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PerioStom™ Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.

PerioStom™ Dental Dressing can be utilized for the pain relief and protection of oral mucosa due to irritation, trauma, or following iatrogenic procedures such as scaling and root planing.

PerioStom™ Dental Dressing is a powder based wound dressing comprised entirely of spray-dried chitosan. PerioStom™ Dental Dressing is provided to the clinician in a stainless steel container and can be applied to the tissue via a dental instrument of their choice (e.g. a Prichard or Howard Periosteal Elevator) or a dry gloved finger. PerioStom™ Dental Dressing is also supplied in preloaded cartridges for application to harder to reach areas of the oral mucosa via the FS Dispenser™.

This FDA submission describes a medical device, the PerioStom™ Dental Dressing, and seeks substantial equivalence to a predicate device. However, this submission does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.

The provided document describes a dental dressing, which is a physical barrier intended for temporary protection of oral mucosal tissue and to provide pain relief. This is a traditional medical device, not an AI/ML-driven device. Therefore, the requested information pertaining to AI/ML device testing (such as performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device (HemCon® Dental Bandage K060363) through:

• Comparison of technological characteristics: Both are spray-dried chitosan-based dressings that form a bioadherent gel.
• Non-clinical performance testing: Viscosity, pH, microbial testing, and wound barrier testing. The results were found to be "substantially equivalent" for the subject and predicate devices.
• Biocompatibility testing: According to ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity). The device met these requirements.

No clinical performance testing was conducted or deemed necessary for this type of device and submission.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML device performance and testing. This document describes a non-AI physical medical device.

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SalivaMAX™ is indicated for dryness of the mouth or throat (hyposalivation, xerostomia, mucositis), regardless of the cause and regardless of whether the condition is temporary or permanent. Relief of dryness of the oral mucosa in these conditions is associated with an amelioration of pain.

SalivaMAX™ is also indicated as an adjunct to standard oral care in treating the mucositis that may be caused by radiation or high dose chemotherapy.

SalivaMAX™ may be used for the relief of dryness of the oral mucosa when hyposalivation results from the following: pre/post surgery, radiotherapy, chemotherapy, infection or dysfunction of the salivary glands, inflammation of the mouth or throat, fever, emotional factors such as fear or anxiety, obstruction of the salivary ducts, Bell's Palsy, and Sjogren's syndrome. SalivaMAX™ is also indicated for dryness of the oral mucosa due to drugs such as antihistamines, atropine, or other anticholinergeic agents that suppress salivary secretion.

SalivaMAX™ may be used as part of an oral hygiene program for patients with dry mouth. SalivaMAX™ provides intensive hygiene of the oral cavity, and may be used to help relieve bad taste, relieve offensive nasal discharge, and crusting.

SalivaMAX™ is an artificial saliva that is provided in disposable packets.

SalivaMAX™ is comprised of powdered ingredients that when combined with 30 mL (1 oz.) of water, produces a supersaturated calcium phosphate solution. SalivaMAX™ is packaged in singleuse packets and will be provided non-sterile and is not intended to be sterilized before use.

Because SalivaMAX™ is to be administered several times per day it will primarily be used at home, office or other non-clinical settings. However, SalivaMAXTM may also be used in clinical or healthcare facility settings where patients are receiving inpatient services.

The goal of administering SalivaMAX™ is to relieve chronic and temporary xerostomia and mucositis. SalivaMAX™ is a partial substitute for natural saliva and intended to moisten, lubricate, and clean the oral cavity including the mucosa of the mouth, tongue, and throat. SalivaMAX™ facilitates chewing and speaking; and can relieve bad breath.

SalivaMAX™ is composed of US Pharmacopeia grade calcium, phosphate, bicarbonate, and chloride electrolytes. Each application of SalivaMAX™ is to swish half the solution for 1 minute, expectorate, then repeat for the remaining solution. Given that the rinse is topical with a maximum rinse time of 20 minutes per day (2 minutes per application x maximum 10 times per day), SalivaMAX™ is considered a surface contacting device with a limited duration of contact.

Key performance specifications of SalivaMAX™ are an in solution pH range of 6.25 - 7.5 and solubility in water.

The provided text describes the SalivaMAX™ device, its indications for use, and a comparison with predicate devices to establish substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for performance.

Therefore, the requested information elements related to a study proving acceptance criteria cannot be fully extracted/answered from this document.

However, based on the Summary of Testing section (page 6), some information can be inferred or directly stated regarding "acceptance criteria" through the lens of establishing substantial equivalence to predicate devices.

Here's what can be extracted, and where information is missing or not applicable, it is noted:

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

2. Sample size 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: Not specified. The document refers to "bench testing" but does not provide details on the number of samples tested for dissolution or pH.
• Data Provenance: Not specified. It's bench testing, likely conducted internally or by a contract lab, but no country of origin or retrospective/prospective nature is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This document describes bench testing (dissolution, pH evaluation) for a liquid solution, not diagnostic performance or a scenario where human experts would establish ground truth for a test set.

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

• Not Applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, not for objective bench tests like dissolution and pH.

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 document is for a medical device (artificial saliva solution) that does not involve AI or human "readers" interpreting cases. The testing described is bench testing for physico-chemical properties.

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

• Not Applicable. This device is a solution for oral rinse, not an algorithm.

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

• For pH and solubility:
  • pH: The "ground truth" is established through standard laboratory measurement techniques using a pH meter, yielding an objective value.
  • Solubility: The "ground truth" is whether the powder dissolves in water, an objective observation.
• For dissolution:
  • The "ground truth" or acceptance standard was equivalence to the predicate device, NeutraSal, which itself would have established its dissolution profile through standard laboratory methods.

8. The sample size for the training set

• Not Applicable. This refers to bench testing of a medical device solution; there is no "training set" in the context of machine learning or algorithms.

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

• Not Applicable. As there is no training set for this type of device and testing.

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OralID™ is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer.

OrallD™ is a battery operated (CR123A), hand-held, oral illumination and examination light designed for use by dental and medical professionals to be used as an adjunctive tool for fluorescence visualization of oral mucosal tissue. OralID™ accessories include two pair of filtered eyewear for both the clinician and patient.

The provided document is a 510(k) summary for the OralID™ device, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not present a detailed study on the device's performance against specific acceptance criteria in terms of diagnostic accuracy or clinical effectiveness.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's what can be extracted based on the document:

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

The document lists performance tests conducted, but does not provide quantitative acceptance criteria or detailed results for these tests in terms of clinical performance. Instead, it focuses on technical and safety aspects.

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

This information is not provided in the document. The performance testing mentioned appears to be related to technical specifications and safety rather than a clinical study with a test set of patient data.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any indication of an AI component in the OralID™ device. The device is a physical illumination and examination light.

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

The OralID™ device is an adjunctive tool for human examination; it is not an algorithm-only device, so this question is not applicable.

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

This information is not provided in the document, as no clinical study with ground truth establishment is detailed.

8. The sample size for the training set

This information is not provided in the document. The device description and performance testing do not suggest a machine learning model that would require a training set.

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

This information is not provided in the document.

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