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510(k) Data Aggregation
(11 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
The SSD-3500 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
Here's an analysis of the provided information regarding the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. In a 510(k) submission for a device like this, the "acceptance criteria" are generally that the new device (Aloka SSD-3500 Ver. 7.8) demonstrates substantial equivalence to a previously cleared predicate device (Aloka SSD-3500 Ver. 7.0). This means the new device must have the same intended use, similar technological characteristics, and demonstrate similar safety and effectiveness.
Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria don't typically involve specific performance metrics like sensitivity or specificity in a diagnostic task, but rather confirmation that the device functions as intended and meets relevant safety standards.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Safety: | |
| - Conformance to applicable medical device safety standards (acoustic output, biocompatibility, cleaning & disinfection, electromagnetic compatibility, electrical, mechanical safety). | "The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards." Additionally, "The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance." |
| Effectiveness: | |
| - Same intended uses as the predicate device. | "It has the same... intended uses... as the predicate device." The system's intended uses are: Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications. (Ophthalmic applications are excluded). |
| - Similar technological characteristics and basic operating modes as the predicate device. | "The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate device." The device description mentions it is a "full feature imaging and analysis system" providing acquisition, processing, and display capability through a "computer type keyboard, specialized controls and a display." The specific operating modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined) are listed for each transducer and clinical application. |
| - No new questions of safety or effectiveness are raised compared to the predicate device. | "Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination. The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-3500 Ver. 7.8 Ultrasound System and its transducers are substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems." |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "2. Clinical Tests: None Required."
Therefore, there is no test set, sample size, or data provenance related to clinical performance testing for this submission. The device's substantial equivalence is based on technical specifications and comparison to a predicate device, not on new clinical performance data from a specific test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical tests were required, there was no test set and therefore no ground truth established by experts for performance evaluation in this submission.
4. Adjudication Method for the Test Set
As there was no clinical test set, no adjudication method was used for establishing 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
No MRMC comparative effectiveness study was conducted or required for this 510(k) submission. This device is a diagnostic ultrasound system, not an AI-powered diagnostic application that would typically undergo such a study to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was conducted. This device is a conventional diagnostic ultrasound system, not an artificial intelligence algorithm that would typically have a standalone performance evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
As mentioned above, no specific clinical ground truth was established for performance evaluation in this 510(k) submission because clinical testing was not required. The "ground truth" for the submission is the regulatory acceptance of its predicate device (Aloka SSD-3500 Ver. 7.0) and the demonstrated technical equivalence and adherence to safety standards.
8. The Sample Size for the Training Set
Since no AI/machine learning algorithm is part of this submission, there is no training set mentioned or used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning algorithm in this submission.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System meets its acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device, the Aloka SSD-3500 Ver. 7.0 (K060059).
The manufacturer (Aloka Co., Ltd.) provided documentation and analysis demonstrating that the new version is "technically comparable and substantially equivalent" to the predicate. This involved:
- Documentation of Shared Characteristics: Confirming that the Aloka SSD-3500 Ver. 7.8 has the "same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes" as the predicate device.
- Non-Clinical Testing: The device and its transducers underwent various non-clinical evaluations to confirm compliance with applicable medical device safety standards. These tests covered:
- Acoustic output
- Biocompatibility
- Cleaning & disinfection effectiveness
- Electromagnetic compatibility
- Electrical safety
- Mechanical safety
- Quality System Conformance: The manufacturer confirmed that their design, development, and quality processes align with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.
The FDA's review of this submission found that "the device is substantially equivalent... to legally marketed predicate devices," thus confirming it meets the regulatory acceptance criteria for market clearance. Clinical testing was not required because the device was demonstrating equivalence to an already approved device and no new questions of safety or effectiveness were raised.
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(10 days)
The device is intended for use by a qualified physician for ultrasound evaluation of the Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Transvaginal , Trans-rectal, Gynecological and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Transrectal, Transvaginal, Fetal, Abdominal, Gynecological, Cardiac, Peripheral Vascular, Small Organ, Intra-operative, Neonatal Cephalic.
The Prosound Alpha 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
This is a 510(k) premarket notification for the Aloka Prosound Alpha 6 Diagnostic Ultrasound System. It is focused on demonstrating substantial equivalence to a predicate device (Aloka SSD-4000 K040719), rather than establishing new performance criteria or efficacy through clinical trials. As such, the document does not contain the typical details of a study designed to prove a device meets specific acceptance criteria in the way an AI/CADe device approval would.
Here's an breakdown based on the provided text, highlighting the absence of information typically requested for AI/CADe approvals:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific performance metrics or acceptance criteria for the Aloka Prosound Alpha 6 in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be expected for a device proving novel diagnostic capabilities. Instead, the "acceptance criteria" are implied to be technical comparability and conformance to safety standards, and the "performance" is stated as being "substantially equivalent" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technical comparability to predicate device (Aloka SSD-4000 K040719) | "technically comparable and substantially equivalent" |
| Same technological characteristics as predicate device | "has the same technological characteristics" |
| Same key safety and effectiveness features as predicate device | "has the same key safety and effectiveness features" |
| Same intended uses and basic operating modes as predicate device | "has the same intended uses and basic operating modes" |
| Conformance with applicable medical device safety standards | "found to conform with applicable medical device safety standards" |
| Compliance with 21 CFR 820, ISO 9001:2000, ISO 13485 quality systems | "confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems" |
| Safe and effective performance (as per diagnostic ultrasound history) | "Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "None Required" for clinical tests for the purpose of demonstrating substantial equivalence. Therefore, there is no test set, sample size, or data provenance relevant to proving diagnostic performance against predefined acceptance criteria. Clinical practices, FDA guidelines, and established patient examination methods are cited as sufficient to confirm intended uses and features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set was used to assess diagnostic performance of the new device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the predicate device and the general understanding of diagnostic ultrasound.
4. Adjudication Method for the Test Set
As there was no clinical test set, there was no adjudication method employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission focuses on substantial equivalence based on technical specifications and established safety, not on improving human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Aloka Prosound Alpha 6 is a diagnostic ultrasound system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study was not applicable and not conducted. It's a medical imaging hardware and software system used by humans.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic accuracy for a new device's performance is not directly addressed. Instead, the ground truth for this 510(k) submission is the established safety and effectiveness record of the predicate device (Aloka SSD-4000) and general diagnostic ultrasound technology. The "truth" is that its technical characteristics and intended uses align with a device already cleared by the FDA, implying similar safety and effectiveness.
8. The Sample Size for the Training Set
The Aloka Prosound Alpha 6 is a traditional ultrasound system, not an AI/ML device that requires a training set in the computational sense. Therefore, there is no training set mentioned or applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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(71 days)
The Stryker Silverglide Bipolar Forceps Reusable Cable and Stryker Silverglide Bipolar Forceps Disposable Cable are intended to transfer electrosurgical power to bipolar forceps from an electrosurgical generator.
The Stryker Silverglide Bipolar Forceps Reusable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Reusable Cable is supplied non-sterile. It must be steam sterilized before use.
The Stryker Silverglide Bipolar Forceps Disposable Cable is an electrosurgical accessory designed to transfer electrosurgical power to bipolar forceps from an electrosurgical generator. The cable is designed to fit standard bipolar forceps and generator connectors. The Silverglide Surgical Bipolar Forceps Disposable Cables is supplied sterile, and is a single-patient use device.
Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the Stryker Silverglide Bipolar Forceps Cables:
This document is a 510(k) summary for a medical device. In the context of 510(k) submissions, the "acceptance criteria" and "study" are typically focused on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance metric against a predefined numerical acceptance criterion. The "study" largely consists of a comparison and justification of equivalence to existing devices.
Therefore, many of the requested fields related to a traditional performance study (e.g., sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, ground truth establishment for training sets) are not applicable in this type of submission. The focus is on design, materials, indications for use, and technological characteristics being sufficiently similar to a legally marketed predicate.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use: Must be the same or similar to predicate devices. | "The Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable have the same intended use as the Techno Instruments (Pvt) Ltd. Reusable Bipolar Forceps Cable and the Modern Medical Equipment Mfg. Ltd. Disposable Bipolar Forceps Cable." |
| Technological Characteristics: Must be sufficiently similar to predicate devices. | ". . . the same technological characteristics, the same operating principles and have similar performance characteristics." |
| Safety and Effectiveness: Must be deemed as safe and effective as predicate devices. | "Based upon the comparison to the predicate devices, the Stryker Silverglide Bipolar Forceps Reusable Cable and the Stryker Silverglide Bipolar Forceps Disposable Cable are substantially equivalent to legally marketed devices." |
Detailed breakdown of other requested information:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission seeking substantial equivalence based on comparison to predicate devices, not a clinical performance study with a test set of data. The "test" is an analytical comparison of device features and intended use.
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. No ground truth for a test set was established in the traditional sense. The "ground truth" for substantial equivalence is the regulatory status and characteristics of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or expert adjudication process as 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
- Not Applicable. This device is a cable for electrosurgical forceps, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (cable), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the established regulatory clearance and performance characteristics of the predicate devices. The new device's characteristics (intended use, technological characteristics, operating principles, and performance characteristics) are compared to these existing, legally marketed devices.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. Not an AI/ML device.
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