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510(k) Data Aggregation
(274 days)
The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short term medical device, normally intended for continuous use for not more than 29 days. It needs periodic replacement.
The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis is a bi-flanged silicone device connected with a stretchable (elastomeric) beaded stem. Both flanges are the same diameter for a given size device. The inner flange is flexible enough to allow folding for trans-fistula insertion by a trained physician. The device is fabricated from implant grade silicone. The product will be offered in three sizes: 25mm, 38mm and 50mm. The size is the outside diameter of the sealing flange size options allow the device to accommodate the size of the fistula in the tissue. The three (3) sizes offered are to close fistulas of size between approximately 6 mm diameter and 25 mm diameter, and tissue thickness from approximately 1.5mm to 25mm. The flanges, which are flexible, allow the device to conform to the contours of the tissue at the site yet minimize leakage. The Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis Insertion and Removal Catheter is supplied as an accessory to insert or remove the 25 mm and 38 mm Blom-Singer ® Adjustable Bi-Flanged Fistula Prostheses.
The provided text describes the Blom-Singer® Adjustable Bi-Flanged Fistula Prosthesis, a Class I medical device for managing hypopharyngeal fistulae. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on non-clinical testing and a retrospective clinical review.
Here's an analysis of the acceptance criteria and the supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it details various non-clinical tests with their outcomes. For the clinical aspect, it reports on the efficacy and safety observed in a retrospective case review.
| Acceptance Criteria (Inferred from Non-Clinical Tests and Clinical Review) | Reported Device Performance |
|---|---|
| Non-Clinical Performance | |
| Non-cytotoxic | Device found to be non-cytotoxic |
| Non-sensitizing | Device found to be non-sensitizing |
| Non-irritating | Device found to be non-irritating |
| Prosthesis closes and seals when placed and adjusted (snug fit) | Met all performance characteristics |
| Stem does not tear or break when placed and adjusted | Met all performance characteristics |
| Locking loop functions as designed to prevent loss of proper fit | Met all performance characteristics |
| Sterility (SAL of 10^-6 at 25 kGy) for Prosthesis | All samples passed sterility |
| Sterility (SAL of 10^-6 at 25 kGy) for Catheter | All samples passed sterility |
| 1-year and 3-year shelf life (burst, dye migration, label integrity) | Product passed acceptance criteria after 1-year and 3-year accelerated aging |
| Catheter 1-year and 3-year shelf life (no deterioration/damage) | Met acceptance criteria |
| Catheter dimensional inspection within tolerance | All samples passed |
| Catheter eyelet ultimate tensile strength (≥ 2.0 pounds) | All samples met requirement |
| Catheter eyelet to beaded stem placement tensile strength (≥ 0.5 pounds) | All samples met requirement |
| Catheter eyelet to beaded stem removal tensile strength (≥ 0.5 pounds) | All samples met requirement |
| Clinical Performance (Retrospective Review) | |
| Control or elimination of salivary leakage | 21 out of 25 (84%) patients reported control/elimination |
| No serious adverse events | Absence of any serious adverse events reported |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" for clinical performance was a retrospective review of existing cases.
- Sample Size: 25 patients.
- Data Provenance: Retrospective review from ten (10) institutions. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the data is likely from the U.S. or North America.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not specify the number of experts or their qualifications used to establish the "ground truth" for the retrospective clinical cases. The review relies on clinical outcomes reported from the institutions that treated the patients with custom-fabricated devices. It states that the custom devices were "technologically similar" to the proposed device.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the retrospective clinical review. It appears to be a summary of reported outcomes from the treating institutions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study was a retrospective review of clinical cases using a technologically similar device. There is no mention of comparing human readers' performance with and without AI assistance. This device is a physical medical prosthesis, not an AI-powered diagnostic tool.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical prosthesis, not an algorithm or AI system. The design verification testing could be considered a "standalone" evaluation of the physical device's performance characteristics.
7. The Type of Ground Truth Used
For the non-clinical tests (cytotoxicity, sensitization, irritation, performance characteristics, sterility, shelf-life), the "ground truth" was established by accepted industry standards and laboratory testing protocols (e.g., ISO 10993-1:2009 for biocompatibility, ANSI/AAMI/ISO 11137-2 for sterilization, physical testing for mechanical properties and shelf life).
For the retrospective clinical review, the "ground truth" was based on reported clinical outcomes from the treating institutions regarding salivary leakage control/elimination and the absence of serious adverse events. This essentially relies on the clinical judgment and patient follow-up records from the physicians involved in those cases.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI. All clinical data presented is from a retrospective "test set" used to demonstrate safety and effectiveness for substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" referenced for an algorithm. The custom-fabricated devices used in the retrospective review could be loosely considered analogous to "training data" in the sense that they provided prior clinical experience for the design of the Blom-Singer® device. However, this is not a formal training set with established ground truth for an AI model.
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(96 days)
The Blom-Singer® Septal Perforation Prosthesis is indicated for use for non-surgical closure of nasal septum perforations.
The Blom-Singer® Septal Perforation Prosthesis is a bi-flanged elastomeric device, each prosthesis are comprised of two (2) pieces which are attached to one another using a set of 2 enclosed magnets at the center of the flanges. The center post is either an oval or circular silicone stem that will fill most of the nasal septal perforation. The overlapping thin section or flange will extend beyond perforation to help with the closure of the perforation and the retention of the device.
The flanges will be offered is various sizes and shapes to accommodate the individual's septal shape. In addition, the clinician may trim the flanges to fit.
The device is intended to be used up to 29 days.
Here is the information about the acceptance criteria and study for the Blom-Singer® Septal Perforation Prosthesis, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance Study
The Blom-Singer® Septal Perforation Prosthesis received 510(k) clearance based on demonstrating substantial equivalence to predicate devices, K013686 (Silmed Nasal Septal Button) and K810738 (Xomed-Treace - Goode-Magne nasal splint). The primary method of demonstrating this equivalence was through non-clinical bench testing and a comparison of key features.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly quantified performance metrics in the way a diagnostic algorithm's sensitivity/specificity would be. Instead, the "acceptance criteria" are implied by demonstrating that the proposed device performs functionally as intended and is safe, similar to the predicate devices, across various non-clinical tests. The reported device performance is that these tests were successfully passed, meeting the "requirements for the intended and environment of use."
| Attribute/Test Type (Implied Acceptance Criteria) | Reported Device Performance |
|---|---|
| Indications for Use Equivalence (Same intended use as predicate) | Outcome: Identical to predicate device K013686: Non-surgical closure of nasal septum perforations. |
| Technology and Construction Equivalence (Similar design, fabrication, shape, size; similar magnetic attachment technology) | Outcome: Design, fabrication, shape, size equivalent to K013686. Magnetic attachment technology equivalent to K810738. Design incorporates 2 thin, flat flanges. |
| Environment of Use Equivalence (Same intended environments) | Outcome: Identical to predicate K013686: Hospital, clinical setting, or at home under medical professional instruction. |
| Patient Population Equivalence (Same target patient group) | Outcome: Equivalent to predicate K013686: Individuals with a perforated nasal septum. |
| Mechanical Strength of Magnets (Magnets hold the device together securely) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific strength not provided, but implies satisfactory performance). |
| Real-time Aging (Device withstands intended use duration) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific aging data not provided, but implies satisfactory performance for up to 29 days). |
| Environmental and Mechanical Testing (Device functions in intended environment and withstands physical stresses) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific tests/results not provided beyond categories, but implies satisfactory performance). |
| Cleaning Degradation (Device integrity maintained after cleaning) | Outcome: Test demonstrated the proposed device meets performance requirements. (Specific data not provided, but implies satisfactory performance). |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous/Irritation) (Materials are safe for patient contact) | Outcome: Tests required based on material classification (Surface Communicating (direct), Mucosal contact, Prolonged duration of use) and were presumably passed to establish safety. Specific results are not detailed but the device was cleared. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable as this was a premarket notification (510(k)) that relied on non-clinical bench testing and comparison to predicates for substantial equivalence. There was no "test set" of patient data in the context of clinical trials. The bench tests would have used an unspecified number of device prototypes or components.
- Data Provenance: Not applicable. The data is from internal bench testing performed by the manufacturer, Helix Medical, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no clinical ground truth established by experts for a test set of patient data. The "ground truth" for the non-clinical tests was likely established by engineering specifications and industry standards for mechanical and material performance.
4. Adjudication Method for the Test Set
Not applicable. There was no test set involving human interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (prosthesis), not an AI algorithm or a diagnostic tool that would typically undergo such a study. The substantial equivalence was based on physical and material characteristics and bench testing.
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
The "ground truth" for this submission was primarily:
- Engineering specifications and performance requirements for the device's mechanical integrity (e.g., magnet strength, aging, environmental resilience).
- Biocompatibility standards and certifications for materials in prolonged mucosal contact.
- The established safety and effectiveness profile of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. There was no "training set" in the context of AI or machine learning for this physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
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(135 days)
The Blom-Singer Indwelling TEP Occluder is indicated for anterograde placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of the indwelling occluder is performed by a qualified, trained medical professional. This device is for use with healed, intact tracheoesophageal puncture fistulas only.
The Blom-Singer Indwelling TEP Occluder is designed to provide fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. The Indwelling TEP Occluder has been modified from its predicate devices by the inclusion of the Indwelling Low Pressure Voice Prosthesis design, and is now available in 16 and 20 fr. Sizes. In addition, this device will be offered in a large esophageal flange version. This version will be identical except for an esophageal flange which is greater in diameter to deter leakage around the device in individuals with unique physiology. These devices are manufactured from medical grade silicone and are latex-free.
Here's an analysis of the provided text regarding the Blom-Singer® Indwelling TEP Occluder, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a medical device, the Blom-Singer® Indwelling TEP Occluder, and references "functional equivalency tests" that demonstrate its performance. However, it does not explicitly state specific quantifiable acceptance criteria with numerical targets. Instead, it relies on demonstrating equivalence to predicate devices by meeting their established performance characteristics.
The "reported device performance" is a qualitative statement of equivalency rather than measured individual performance metrics against predefined criteria.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Fistula Maintenance and Leakage Prevention: Device should maintain the TE puncture and prevent leakage of liquids from the esophagus into the trachea. | The device provides fistula maintenance while preventing leakage of liquids from the esophagus into the trachea after total laryngectomy. Functional equivalency tests demonstrated the equivalency of device performance with the three designs (including predicate devices). |
| Pressure Decay: Performance regarding pressure decay should be equivalent to predicate devices. | Non-clinical tests, including Pressure Decay, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided). |
| Flange Retention Force: Performance regarding flange retention force should be equivalent to predicate devices. | Non-clinical tests, including Flange Retention Force, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. (Specific performance values or equivalence margins are not provided). |
| Gel Cap Insertion Method: The gel cap insertion system should facilitate placement effectively and be equivalent to predicate devices. | Non-clinical tests, including Gel cap Insertion method, were performed. The conclusions drawn from these tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices. The gel cap insertion system facilitates placement. (Specific performance values or equivalence margins are not provided). |
| Biocompatibility/Material Safety: Device should be made from safe, medical-grade materials. | Manufactured from medical grade silicone and are latex-free. Predicate devices are also manufactured from medical grade silicone and latex-free. |
2. Sample Sizes Used for the Test Set and Data Provenance
The text describes "non-clinical tests" (Pressure Decay, Flange Retention Force, and Gel Cap Insertion method).
- Sample Size: The document does not specify the sample sizes used for these non-clinical tests.
- Data Provenance: The document does not provide information on the country of origin of the data, nor does it specify if the data was retrospective or prospective. Given these are "non-clinical tests," they likely involved laboratory testing of the devices themselves rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not provided in the document. As the tests were non-clinical, they likely involved engineers or technicians conducting laboratory measurements, rather than clinical experts establishing ground truth in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the non-clinical nature of the tests, an adjudication method for human interpretation (like 2+1 or 3+1) is not applicable. The tests likely involved direct measurement and comparison to established specifications or predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not done. The application describes non-clinical, functional equivalency tests comparing the device to predicate devices, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- A standalone performance study in the context of an algorithm's performance was not done. This device is a physical medical device, not an AI algorithm. The performance described relates to its physical and functional properties.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests appears to be established performance characteristics of the predicate devices and general safety/effectiveness standards for similar medical devices. The tests aimed to demonstrate that the new device's performance was "as well or better than the predicate devices" for the specific functional attributes (Pressure Decay, Flange Retention Force, Gel Cap Insertion method). This is a form of engineering or functional validation against existing benchmarks.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. This device is a physical medical component, not an AI model.
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(30 days)
The Blom-Singer Indwelling voice prosthesis is indicated for tracheoesophageal voice restoration following total laryngectomy, when placement, or replacement, of an indwelling voice prosthesis is performed by a qualified, trained medical professonal.
The Blom-Singer Dual Valve Indwelling Voice Prosthesis is provided for the same indications for use as the other Blom-Singer Indwelling Voice Prosthesis product lines. The Dual Valve Indwelling Voice Prosthesis has been modified from its predicate devices by the addition of a second valve intended to continue to function when leakage occurs in the primary valve.
The Blom-Singer Dual Valve Indwelling Prosthesis has been modified from its predicate devices by the addition of a second valve, consisting of a valve and valve seat, intended to continue to function when leakage occurs in the primary valve. The prosthesis is still primarily silicone. A second modification is the introduction of a slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap containing the prosthesis' esophageal flange. When the gel cap dissolves the inserter moves forward, indicating flange deployment.
Accessory Devices: The device will be offered with the following accessories: inserter stick, flushing device, flange introducer, gel caps, and lubricant,
The provided document is a 510(k) summary for the Blom-Singer Dual Valve Voice Prosthesis. It does not contain information typically found in a study proving a device meets acceptance criteria, such as a detailed clinical study with specific acceptance criteria, sample sizes, expert involvement, or statistical analysis.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical functional equivalency tests.
Here's a breakdown of the requested information based on the provided text, and where the information is not available:
Acceptance Criteria and Device Performance Study Details (Blom-Singer Dual Valve Voice Prosthesis)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate devices) | Reported Device Performance (Blom-Singer Dual Valve Voice Prosthesis) |
|---|---|
| Functioning of primary valve for voicing | The device includes a "second valve intended to continue to function when leakage occurs in the primary valve," implying improved sustained function related to leakage compared to predicate devices which presumably had only one valve. Implicitly performs at least as well as the predicate's single valve function, with the added benefit of the secondary valve. |
| Airflow characteristics | "Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "Non-clinical tests referenced for a determination of substantial equivalence are Airflow..." |
| Pressure Decay characteristics | "Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Pressure Decay..." |
| Flange Retention Force | "Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Flange Retention Force..." |
| Valve Attachment Integrity | "Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Valve Attachment Integrity..." |
| Inserter Deployment | "Functional equivalency tests have been performed on the Blom-Singer prostheses, which demonstrate the equivalency of the valve performance with the predicate designs." Specifically, "...Inserter Deployment." Additionally, a modification involving "slight tension in the voice prosthesis strap when loaded on the inserter with a gel cap" is described, indicating a design change to aid deployment. |
Summary of Device Performance: The document explicitly states: "The conclusions drawn from the nonclinical tests demonstrate that the device is safe, as effective, and performs as well or better than the predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "nonclinical tests" and "functional equivalency tests" but does not provide any numerical sample sizes for these tests.
- Data Provenance (Country of origin, retrospective/prospective): Not specified. These were likely bench tests conducted by the manufacturer, Helix Medical, LLC, which is based in Carpinteria, CA, USA. The nature of the tests (non-clinical) implies they are not human clinical data, and thus the terms "retrospective" or "prospective" as applied to clinical studies are not applicable.
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 non-clinical, functional equivalency bench tests, not a clinical study requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable as the document describes non-clinical, functional equivalency bench tests, not a clinical study requiring adjudication.
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. The device is a voice prosthesis, not an AI or imaging diagnostic tool that would 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. The device is a physical medical device (voice prosthesis), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical functional equivalency tests would be established by engineering specifications and performance metrics derived from the predicate devices. The tests aimed to show that the new device's performance in specific areas (Airflow, Pressure Decay, Flange Retention Force, Valve Attachment Integrity, Inserter Deployment) was "equivalent" to the predicate devices.
8. The sample size for the training set
- This information is not applicable. The document describes the submission of a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable. As above, the device is not a machine learning model.
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