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The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.

The ZZIREN™ Orogastric Tube is a non-sterile, single use device comprising a 37-inch-long insertion tube, a Y extension containing a suction regulating valve, and a pinch clamp. An accessory straight connector is included. The insertion is made of flexible polyvinylchloride (PVC). The suction requlating valve limits negative pressure applied to the stomach or intestine to less than 175 mmHg, produces an audible signal when the suction pressure exceeds ~160 mmHg, and is identical in all models. All six models have multiple apertures in proximity to a rounded distal tip. Three of the models, ZZ-SGT-36, ZZ-SGT-40 have side-holes extending 13 cm from the tip, and three models, ZZ-GBT-36, and ZZ-GBT-40, have side-holes extending 6 cm from the tip. The insertion tubes have diameters of 32, 36, and 40 Fr and humeric markings to indicate depth of insertion.

The provided text is a 510(k) summary for the ZZIREN™ Orogastric Tube. It describes a medical device and its substantial equivalence to predicate devices. However, it does not contain any information about a study proving the device meets specific acceptance criteria in the context of device performance related to a diagnostic AI/ML algorithm or similar technology.

The document primarily focuses on:

• Device Description: Physical characteristics and components of the ZZIREN™ Orogastric Tube.
• Intended Use/Indications for Use: What the device is used for (gastric aspiration and lavage, size guide, leak testing in gastric/bariatric surgery).
• Technological Comparison: How the ZZIREN™ Orogastric Tube is similar to and differs from its predicate devices in terms of materials, design features (Y extension, FR sizes, number of apertures), and suction regulating mechanisms.
• Non-Clinical Tests Summary & Conclusions: Results from bench tests (e.g., kink test, stiffness test, compression test, pinch clamp test, connector tests, air syringe compatibility test, dimensional analysis). These tests aim to demonstrate that the new device performs similarly and safely compared to the predicate, and meets its design specifications.

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance in the context you've provided (which implies a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or AUC). The document is about a mechanical, single-use surgical accessory, and its "performance" is assessed through physical and functional bench tests, not clinical performance or diagnostic accuracy.

To directly answer your numbered points based on the provided text, where applicable, and noting where the information is absent:

1. A table of acceptance criteria and the reported device performance:
   The document describes non-clinical tests and their conclusions, which implicitly serve as performance demonstrations against internal acceptance criteria (e.g., "equally or less stiff," "substantially equivalent," "fit and function well"). However, a formal table of acceptance criteria with quantitative thresholds is not explicitly provided. The conclusions are qualitative comparisons to the predicate devices.

   Acceptance Criteria (Inferred from Test Goals)	Reported Device Performance (Summary)
   Propensity to kink	Substantially equivalent to predicate SIREN SGT™
   Stiffness	Equally or less stiff than corresponding predicate device
   Inadvertent stapling likelihood	Equally or less likely to be inadvertently stapled than corresponding predicate device
   Pinch Clamp performance	Substantially equivalent to predicate SIREN SGT™
   Accessory tubing connector fit and function	Attach easily, reversibly, securely; provide reliable connection
   Compatibility with leak testing device (Air Syringe)	Compatible and may be safely used together for leak testing
   Adherence to design specifications	All models made to design specifications

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The tests described are bench tests on the device itself, not clinical studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the document describes bench testing of a physical device, not an AI/ML or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable for the same reason as point 3.

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 as the document describes a physical medical device, not an AI/ML or imaging interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable as the document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the bench tests would be the established physical properties and functional requirements of the predicate devices or engineering specifications. For example, the "truth" for the kink test is whether the tube kinks or not under certain conditions, compared to the predicate. There is no biological or diagnostic ground truth mentioned.

8. The sample size for the training set:
   This information is not applicable as the document describes a physical medical device, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:
   This information is not applicable for the same reason as point 8.

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The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.

The Tools for Surgery™ SIREN SGT™ gastric tube is a clean, non-sterile, single patient use device, comprising a 36 Fr insertion tube portion 109 cm long, a hub containing a suction regulating valve, an extension tube, pinch clamp, and connector. Tubular portions including the hub are flexible polyvinylchloride (PVC). There are multiple apertures in proximity to a rounded distal tip. Line and numeric markings are provided to indicate depth of insertion. The suction regulating valve limits negative pressure applied to the stomach to less than 175 mmHg, and produces an audible signal when the suction pressure in the stomach exceeds ≈160 mmHg.

The document describes the Siren SGT™, a gastric tube used in bariatric and gastric surgical procedures. The provided content is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission usually focuses on demonstrating equivalence through comparison of technical characteristics and performance testing rather than establishing clinical efficacy or a specific "acceptance criteria" measured using clinical outcomes.

Based on the provided information, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to the predicate device (Boehringer Laboratories Gastric Sizing Tube, ViSiGi 3D®, K130483). The performance testing described is intended to show that despite some differences in design, the Siren SGT™ performs comparably and safely for its intended use.

Here's an attempt to extract and organize the information according to your request, acknowledging that a typical "acceptance criteria" table with performance metrics as you might see for a diagnostic AI device isn't explicitly laid out in this type of submission.

Table of Implicit Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)

Since this is a 510(k) submission for a physical medical device, the "acceptance criteria" are not framed in terms of precision, sensitivity, or specificity as they would be for an AI/diagnostic tool. Instead, the criteria revolve around demonstrating equivalent performance to a predicate device. The "reported device performance" refers to the results of the non-clinical tests that show the Siren SGT™ functions as intended and comparably to the predicate.

• VALVE FUNCTION TEST
• MAXIMAL NEGATIVE PRESSURE TEST: Confirmed the pressure relief valve opens at 103 to 155 mmHg and limits negative pressure to

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The Hemorrhage Occluder Pin is indicated for the control of localized severe presacral hemorrhage during pelvic surgery. When other techniques (cautery, suture, clamping, etc.) are judged ineffective.

The Hemorrhage Occluder Pin is a 7 mm long pin capped with an 8 mm diameter, 1.5 mm thick truncated conc-shaped head. The 1.25 mm diameter pin section has four tissue and bone retaining ridges formed by machining four equally spaced truncated conical sections. It is made of medical grade titanium suitable for implantation.

The provided text describes a medical device called the "Hemorrhage Occluder Pin" and its submission for 510(k) clearance. The submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds or performance targets for a device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. The acceptance is based on the new device being "as safe and effective as the predicate device." The "reported device performance" in this context is that its characteristics and function are materially identical to the predicate.

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

The document does not describe a "test set" in the context of a performance study with a specific sample size. The claim for performance is based on "clinical experience of the product device validates the performance" and "prior clinical experience with the predicate pins." This suggests reliance on existing clinical data and the historical performance of the predicate device, rather than a new prospective study with a defined sample size. The provenance of this "clinical experience" or "prior clinical experience" is 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 (e.g. radiologist with 10 years of experience)

No information is provided about experts used to establish ground truth. This type of detail is typical for studies involving diagnostic or analytical devices, not typically for mechanical implants demonstrating substantial equivalence where the primary evidence is material equivalence and historical safety data.

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

No test set or adjudication method 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

This is not applicable. The device is a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI assistance effect size would be relevant or performed.

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

This is not applicable. The device is a physical implant, and there is no algorithm or standalone performance being evaluated.

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

The "ground truth" for the device's safety and effectiveness relies on the demonstrated substantial equivalence to a legally marketed predicate device. This includes:

• Material equivalence: Medical grade titanium identical to the predicate.
• Design equivalence: Reverse engineered from the predicate.
• Intended use and indications for use equivalence: Identical to the predicate.
• Historical clinical experience/outcomes data from the predicate device: The document mentions "prior clinical experience with the predicate pins" and "long successful clinical usage" of the predicate. This historical data serves as the "ground truth" for the safety and effectiveness of the device by proxy of its substantial equivalence.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device.

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

This is not applicable. There is no training set.

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The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.

The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing, to which is bonded at each end a 1.45" long generally arrowshaped slotted PVC coupling member whose shape allows easy passage through the mesentery for placement of the device while resisting unintended withdrawal , and whose shape and slots permit interlocking of the two ends of the device to form a closed loop around the exteriorized loop of bowel.

This document is a 510(k) premarket notification for a medical device called "Easy Loop" and does not contain information about explicit acceptance criteria or a detailed study proving its performance against such criteria. Instead, it claims substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission claims substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria.

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

This information is not provided. The document states that the device "has been successfully employed by Board Certified Colon and Rectal Surgeons," but it does not specify what constitutes this "successful employment," the number of cases, or the nature of any "test set." The data provenance is also not specified beyond the implicit use in a clinical setting by surgeons. It's likely retrospective observation rather than a structured prospective study for the purpose of this 510(k).

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

This information is not provided. The document mentions that Board Certified Colon and Rectal Surgeons "found [the device] to be as safe and effective as the predicate device," but it doesn't detail how many surgeons were involved in this assessment or what specific "ground truth" they were establishing beyond a general assessment of safety and effectiveness.

4. Adjudication Method for the Test Set

This information is not provided. Given the lack of a structured "test set" and a formal evaluation method described, an adjudication method would not be applicable here.

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

No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is based on a claim of substantial equivalence to a predicate device, not on a comparative study with human readers (surgeons in this context) and AI. This device is a physical medical instrument, not an AI/software device.

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

Not applicable. The "Easy Loop" is a physical medical device (a colostomy rod), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The ground truth implicitly used for the claim of safety and effectiveness appears to be expert opinion/clinical experience of Board Certified Colon and Rectal Surgeons. They deemed the device "as safe and effective as the predicate device," indicating an observational, real-world assessment by qualified professionals. There's no mention of pathology, objective outcomes data, or a controlled study to establish a formal "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Device Rationale and "Proof" of Meeting Acceptance Criteria (as per the document):

The submission argues for substantial equivalence by comparing the technological characteristics of the Easy Loop with a legally marketed predicate device (Loop Ostomy Rod by Convatec, 510(K) #K830945). The "proof" relies on:

• Clinical Experience/Expert Opinion: "This device has been successfully employed by Board Certified Colon and Rectal Surgeons and was found to be as safe and effective as the predicate device cited above."
• Tabulated Comparison of Technological Characteristics: The document states, "Please find a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution." (The table itself is not included in the provided text snippets but is referenced as being part of the original submission).

Essentially, the "acceptance criteria" were met by demonstrating that the Easy Loop is sufficiently similar in design, materials, and intended use to a previously approved device, and that clinical experience with it supports its equivalence in safety and effectiveness when compared to the predicate, according to Board Certified Colon and Rectal Surgeons. No specific quantitative performance metrics or formal study results are presented in these excerpts.

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