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510(k) Data Aggregation
(22 days)
The Seal Single Use Biopsy Valve is intended to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
The Seal™ Single-Use Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Seal™ Single Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
The provided text does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding study design elements such as sample sizes, expert involvement, or ground truth establishment.
The text is a 510(k) summary for the Boston Scientific Seal Single Use Biopsy Valve, outlining its intended use, technological characteristics, and a statement that bench testing was performed.
Here's what can be extracted:
- Device Name: Seal Single Use Biopsy Valve
- Intended Use: To provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
- Performance Data Mentioned:
- Bench testing for air and water leak testing, device insertion and removal, and scope compatibility.
- Biocompatibility testing (cytotoxicity, sensitization, and irritation testing).
- Result of Performance Data: The device "passed all Bench testing" and "passed all Biocompatibility testing."
However, none of the specific details requested in your prompt regarding acceptance criteria values, performance metrics, study design specifics (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types and establishment, training set details) are present in the provided document.
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(274 days)
The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.
The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.
The provided text is a 510(k) summary for the Seal Rite Non-Rebreathing Valve (K152521). It describes the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device was tested to ensure conformance with the FDA Recognized AS 4259-1995 standard ("Ancillary devices for expired air resuscitation") and passed all testing requirements. The table below summarizes the key performance parameters tested and the reported results. The explicit acceptance criteria (e.g., maximum allowable resistance values per the standard) are not fully detailed in the provided text, but the text states that the device "passed all testing requirements" and "performs as intended and meets the requirements of the AS 4259-1995 standard." I've extracted specific quantitative performance values where available and indicated "Pass" for qualitative tests.
| Acceptance Criteria (Implied by standard AS 4259-1995) | Reported Device Performance (Seal Rite™ Non-Rebreathing Valve) | Predicate Device Performance (Respironics Rescue Valve) |
|---|---|---|
| Biocompatibility: | ||
| Meet Cytotoxicity requirements (ISO 10993-5) | Pass | Not explicitly stated for predicate in this document |
| Meet Irritation requirements (ISO 10993-10) | Pass | Not explicitly stated for predicate in this document |
| Meet Sensitization requirements (ISO 10993-12) | Pass | Not explicitly stated for predicate in this document |
| Bench Testing (Functional Performance/Conformity to AS 4259-1995): | ||
| Ventilation Performance requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance for the Patient requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance for the Rescuer requirements | Pass | Not explicitly stated for predicate in this document |
| Inspiratory Resistance for a Spontaneously Breathing Patient requirements | Pass | Not explicitly stated for predicate in this document |
| Function After Contamination with Stomach Contents requirements | Pass | Not explicitly stated for predicate in this document |
| Function After Immersion in Water requirements | Pass | Not explicitly stated for predicate in this document |
| Measurement of Dead Space requirements | Pass | Not explicitly stated for predicate in this document |
| Resistance to Disengagement of Parts requirements | Pass | Not explicitly stated for predicate in this document |
| High and Low Storage Conditions requirements | Pass | Not explicitly stated for predicate in this document |
| High Temperature Operation requirements | Pass | Not explicitly stated for predicate in this document |
| Low Temperature Operation requirements | Pass | Not explicitly stated for predicate in this document |
| Attempted Displacement of Valve by Finger, Function After Dropping, Function After Potentially Deforming Weight requirements | Pass | Not explicitly stated for predicate in this document |
| Conformance of Connectors requirements | Pass | Not explicitly stated for predicate in this document |
| ISTA Procedure 2A Shipping Testing requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance at 50 LPM | 0.327 cm H2O (0.0321 kPa) | 0.25 cm H2O at 50 LPM (per K142402 510(k) Summary) |
| Inspiratory Resistance at 50 LPM | 1.15 cm H2O (0.113 kPa) | 1.85 cm H2O at 50 LPM (per K142402 510(k) Summary) |
| Inlet Connector | Standard 22 mm ID | Standard 22 mm ID |
| Outlet Connector | Standard 22 mm OD/15 mm ID | Standard 22 mm OD/15 mm ID |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the non-clinical tests (biocompatibility and bench testing). It mentions that the testing was conducted according to recognized standards (FDA Blue Book Memo G95-1, ISO 10993 series, AS 4259-1995, ISTA Procedure 2A). Typically, these standards specify the number of samples required for each test. The data provenance is implied to be from laboratory testing as mandated by these standards, not from human subjects or real-world use. It is retrospective in the sense that the testing was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards, not on expert interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards. There is no human 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
This information is not applicable. The Seal Rite Non-Rebreathing Valve is a mechanical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers (or AI assistance) would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a mechanical non-rebreathing valve, not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device according to engineering and biocompatibility standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering standards and biocompatibility standards. Specifically:
- AS 4259-1995: "Ancillary devices for expired air resuscitation"
- FDA Blue Book Memo G95-1: Guidance for biocompatibility testing.
- ISO 10993-5: Biocompatibility testing (Cytotoxicity)
- ISO 10993-10: Biocompatibility testing (Irritation)
- ISO 10993-12: Biocompatibility testing (Sensitization)
- ISTA Procedure 2A: Shipping testing.
These standards define the acceptable performance parameters and test methods for such devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a mechanical non-rebreathing valve, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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(30 days)
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Seal "Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
The provided text is a 510(k) summary for a medical device (Seal Biopsy Valve) and does not contain information about acceptance criteria for a study or the study details you are asking for. It focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document details administrative information, the intended use of the device, its description, and a comparison to a predicate device to confirm substantial equivalence, rather than a performance study with acceptance criteria.
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(100 days)
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal Is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Seal Single-Use Biopsy Valve:
The provided text (K133734) is a 510(k) Summary for a Seal Single-Use Biopsy Valve device, which is a modification of a previously cleared device (K111821). The document primarily focuses on demonstrating substantial equivalence to the predicate device, rather than detailed performance studies with clinical outcomes or human-in-the-loop assessments.
Therefore, many of the requested criteria in your prompt are not applicable or cannot be extracted from this type of regulatory submission. This document highlights bench testing and biocompatibility testing to demonstrate that the modified device performs as well as the predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Modified Device) |
|---|---|---|
| Pressure Integrity | 1 minute pressure test at 10 PSI – with device in biopsy valve | Pass |
| Pressure Integrity | 1 minute pressure test at 10 PSI – with device in biopsy valve (re-listed) | Pass |
| Pressure Integrity | 1 minute pressure test at 10 PSI after removing device from biopsy valve | Pass |
| Biocompatibility | Cytotoxicity (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | Sensitization (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | Intracutaneous injection test (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | System injection test (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Material | Thermoplastic elastomer | Thermoplastic elastomer (Matches predicate) |
| Valve Inner Diameter | Designed to be 7.1 mm (vs. 7 mm predicate) | 7.1 mm |
| Endoscope Compatibility | Olympus series 160, 180, and 190; Fujinon series 530, 590, and 600; EndoChoice Fuse | Compatible with listed endoscopes |
| Slit Accommodation | Accommodates devices up to 3.2 mm (Matches predicate) | Up to 3.2 mm |
| Overall Height | Reduction in overall height for improved fit | Improved fit confirmed (implied by design change) |
Study Details (Based on provided text)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many biopsy valves were pressure tested). However, "bench testing" was performed.
- Data Provenance: The testing appears to be conducted in a laboratory setting ("bench testing," "laboratory biocompatibility testing"). No country of origin is specified, but given the submission to the FDA, it's likely relevant to US regulatory standards. It is a retrospective analysis in the sense that the results are being presented after the tests were conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes performance and biocompatibility testing of a medical device, not a diagnostic or AI-assisted device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is the physical measurement or chemical reaction in the bench and biocompatibility tests.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for establishing ground truth in clinical studies involving interpretation of data (e.g., radiology reads). This document focuses on physical and biological performance tests.
-
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. This is a single-use biopsy valve, not an AI-assisted diagnostic device. Therefore, no MRMC study was conducted or is relevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical component (biopsy valve), not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Established physical and biological testing standards. For pressure tests, the "ground truth" is a pass/fail criterion based on maintaining pressure at 10 PSI for 1 minute. For biocompatibility, the ground truth is determined by established laboratory protocols and thresholds for cytotoxicity, sensitization, etc., as per 21 CFR Part 58.
-
The sample size for the training set:
- Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
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(106 days)
The device is intended to provide access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Seal Reusable biopsy valve is composed of a cylindrical base and a connected cap. The device is designed to mount easily and seal securely on the biopsy port of endoscopes. It allows passage of instruments or devices of up to 3.2 mm in diameter. providing a seal both during use and following removal of the device. The Seal reusable biopsy valve is compatible with Olympus series 160, 180, and 190. Fujinon series 530. 590, and 600, and Fuse gastrointestinal endoscopes.
To use the device, the operator positions the device onto the instrument channel, pushing down on the cap and pressing the valve on the port until it fits snugly. Instruments of up to 3.2 mm in diameter may then be passed through the slit in the diaphragm of the valve. The deformation of the material provides a seal around the introduced device. After the procedure, the instrument is withdrawn prior to removal of the biopsy seal from the port. Users are instructed to remove the cap from the seal prior to pre-cleaning.
By maintaining a seal at the biopsy port, the device allows irrigation access while allowing insufflation to be maintained, and it minimizes leakage of biomaterial from the biopsy port during the endoscopic procedure.
The Seal reusable biopsy valve is provided non-sterile. It does not bear single-use labeling, and includes steps for cleaning and disinfection in the instructions for use (see section 13, proposed labeling).
Here's an analysis of the provided text regarding the Seal Biopsy Valve - reusable, focusing on the acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific pass/fail acceptance criteria (e.g., minimum seal pressure, maximum leakage rate). Instead, it relies on a general statement of equivalency to a predicate device and positive outcomes from a suite of tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | Benchtop functional performance testing: "All test results passed, demonstrating that the device is safe and effective in comparison with predicate devices." (Implied: device effectively provides access for instruments, maintains insufflation, and minimizes biomaterial leakage as intended). |
| Cleaning Effectiveness: | Laboratory validation testing of the cleaning instructions: "All test results passed..." (Implied: cleaning instructions are effective in preparing the device for reuse). |
| Disinfection Effectiveness: | Laboratory validation testing of the high-level disinfection instructions: "All test results passed..." (Implied: high-level disinfection instructions are effective in preparing the device for reuse). |
| Biocompatibility: | Biocompatibility testing in conformance with ISO 10993-1: "All test results passed..." (Implied: the device materials are not harmful to biological systems). |
| Substantial Equivalence: | Intended use, design, materials, and labeling are all substantially equivalent to the predicate (Seal Single Use biopsy valve K111821). The principle of operation is the same. Materials (Thermoplastic elastomer for predicate, silicone for new device) are considered equivalent in elastic properties. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any of the non-clinical tests (benchtop functional performance, cleaning validation, HLD validation, biocompatibility testing). It only states that the tests were performed.
The data provenance is retrospective in the sense that the studies were performed specifically for this 510(k) submission, but the source of the data (e.g., patient data, specific lab environment) is not detailed beyond being "benchtop" and "laboratory validation." No geographical data provenance is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The tests described are laboratory and benchtop evaluations of the device's physical and biological properties.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests performed are primarily objective measurements against predefined (but not explicitly stated in the document) criteria, not subjective assessments requiring expert consensus.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically used for AI-powered diagnostic tools or systems where human performance is enhanced by the AI. The Seal Biopsy Valve is a mechanical accessory, not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
A standalone performance evaluation (algorithm only) was not performed because this device is a mechanical accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been established by:
- Engineering Specifications/Performance Standards: For benchtop functional performance, the "ground truth" would be the device meeting predefined engineering specifications related to sealing, instrument passage, and maintaining insufflation.
- Industry Standards (e.g., ISO 10993-1): For biocompatibility, the ground truth is conformance to the requirements outlined in ISO 10993-1.
- Validated Cleaning/Disinfection Protocols: For cleaning and high-level disinfection, the "ground truth" would be the successful reduction of microbial load and removal of organic soil based on established and validated laboratory protocols.
No pathology, expert consensus (in the clinical sense), or outcomes data was used for establishing ground truth for this device's non-clinical testing.
8. The Sample Size for the Training Set
There is no training set mentioned or applicable, as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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(188 days)
The indication for use of Seal Block PRO is to relieve sensitive teeth. Seal Block PRO is used to relieve sensitive teeth by blocking the pain caused by: Hot, Cold, Sweet, Acidic, Dental whitening agents. Seal Block PRO can also be used to relieve sensitivity: Prior to temporization (placement of provisional restorations). Prior to permanent cementation of indirect restorations. Prior to placement of direct restorations. When root surfaces are exposed.
Seal Block relieves sensitive teeth by blocking the pain caused by: heat, cold, sweets, acidic foods and drinks, dental whitening agents.
Seal Block is applied using an applicator to the sensitive tooth/teeth. It forms calcium oxalate crystals that occlude dentinal tubules resulting in desensitization of natural dentition.
The provided 510(k) summary for K123653, "Seal Block Tooth Desensitizer," states that the device's substantial equivalence to predicate devices (BisBlock, Super Seal, and Super Seal Tooth Desensitizer) is based on "Technological Characteristics" and "Performance Data" which primarily involve in vitro testing and chemical composition comparison. It does not describe acceptance criteria in the typical sense of quantitative performance metrics from a clinical study, nor a comparative effectiveness study involving human readers.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the form of specific thresholds (e.g., sensitivity > X%, specificity > Y%) for clinical performance, as one might find for diagnostic AI devices. Instead, the device's performance is demonstrated through comparison to predicate devices and in vitro R&D testing. The acceptance is based on demonstrating substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Chemical Composition Equivalence | Seal Block (Pro and OTC) has "Oxalate Solution" and is "Water Based," matching predicates. |
| Physical/Mechanical Property Equivalence (e.g., viscosity, SEM comparison) | Seal Block has "Low viscosity" and "SEM Comparison" data matches predicates where available. |
| Dentin Permeability Reduction (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Shear Bond Strength (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| pH (R&D testing) | Tested in the lab; results support effectiveness for indications of use (details not provided). |
| Biocompatibility | Evaluation conducted; concluded safe based on evaluation and ADA Oral Toxicity Study (10 rats, 14 days). |
| Safety and Efficacy (Overall Conclusion) | Concluded to be safe and efficacious based on substantial equivalence to predicates and provided data. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size:
- For physical/mechanical properties and dentin permeability, shear bond strength, and pH, the sample sizes for these in vitro R&D tests are not specified in the document.
- For biocompatibility, an "ADA Oral Toxicity Study" was conducted on 10 rats.
- Data Provenance: The R&D testing was conducted "in the lab," implying an in-house (Bisco, Inc.) development and testing environment. The ADA Oral Toxicity Study would likely have been conducted in a specialized laboratory for animal testing. The document does not specify a country of origin beyond "U.S.A." for Bisco, Inc. All data appears to be prospective in nature, as it was generated specifically for this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable, as no human expert-driven ground truth was established for a test set in the context of device performance as described. The device's performance is assessed through in vitro and animal studies, not by human interpretation.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as there was no test set requiring human adjudication for diagnostic or interpretive performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a desensitizer, not an interpretive AI diagnostic tool.
- Effect Size of AI Assistance: Not applicable.
6. Standalone Performance Study
- Standalone Study: Yes, performance data on "Seal Block" was generated through in vitro R&D testing (dentin permeability reduction, shear bond strength, pH) and an animal study (biocompatibility on 10 rats). This represents the algorithm-only performance for the device's stated function (blocking pain by occluding dentinal tubules). There is no "human-in-the-loop" component described for the device's direct function.
7. Type of Ground Truth Used
- Ground Truth Type:
- For chemical composition and physical/mechanical properties, the ground truth is established by chemical analysis and physical measurements (e.g., rheology for viscosity, microscopy for SEM).
- For dentin permeability, shear bond strength, and pH, the ground truth is established by laboratory measurements taken under R&D protocols.
- For biocompatibility, the ground truth is based on the results of the "ADA Oral Toxicity Study" in rats, which measures biological responses to the device material.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is based on its chemical formulation and physical properties, tested directly in lab settings and animal models.
9. How Ground Truth for Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.
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(61 days)
The SEAL ONE Radial compression Device is used for coronary angiography and angioplasty procedures practiced in a radial approach to compress the puncture site.
The SEAL ONE® may be used on the right or left wrist. The device placement time should be set on the time indicator, which should subsequently be locked. Wrist strap is secured by a strap which is clipped. The wrist strap can be twisted in to shorten it. Compression is applied by turning the compression knob clockwise. Decompression is done by pressing simultaneously on the safety button and turning the compression knob anticlockwise. It is possible to write on the wrist strap with ballpoint pen or indelible felt pen, to indicate the times at which the device was checked and steps during decompression. The dedicated positions for this are shown by the following symbols at the ends of the wrist strap.
The PEROUSE MEDICAL SEAL ONE® Radial Compression Device is intended for use in coronary angiography and angioplasty procedures to compress the puncture site when a radial approach is used. The device's performance was evaluated through various preclinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met biocompatibility requirements (demonstrating safety in terms of biological interactions). |
| Safety and Functionality - Bench Testing | The device successfully underwent testing during design qualification, in accordance with an internal protocol. This included evaluation of: |
| - Aspect | The physical appearance of the device met specified requirements. |
| - Preparation of the system | The device could be prepared for use as intended. |
| - Positioning of the system on the wrist | The device could be correctly positioned on the wrist. |
| - Compression / decompression functionality | The compression and decompression mechanisms operated as designed (i.e., turning the knob clockwise for compression, and simultaneously pressing the safety button and turning anticlockwise for decompression). |
| - Device positioned and functioning | The device remained correctly positioned and functioned effectively during use. |
| - Removal of the device at the end of process | The device could be safely and easily removed after the procedure. |
| - Used on a patient in the coronary and angiography environment | The device demonstrated functionality and suitability for use in a clinical (coronary and angiography) environment, though details of this "use" are not elaborated as a formal patient study. |
Study Details:
The provided summary describes a submission for 510(k) clearance, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (TR BAND™) and thorough preclinical testing rather than a clinical trial with a large test set of patient data.
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2. Sample size used for the test set and the data provenance:
The document does not specify a patient-based test set size or data provenance for evaluating the device's performance through a clinical study. The performance data listed (biocompatibility, safety and functionality bench testing, and "used on a patient in the coronary and angiography environment") appear to be from preclinical and possibly limited clinical observations (without formal study design details). The reference to "used on a patient" is vague and does not indicate a structured sample size. -
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given the nature of the tests (bench testing), external expert adjudication of ground truth in the traditional sense would not be applicable in the same way it would be for diagnostic AI. The "ground truth" for bench tests is adherence to design specifications and functional requirements. -
4. Adjudication method for the test set:
An adjudication method like 2+1 or 3+1 is not applicable as there was no formal clinical study with a test set requiring independent assessment of outcomes. The evaluation involved successful completion of predefined internal protocols for bench testing and potentially observational use. -
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was performed or is relevant to this device. This device is a radial compression device, not an AI-assisted diagnostic tool. -
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable as the SEAL ONE® is a physical medical device, not a software algorithm. -
7. The type of ground truth used:
The "ground truth" for this device's performance was based on engineering specifications, functional requirements, and internal test protocols. For biocompatibility, it would be adherence to relevant ISO standards. For functionality, it was the successful operation of the device as designed during bench testing. -
8. The sample size for the training set:
This question is not applicable as there is no mention or implication of a training set, as the device is a physical medical device, not a machine learning algorithm. -
9. How the ground truth for the training set was established:
This question is not applicable for the reasons stated above.
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(77 days)
Seal & Protect™ Protective Sealant is a protective sealant for exposed dentine. 'The indications for use are:
- Reduction of abrasion and erosion of exposed cervical dentine .
- Treatment of hypersensitive cervical areas .
Seal & Protect™ Protective Varnish is a nanofilled light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.
This 510(k) summary describes a device (Seal & Protect™ Protective Sealant) that is considered substantially equivalent to a predicate device (Seal & Protect™ Protective Varnish K992822). The submission states that the new device is "identical to K992822, with the exception of the addition of a contraindication." Therefore, the focus is on demonstrating this equivalence rather than providing a separate study with acceptance criteria for the new device's performance.
Based on the provided document, there is no study conducted for Seal & Protect™ Protective Sealant to demonstrate its performance against specific acceptance criteria.
The entire premise of this 510(k) submission is that the new device is functionally the same as the predicate device, with only a minor change (an added contraindication). Therefore, the performance is assumed to be equivalent to the predicate device, for which performance would have been established previously.
Here's a breakdown based on your requested information, highlighting why much of it is not applicable or not provided in this specific 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: This 510(k) relies on substantial equivalence to a predicate device (Seal & Protect™ Protective Varnish K992822) rather than presenting new performance data against acceptance criteria for the "new" device. The claim is that the device is "identical... with the exception of the addition of a contraindication," implying its performance is the same as the predicate.
Regarding a study proving the device meets acceptance criteria: There is no study described in this 510(k) pertaining to the performance of Seal & Protect™ Protective Sealant against specific acceptance criteria. The submission is a claim of substantial equivalence based on the device being nearly identical to a previously cleared product.
Therefore, the following points are not applicable or cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable, as no new performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 device is a dental sealant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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(86 days)
SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The Indications for Use are: (1) Reduction of abrasion and erosion of exposed cervical dentine; and (2) Treatment of hypersensitive cervical areas.
SEAL & PROTECT™ DENTAL VARNISH is a nanofilied light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.
This submission describes SEAL & PROTECT™ DENTAL VARNISH, a nanofilled light-curing dental varnish. The primary claim of the device is its safety and effectiveness.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance (as demonstrated in the study) |
|---|---|
| Absence of cytotoxicity | The device was evaluated for cytotoxicity (L929). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed." |
| Absence of mutagenicity | The device was evaluated for mutagenicity (Ames Test). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed." |
| Safety regarding migration of constituents | "The possibility of migration of constituents occurring during the application and polymerization phase cannot be absolutely ruled out. However, in light of the low volume of material applied, the low solubility in physiological liquids and the inert properties of the polymerized synthetic matrix, the amount and type of the substances temporarily released from the product must be considered as harmless." (This is a qualitative risk assessment rather than a quantitative performance metric). |
| Equivalence to predicate devices (Prime & Bond® NT™ Universal Dental Adhesive K982394) | The submission states, "We believe that the prior use of the components of SEAL & PROTECT™ DENTAL VARNISH in legally marketed devices, the results of biocompatibility testing, and the performance data support the safety and effectiveness of SEAL & PROTECT™ DENTAL VARNISH for the indicated uses." The FDA's substantial equivalence letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly mentioned in terms of subject or clinical data. The testing described (cytotoxicity and mutagenicity) refers to laboratory tests.
- Data Provenance: Not specified. The biocompatibility tests (L929 toxicity and Ames Test) are commonly in-vitro laboratory tests and typically do not involve human subjects or specific country data provenance in this context. They are likely conducted in a lab setting. It is not specified if the data is retrospective or prospective, but given the nature of the tests, they would be experimental.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The ground truth for the cytotoxicity and mutagenicity tests would be based on established scientific protocols and interpretation by qualified toxicologists or biologists, but specifics are absent.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical trials where multiple experts assess outcomes. For in-vitro biocompatibility tests, the interpretation typically relies on a single, qualified expert following established scientific guidelines.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on biocompatibility and general safety, and substantial equivalence to a predicate device, rather than comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This device is a dental varnish, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The ground truth used for the reported performance (cytotoxicity, mutagenicity, and safety assessment) is based on:
- Standardized in-vitro biocompatibility tests: L929 cell culture for cytotoxicity and Ames Test for mutagenicity, which have defined positive and negative controls and interpretation criteria.
- Expert qualitative assessment: For the migration of constituents, a qualitative assessment by DENTSPLY experts concluded the amount and type of temporarily released substances were "harmless" based on material properties and application volume.
- Predicate device equivalence: Implied safety and effectiveness grounded in the regulatory history and proven performance of the designated predicate device (Prime & Bond® NT™ Universal Dental Adhesive).
8. The Sample Size for the Training Set
N/A. This device is not an AI/ML algorithm that requires a training set. The "training" for this product would be its formulation and development based on established dental material science principles.
9. How the Ground Truth for the Training Set Was Established
N/A. As this is not an AI/ML algorithm, there is no "training set" or ground truth established for it in that context. The "ground truth" for the material's properties and intended function would have been established through extensive research and development in dental materials science.
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