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The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.

The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.

The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.

The provided document describes the "Oral Matrix" device and its FDA 510(k) summary, which often includes information on acceptance criteria and supporting studies. However, this specific document focuses on demonstrating substantial equivalence to a predicate device rather than providing explicit acceptance criteria with numerical targets for clinical performance metrics or a detailed standalone study for human-in-the-loop performance. Instead, it relies on non-clinical and animal studies to justify equivalence based on product performance and composition.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

The document does not explicitly list quantitative acceptance criteria in a table format with specific performance targets for the device's intended clinical use (e.g., success rate of socket preservation, bone regeneration metrics). Instead, it presents various non-clinical and animal study findings which implicitly serve as evidence that the device performs similarly to the predicate device or meets regulatory standards.

Implicit "Acceptance Criteria" through Equivalence and Standards Compliance:

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

• Test Sets:
  • Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life, Biocompatibility): The document doesn't specify sample sizes for these tests. The data provenance is not explicitly stated as country of origin, but the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, and the testing was likely conducted in a setting compliant with international standards (ISO, ASTM). These are generally prospective tests conducted specifically for the submission.
  • Virus Inactivation: Not specified, but likely an in-vitro study designed to demonstrate log reduction, which is a prospective test.
  • Animal Study: The sample size for the canine model is not specified. The study was performed in an animal model, which is a prospective study. Data provenance in terms of country is not specified, but usually, animal studies are conducted by or for the submitting company.

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 section is not applicable as the document describes non-clinical and animal studies, not studies involving human expert interpretation for ground truth. Ground truth for these types of tests is established through laboratory methods and histopathological analysis (for the animal study), not expert consensus on human data.

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

This is not applicable as the studies described (non-clinical, animal) do not involve human interpretation or adjudication processes typical of clinical diagnostic studies.

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

No MRMC comparative effectiveness study was done or mentioned. The device is a bone grafting material, not an AI-assisted diagnostic tool.

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

Not Applicable. The device is not an algorithm, but a physical bone grafting material. There is no "algorithm only" performance to evaluate. The performance evaluations described are for the physical properties and biological effects of the material itself.

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

• Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life): Ground truth is established by physical and chemical measurements against established standards (e.g., ASTM, ISO guidelines) and comparative data from the predicate device.
• Virus Inactivation: Ground truth is established by virological assays to determine viral load reduction.
• Biocompatibility: Ground truth is established by in vitro and in vivo biological assays (e.g., cytotoxicity, sensitization, implantation responses) adhering to ISO 10993 series standards.
• Animal Study: Ground truth for socket preservation would be established by histopathological examination of the extracted socket sites, potentially including measurements of bone formation, reduction in ridge resorption, and inflammation, compared to control groups.

8. The sample size for the training set

Not Applicable. The device is a bioabsorbable extracellular collagen membrane matrix, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of an AI model.

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

Not Applicable. As explained above, there is no training set for this type of device.

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A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

The proposed device is a powder free medical glove. The device is made from a nitrile latex compound, blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The device is available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The device can be provided in non-sterile.

This document is a 510(k) Premarket Notification for "Medical Gloves" (K203622). It describes the device's characteristics, its intended use, and comparative testing against a predicate device (K180467) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Under Evaluation: Medical Gloves (powder-free patient examination glove, nitrile latex compound, blue color)

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical Testing):

The document explicitly states: "Non clinical tests were conducted to provide data that the proposed devices met the acceptance criteria or the specification for the test methodology or standard shown below. The test results demonstrated that the proposed devices comply with the following standards."

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

• Sample Size: The document does not explicitly state the specific number of gloves or animals used for each test. However, it references specific ASTM and ISO standards (e.g., ASTM D5151-19, which specifies AQL levels and inspection levels for Freedom from Holes). These standards define appropriate sample sizes for testing compliance. For instance, ASTM D5151-19, AQL 2.5, Inspection Level G-1 means the sample size is determined by the lot size, but for the specifically mentioned acceptance/rejection criteria (Accept at 5 failures, Reject at 6 failures), it implies a certain sample size bracket within the standard.
• Data Provenance: The document does not specify the country of origin where the non-clinical tests were performed. It states the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, so it's reasonable to infer the tests were conducted in or overseen by this entity. The data is retrospective in the sense that the tests were performed, and the results are being reported as part of a premarket submission.

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

• This section talks about the establishment of ground truth for a test set, typically relevant for AI/ML device evaluations. This document describes the evaluation of a physical medical device (gloves) against established performance standards. Therefore, the "ground truth" is based on objective, standardized test methods and their defined acceptance criteria. It is not based on expert consensus interpreting subjective data.
• The tests themselves are performed by trained personnel in a laboratory setting, but the document does not specify the number or qualifications of these individuals, as it's not a multi-reader study.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study involving human readers or subjective interpretations requiring adjudication. The tests are objective and based on physical measurements and chemical analyses as per established standards.

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 not an AI/ML device that assists human readers. It is a physical medical device (gloves).

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

• Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's ability to meet the specified performance criteria as tested in isolation according to the listed ASTM and ISO standards. The results table clearly indicates that the device met these criteria.

7. The Type of Ground Truth Used

• The ground truth used for this device's evaluation is primarily objective, standardized test results based on established international (ISO) and national (ASTM) consensus standards. These standards define measurable physical, chemical, and biological properties, along with clear acceptance/rejection criteria. For biocompatibility tests (skin sensitization, irritation, acute toxicity), the ground truth is established by the biological responses observed in the test models (e.g., animal models) according to the protocols defined in ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set." The device itself is a manufactured product, not a learned algorithm.

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

• Not applicable, as there is no training set for this type of device.

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The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.

The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.

The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.

Disposable Circular Stapler places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five specifications. The staple is available in 4.5mm and 4.8mm two different heights.

Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.

Disposable Hemorrhoidal Stapler is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded.

Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure.

The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.

The provided document is a 510(k) Summary for various disposable staplers and reload devices. It describes non-clinical tests to verify performance but does not include any information about studies involving acceptance criteria related to AI/human reader performance, ground truth establishment by experts, or any MRMC comparative effectiveness studies.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to medical device regulatory submission for staplers, not AI medical devices.

However, I can provide the following based on the Non-Clinical Test Conclusion section:

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

The document mentions several tests and standards the device complies with, which would imply passing these as acceptance criteria. It doesn't provide specific numerical acceptance criteria or performance metrics for each test, but generally states that the device "met all design specifications" and "complies with the following standards".

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: Not specified for any of the non-clinical tests.
• Data Provenance: The ex-vivo and jugular vein tests were conducted on "porcine stomach and intestine tissue" and a "porcine model," respectively. This indicates animal tissue, not human data. The geographical origin of the tests is within "Beijing Biosis Healing Biological Technology Co., Ltd." in China (derived from company address). The tests are described as non-clinical "conducted to verify," implying prospective testing for the submission.

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. There is no mention of experts or ground truth establishment for a test set in the context of human interpretation or AI performance studies. The testing is for medical staplers, not an AI device.

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

Not applicable. There is no mention of adjudication methods for a test set, as this document refers to physical device testing rather than expert-based assessments of data.

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

No. This document explicitly states: "No clinical study is included in this submission." Furthermore, the device is a surgical stapler, not an AI diagnostic tool.

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

Not applicable. The device is a surgical stapler, not an algorithm.

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

For the ex-vivo and jugular vein tests, the "ground truth" would be the direct measurements and observations of the physical performance characteristics (e.g., staple formation, burst pressure, seal strength) as defined by engineering specifications and relevant standards, demonstrated through the "device met all design specifications" claim. This is physical performance testing, not diagnostic accuracy evaluation.

8. The sample size for the training set

Not applicable. The document describes a physical medical device (stapler), not an AI algorithm that requires a training set.

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

Not applicable. As above, this document does not describe an AI algorithm or a training set.

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The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.

The document provided is a 510(k) Summary for a medical device called "Disposable Laparoscope Trocar." This summary describes the device and its equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about acceptance criteria for a device performance study in the context of diagnostic accuracy, AI, or human reader performance.

Instead, the "acceptance criteria" discussed are related to standard engineering and biocompatibility tests for a surgical instrument. The study described is a series of non-clinical bench tests and an in-vivo animal study to demonstrate the safety and foundational performance characteristics of the trocar.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the benchmarks set by the predicate and reference devices, and by compliance with relevant ISO and ASTM standards. The reported device performance is mainly comparative to these existing devices and standards.

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

• Test Set Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for statistical validity in engineering tests. For the in vivo study, it mentions a "porcine model," implying a number of animal subjects were used, but the exact count is not given.
• Data Provenance: Not specified where these tests were conducted, beyond the applicant being Beijing Biosis Healing Biological Technology Co., Ltd. (China). The tests are presumably retrospective data collected during device development.

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

• This is not applicable as the evaluation involves physical and chemical property testing, not subjective expert assessment of clinical data or images.

4. Adjudication Method for the Test Set

• This is not applicable. Objective measurements and established testing protocols are used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable as the device is a physical surgical tool (trocar), not an AI-powered diagnostic or assistive technology.

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

• This is not applicable as the device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for these tests are the established definitions and methodologies within the cited ISO and ASTM standards, as well as the performance characteristics of legally marketed predicate devices. For biocompatibility, it's the biological response as per standardized tests. For mechanical properties, it's the quantifiable physical measurements.
• For the in vivo study, the ground truth would be the direct observation of insertion force, fixation force, visualization, and tip integrity in a live biological model.

8. The Sample Size for the Training Set

• This is not applicable as there is no "training set" in the context of a physical medical device. This is not an AI/machine learning device.

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

• This is not applicable for the same reason as above.

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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, steel sheet, plug, inner sleeve, outer sleeve, pull ring, outer introducer handle, joint, tightening line, pick rod and inner introducer handle. The device is available in a series of models: RJRB-50, RJRB-100, RJRB-120, RJRB-150, RJRN-200, RJRB-250, RJRB-300, RJRB-320, RJRB-420. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use

This document is a 510(k) premarket notification for a "Disposable Specimen Retrieval Bag" and does not describe an AI/ML medical device. Therefore, it does not contain information about acceptance criteria for an AI device, a study proving an AI device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is for a physical medical device and is primarily focused on demonstrating "Substantial Equivalence" to a previously marketed predicate device based on non-clinical performance and biocompatibility tests.

The device is a physical medical device, not an AI medical device. Therefore, the requested information regarding AI device acceptance criteria, studies, and related data is not applicable and not present in the provided text.

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