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The Fischer Cone Biopsy device is indicated for Large Loop Excision Of The Transformation Zone (LLETZ) in the diagnosis and treatment of some cervical intraepithelial neoplasias (CIN) and dysplasias.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device called the "Fischer Cone Biopsy Excisor." This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it.

The document does NOT contain the following information that you requested:

• A table of acceptance criteria and reported device performance. The FDA clearance letter does not detail the specific performance metrics or acceptance criteria used in the substantial equivalence determination. It focuses on regulatory compliance rather than detailed device efficacy or safety study results in this letter.
• Sample size used for the test set and data provenance. This information would typically be found in the device's 510(k) submission, not the clearance letter.
• Number of experts used to establish the ground truth and their qualifications. Again, this level of detail about study design is not in this document.
• Adjudication method.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with AI vs. without AI assistance. This device is a surgical excisor, not an AI-assisted diagnostic tool, so such a study would not be applicable.
• If a standalone performance (algorithm only) was done. Not applicable as it's not an algorithm.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text. The FDA letter only states that the device is "substantially equivalent" for its indicated uses to previously marketed devices.

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The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in nonurgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

The Apple Medical OB/Mobius® Elastic Retractor is a sterile disposable abdominal retractor consisting of two flexible plastic rings connected by a sleeve of soft, high yield strength, clear plastic film. The internal ring has a circular cross-section (o-ring) and the external ring has a cruciform cross-section (quad-ring). The inner diameter of the internal o-ring limits the radius of abdominal retraction. The diameter of the external quad-ring is the same as the diameter of the internal o-ring and the sleeve. When completely unwound, the height of the cylinder is 10.6 inches. When the quad ring is rolled down, the sleeve is wrapped around the circumference of the ring reducing the height of the sleeve by 1.5 inches per rotation. Because the sleeve film is radially unyielding, the reduction in height causes the radial retraction of the incision site.

The provided text describes a 510(k) summary for the Apple Medical OB/Mobius® Elastic Retractor. This is a medical device submission, not an AI/ML device, and therefore the information typically requested in an acceptance criteria and study description for AI/ML devices (like sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) is not applicable or present in this document.

The "Testing" section only states: "The Apple Medical OB/Mobius Elastic Retractor has been clinically evaluated for the cesarean section indication and shown to be substantially equivalent to the predicate mechanical abdominal retractors."

Given the information in the document, here's what can be extracted:

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

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner typical for performance metrics. Instead, the basis for approval is "substantial equivalence" to predicate devices. The performance is indirectly described by its intended use and successful clinical evaluation to achieve substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified, other than "clinically evaluated." It does not mention country of origin or whether it was retrospective or prospective.

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 as the device is a physical retractor, not an AI/ML diagnostic tool requiring expert ground truth establishment in the same way. The "clinical evaluation" would likely involve surgeons and medical staff, but specific numbers and qualifications for ground truth are not detailed.

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

• Not applicable/Not specified for this type of device and submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a physical surgical retractor, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a manual surgical instrument, always used with human involvement.

7. The type of ground truth used:

• Not explicitly defined in terms of "ground truth" as it would be for an AI model. The "clinical evaluation" would have assessed the device's performance against clinical outcomes and the performance of existing predicate devices.

8. The sample size for the training set:

• Not applicable/Not specified. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device.

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The Apple Medical OB Mobius Elastic Retractor is indicated for use to assist in laparotomy procedures. It is intended to provide incision retraction and to protect against wound contamination during open surgery.

The Apple Medical OB Mobius Elastic Retractor is used for laparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal o-ring is manually collapsed and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin. The radial force of the two rings act to retract the abdominal wall to the desired circular geometry.

The provided text is a 510(k) summary for the Apple Medical OB Mobius Elastic Retractor. It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical properties testing. However, it does not contain information typically found in acceptance criteria or a study proving the device meets said criteria for an AI/ML medical device.

The document states:

• "The Apple Medical OB Mobius Elastic Retractor has been shown to be substantially equivalent to the predicate Alexis™ device through mechanical properties testing."
• "The subject device has the same technological characteristics as the predicate devices. The only changes involve a change to the dimensions and labeling for the OB Mobius device. These changes do not affect the safety and effectiveness of the device."

This indicates a comparison to a predicate device, which is a common pathway for 510(k) clearance, rather than a detailed study with acceptance criteria and performance metrics as would be typical for an AI/ML device.

Therefore, many of the requested details about acceptance criteria, study design, and AI-specific metrics (like sample size for test/training sets, expert ground truth, MRMC studies) are not available in this document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not applicable/Not provided. This is a mechanical device, not an AI/ML device relying on "test sets" of data. The "testing" referred to is mechanical properties testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. This is a mechanical device and does not involve establishing ground truth from experts in the way an AI/ML device would.

4. Adjudication method for the test set

• Not applicable/Not provided. No "test set" or human adjudication is described for a mechanical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is a mechanical device, not an AI/ML device. MRMC studies are not relevant here.

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

• Not applicable/Not provided. This is a mechanical device, not an algorithm.

7. The type of ground truth used

• Not applicable. For this mechanical device, the "ground truth" for proving substantial equivalence relates to its physical and mechanical properties being comparable to the predicate device, not to diagnostic outcomes.

8. The sample size for the training set

• Not applicable/Not provided. This is a mechanical device, not an AI/ML device using a "training set."

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

• Not applicable/Not provided. This is a mechanical device, not an AI/ML device.

In summary, the provided document details the regulatory clearance of a physical medical device (an abdominal retractor) based on its substantial equivalence to a predicate device, supported by mechanical properties testing. It does not provide the kind of information requested for an AI/ML device's acceptance criteria and validation study.

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The Apple Medical Mobius Elastic Retractor is indicated for use to assist in minilaparotomy incision retraction and to protect against wound contamination during open surgery.

The Apple retractor is used for minilaparotomy procedures where a transverse suprapubic incision is made in the abdominal wall allowing access to the peritoneal cavity. Once the incision is made, the internal om and aboundar wan and inserted through the abdominal incision where it is allowed to spring open against the parietal peritoneum. The external quad-ring is then pulled upward placing the cylindrical sleeve in tension and the operator rolls the ring down the sleeve until the ring sits firmly against the skin (ref. Directions for Use). The radial force of the two rings place the sleeve material in tension and the sleeve now acts to retract the abdominal wall to the desired circular geometry. Both the proposed Apple device and the predicate Dexterity device function in an identical way to retract the abdomen. The difference in the two devices is in the ergonomical efficiency of deploying the two devices. The external quad-ring of the proposed Apple device was engineered to have more points around the 360 degree circumference for increased tactile manipulation ability (the predicate has two points in an "oblate spheroid" type of crosssection and the Apple device has four points in a truncated astroid, or "cruciform", cross-section). Further, the Apple device's external quad-ring is formed into a mobius strip during fabrication thus imparting a preset outward torque on the device. This "mobius" type of fabrication coupled with the four points for tactile feel, results in an external quad-ring which is easier to manipulate into the desired position than is the recircate device while still possessing an equivalent resistance to rollback as the predicate.

Here's an analysis of the provided text regarding the Apple Medical Mobius Elastic Retractor, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) Premarket Notification summary. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial data for novel devices. Therefore, the information related to detailed acceptance criteria, specific performance metrics, and rigorous study methodologies (like blinding, statistical power calculations, etc.) is less detailed than what might be found for a New Drug Application or a Class III medical device PMA.

Based on the document:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" in this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device (Dexterity Surgical, Inc.'s abdominal retractor, K954824) in terms of safety and effectiveness, particularly its mechanism of operation.

Study Details

The document describes several tests conducted to demonstrate equivalence:

Bench Testing:

2. Sample Size and Data Provenance: Not explicitly stated. The testing was performed by Intertek Testing Services (ITS), an independent entity.
3. Number of Experts and Qualifications: Not applicable for bench testing.
4. Adjudication Method: Not applicable for bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. Bench testing does not involve human readers.
6. Standalone Performance: Yes, the device's mechanical properties were evaluated independently and in comparison to the predicate.
7. Type of Ground Truth: Direct measurement and comparative assessment of mechanical properties and ease of use in a controlled laboratory setting.
8. Sample Size for Training Set: Not applicable for bench testing.
9. Ground Truth for Training Set: Not applicable for bench testing.

Animal Study (Porcine Model):

2. Sample Size and Data Provenance: Not explicitly stated for the animal study. The study was conducted by Dr. Marco Pelosi at Bu Piner Diedicelous (likely a misspelling/OCR error of a clinic or institution).
3. Number of Experts and Qualifications: Dr. Marco Pelosi is mentioned as independently finding the results. His specific qualifications are not detailed beyond "Dr."
4. Adjudication Method: Not explicitly stated, but implies the single expert's findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This was an in-vivo comparison study, likely observational or involving direct manipulation by the surgeon.
6. Standalone Performance: Yes, the device's operability and rollback resistance were evaluated in a living system.
7. Type of Ground Truth: Direct observation and assessment of the device's performance (operability, resistance to rollback) within the porcine model by a surgeon.
8. Sample Size for Training Set: Not applicable. This was an evaluation/test study.
9. Ground Truth for Training Set: Not applicable.

Survey (mentioned but not detailed):

The document mentions "survey" as a method used, but provides no details on its methodology, sample size, or findings. Without further information, it's impossible to describe the specifics of this "survey."

Summary of Approach:

The overall approach to demonstrating substantial equivalence for this Class II abdominal retractor relied on:

• Bench testing: To compare the physical and mechanical characteristics, including "ergonomical efficiency" (ease of deployment) and "resistance to rollback."
• Animal study (porcine model): To confirm operability and resistance to rollback in a biological context.
• Comparison to Predicate Device: The key was to show that the Apple Medical Mobius Elastic Retractor performs equivalently or superiorly to the legally marketed predicate device (K954824) for the specified indications for use. The differences in design (quad-ring, mobius strip fabrication) were presented as improvements in "ergonomical efficiency" without compromising key safety/performance parameters like rollback resistance.

The absence of detailed statistical results, blinding, or human reader effectiveness studies is typical for 510(k) submissions of this nature, especially for a Class II device that is demonstrating equivalence to a well-established technology.

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The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.

This 510(k) Premarket Notification for the Apple Medical Corp. Pneumo-Matic Insufflation Needle does not contain the information requested in your prompt.

The document describes a medical device (a Veress needle for insufflation) and its premarket notification to the FDA. It outlines the device's description, indications for use, and summaries of biocompatibility and safety and performance tests.

However, the prompt is geared towards evaluating a system that would typically involve an algorithm or AI, requiring metrics like sensitivity, specificity, or improvement in human reader performance. None of that information is present in this filing.

Specifically, the following points from your prompt cannot be addressed by the provided text:

1. Table of acceptance criteria and reported device performance: While there are lists of "tests performed," there are no specific numerical acceptance criteria or performance metrics reported that would be relevant to evaluating an AI or algorithm. For example, there's a "Needle Puncture Test" but no pass/fail criteria or results like "penetration achieved 99% of the time."
2. Sample size used for the test set and the data provenance: Not applicable; this is a physical medical device.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable; there is no AI or human reader involved in the performance of this physical device in the context described.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the AI/algorithm sense. The "ground truth" for these tests would be objective physical measurements or observations (e.g., did the spring obturator operate correctly), not expert consensus on an image or data.
8. Sample size for the training set: Not applicable; no AI or algorithm for this device.
9. How the ground truth for the training set was established: Not applicable.

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