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The TeleMed Systems PPD™ Balloon Dilatation Catheter is indicated for use in dillatation of gastrointestinal strictures of various etiologies (inflammatory, neoplastic, congenital, anastomotic) involving the esophagus, pylorus, biliary tract, sphincter of Oddi and colon.

The PPD Balloon Dilatation Catheter consists of a polymer balloon mounted on a plastic shaft. The balloon can be inflated to different diameters depending on the inflation pressure; each balloon is capable of inflation to three or four distinct and progressively larger sized diameters at the recommended pressures. Proximal luer connectors are provided for balloon inflation and quidewire passage.

Here's a breakdown of the acceptance criteria and study information based on the provided documents:

Acceptance Criteria and Device Performance

Study Details

The provided documents describe a Special 510(k): Device Modification submission for the TeleMed Systems PPD™ Balloon Dilatation Catheter. This type of submission generally relies on bench testing (laboratory studies) and comparison to predicate devices, rather than clinical trials with human participants, especially for Class II devices with established mechanisms of action.

Given this context, many of the typical elements of a clinical study (like sample size for test sets, ground truth establishment for AI, MRMC studies) are not applicable here.

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

   • Test Set Sample Size: Not explicitly stated in terms of a "test set" from a patient population, as this was primarily bench testing. The "sample size" would refer to the number of catheters tested in each bench test (e.g., how many balloons were burst, how many were tested for pressure-diameter). This information is not provided in the summary.
   • Data Provenance: The data provenance is from bench testing performed by TeleMed Systems, Inc. at their manufacturing site in Hudson, MA, USA. This is retrospective in the sense that the studies were performed on the device after its design, but not on patient data.

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

   • Not applicable. The "ground truth" for bench testing is derived from engineering specifications and established test methodologies (e.g., a balloon bursts or it doesn't; it inflates to a certain diameter at a given pressure or it doesn't). Expert consensus in a clinical sense is not relevant for this type of testing.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of patient data. For bench testing, results are typically objective measurements.

4. 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 medical device (catheter) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

   • Not applicable. This is a physical medical device, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for the performance testing (balloon burst, pressure vs. diameter, scope passage) would be engineering specifications and physical measurements demonstrating the device's ability to meet its design requirements and function safely as intended.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable. As above, no training set is involved.

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The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.

The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a Special 510(k) for a device modification, focusing on proving substantial equivalence to a predicate device rather than setting new performance acceptance criteria for a novel device. Therefore, explicit, quantifiable acceptance criteria with corresponding reported performance values like sensitivity, specificity, or accuracy are not present as they would be for an AI/ML diagnostic.

Instead, the "acceptance criteria" are implied to be adherence to design specifications and demonstration that the modified device is as safe and effective as the predicate device. The "reported device performance" is the successful completion of Design Verification and Validation (V&V) testing.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document refers to "Design Verification and Validation testing" but does not detail the number of units or data points used in this testing.
• Data Provenance: Not specified. Given the nature of a medical device modification (Occlusion Balloon Catheter), the V&V testing would likely involve bench testing, simulated use, and potentially pre-clinical animal studies, but the origin (e.g., country) of any data used is not mentioned. It is implicitly prospective testing as it's part of design validation for a new modification.

3. Number of Experts and Qualifications:

Not applicable. This is a medical device submission for an occlusion balloon catheter, which does not involve interpretation of medical images or data by human experts for ground truth establishment in the way AI/ML diagnostic devices do.

4. Adjudication Method:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. See point 3. This device is a physical medical instrument, not a diagnostic AI/ML algorithm.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. See point 3. This is not an algorithm but a physical device.

7. Type of Ground Truth Used:

The "ground truth" for this device is derived from engineering specifications, material properties, mechanical testing results, and functional performance benchmarks against the predicate device. For example, balloon inflation pressures, lumen patency, material strength, and sterilization efficacy would be assessed against predefined criteria. It is based on objective, measurable physical properties and functional outcomes rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the design and manufacturing process, where iterations and physical testing lead to the final design.

9. How Ground Truth for Training Set was Established:

Not applicable. As this is not an AI/ML device, there is no "training set." The design and manufacturing processes are guided by regulatory standards, engineering principles, internal quality management systems (e.g., 21 CFR 820.30 Design Control), and the performance characteristics of the predicate device. Ground truth for these processes is established through engineering design reviews, risk analysis, material specification, and rigorous physical testing of prototypes and production samples.

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The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.

The TeleMed Systems Flexible Endoscopic Scissors are reusable, metallic surgical scissors that may be passed through a gastrointestinal endoscope and used to incise tissue.

The provided text is a 510(k) summary for a medical device: "TeleMed Systems Flexible Endoscopic Scissors." This document is a premarket notification to the FDA, asserting substantial equivalence to existing devices.

The critical piece of information here, in the "Safety and Performance" section, explicitly states: "Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification."

This single sentence means that the submission did not include a study to prove the device meets acceptance criteria. Instead, it relied on comparing the design and characteristics of the new device to existing, legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document, because such studies were not performed or submitted as part of this particular 510(k) notification. The submission focused purely on demonstrating design equivalence to predicate devices.

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Cannulation of the biliary ductal system with infusion of contrast and sphincterotomy.

Three Lumen Papillotome/Sphincterotome

Here's an analysis of the provided text regarding acceptance criteria and a device study:

Important Note: The provided documents (FDA 510(k) K992402 letter and "Indications For Use" attachment) are for a Three Lumen Papillotome/Sphincterotome, which is a medical device, not an AI/software device. The questions you've asked (e.g., about AI assistance, standalone algorithm performance, training sets, expert consensus for ground truth) are highly specific to AI/software products.

Therefore, the information you're requesting, particularly points 1, 2, 3, 4, 5, 6, 7, 8, and 9 about detailed study design and acceptance criteria for an AI device, cannot be extracted from these documents. These documents confirm the device's substantial equivalence to a predicate device, which is a regulatory pathway for hardware medical devices, not a detailed performance study for an AI algorithm.

Based only on the provided documents, I can answer the following, while clarifying that AI-specific details are absent:

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

• Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission was the demonstration of substantial equivalence to legally marketed predicate devices. The documents do not detail specific performance metrics (like sensitivity, specificity, accuracy) or associated thresholds typically seen for AI devices.
• Reported Device Performance: The documents do not report specific performance metrics for the device itself (e.g., success rates, complication rates from a clinical study). The FDA statement focuses on the determination of substantial equivalence (i.e., that it's as safe and effective as existing devices), not on a quantitative performance report.

The following points (2-9) are not applicable or cannot be answered from the provided documents as they pertain to AI device studies, which is not what this 510(k) describes.

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

• Not Applicable: This information is not present in the 510(k) documents as it's not an AI device study requiring a "test set" in that context. The 510(k) likely relied on bench testing, biocompatibility data, and comparison to predicate device characteristics.

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 relates to AI/diagnostic imaging ground truth establishment, which is not relevant to this mechanical device submission.

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

• Not Applicable: This is for AI/diagnostic studies for resolving discrepancies in ground truth.

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 specific to AI-assisted reading studies.

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

• Not Applicable: There is no algorithm for this mechanical device.

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

• Not Applicable: Ground truth as described is not relevant to a 510(k) submission for a mechanical device. The "truth" in this context is its safe and effective deployment based on its design and comparison to existing products.

8. The sample size for the training set

• Not Applicable: This refers to AI model training, which is not involved here.

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

• Not Applicable: This refers to AI model training, which is not involved here.

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For Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract.

Not Found

The provided documents are a 510(k) clearance letter and an Indications For Use statement for "Hot Biopsy Forceps, Models 1592, 1594, 1596 and 1598." These documents do not contain any information regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The 510(k) clearance process by the FDA is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving performance against specific acceptance criteria through clinical studies in the same way a Premarket Approval (PMA) would.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
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 relevant to this device; this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant to this device; this is not an AI algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not relevant to this device; this is not an AI algorithm.
9. How the ground truth for the training set was established: Not relevant to this device; this is not an AI algorithm.

The documents indicate that the device is "Hot Biopsy Forceps" for "Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract." The clearance is based on substantial equivalence to a predicate device, as opposed to de novo pre-market clinical study data demonstrating specific performance metrics.

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The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs

Reusable Biopsy Forceps

I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for the "TeleMed Systems Reusable Biopsy Forceps." The document is an FDA 510(k) clearance letter dated January 21, 1998, which states that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not include any performance data or study design specifics.

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The Tele Med Systems, INC. Retrieval Basket is for use with The Endoscopic Gate I track.

Retrieval Basket

The provided text is an FDA 510(k) clearance letter for the "TeleMed System Retrieval Basket" from 1997. This type of document, especially from this era, primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria for a novel AI/ML device.

Therefore, the information required to populate the fields regarding acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and sample sizes for training and testing is not available in the provided text.

The clearance letter confirms that the device is substantially equivalent to legally marketed devices based on its indications for use, and it mentions compliance with Current Good Manufacturing Practice (GMP) requirements. However, it does not describe specific performance metrics or the studies used to validate them in the way a modern AI/ML device submission would.

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