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The Rutler Supra Stomal Stent is indicated for the prevention and treatment of laryngeal and tracheal stenosis.

Not Found

This document is a 510(k) substantially equivalent letter from the FDA regarding the "Rutter Supra Stomal Stents." It does not contain information about acceptance criteria, device performance metrics, or study details. It is a regulatory approval letter.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and the substantial equivalence determination, not on a detailed scientific study supporting device performance.

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The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure.

The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants.

Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.

The provided document, K97223/7, is a 510(k) summary for the Montgomery® Thyroplasty Implant System. It describes the device, its intended use, and claims substantial equivalence to legally marketed predicate devices. The section on "CLINICAL STUDIES" briefly mentions a clinical study, but it does not provide detailed acceptance criteria or a comprehensive report of device performance against specific metrics.

Here's an analysis of the information available and what is missing based on your requested format:

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

Missing Information:

• Specific numerical targets or thresholds for "low number of complications" (e.g., complication rate < X%).
• Specific metrics and thresholds for "improvement of voice quality" (e.g., a specific percentage increase in a voice quality score, a certain change in acoustic parameters, or a defined improvement in stroboscopic findings). Without these, it's impossible to quantitatively assess if the device "meets" the criteria.

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

• Sample Size for Test Set: 44 patients
• Data Provenance: Not specified (e.g., country of origin).
• Study Type: The summary states "Clinical data for a cohort of 44 patients treated...", implying a prospective cohort study, but it doesn't explicitly state "prospective" or "retrospective." This type of study would typically be prospective to evaluate a new device directly.

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)

Missing Information: The document mentions "acoustic analysis, and stroboscopy," which would typically be assessed by qualified professionals (e.g., otolaryngologists, speech-language pathologists). However, it does not specify the number of experts, their qualifications, or their role in establishing "ground truth" (e.g., for what constitutes improved voice quality) for the clinical study.

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

Missing Information: The document does not describe any adjudication method for the clinical study's outcomes.

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 an implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.

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

Not Applicable: This device is a medical implant, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

• For Safety: Clinical observation of complications (outcomes data).
• For Effectiveness ("Improvement of voice quality"):
  • Patient survey responses (patient-reported outcomes data).
  • Acoustic analysis (objective measurement data, likely interpreted by experts but the process isn't detailed).
  • Stroboscopy (imaging/visual assessment, likely interpreted by experts but the process isn't detailed).

Missing Information: While types of data are mentioned, the process by which "ground truth" for "improvement" was established (e.g., expert consensus on what constitutes significant improvement based on these measures) is not detailed.

8. The sample size for the training set

Not Applicable/Missing: This device is a physical implant, not an AI algorithm that requires a training set. If the question implicitly refers to pilot studies or early development, that information is not provided.

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

Not Applicable/Missing: As above, this is not an AI algorithm with a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document briefly describes a clinical study involving a cohort of 44 patients.

• Purpose: To demonstrate the safety and effectiveness of the Montgomery® Thyroplasty Implant System.
• Safety Assessment: Based on a "low number of complications." (No specific numerical criteria provided).
• Effectiveness Assessment: Based on "improvement of voice quality," supported by:
  • Patient survey responses.
  • Acoustic analysis.
  • Stroboscopy.
  • (No specific numerical criteria or methods for defining "improvement" are provided).

The determination of "substantial equivalence" for 510(k) clearance primarily relies on a comparison to predicate devices, and while clinical data for this type of device is often included, it usually aims to confirm that the differences from predicates do not raise new questions of safety or effectiveness. The study described is an internal study presented to the FDA as part of the 510(k) submission. However, the provided text does not offer the level of detail typically found in a full clinical study report, particularly regarding detailed acceptance criteria and quantitative results.

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For use as a nasal packing to treat epistaxis.

RHINOCELL™ Nasal Packings are constructed of polyvinyl alcohol (PVA) sponge using a patented formula. The packings will expand as fluid is introduced, giving the surgeon time for accurate positioning. There is a variety of RHINOCELL™ shapes and sizes to choose from, both with and without integral airways. All RHINOCELL™ packings are sold sterile, ready to use.

The provided text is a 510(k) summary for the RHINOCELL™ Nasal Packings device and a corresponding FDA letter. This document does not describe any acceptance criteria or a study proving the device meets said criteria in the way you've outlined for performance of a diagnostic or AI-based device.

Instead, this is a premarket notification for a medical device (a nasal packing). The "testing" mentioned is a general statement about its construction from "well-established polyvinyl alcohol (PVA) sponge," which implies prior knowledge of the material's properties, not a specific performance study against defined acceptance criteria for the final device. The FDA's review focuses on "substantial equivalence" to predicate devices, not on a detailed analysis of performance metrics.

Therefore, I cannot extract the information requested as it is not present in the provided text.

Here's why each point cannot be fulfilled based on the given information:

1. A table of acceptance criteria and the reported device performance: Not provided. The document describes the device and its indication for use, but not specific performance metrics or acceptance criteria for those metrics.
2. Sample sized used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic test or ground truth mentioned.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, as this is a physical medical device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document indicates that the device's approval is based on its substantial equivalence to predicate devices (Product Nos. Q600314 - Q603113 manufactured by M-Pact) and its construction from a "well-established polyvinyl alcohol (PVA) sponge." This is a regulatory pathway for approving devices that are similar to already legally marketed devices, rather than requiring extensive de novo performance studies with acceptance criteria as one might see for novel diagnostic or AI technologies.

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To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

The Bivalve Nasal Splint, constructed of medical grade flouroplastic (i.e. Teflon®), is designed to provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splint is available in two sizes, standard and large, with two thicknesses (0.25mm and 0.50mm) for each size. The standard size is for routine use, while the large size can be be trimmed for individual applications. Both sizes feature a lengthwise slit facilitating placement and removal, and pre-formed suture holes for stabilizing the splint.

The Bivalve Nasal Splint is supplied sterile, two splints per packages per box.

The provided text describes a medical device, the Bivalve Nasal Splint, and its FDA 510(k) summary for market clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to proving the device meets acceptance criteria.

The document is a standard FDA 510(k) submission, focusing on:

• Description of the device: Bivalve Nasal Splint, made of medical grade fluoroplastic (Teflon®), available in two sizes and two thicknesses, with a lengthwise slit and suture holes.
• Indication for Use: To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
• Contraindications: None known.
• Predicate Device: Invotec International, Inc. nasal splints (Product Nos. 20-10650, 20-10655, 20-10660, and 20-10665).
• Testing (briefly mentioned): "Device is constructed using well-established medical grade flouroplastic." This is a general statement and not a description of performance testing against specific acceptance criteria.
• FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval document and not a clinical study report. Clinical study data, if any, would typically be in a separate report that might be referenced or summarized in a PMA (Premarket Approval) submission, but a 510(k) for a device like a nasal splint primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than novel clinical effectiveness studies against specific, quantitative performance criteria.

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1. To be used for control of posterior nasal epistaxis.
2. To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.

The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement. The Post-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.

The provided text describes a 510(k) submission for the Post-Stop™ Epistaxis Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or novel medical device might.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document because it is a regulatory summary for a device seeking substantial equivalence, not a standalone clinical study report.

Here's an attempt to address the request based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or specific performance metrics in the format of a clinical study. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

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

• Sample Size: Not applicable. The 510(k) summary does not describe a clinical test set in the traditional sense. It relies on the claimed substantial equivalence to a predicate device, which implies that the predicate device's performance data (or general understanding of such devices) is the basis for equivalence, not a new test set for this specific device.
• Data Provenance: Not applicable. No specific clinical data from a "test set" is presented.

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

• Not applicable. As no new clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set 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 is a medical device (catheter) and the submission refers to a 510(k) for substantial equivalence, not an AI-powered diagnostic or therapeutic device. No MRMC study or AI component is mentioned.

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

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

7. The Type of Ground Truth Used

• Not applicable in the context of a new clinical study. The "ground truth" for a 510(k) submission is the established safety and effectiveness of the predicate device that the new device is compared against.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• Not applicable.

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To maintain a nasal airway while providing septal support following surgery.

The Nasal Airway Splint is designed provide septal support and allow nasal breathing post-operatively through the integral airway. The splints can be sutured through the preformed holes in the anterior tips for stabilization. The Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.

The provided text is a 510(k) premarket notification for a medical device (Nasal Airway Splint). It describes the device, its intended use, and states that it has been determined substantially equivalent to a predicate device. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot populate the table or answer the specific questions about device performance and validation studies. The document states "Testing: Device is constructed using well-established medical grade silicone," which implies material testing but not performance in a clinical or simulated clinical setting against specific acceptance criteria.

Based on the provided text, none of the requested information regarding acceptance criteria and the study proving the device meets them is available.

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To maintain a nasal airway while providing septal support following surgery.

The Doyle Combo Nasal Airway Splint is designed to provide septal support and allow nasal breathing post-operatively through the integral airway. The patented design features an expandable PVA sponge layer for added comfort and stabilization. For additional security, the splints can be sutured through the pre-formed holes in the anterior tips. The Doyle Combo Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.

The provided text is a 510(k) summary for the Doyle Combo Nasal Airway Splint. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a detailed clinical study demonstrating performance metrics like sensitivity or specificity.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This information is not present. The 510(k) summary focuses on the device description, indications for use, contraindications, and identification of predicate devices. There are no performance metrics (e.g., accuracy, sensitivity, specificity, or specific measurements) reported, nor are there acceptance criteria defined.
• Sample size and data provenance: No clinical study data is presented, so no sample size information is available.
• Number of experts and qualifications: Not applicable as no expert-derived ground truth or performance study is detailed.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or summarized.
• Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
• Type of ground truth used: Not applicable as no clinical performance study is detailed.
• Sample size for the training set: Not applicable as no machine learning algorithm development or training set information is relevant to this submission.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding "Testing":

The document mentions: "Testing: Device is constructed using well-established medical grade silicone and PVA sponge." This refers to material verification rather than clinical performance testing against specific criteria for effectiveness. The FDA's 510(k) clearance in {1} confirms substantial equivalence based on this and the comparison to predicate devices, not on a detailed study proving performance against acceptance criteria.

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To be used for non-surgical closure of nasal perforations.

The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.

The provided document is a 510(k) summary for the Boston Medical Products Nasal Septal Button. This type of regulatory submission is not typically accompanied by detailed studies proving acceptance criteria in the way a new, innovative device might require. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, the specific information requested, such as a table of acceptance criteria with reported device performance metrics, sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details on training sets, are not present in this document.

Here's an explanation based on the available information:

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

• Not present. The document states: "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." However, it does not present specific acceptance criteria (e.g., "epistaxis decrease by X%") or quantitative performance data from a specific study.

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

• Not present. No information about a specific test set, its sample size, or data provenance is provided. The document refers generally to "Studies" that have shown decreased symptoms.

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 present. No details on expert involvement for ground truth establishment.

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

• Not present. No information about adjudication methods.

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/Not present. This device is a physical medical implant (nasal septal button), not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this product.

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

• Not applicable/Not present. As this is a physical device, not an algorithm, standalone performance as described for AI is not relevant.

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

• Not explicitly stated, but implied by 'substantial equivalence'. For a 510(k), the "ground truth" for demonstrating safety and effectiveness often comes from the established clinical use and performance of the predicate device. The general statement "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting" suggests that clinical outcomes (symptom reduction) served as a basis for understanding effectiveness, likely derived from clinical observations or existing literature on such devices.

8. The sample size for the training set:

• Not applicable/Not present. This product is a physical device and does not involve a "training set" in the context of machine learning or AI models.

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

• Not applicable/Not present. As above, no training set is relevant.

Summary of the document's core message regarding "testing":

The primary "testing" mentioned in this 510(k) summary is:

• Material Compatibility: "Device is constructed using medical grade silicone, a well-established material for this application." This implies that the safety and biocompatibility of the material itself are well-understood and accepted, negating the need for novel material studies.
• Clinical Effectiveness (Historical/Literature-based): "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." This statement refers to the general clinical experience and evidence supporting the class of device, rather than specific performance data for this particular device model in a controlled study presented in the submission. The substantial equivalence argument relies on this existing evidence for similar devices and the fact that this device shares similar design and materials with its predicate.

In conclusion, this 510(k) document establishes "substantial equivalence" based on similar materials, design, and intended use as a predicate device, relying on the generally accepted clinical outcomes for this type of device, rather than presenting a detailed study with specific acceptance criteria and performance data for this new device.

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To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.

The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses. The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.

The provided text describes Boston Medical Products' Custom Nasal Splints, their indications for use, and a 510(k) submission for market clearance. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods.

The document is a US FDA 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the input text. The text only confirms that the device is "constructed using well-established medical grade flouroplastic or medical grade silicone", and that it was deemed "substantially equivalent" to predicate devices, allowing it to proceed to market.

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1. To be used for control of anterior nasal epistaxis.
2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.

The Epi-Stop™ is a single balloon catheter with integral airway designed for both nasal packing and control of anterior nasal hemorrhage. The Epi-Stop™ can be used to control the bleeding of an anterior epistaxis. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures. The Epi-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.

This document is a 510(k) summary for the Epi-Stop™ Epistaxis Catheter. It describes the device, its intended use, and its predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary states that "Device is constructed using well-established medical grade silicone," implying that the device was deemed substantially equivalent to a predicate device based on material and design, rather than performance studies with acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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