document explicitly states: "From the foregoing, we conclude that the subject Step® device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications." This is a qualitative claim of equivalence, not a quantitative performance metric.

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. This is a premarket notification based on substantial equivalence, not a clinical study with a test set of patient data. Performance is assessed by comparing technical characteristics and intended use to existing, legally marketed 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. No ground truth determination on patient data is described as part of this submission. The "ground truth" for this regulatory pathway is the established safety and effectiveness of the predicate devices.

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

• Not Applicable. There is no test set or adjudication process 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 device is a surgical access port, not an AI-assisted diagnostic tool.

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)

• Implicit Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness record of the predicate devices to which the new device is compared. This is derived from their historical marketing and regulatory clearance, which would have been based on appropriate evidence (e.g., clinical experience, scientific literature, prior studies for those predicates).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of this type of medical device submission.

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

• Not Applicable. See point 8.

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

The Radially Expanding Vascular Access System (Heparin Coated) 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 ver a previously placed guidewire according to the techniques of Seldinger. (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 sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the 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 sleeve while leaving the sleeve 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.

This document is a 510(k) premarket notification for the InnerDyne Radially Expanding Vascular Access System (Heparin Coated). The FDA's review of 510(k) submissions primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria that would typically be associated with novel, high-risk devices.

Therefore, many of the typical elements requested in your prompt regarding acceptance criteria and detailed study information are not present or not applicable in this type of submission. The key finding is "substantial equivalence" based on design, function, materials, and indications for use being similar to a predicate device, with an added heparin coating and an expanded sheath diameter range noted as the primary differences.

Here's an attempt to address your points based on the provided text, highlighting where information is absent or not relevant to a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the device is substantially equivalent to a predicate device in terms of safety and effectiveness, based on similar technological characteristics and intended use. Performance data in the context of specific quantitative measures with defined thresholds is typically not required for 510(k) clearance unless there are new technological features posing different risks.

The document states: "From the foregoing, we conclude that the Radially Expanding Vascular Access System (Heparin Coated) device is as safe and effective as currently marketed devices for the stated indications." This is the broad "performance" claim, achieved by comparison to the predicate.

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

This information is not provided. The submission relies on a comparison to a predicate device, not on new clinical performance data from a specific test set.

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

This information is not applicable/provided. No "test set" in the sense of patient data requiring expert ground truth assessment is described as part of this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable/provided.

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

This information is not applicable. This device is a physical medical device (vascular access system), not an AI algorithm or imaging device that would typically involve human readers or MRMC studies.

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

This information is not applicable.

7. The Type of Ground Truth Used

This information is not applicable/provided. The basis for clearance is substantial equivalence to an existing legally marketed device (the predicate). The "truth" in this context is that the new device is as safe and effective as the predicate.

8. The Sample Size for the Training Set

This information is not applicable/provided. There is no mention of a "training set" as this is not an AI or machine learning device.

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

This information is not applicable/provided.

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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 Sherwood Medicat Company; Kangaroo®, EntriStar®; "Percutaneous Gastrostomy Kit" is a medical device for the percutaneous placement of a long-term enteral feeding tube.

The Kangaroo®, EntriStar®, "Percutaneous Gastrostomy Kit" is a sterile, single use system containing a gastrostomy tube for enteral feeding and the components required to insert the tube percutaneously, which may include endoscopic and/or laparoscopic methodology. The kit consists of a radially expanding access device, gastrostomy tube, obturator, insertion/removal device, "Y" connector, luer adapter, external retention disk, retention band, #11 scalpel, drape, gauze pads, lubricant, and Instruction for Use (IFU).

The radially expanding access device is an expandable dilator sheath assembly with an access needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal tissue into the gastric cavity.

If endoscopic technique is utilized, an endoscope is advanced into the stomach using standard techniques, followed by stomach insufflation. An abdominal incision is made and the access needle/sheath assembly is inserted directly through the abdominal and stomach walls into the stomach. The access needle is removed and the cannula/dilator is advanced through the radially expanding sleeve. If laparoscopic technique is utilized, under laparoscopic vision the abdominal cavity is entered and the stomach site is selected for insertion of the gastrostomy tube.

This document is a 510(k) premarket notification for a medical device and does not contain a study describing acceptance criteria and device performance.

Instead, it's a submission to the FDA to demonstrate that the Sherwood Medical Company's "Percutaneous Gastrostomy Kit" is substantially equivalent to legally marketed predicate devices. The FDA's letter confirms this substantial equivalence.

Therefore, I cannot provide the requested information based on the provided text. There is no performance study, acceptance criteria, sample sizes, expert qualifications, or ground truth details within this regulatory document.

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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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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 Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments.

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

The provided text is a summary of safety and effectiveness information for a medical device (InnerDyne, Inc., OneStep® device), a type of dilator with a sheath used in minimally invasive surgery. It describes the device, its function, and claims substantial equivalence to predicate devices. However, this document does not describe an AI/ML device or a study proving that an AI/ML device meets specific acceptance criteria.

Therefore, I cannot extract the information required by your request, as it pertains to AI/ML device performance and testing, which is not present in the provided text. The document focuses on the mechanical and functional aspects of a surgical dilator, comparing it to previous versions and existing surgical tools.

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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 Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments.

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger 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 Summary of Safety & Effectiveness Information for a medical device called the InnerDyne Step Trocar Expandable Port, "MiniStep®". It's a 510(k) submission, comparing the MiniStep® to existing predicate devices to demonstrate substantial equivalence.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific clinical outcomes) are not explicitly stated. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" is largely described in qualitative terms and by referencing studies that show similarity or improvement over existing methods.

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

• Test Set Sample Size: The primary testing mentioned utilized porcine models. The text does not specify a numerical sample size (e.g., how many pigs, how many insertions).
• Data Provenance: The studies mentioned were conducted at the University of California, San Francisco. The studies appear to be prospective in nature, as they involve actively using the device in a controlled setting (porcine models, clinical overviews of user experiences). The study examining tissue defects by Drs. Bhoyrul, Mori, and Way seems to be a specific prospective study comparing the Step® devices with conventional trocars.

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

• Study on Tissue Defects: Conducted by Drs. Bhoyrul, Mori, and Way at the University of California, San Francisco. The text does not explicitly state their specializations (e.g., "radiologist with 10 years of experience") but implies they are medical professionals and researchers involved in surgical or related fields, given their focus on "tissue defects" and "trocar related complications." The number of experts stated is three.
• Clinical Overviews: "Additional clinical overviews have been published within the literature by other users outlining their experience with Step® products." The number and specific qualifications of these "other users" are not detailed.

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

• The text does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The studies mentioned appear to be direct observations and comparisons by the researchers.

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, a MRMC comparative effectiveness study was not done. This document is for a mechanical surgical device (trocar), not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

• No, a standalone algorithm-only performance study was not done. As mentioned above, this is a mechanical surgical device, not an algorithm.

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

For the specific study mentioned by Drs. Bhoyrul, Mori, and Way, the ground truth appears to be based on:

• Direct observation and measurement of tissue defects: This would likely involve macroscopic and potentially microscopic examination of the tissue after device use, which is a form of pathology/histology or direct anatomical assessment.
• Clinical assessment of ecchymosis: This is a form of outcomes data related to tissue trauma.
• Clinical observation of functionality and ease of use: In porcine models ("access for instruments," "primary and secondary sticks made without difficulty").

For the "additional clinical overviews," the ground truth would be based on clinical experience and outcomes data reported by other users.

8. The sample size for the training set:

• Not applicable / Not mentioned. This document describes a surgical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

• Not applicable / Not mentioned. (See point 8).

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